Celcuity Announces Closing of Initial Public Offering

MINNEAPOLIS–()–Celcuity Inc. (“Celcuity”) (NASDAQ: CELC), a functional cellular
analysis company that is discovering new cancer subtypes and
commercializing diagnostic tests designed to significantly improve
clinical outcomes of cancer patients treated with targeted therapies,
announced today the closing of its initial public offering. The closing
included an additional 360,000 shares sold to the underwriter pursuant
to their option to purchase additional shares to cover over-allotments.
The total number of shares sold was 2,760,000 and the total gross
proceeds of the offering were $26,220,000. All of the shares were sold
by Celcuity. Celcuity’s common stock began trading on September 20, 2017
on the NASDAQ Capital Market under the symbol “CELC.”

Celcuity expects to use the net proceeds from the offering to support
research and development activities, clinical trials, development of
operational processes and capital expenditures, and for working capital
and other general corporate purposes.

Craig-Hallum Capital Group LLC acted as the sole managing underwriter
for the initial public offering.

A registration statement relating to these securities has been filed
with and was declared effective by the U.S. Securities and Exchange
Commission (“SEC”) on September 19, 2017. This press release shall not
constitute an offer to sell or a solicitation of an offer to buy these
securities, nor shall there be any sale of these securities in any state
or jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the securities
laws of any such state or jurisdiction.

The offering was made only by means of a prospectus. A copy of the final
prospectus related to the offering may be obtained from Craig-Hallum
Capital Group LLC at 222 South Ninth Street, Suite 350, Minneapolis,
Minnesota 55402, Attention: Equity Capital Markets, by telephone at
612-334-6300, or by e-mail at prospectus@chlm.com.

buy Pregabalin cheap uk About Celcuity

We are a cellular analysis company that is discovering new cancer
sub-types and commercializing diagnostic tests designed to significantly
improve the clinical outcomes of cancer patients treated with targeted
therapies. Our proprietary CELx diagnostic platform uses a patient’s
living tumor cells to identify the specific abnormal cellular activity
driving a patient’s cancer and the targeted therapy that can best treat
that patient’s disease.

buy Tastyliaonline no prescription Forward-Looking Statements

This press release contains statements that constitute “forward-looking
statements,” including the anticipated use of the net proceeds. No
assurance can be given that the net proceeds of the offering will be
used as indicated. Forward-looking statements are subject to numerous
conditions, many of which are beyond the control of Celcuity, including
those set forth in the Risk Factors section of Celcuity’s registration
statement and prospectus for Celcuity’s offering filed with the SEC.
Copies are available on the SEC’s website, www.sec.gov.
Celcuity undertakes no obligation to update these statements for
revisions or changes after the date of this release, except as required
by law.

Sage Therapeutics to Participate in Leerink Investor Conference

CAMBRIDGE, Mass.–()–Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical
company developing novel medicines to treat life-altering central
nervous system (CNS) disorders, today announced that the Company will
participate in the Leerink Partners Rare Disease Roundtable on
Wednesday, September 27, 2017, with a presentation at 2:00 p.m. ET in
New York, NY.

A live webcast of the presentation can be accessed on the investor page
of Sage’s website at investor.sagerx.com.
A replay of the webcast will also be archived for up to 30 days on
Sage’s website following the conference.

About Sage Therapeutics

Sage Therapeutics is a clinical-stage biopharmaceutical company
committed to developing novel medicines to transform the lives of
patients with life-altering central nervous system (CNS) disorders. Sage
has a portfolio of novel product candidates targeting critical CNS
receptor systems, GABA and NMDA. Sage’s lead program, brexanolone
(SAGE-547), is in Phase 3 clinical development for postpartum
depression. Sage is developing its next generation modulators, including
SAGE-217 and SAGE-718, in various CNS disorders. For more information,
please visit www.sagerx.com.

Enzo Biochem Schedules Teleconference to Discuss Fourth Quarter 2017 Results Thursday September 28, 2017 at 8:30 AM E.T.

NEW YORK–()–Enzo
Biochem, Inc.
(NYSE:ENZ) will hold a conference call to discuss
fiscal 2017 fourth quarter results Thursday, September 28, 2017, at 8:30
AM E.T.

To listen to the conference call dial 1-888-459-5609. International
callers can dial 1-973-321-1024. When prompted, use PIN number 83042522.
Dial in approximately ten minutes prior to the scheduled teleconference
time. A rebroadcast of the call will be available starting approximately
two hours after the conference call ends, through midnight (E.T.)
Wednesday October 4, 2017. The replay of the conference call can be
accessed by dialing 1-800-585-8367 (International callers can dial
1-404-537-3406) and, when prompted, use the same PIN number 83042522.

Enzo’s conference call can also be accessed live over the Internet at: https://tinyurl.com/yafy94jl.

To listen to the live call, individuals should go to the web site at
least 15 minutes early to register, download and install any necessary
audio software. Any pop up blocker installed on your PC should be
disabled while accessing the webcast.

