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

Health Highlights: May 25, 2016

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Family of Baseball's Tony Gwynn Sues Tobacco Industry The family of deceased baseball Hall of Famer Tony Gwynn is suing the tobacco industry. Gwynn died of salivary gland cancer in 2014. In a wrongful-death lawsuit filed Monday in Superior Court in San Diego, his family accuses Altria Group Inc. and several other...

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Hepatitis C Patients More Likely to Drink, Study Finds

Posted today in Medical

WEDNESDAY, May 25, 2016 -- People infected with hepatitis C are more likely to be current or former heavy drinkers, a new study suggests. Unfortunately, alcohol may accelerate the liver damage associated with the virus, the researchers added. Adults with hepatitis C were three times more likely to have five or more drinks daily -- currently or in the past -- than people who didn't have the virus, according to the...

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'Fat Shaming' Begins in First Grade

Posted today in Medical

WEDNESDAY, May 25, 2016 -- As early as first grade, severely obese children are getting teased, picked on and bullied more than normal-weight kids, a new study finds. The new research also found that these severely obese youngsters are more likely to be depressed and withdrawn. Obese children may turn to eating to cope with the pain of rejection or skip school to avoid being bullied, the researchers said. "The...

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What Doctors Aren't Telling Obese, Young Adults

Posted today in Medical

WEDNESDAY, May 25, 2016 -- Many obese young adults in the United States don't know they're at increased risk for kidney disease, researchers report. "Even though chronic kidney disease typically manifests in older people, the disease can start much earlier but often is not recognized early on," said study leader Dr. Michal Melamed, an associate professor of medicine at Albert Einstein College of Medicine, in New...

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Predeployment Riskiest Time for Military Suicide Attempts

Posted today in Medical

WEDNESDAY, May 25, 2016 -- Suicide attempts in the military aren't necessarily combat-driven. At the height of the wars in Iraq and Afghanistan, the U.S. Army soldiers most likely to try to kill themselves were never deployed, new research shows. Moreover, risk was greatest just two months into service, according to the study of more than 163,000 soldiers. But the findings aren't a sign that going to war protects...

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Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%

Posted yesterday in New Drug Applications

DUBLIN, May 24, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Allergan expects the Prescription...

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IDegLira Receives Positive 16-0 Vote in Favour of Approval from FDA Advisory Committee

Posted yesterday in New Drug Applications

Bagsværd, Denmark, 24 May 2016 - Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. IDegLira is a once-daily, single injection fixed combination of insulin degludec (Tresiba®) and liraglutide (Victoza®) for the treatment of ad...

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Merck Announces FDA Accepts Samsung Bioepis’ BLA for SB2 (infliximab), an Investigational Biosimilar of Remicade

Posted 2 days ago in New Drug Applications

KENILWORTH, N.J., May 23, 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 a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade. This BLA is the first application filed in the United States by Samsung B...

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Acorda to Discontinue Development of Plumiaz for Treatment of Epilepsy Seizure Clusters

Posted 4 days ago in New Drug Applications

ARDSLEY, N.Y., May 20, 2016 --(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it will discontinue development of Plumiaz (diazepam) Nasal Spray, an investigational therapy being studied for the treatment of seizure clusters in people with epilepsy. Data from the ongoing clinical trials do not demonstrate its bioequivalence to Diastat® rectal gel, needed to re-file the New Drug ...

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FDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma

Posted 6 days ago in New Drug Approvals

May 18, 2016 -- The U.S. Food and Drug Administration today approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat this type of cancer. "Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway," said Richard Pazdur, M.D., director of the Office of...

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Opdivo (nivolumab) FDA Approved for the Treatment of Hodgkin Lymphoma

Posted 7 days ago in New Drug Approvals

PRINCETON, N.J., May 17, 2016 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.1 This accelerated...

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FDA Approves Lenvima (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma

Posted 12 days ago in New Drug Approvals

WOODCLIFF LAKE, N.J., May 13, 2016 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Lenvima (lenvatinib), the company's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy. This approval was based on the...

