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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: April 29, 2016

Posted 2 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: First Commercial Zika Test Approved by FDA The first commercial test to diagnose Zika virus was approved Thursday by the U.S. Food and Drug Administration. The test from Quest Diagnostics uses the same method that government labs use to check for Zika virus in a person's blood, NBC News reported. Currently, it can...

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More U.S. Kids Have Chronic Health Problems: Study

Posted yesterday in Medical

SATURDAY, April 30, 2016 -- The number of American kids suffering from asthma and attention deficit hyperactivity disorder (ADHD) is on the increase, with poor children being hit the hardest, researchers report. Children living in extreme poverty who had asthma and ADHD were nearly twice as likely to have at least one other chronic medical condition. These conditions included developmental delays, autism,...

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Study Suggests Aerial Pesticide Spraying Tied to Higher Autism Rates

Posted yesterday in Medical

SATURDAY, April 30, 2016 -- Children living in an area of New York state that uses aerial pesticides to control mosquitoes have a higher rate of autism than children in neighboring areas, a new study finds. Researchers found that children living in a swampy region in central New York were 25 percent more likely to have been diagnosed with autism or general developmental delay, compared to children in other parts of...

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Bullying Can Turn Victims Into Bullies

Posted yesterday in Medical

SATURDAY, April 30, 2016 -- A combination of face-to-face taunting and cyberbullying may greatly increase the risk that victims will become bullies themselves, a new study suggests. "Students who are victimized are more likely to exhibit aggressive behaviors towards others," said study principal investigator Alexandra Hua, from Cohen Children's Medical Center of New York. "This phenomenon may lead to a vicious...

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Autism Diagnosed at Younger Ages

Posted yesterday in Medical

SATURDAY, April 30, 2016 -- Children are being diagnosed with autism at younger ages since the American Academy of Pediatrics (AAP) made changes to their diagnosis guidelines in 2007, a new study says. The AAP guidelines now advise doctors to screen all children for autism during well-child visits when children are 18 months and 24 months old. By screening all children, those who have the condition can receive...

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Monthly News Roundup - April 2016

Posted yesterday in Pharma Industry News

First-Time Generic Approved for Statin Crestor High cholesterol, high low-density lipoprotein (LDL) or “bad cholesterol”, and triglycerides increase the risk for serious heart disease and may lead to heart attacks and strokes. The FDA has now approved the first generic version for Crestor, known by the generic name of rosuvastatin. Rosuvastatin was approved for three uses: high triglycerides in addition to diet; p...

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FDA Approves First Generic Crestor

Posted 2 days ago in Pharma Industry News

April 29, 2016 -- The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses: in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults; in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper...

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Teva Announces FDA Approval of ProAir RespiClick (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11

Posted 2 days ago in New Drug Approvals

JERUSALEM--(BUSINESS WIRE)--Apr. 29, 2016-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm...

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FDA Approves Nuplazid (pimavanserin) for Parkinson’s Disease Psychosis

Posted 2 days ago in New Drug Approvals

April 29, 2016 -- The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson’s disease at some time during the course of their illness. People who experience t...

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Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties

Posted 5 days ago in New Drug Approvals

CANTON, Mass., April 26, 2016 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that the U.S. Food and Drug Administration (FDA) approved Xtampza ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are...

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Exelixis Announces FDA Approval of Cabometyx (cabozantinib) for Patients with Advanced Renal Cell Carcinoma

Posted 5 days ago in New Drug Approvals

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr. 25, 2016-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved Cabometyx (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. Cabometyx, which was granted Fast Track...

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Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy

Posted 6 days ago in New Drug Applications

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 25, 2016-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-based therapeutics, today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review the new drug application (NDA) for eteplirsen as a treatment for Duchenne muscular dystrophy amenable to exon 51 skipping. The a...

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Bevespi Aerosphere Approved by the FDA for Patients with COPD

Posted 6 days ago in New Drug Approvals

25 April 2016 -- AstraZeneca today announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Sean Bohen, Executive Vice-President, Global Medicines...