A press release announcing fourth quarter results will be distributed,
Wednesday, September 27, 2017 after the market closes.

About
Enzo Biochem

Enzo Biochem is a pioneer in molecular diagnostics, leading the
convergence of clinical laboratories, life sciences and intellectual
property through the development of unique diagnostic platform
technologies that provide numerous advantages over previous standards. A
global company, Enzo Biochem utilizes cross-functional teams to develop
and deploy products, systems and services that meet the ever-changing
and rapidly growing needs of health care today and into the future.
Underpinning Enzo Biochem’s products and technologies is a broad and
deep intellectual property portfolio, with patent coverage across a
number of key enabling technologies.

Except for historical information, the matters discussed in this news
release may be considered “forward-looking” statements within the
meaning of Section 27A of the Securities Act of 1933, as amended and
Section 21E of the Securities Exchange Act of 1934, as amended. Such
statements include declarations regarding the intent, belief or current
expectations of the Company and its management, including those related
to cash flow, gross margins, revenues, and expenses which are dependent
on a number of factors outside of the control of the Company including,
inter alia, the markets for the Company’s products and services, costs
of goods and services, other expenses, government regulations,
litigation, and general business conditions. See Risk Factors in the
Company’s Form 10-K for the fiscal year ended July 31, 2016. Investors
are cautioned that any such forward-looking statements are not
guarantees of future performance and involve a number of risks and
uncertainties that could materially affect actual results. The Company
disclaims any obligations to update any forward-looking statement as a
result of developments occurring after the date of this press release.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1 (CPS Greater Than or Equal to 1)

KENILWORTH, N.J.–()–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1
(programmed death receptor-1) therapy, for the treatment of patients
with recurrent locally advanced or metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an
FDA-approved test, with disease progression on or after two or more
prior lines of therapy including fluoropyrimidine- and
platinum-containing chemotherapy and if appropriate, HER2/neu-targeted
therapy. This indication is approved under the FDA’s accelerated
approval regulations based on tumor response rate and durability of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory
trials.

“Historically, advanced gastric cancer has been particularly challenging
to treat, and new treatment options are needed for these patients,” said
Charles S. Fuchs, M.D., MPH, lead investigator and director of Yale
Cancer Center. “The results observed in the diverse population of
heavily pretreated advanced gastric or GEJ patients from the KEYNOTE-059
clinical trial demonstrate that pembrolizumab in the third-line setting
has the potential to shift how we care for certain patients facing this
difficult-to-treat disease.”

Immune-mediated adverse reactions occurred with KEYTRUDA including
pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin
adverse reactions. Based on the severity of the adverse reaction,
KEYTRUDA (pembrolizumab) should be withheld or discontinued and
corticosteroids administered if appropriate. KEYTRUDA can also cause
severe or life-threatening infusion-related reactions. Monitor patients
for signs and symptoms of infusion-related reactions; for Grade 3 or 4
reactions, stop infusion and permanently discontinue KEYTRUDA. Based on
its mechanism of action, KEYTRUDA can cause fetal harm when administered
to a pregnant woman. Female patients of reproductive potential should be
advised of the potential hazard to a fetus. For more information
regarding immune-mediated and infusion-related adverse reactions and use
in pregnancy, see “Selected Important Safety Information” below.

“KEYTRUDA is now the first PD-1 checkpoint inhibitor approved in the
United States for previously treated advanced gastric or GEJ cancer,
helping to address a recognized treatment gap,” said Dr. Roger M.
Perlmutter, president, Merck Research Laboratories. “This approval marks
another milestone – the tenth new indication for KEYTRUDA in just three
years – which further demonstrates both our commitment to patients and
the progress we have made in the fight against many cancers.”

Data Supporting the Approval

The accelerated approval for KEYTRUDA was based on data from a global,
multicenter, non-randomized, open-label multi-cohort trial, KEYNOTE-059,
that enrolled 259 patients with gastric or GEJ adenocarcinoma who
progressed on at least two prior systemic treatments for advanced
disease. Previous treatment must have included a fluoropyrimidine and
platinum doublet; HER2/neu-positive patients must have previously
received treatment with approved HER2/neu-targeted therapy. Patients
with active autoimmune disease or a medical condition that required
immunosuppression or with clinical evidence of ascites by physical exam
were ineligible. Patients received KEYTRUDA at a dose of 200 mg every
three weeks until unacceptable toxicity or disease progression that was
symptomatic, rapidly progressive, required urgent intervention, occurred
with a decline in performance status, or was confirmed at least four
weeks later with repeat imaging. Patients without disease progression
were treated for up to 24 months. Assessment of tumor status was
performed every six to nine weeks. The major efficacy outcome measures
were objective response rate (ORR) according to the Response Evaluation
Criteria In Solid Tumors (RECIST) 1.1, as assessed by independent
central review, and duration of response.