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Biofrontera Announces U.S. FDA Approval of Ameluz and Activating BF-RhodoLED Device for Treatment of Actinic Keratosis

Posted 13 days ago in New Drug Approvals

Leverkusen, Germany, May 11, 2016 – Biofrontera AG (FSE: B8F), the specialist for the treatment of sun-induced skin cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of its combination topical prescription drug Ameluz (BF-200 ALA) and medical device BF-RhodoLED® for photodynamic therapy (PDT) treatment of mild to moderate actinic keratosis (AK) on the face and scalp. The ap...

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Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin)

Posted 2 weeks ago in New Drug Approvals

DUBLIN, IRELAND -- (Marketwired) -- 05/09/16 -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for Vibativ (telavancin) to expand the product's label to include data describing the treatment of patients with concurrent Staphylococcus aureus (S....

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FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

Posted 2 weeks ago in Pharma Industry News

May 5, 2016 -- Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use...

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FDA reminds health care professionals not to use drug products intended to be sterile from Medaus

Posted 2 weeks ago in Pharma Industry News

May 5, 2016 -- The U.S. Food and Drug Administration is reminding health care professionals and patients not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The FDA has issued a formal request to the Birmingham, Alabama, compounding pharmacy to recall all non-expired lots of drug products intended to be sterile. Administration of a non-sterile drug...

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Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz

Posted 2 weeks ago in New Drug Applications

CORALVILLE, Iowa, May 05, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) reviewed and voted on Apadaz...

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FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults

Posted 3 weeks ago in Pharma Industry News

May 2, 2016 -- The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults ages 18-24. Of the more than 2 million LGBT young adults in the U.S., more than 800,000 smoke occasionally. The “This Free Life” campaign is designed to specifically reach the occasional or ...

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Monthly News Roundup - April 2016

Posted 3 weeks ago 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 3 weeks 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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IL-23 Inhibitor Risankizumab Induces Remission in Phase II Study in Patients with Moderate-to-Severe Crohn's Disease

Posted yesterday in Clinical Trials

INGELHEIM, Germany, and NORTH CHICAGO, Ill., May 24, 2016 /PRNewswire/ -- Results were presented today from a proof-of-concept, Phase II, randomized, placebo-controlled study (NCT02031276) in Crohn's disease with investigational biologic, risankizumab (formerly BI 655066), a compound from Boehringer Ingelheim research and recently licensed by AbbVie (NYSE: ABBV). Risankizumab was shown to be more effective than...

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Celator Pharmaceuticals Announces Vyxeos Granted Breakthrough Therapy Designation

Posted 6 days ago in Clinical Trials

EWING, N.J., May 19, 2016 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Vyxeos (also known as CPX-351). Vyxeos is an investigational product in development as a treatment for AML and other blood cancers. The Breakthrough Therapy designation is primarily based upon the positive...

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AstraZeneca announces positive results from benralizumab phase III programme in severe asthma

Posted 7 days ago in Clinical Trials

May 17, 2016 -- AstraZeneca today announced that benralizumab, a potential new medicine and anti-eosinophil monoclonal antibody, was well tolerated and achieved the primary endpoint in two pivotal Phase III registrational trials (SIROCCO and CALIMA), demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo. Sean Bohen, Executive Vice President, Global Medicines Development...

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Selumetinib granted Orphan Drug Designation in the US for adjuvant treatment of differentiated thyroid cancer

Posted 7 days ago in Clinical Trials

May 12, 2016 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). DTC is diagnosed in approximately 60,000 people in the US each year,1 and radioactive iodine (RAI) is recommended for...

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Poliovirus Therapy Wins 'Breakthrough' Status

Posted 9 days ago in Clinical Trials

May 16, 2016 -- In a poignant, two-part segment May 15, CBS’s 60 Minutes returned to Duke to update viewers on the poliovirus therapy developed and tested by researchers at the Preston Robert Tisch Brain Tumor Center. Anchor Scott Pelley again led the reporting of the program, which spanned more than two years. It provides major updates to the news magazine’s initial two-part segment, “Killing Cancer,” which aired...

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