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The Lead

POZEN’s YOSPRALA™ Receives Second Complete Response Letter from the FDA

December 18, 2014 | Comments

POZEN said that their investigational drug candidates YOSPRALA™ 81/40 and 325/40 have received a second complete response letter from the FDA, with wording identical to the first.            


Biothera Joins Cancer Research UK Combinations Alliance

December 18, 2014 11:36 am | Comments

Biothera has joined AstraZeneca, Astex Pharmaceuticals, Eli Lilly and Company, MedImmune and Verastem as the latest pharmaceutical partner in Cancer Research UK's Combinations Alliance.           


Tetraphase Soars After Releasing Clinical Trial Results

December 18, 2014 11:08 am | by The Associated Press | Comments

The Watertown, Massachusetts, company said eravacycline proved to be not inferior to a competing drug, ertapenem, and patients taking it had no serious, drug-related side effects, according to early results from the study.     


Pfizer Reports Top-Line Results from a Phase III Pain Study

December 18, 2014 10:08 am | Comments

Pfizer has announced top-line results from a double-blind Phase III study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherapeutic neuralgia (pain after shingles or PHN).        


Colorado Funds Medical Marijuana Research

December 18, 2014 9:44 am | by KRISTEN WYATT, Associated Press | Comments

The grants awarded by the Colorado Board of Health will go to studies on whether marijuana helps treat epilepsy, brain tumors, Parkinson's disease and post-traumatic stress disorder. Some of the studies still need federal approval.   


Experts: It Was A Busy, Black-Eye Year for Disease Control

December 18, 2014 9:32 am | by MIKE STOBBE, AP Medical Writer | Comments

Health officials are celebrating some important victories in 2014, and Time magazine even named Ebola fighters the persons of the year. Nevertheless, this was a black-eye year for public health.          


European Commission Approves Lynparza™ for Advanced BRCA-Mutated Ovarian cancer

December 18, 2014 9:04 am | Comments

AstraZeneca today announced that the European Commission has granted Marketing Authorization for Lynparza™ capsules as the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cance.


Supplement Maker Lied About Ingredients

December 18, 2014 8:47 am | Comments

Federal prosecutors say the owner and president of a dietary supplement company has admitted his role in the sale of diluted and adulterated dietary ingredients and supplements sold by his company.               


Painkillers Lawsuit Against NFL Dismissed

December 18, 2014 8:40 am | Comments

A federal judge dismissed a lawsuit by 1,300 former players against the NFL, writing that the collective bargaining agreement between the league and the union was the appropriate forum to resolve claims that teams damaged the players' by routinely dispensing painkillers.


U.S. Incentive Program May Alter the Challenging Economics of Ebola Vaccines

December 18, 2014 8:09 am | by Helen Branswell, The Canadian Press | Comments

Earlier this week, President Barack Obama signed into law a little piece of legislation that may significantly change the economics of making drugs or vaccines to protect against Ebola and other viruses in its deadly family.     


Merck Acquires OncoEthix for $110M

December 18, 2014 8:05 am | Comments

Merck has acquired, through a subsidiary, OncoEthix, a Swiss-based privately held biotechnology company specializing in oncology drug development. Through the acquisition, Merck has gained an investigational, novel oral BET inhibitor, OTX015, which is currently in Phase 1b studies for the treatment of hematological malignancies and advanced solid tumors.


Alcon's Xtoro Approved to Treat Swimmer’s Ear

December 17, 2014 4:17 pm | Comments

The FDA has approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal.


United Therapeutics Announces Executive Promotions and CEO Compensation Change

December 17, 2014 3:11 pm | Comments

United Therapeutics Corporation has announced two senior executive promotions as well as changes to Martine Rothblatt, Ph.D's compensation program.                 


Study: Removing Clot Helps Limit Stroke Disability

December 17, 2014 2:54 pm | by MARILYNN MARCHIONE, AP Chief Medical Writer | Comments

Researchers in the Netherlands found that mechanically removing a clot in addition to using a clot-busting medicine lowered the risk that a stroke sufferer would end up severely disabled.           


Fourteen Charged for Roles in Meningitis Outbreak

December 17, 2014 12:04 pm | by DENISE LAVOIE, Associated Press | Comments

Fourteen owners or employees of a Massachusetts pharmacy were charged Wednesday in connection with a 2012 meningitis outbreak that killed 64 people nationwide and was traced to tainted drug injections.        


FDA Accepts Apotex’ Filing of its Biosimilar Application for Pegfilgrastim

December 17, 2014 11:24 am | Comments

Apotex has announced that the FDA has accepted for filing the company's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta. The product has been jointly developed with Intas Pharmaceuticals.  The application was filed under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA).



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