Among the 259 patients, 55 percent (n=143) had tumors that expressed
PD-L1 with a CPS ≥1 and microsatellite stable (MSS) tumor status or
undetermined microsatellite instability (MSI) or mismatch repair (MMR)
status. The baseline characteristics of these 143 patients were: median
age 64 years (47% age 65 or older); 77 percent male; 82 percent White,
11 percent Asian; and ECOG performance status (PS) of 0 (43%) and 1
(57%). Eighty-five percent had M1 disease and seven percent had M0
disease. Fifty-one percent had two and 49 percent had three or more
prior lines of therapy in the recurrent or metastatic setting.

For the 143 patients, the ORR was 13.3 percent (95% CI: 8.2, 20.0) –
with a complete response rate of 1.4 percent and a partial response rate
of 11.9 percent. Among the 19 responding patients, the duration of
response ranged from 2.8+ to 19.4+ months, with 11 patients (58%) having
responses of six months or longer and five patients (26%) having
responses of 12 months or longer.

Among the 259 patients, 7 (3%) had tumors that were determined to be
MSI-High. An objective response was observed in 4 patients, including 1
complete response. The duration of response ranged from 5.3+ to 14.1+
months.

Adverse reactions occurring in patients with gastric cancer were similar
to those occurring in patients with melanoma or non-small cell lung
cancer (NSCLC). The most common adverse reactions for KEYTRUDA
(pembrolizumab) (reported in ≥20% of patients) were fatigue,
musculoskeletal pain, decreased appetite, pruritis, diarrhea, nausea,
rash, pyrexia, cough, dyspnea, and constipation.

About KEYTRUDA® (pembrolizumab) Injection
100mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of
the body’s immune system to help detect and fight tumor cells. KEYTRUDA
is a humanized monoclonal antibody that blocks the interaction between
PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes
which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research
program, which currently involves more than 550 trials studying KEYTRUDA
across a wide variety of cancers and treatment settings. The KEYTRUDA
clinical program seeks to understand the role of KEYTRUDA across cancers
and the factors that may predict a patient’s likelihood of benefitting
from treatment with KEYTRUDA, including exploring several different
biomarkers.

KEYTRUDA (pembrolizumab) Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or
metastatic melanoma at a fixed dose of 200 mg every three weeks until
disease progression or unacceptable toxicity.

Lung Cancer

KEYTRUDA, as a single agent, is indicated for the first-line treatment
of patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as
determined by an FDA-approved test, with no EGFR or ALK genomic tumor
aberrations.

KEYTRUDA (pembrolizumab), as a single agent, is also indicated for the
treatment of patients with metastatic NSCLC whose tumors express PD-L1
(TPS ≥1%) as determined by an FDA-approved test, with disease
progression on or after platinum-containing chemotherapy. Patients with
EGFR or ALK genomic tumor aberrations should have disease progression on
FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated
for the first-line treatment of patients with metastatic nonsquamous
NSCLC. This indication is approved under accelerated approval based on
tumor response rate and progression-free survival. Continued approval
for this indication may be contingent upon verification and description
of clinical benefit in the confirmatory trials.

In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg
every three weeks until disease progression, unacceptable toxicity, or
up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA
should be administered prior to chemotherapy when given on the same day.
See also the Prescribing Information for pemetrexed and carboplatin.

Head and Neck Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or
metastatic head and neck squamous cell carcinoma (HNSCC) with disease
progression on or after platinum-containing chemotherapy. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA is
administered at a fixed dose of 200 mg every three weeks until disease
progression, unacceptable toxicity, or up to 24 months in patients
without disease progression.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients
with refractory classical Hodgkin lymphoma (cHL), or who have relapsed
after three or more prior lines of therapy. This indication is approved
under accelerated approval based on tumor response rate and durability
of response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials. In adults with cHL, KEYTRUDA is administered at a
fixed dose of 200 mg every three weeks until disease progression or
unacceptable toxicity, or up to 24 months in patients without disease
progression. In pediatric patients with cHL, KEYTRUDA (pembrolizumab) is
administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every
three weeks until disease progression or unacceptable toxicity, or up to
24 months in patients without disease progression.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who are not eligible for
cisplatin-containing chemotherapy. This indication is approved under
accelerated approval based on tumor response rate and duration of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory
trials.

KEYTRUDA is also indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who have disease progression
during or following platinum-containing chemotherapy or within 12 months
of neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy.

In locally advanced or metastatic urothelial carcinoma, KEYTRUDA is
administered at a fixed dose of 200 mg every three weeks until disease
progression or unacceptable toxicity, or up to 24 months in patients
without disease progression.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients
with unresectable or metastatic microsatellite instability-high (MSI-H)
or mismatch repair deficient (dMMR)

  • solid tumors that have progressed following prior treatment and who
    have no satisfactory alternative treatment options, or
  • colorectal cancer that has progressed following treatment with
    fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. The safety and
effectiveness of KEYTRUDA in pediatric patients with MSI-H central
nervous system cancers have not been established.