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FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

Posted 9 days ago in Pharma Industry News

April 22, 2016 - The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling. The FDA takes the act of banning a device only on rare occasions when it is necessary to...

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FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens

Posted 12 days ago in Pharma Industry News

April 19, 2016 -- The U.S. Food and Drug Administration announced today it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highl...

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FDA approves folic acid fortification of corn masa flour

Posted 2 weeks ago in Pharma Industry News

April 14, 2016 -- The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains. Folic acid, a synthetic form of folate, is a B vitamin that when taken by a pregnant woman may help prevent neural...

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Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet

Posted 2 weeks ago in New Drug Applications

KENILWORTH, N.J., April 12, 2016 -– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-8237, Merck’s house dust mite sublingual allergy immunotherapy (SLIT) tablet. The BLA for Merck's investigational house dust mite SLIT-tablet is supported by a comprehensive c...

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FDA Accepts Remoxy NDA for Review

Posted 2 weeks ago in New Drug Applications

AUSTIN, Texas, April 12, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that the U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) resubmission for Remoxy, an abuse-deterrent formulation of extended-release oxycodone (CII) capsules, is sufficiently complete to permit a substantive review. September 25, 2016 is the target action date under the...

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Clovis Oncology Provides Update on FDA Oncologic Drugs Advisory Committee Meeting to Review Rociletinib

Posted 2 weeks ago in New Drug Applications

BOULDER, Colo.--(BUSINESS WIRE)--Apr. 12, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss approval of the New Drug Application (NDA) for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who...

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FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva (obeticholic acid) for the Treatment of Primary Biliary Cirrhosis

Posted 3 weeks ago in New Drug Applications

NEW YORK, April 07, 2016 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of...

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Agenus Commences Phase 1 Clinical Trial of its CTLA-4 Checkpoint Antibody to Treat Solid Tumors

Posted 4 days ago in Clinical Trials

LEXINGTON, Mass., April 27, 2016 --(BUSINESS WIRE)--Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing checkpoint antibodies and cancer vaccines, today announced that the first patient has been dosed in the company’s Phase 1 clinical trial of AGEN1884, an anti-CTLA-4 checkpoint (CPM) antibody. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the s...

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Ohr Pharmaceutical, Inc. Announces Enrollment of First Patient in Phase III Wet AMD Clinical Program

Posted 13 days ago in Clinical Trials

NEW YORK, April 18, 2016 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (NASDAQ:OHRP), a clinical-stage biotechnology company developing novel therapies for ophthalmic diseases, today announced that the first patient has been enrolled in the first Phase III clinical trial of its lead drug candidate squalamine lactate ophthalmic solution, 0.2% (“Squalamine”, also known as OHR-102), for the treatment of neovascular age...

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Acucela Announces End of Treatment Period in Phase 2b/3 Clinical Trial of Emixustat Hydrochloride

Posted 13 days ago in Clinical Trials

SEATTLE (April 18, 2016) — Acucela Inc. (Tokyo: 4589) (“Acucela”), a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, announced today the completion of the treatment period in the ongoing Phase 2b/3 clinical trial, the S.E.A.T.T.L.E. study, of the investigational visual cycle modulator emi...

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Ignyta Announces Updated Data from Entrectinib Phase 1 Clinical Trials at the 2016 AACR Annual Meeting

Posted 2 weeks ago in Clinical Trials

SAN DIEGO, April 17, 2016 --(BUSINESS WIRE)-- Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, today announced that updated results of its Phase 1 clinical trials of entrectinib, the company's proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK, were presented in an oral plenary session at the 2016 Annual...

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ARIAD Presents Updated Phase 1/2 Clinical Data on Brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer

Posted 2 weeks ago in Clinical Trials

GENEVA & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 15, 2016-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data on its investigational tyrosine kinase inhibitor, brigatinib, in patients with advanced malignancies, including anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC), from an ongoing Phase 1/2 trial. This report includes updated data on the...

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