In adult patients with MSI-H cancer, KEYTRUDA is administered at a fixed
dose of 200 mg every three weeks until disease progression, unacceptable
toxicity, or up to 24 months in patients without disease progression. In
children with MSI-H cancer, KEYTRUDA is administered at a dose of 2
mg/kg (up to a maximum of 200 mg) every three weeks until disease
progression or unacceptable toxicity, or up to 24 months in patients
without disease progression.

Gastric Cancer

KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with
recurrent locally advanced or metastatic gastric or gastroesophageal
junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined
Positive Score (CPS) ≥1] as determined by an FDA-approved test, with
disease progression on or after two or more prior lines of therapy
including fluoropyrimidine- and platinum-containing chemotherapy and if
appropriate, HER2/neu-targeted therapy. This indication is approved
under accelerated approval based on tumor response rate and durability
of response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials. The recommended dose of KEYTRUDA is 200 mg every
three weeks until disease progression, unacceptable toxicity, or up to
24 months in patients without disease progression.

Selected Important Safety Information for KEYTRUDA® (pembrolizumab)

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases.
Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving KEYTRUDA,
including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%)
pneumonitis, and occurred more frequently in patients with a history of
prior thoracic radiation (6.9%) compared to those without (2.9%).
Monitor patients for signs and symptoms of pneumonitis. Evaluate
suspected pneumonitis with radiographic imaging. Administer
corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA
for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or
recurrent Grade 2 pneumonitis.

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 48
(1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.4%), 3
(1.1%), and 4 (<0.1%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 19
(0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3
(0.4%), and 4 (<0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17 (0.6%) of
2799 patients receiving KEYTRUDA, including Grade 2 (0.2%), 3 (0.3%),
and 4 (<0.1%) hypophysitis. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA (pembrolizumab) for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.

KEYTRUDA can cause thyroid disorders, including hyperthyroidism,
hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96 (3.4%)
of 2799 patients receiving KEYTRUDA, including Grade 2 (0.8%) and 3
(0.1%) hyperthyroidism. Hypothyroidism occurred in 237 (8.5%) of 2799
patients receiving KEYTRUDA, including Grade 2 (6.2%) and 3 (0.1%)
hypothyroidism. Thyroiditis occurred in 16 (0.6%) of 2799 patients
receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis. Monitor
patients for changes in thyroid function (at the start of treatment,
periodically during treatment, and as indicated based on clinical
evaluation) and for clinical signs and symptoms of thyroid disorders.
Administer replacement hormones for hypothyroidism and manage
hyperthyroidism with thionamides and beta-blockers as appropriate.
Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism.

KEYTRUDA can cause type 1 diabetes mellitus, including diabetic
ketoacidosis, which have been reported in 6 (0.2%) of 2799 patients.
Monitor patients for hyperglycemia or other signs and symptoms of
diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA
and administer antihyperglycemics in patients with severe hyperglycemia.

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 9
(0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3
(0.1%), and 4 (<0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic
epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative
dermatitis, and bullous pemphigoid can occur. Monitor patients for
suspected severe skin reactions and based on the severity of the adverse
reaction, withhold or permanently discontinue KEYTRUDA and administer
corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA
and refer the patient for specialized care for assessment and treatment.
If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

KEYTRUDA can cause other clinically important immune-mediated adverse
reactions. These immune-mediated reactions may occur in any organ
system. For suspected immune-mediated adverse reactions, ensure adequate
evaluation to confirm etiology or exclude other causes. Based on the
severity of the adverse reaction, withhold KEYTRUDA and administer
corticosteroids. Upon improvement to Grade 1 or less, initiate
corticosteroid taper and continue to taper over at least 1 month. Based
on limited data from clinical studies in patients whose immune-related
adverse reactions could not be controlled with corticosteroid use,
administration of other systemic immunosuppressants can be considered.
Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less
following corticosteroid taper. Permanently discontinue KEYTRUDA
(pembrolizumab) for any Grade 3 immune-mediated adverse reaction that
recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions
occurred in less than 1% (unless otherwise indicated) of 2799 patients:
arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia
gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures
arising in a patient with inflammatory foci in brain parenchyma. In
addition, myelitis and myocarditis were reported in other clinical
trials, including classical Hodgkin lymphoma, and postmarketing use.

Solid organ transplant rejection has been reported in postmarketing use
of KEYTRUDA. Treatment with KEYTRUDA may increase the risk of rejection
in solid organ transplant recipients. Consider the benefit of treatment
with KEYTRUDA vs the risk of possible organ rejection in these patients.

KEYTRUDA can cause severe or life-threatening infusion-related
reactions, including hypersensitivity and anaphylaxis, which have been
reported in 6 (0.2%) of 2799 patients. Monitor patients for signs and
symptoms of infusion-related reactions, including rigors, chills,
wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever.
For Grade 3 or 4 reactions, stop infusion and permanently discontinue
KEYTRUDA.

Immune-mediated complications, including fatal events, occurred in
patients who underwent allogeneic hematopoietic stem cell
transplantation (HSCT) after being treated with KEYTRUDA. Of 23 patients
with cHL who proceeded to allogeneic HSCT after treatment with KEYTRUDA
on any trial, 6 patients (26%) developed graft-versus-host-disease
(GVHD), one of which was fatal, and 2 patients (9%) developed severe
hepatic veno-occlusive disease (VOD) after reduced-intensity
conditioning, one of which was fatal. Cases of fatal hyperacute GVHD
after allogeneic HSCT have also been reported in patients with lymphoma
who received a PD-1 receptor–blocking antibody before transplantation.
These complications may occur despite intervening therapy between PD-1
blockade and allogeneic HSCT. Follow patients closely for early evidence
of transplant-related complications such as hyperacute GVHD, severe
(Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic
VOD, and other immune-mediated adverse reactions, and intervene promptly.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when
administered to a pregnant woman. If used during pregnancy, or if the
patient becomes pregnant during treatment, apprise the patient of the
potential hazard to a fetus. Advise females of reproductive potential to
use highly effective contraception during treatment and for 4 months
after the last dose of KEYTRUDA.

Adverse reactions occurring in patients with gastric cancer were similar
to those occurring in patients with melanoma or non-small cell lung
cancer (NSCLC). The most common adverse reactions for KEYTRUDA
(pembrolizumab) (reported in ≥20% of patients) were fatigue,
musculoskeletal pain, decreased appetite, pruritis, diarrhea, nausea,
rash, pyrexia, cough, dyspnea, and constipation.

It is not known whether KEYTRUDA is excreted in human milk. Because many
drugs are excreted in human milk, instruct women to discontinue nursing
during treatment with KEYTRUDA and for 4 months after the final dose.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology
medicines to help people with cancer worldwide. At Merck, helping people
fight cancer is our passion and supporting accessibility to our cancer
medicines is our commitment. Our focus is on pursuing research in
immuno-oncology and we are accelerating every step in the journey – from
lab to clinic – to potentially bring new hope to people with cancer.

As part of our focus on cancer, Merck is committed to exploring the
potential of immuno-oncology with one of the fastest-growing development
programs in the industry. We are currently executing an expansive
research program evaluating our anti-PD-1 therapy across more than 30
tumor types. We also continue to strengthen our immuno-oncology
portfolio through strategic acquisitions and are prioritizing the
development of several promising immunotherapeutic candidates with the
potential to improve the treatment of advanced cancers.

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About the Merck Access Program for KEYTRUDA

At Merck, we are committed to supporting accessibility to our cancer
medicines. Merck provides multiple programs to help ensure that
appropriate patients who are prescribed KEYTRUDA have access to our
anti-PD-1 therapy. The Merck Access Program provides reimbursement
support for patients receiving KEYTRUDA, including information to help
with out-of-pocket costs and co-pay assistance for eligible patients.
Merck also offers free product through our patient assistance program to
eligible patients, primarily the uninsured, who, without our assistance,
could not afford their medicine. More information is available by
calling 855-257-3932 or visiting www.merckaccessprogram-keytruda.com.

About Merck’s Patient Support Program for KEYTRUDA

Merck is committed to helping provide patients and their caregivers
support throughout their treatment with KEYTRUDA. The KEY+YOU Patient
Support Program provides a range of resources and services. For further
information and to sign up, patients and physicians may call 85-KEYTRUDA
(855-398-7832) or visit www.keytruda.com.

About Merck

For more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. Through our prescription
medicines, vaccines, biologic therapies and animal health products, we
work with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to health care through far-reaching policies, programs
and partnerships. Today, Merck continues to be at the forefront of
research to advance the prevention and treatment of diseases that
threaten people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease
and infectious diseases including HIV and Ebola. For more information,
visit www.merck.com
and connect with us on TwitterFacebookInstagram,
YouTube
and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing difficulties
or delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of the company’s patents
and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause results
to differ materially from those described in the forward-looking
statements can be found in the company’s 2016 Annual Report on Form 10-K
and the company’s other filings with the Securities and Exchange
Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and
Patient
Information/Medication Guide for KEYTRUDA at 
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.

BioAlberta Recognizes Alberta Innovators and Entrepreneurs at 2017 AGM and Awards Gala

EDMONTON, Alberta–()–BioAlberta, in conjunction with TEC Edmonton, hosted the Health and Life
Sciences Showcase, and BioAlberta hosted its 18th
annual Awards Gala in Edmonton. Throughout the day, over 250
representatives from industry, educational institutions and government
took part in the event. The Awards Gala recognized leaders within
Alberta’s life sciences industry for their innovation and achievements.
BioAlberta would like to congratulate the following BioAlberta Industry
Award winners for inspiring new ways of thinking and for their
contributions to the industry:

Botaneco Inc. is the recipient of the Company of the Year
Award.
This award, accepted by President and CEO James Szarko, is
presented to a company that has shown significant achievement within the
marketplace and Alberta’s business community through strong performance
or a leadership role. Botaneco, a Calgary-based company, developed a
unique patented oilseed processing platform technology, based around
novel separation and purification techniques, enabling the recovery of
high-quality proteins and oleosomes. These unique purified extracts –
Hydresia ® Oleosomes, Karmyn™ protein and CapSol™ – are then used to
improve the natural authenticity and performance of personal care
products. For more information, go to: www.botaneco.com.

Mr. Cristian Scurtescu is the recipient of the Scientific
Achievement and Innovation Award
. This award recognizes an
individual or a team responsible for a breakthrough innovation with
commercial application. Cristian is the founder, president and CEO of
SmileSonica Inc., an Edmonton-based company focused on the research,
development, manufacturing, and commercialization of medical devices for
dental and health care applications. Mr. Scurtescu and his team
developed a flagship product called the Aevo System™ medical device,
which is approved for sale in Canada, Europe and Australia. The Aevo
System™ enhances the physiological processes associated with orthodontic
treatment. For more information, go to: www.smilesonica.com.

“It is important that we recognize and acknowledge, not only innovative
thinking and leadership within the industry, but also the incremental
achievements that our members have accomplished. We are very pleased to
be honouring these exceptional award recipients who exemplify the
excellence in Alberta’s life sciences industry,” said Mel Wong,
President and CEO of BioAlberta. “To achieve our vision of building a
thriving and globally competitive industry, and fueling and accelerating
the economic diversification of Alberta’s economy, it is important that
BioAlberta creates awareness of the achievements of our member
companies.”

About BioAlberta

BioAlberta is the leading voice and champion for the life sciences in
Alberta. The Association’s vision is to create a thriving and
competitive life sciences industry to facilitate and accelerate economic
diversification, investment attraction and job growth in Alberta.
BioAlberta is a private, not-for-profit industry association,
representing more than 160 members of Alberta’s steadily growing life
sciences industry of researchers, producers and suppliers in the
province. These members operate in specialized sectors, such as
pharmaceuticals, medical devices, natural health products, as well as
environmental, agricultural and industrial biotechnology. BioAlberta’s
activities are focused on advocacy, promotion and proactively
facilitating the growth of Alberta’s life sciences industry. For more
information, go to: www.bioalberta.com.

FDAnews Announces: Early Bird Pricing Ends Sept. 29 for Drug Quality…

Drug Quality Risk Management

Past News Releases

RSS

Drug Quality Risk Management:

Beyond FMEA — Developing a Comprehensive Risk Toolkit

**Presented by FDAnews and Valsource Learning Solutions **

Oct. 26-27, 2017 – Arlington, VA

http://www.fdanews.com/drugriskmanagement

Early bird pricing for Drug Quality Risk Management ends on Friday, Sept. 29.

The types and severity of risk drug manufacturers must manage continues to increase. First, there is the struggle to consistently apply quality risk management principles to drug development, manufacturing, distribution, and inspection and submissions review processes.

Plus, an effective risk management program requires multiple levels of management buy in, innovative managers that are trained appropriately, a comprehensive strategic plan, and consistent execution. That’s a lot to manage so it’s no surprise drug manufacturers, like everyone else managing risk, continue to struggle.

Many drug manufacturers rely on FMEA, sometimes called the “Swiss Army knife” of risk management, as a useful tool to manage risk, but experts say that’s not enough. The complexity of most situations requires a set of tools to manage risk.

FDAnews and world class risk management expert Jim Vesper are proud to present Drug Quality Risk Management: Beyond FMEA – Developing a Comprehensive Risk Toolkit.

At this two-day workshop attendees will learn how to create a drug quality risk management strategy, and how to build a roadmap to get their companies to apply risk management principles.

But this isn’t some theoretical discussion, highlighted with dull PowerPoint slides.

A series of interactive exercises and case studies to walk attendees through real-world examples, and give them the tools needed to apply principles right away.

Exercises and case studies include:

  •     Two-minute talk — Exchange ideas with colleagues about how they define risk.
  •     Ranking risk —Attendees will be given a list of risks and asked to rank them in order of probably causes of death. This will gauge the perception of risk versus peers.
  •     Real world hazard identification — Work with a smaller group to consider product characteristics and the potential sources of harm, then relate them back to actual situations and share the findings with the group.
  •     Risk estimation activity — Groups will establish a risk question to identify a specific hard, use a scale and find the probability and severity of its impact.
  •     Probability case study — Using a real world case study, attendees will learn how to detail the results of a risk evaluation and report on the level of probability.
  •     Mini-presentation of risk assessment conclusions — Review and evaluate a case study in mock risk management teams to correctly document and communicate all risk assessment conclusions and share the results.

This is event is focused on real-life examples, to provide attendees with the skills needed to apply risk management principles back at the office. Early bird pricing ends on Friday, Sept. 29.

The exercises will be led by Jim Vesper, Senior Director at Valsource Learning Solutions, who designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. Since 1991, he has been creating innovative instructional training products for drug companies, creating integrated curricula for personnel and customized training courses targeted to specific needs. Jim has 29 years of experience in the pharmaceutical industry, including 11 years at Eli Lilly and Company where he worked in Corporate Quality Assurance. He was responsible for issues concerning the manufacture and testing of parenteral products made by Eli Lilly facilities and third parties worldwide. His last assignment was as Project Leader of GMP education and Instruction, establishing the department and its mission.

Who Will Benefit:

  •     Auditors
  •     QA/QC personnel
  •     R&D management
  •     Compliance officers
  •     Executive management
  •     Laboratory management
  •     Risk management specialists
  •     Regulatory/legislative professionals
  •     Manufacturing directors and supervisors
  •     Validation specialists, scientists

Conference Details:

Drug Quality Risk Management:

Beyond FMEA — Developing a Comprehensive Risk Toolkit

**Presented by FDAnews and Valsource Learning Solutions **

Oct. 26-27, 2017 – Arlington, VA

http://www.fdanews.com/drugriskmanagement

Tuition:

Early Bird (until Sept. 29): $1,597

Regular Price: $1,797

Significant team discounts are available.

Easy Ways to Register:

Online: http://www.fdanews.com/drugriskmanagement

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

Share article on social media or email:

Media Advisory to Attend Rally in Albert Lea, MN

SOH Supporters with Mayo Brothers Statue in Rochester, MN

MEDIA OPPORTUNITY:

Save Our Hospital – Albert Lea will host media (photo and video) at its rally to interview citizens on why they are rallying against Mayo Clinic. Specifically, media can talk to steering committee members and patients regarding their stories and commitment to this effort against Dr. Noseworthy’s (CEO) decision to close the Albert Lea hospital.

The rally aims to protect the most vulnerable and very sick who will no longer have access to intensive care services. Everyone from the Governor of Minnesota, Attorney General of Minnesota, citizens, and the AARP have asked Mayo to delay its decision and communicate with citizens. Dr. Noseworthy has ignored all pleas and betrayed every core value established by the Mayo Brothers.

WHO:    

-Ask Albert Lea Citizens/Patients about impact of Mayo’s decision on them.

-Interview Save Our Hospital Steering Committee on next steps.

-Interview elected officials on why they are supporting effort.

-Video and photograph protesters of Mayo Clinic leadership’s decision to close hospital.

WHEN:

Saturday, September 30, 2017 at 1:00 p.m. – 3:00 p.m.

WHERE:        

Albert Lea Central Park

315 Water Street

Albert Lea, MN 56007

Please follow us on Facebook at: ALBERT LEA – SAVE OUR HOSPITAL where you can learn all about why citizens are rising up against a corporation that is now putting profits before patients. SOH is a grassroots group of citizens from Albert Lea and surrounding communities who share a commitment to keeping a full-service, acute care hospital in Albert Lea (population 18,000 with a service area of 55,000+). We are endorsed by the Albert Lea City Council, Freeborn County Commissioners, Albert Lea School Board, Albert Lea Economic Development Agency, and AARP. Email: sohinalbertlea@gmail.com.

Logistics Contact: Angie Hanson, 507-438-6250, AngieLynnHanson@gmail.com

Share article on social media or email:

Skin Medication Matrix Targets Venous Leg Ulcer Healing in New USA…

The company, Factor Therapeutics Limited (ASX:FTT), previously ran a 53-patient trial where one-third of the ulcers healed in 12 weeks, with another half reducing in size by at least 70 per cent.

The effectiveness of a new wound healing skin medication for venous leg ulcers is now being assessed in clinical trials in the United States. (clinicaltrials.gov : NCT02973893)

To find out more about this clinical trial please talk to your nurse or physician or find your nearest participating clinic here https://factor-therapeutics.com/clinical-trials/ and discuss your condition with one of the medical team.

The new treatment, VF001-DP, is a synthetic skin medication that attaches to the base of the ulcer and creates a microscopic scaffold matrix which encourages the body’s skin cells to move into the wound and regrow skin layers.

Venous ulcers account for 70%–90% of ulcers found on the lower leg, and cost the health system $3.5 billion each year.

Up to one-third of all patients with venous ulcers have recurring wounds, some up to four or more times.

Most sufferers are over 40 years old and are cared for in more than 1,000 out-patient wound care centers in the United States.

The clinical trial, VF00102, is open to 168 people over the age of 18 with non-healing venous ulcers who meet the eligibility criteria – these include:

1. a small ulcer (approx. size of a Dime) that has been there for more than 6 months; or

2. a larger one that has been there for less than 6 months

The company, Factor Therapeutics Limited (ASX:FTT), previously ran a 53-patient trial where one-third of the ulcers healed in 12 weeks, with another half reducing in size by at least 70 per cent.

Participants will have a two-week screening period, then randomised patients will be treated weekly for 12 weeks, with a 12-week follow-up period. All patients enrolled in the study will also receive high quality standard care as part of the trial.

To find out more about this clinical trial please talk to your nurse or physician or find your nearest participating clinic here https://factor-therapeutics.com/clinical-trials/ and discuss your condition with one of the medical team.

Qualified participants will receive all trial related care and financial compensation for time and travel. No insurance is required.

Share article on social media or email:

Head-Aid® Products Available Now on RonnieColemanNutrition.com

“Our products were created to fill a void in the marketplace for easy-to-use, affordable, effective, natural products to meet the need of the headache sufferer,” Kinder said.

All-natural and fast-acting Head-Aid® brand migraine, headache and post-concussion relief dietary supplements are available to order now on health and wellness website RonnieColemanNutrition.com.

The Head-Aid® line has three different options of effervescent drink mix formulas available on RonnieColemanNutrition.com: the Head-Aid® Daily Mixed Berry flavor, the Fast Acting Day Lemon Ginger flavor and the Fast Acting Night Chamomile Ginger flavor.

“Our objective is to help the headache sufferer with products to address their symptoms free from side-effects,” Head-Aid® CEO Thomas Kinder said. “Our products are clinically supported using clinically studied ingredients, and they are of course all-natural with no MSG, no dyes or nitrates, and no wheat or gluten.”

Many conventional pharmaceutical solutions for migraine headaches have the potential to cause damage to the digestive tract, and can cause heart attacks or strokes. They also are often opiate-based, making them highly addictive. Head-Aid® is an all-natural, effective supplement to help rid yourself of migraines and headaches safely, and without the side effects.

Head-Aid® went through a series of clinical trials during its development, including analysis of how it performed against a placebo. Physicians also have begun recommending the supplement for use by menopausal women, who are more prone to get migraines due to waning estrogen levels.

Head-Aid® supplements contain magnesium to stabilize blood vessels, reduce headache frequency and intensity, and reduce light/audio sensitivity. The Daily Mixed Berry flavor also contains CoQ10, which helps reduce the frequency and severity of migraines, and Melatonin, a sleep-aid and anti-inflammatory the body produces naturally.

The Day formula contains caffeine, which improves headache relief and enhances wakefulness, while the Night formula contains the sleep aid 5-HTP, which also elevates mood; peppermint, which combats severe nausea, and Chamomile; a sleep aid and anti-inflammatory.

“Our products were created to fill a void in the marketplace for easy-to-use, affordable, effective, natural products to meet the need of the headache sufferer,” Kinder said, “and we’re happy to be live on eight-time Mr. Olympia Ronnie Coleman’s health and wellness site.”

For more information on Head-Aid® products, visit http://www.headaid.net.

Share article on social media or email:

Happy Living Presents a Night of Theatre, Wines & Books

The Greener The Grass starring Scott Barry

It’s like watching a beautiful, magnificent sports car as it crashes into a brick wall, leaving only a mangled heap of steel. You almost can’t look, but you also can’t look away!”

Happy Living’s mission – to improve the health and wellbeing of the world, one person at a time – carries it into the entertaining and delicious worlds of theatre and wines.

After watching Scott Barry perform on stage last year, Matt Gersper (founder of Happy Living) convinced him to turn his play into a book. The Greener The Grass (https://www.happyliving.com/books/the-greener-the-grass) was published on March 15, 2017. Now, the two men (both University of California, Davis alumni) are collaborating again to bring the book back to the stage. Happy Living proudly presents The Greener The Grass, a monologue delving into Scott’s pursuit of fame in professional sports, combined with elements of poetry, spoken-word and live music (courtesy of bassist Ed Ivey), at the intimate Geery Theater in Midtown, Sacramento on Friday, September 29. Mr. Gersper says, “It’s like watching a beautiful, magnificent sports car as it crashes into a brick wall, leaving only a mangled heap of steel. You almost can’t look, but you also can’t look away!”

The San Francisco Bay Times called the show “Funny and poignant. A brilliant Joycean reverie,” the San Francisco Bay Guardian, “Engrossing. A beautifully written and constructed jazz riff,” and the San Jose Mercury News, “Hilarious.”

A ticket price of $20 includes the tasting of the best organic, lab-tested, healthy wines available on earth. “Dry Farm Wines will be serving our guests before and after the performance,” Matt says, and then continues, “You just won’t believe how delicious these wines are.” Guests will also receive a signed copy of Scotts book.

Get your tickets here: http://buytickets.bpt.me/

About Happy Living

Happy Living is on a mission to improve the health and wellbeing of the world, one person at a time. We write to inspire others to take action on their own ideas and to believe that a better self is always possible – today, every day and for the rest of their lives. The Seven Foundations of Health guide our blog, books and talks and is our framework for creating a more meaningful, successful, and happy life. Matt Gersper and a handpicked team of Happy Living Experts practice Happy Living every day and collect ideas to share with you along the way. New members receive a book and inspiring five-minute-to-read blog posts, rousing mini one-man Blog Theatre™ shows, and other special promotions. All these exclusive offers are to help others create a more meaningful, successful, and happy life… delivered right to their inbox once a week. Join us at http://www.HappyLiving.com.

Follow us:

https://twitter.com/veryhappyliving

https://www.facebook.com/veryhappyliving

Share article on social media or email: