FDA

AMAG Pharmaceuticals acquires Lumara Health's Maternal Health Business

Wednesday, July 1, 2015 10:20 AM

AMAG Pharmaceuticals, a Massachusetts-based specialty pharmaceutical company, has completed the acquisition of Lumara Health, a St. Louis, Mo.-based specialty pharmaceutical company with a particular focus on maternal health. The transaction was announced on September 29, 2014 and included upfront consideration of $600 million in cash and 3,209,971 shares of AMAG common stock, and additional contingent consideration of up to $350 million based on the achievement of sales milestones. 

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PharmaEngine receives FDA Priority Review, EMA MMA acceptance for MM-398

Monday, June 29, 2015 10:16 AM

PharmaEngine has announced that its license partner, Merrimack Pharmaceuticals, has received FDA acceptance and Priority Review designation for their NDA and its sublicense partner, Baxalta, a wholly owned subsidiary of Baxter International, has received Market Authorization Application (MAA) from the EMA, of MM-398 (irinotecan liposome injection, also known as nal-IRI) in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

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FORUM Pharmaceuticals receives FDA Fast Track for schizophrenia

Thursday, June 25, 2015 12:12 PM

The FDA has granted Fast Track designation to encenicline, FORUM Pharmaceuticals’ lead compound in development to treat cognitive impairment in schizophrenia. Encenicline is a novel alpha 7 agonist in phase III development by FORUM to treat cognitive impairment in schizophrenia and Alzheimer's disease. The company recently completed patient enrollment in its pivotal phase III COGNITIV SZ clinical trial program investigating the use of encenicline as a pro-cognitive therapy in patients with schizophrenia who are currently being treated with atypical antipsychotics.

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HHS announces innovation award winners

Thursday, June 25, 2015 12:05 PM

Department of Health and Human Services Secretary Sylvia M. Burwell has announced the seven winners of the 2015 HHS Innovates Awards. This annual award program, in its eighth round, recognizes creative solutions developed by HHS employees in response to some of the nation’s most challenging problems in health, health care and government. Winners this year reflected a number of collaborative innovation projects representing seven different operating divisions.

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DBV Technologies planning Viaskin Peanut global phase III trial in children

Thursday, June 25, 2015 11:11 AM

DBV Technologies, a clinical-stage specialty biopharmaceutical company, has announced the completion of its End-of-Phase II meeting with the FDA. The outcome of this meeting on the clinical development plan for Viaskin Peanut is consistent with the previously announced positive opinion of the Pediatric Committee of the EMA on Viaskin Peanut’s Pediatric Investigation Plan (PIP).

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Pfizer enrolls first patient in phase III sickle cell disease trial

Thursday, June 25, 2015 10:54 AM

Pfizer has announced that the first patient has been enrolled in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study—a phase III clinical trial assessing the efficacy and safety of rivipansel for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease who are 6 years of age or older.

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ASBM responds to Australia’s breaks with other regulators on biosimilar substitution

Wednesday, June 24, 2015 10:20 AM

The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.

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FDA, TransCelerate, INC Research to speak at 10th Annual Global Site Solutions Summit

Wednesday, June 24, 2015 10:11 AM

The Society for Clinical Research Sites (SCRS), a global trade organization representing the interests of clinical research sites, has announced an invigorated, solution-driven program for the 10th Annual Global Site Solutions Summit. The Summit will be Oct. 8-11, in Amelia Island, Fla. The annual meeting, which attracts investigators, site executives and industry executives from around the globe, is inclusive of interactive sessions, knowledge and best practice sharing, and networking opportunities, centered around the collaboration-focused theme “Better Together.”

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Eli Lilly partners with Dana-Farber Cancer Institute, Sarah Cannon Research Institute

Monday, June 22, 2015 10:38 AM

Eli Lilly has inked two separate deals, one with the Dana-Farber Cancer Institute to research new medicines under development to fight cancer, and the second with the Sarah Cannon Research Institute (SCRI) to co-develop an investigational oncology compound, LY3023414, a PI3K/mTOR dual inhibitor.

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Allergan to acquire Kythera Biopharmaceuticals

Monday, June 22, 2015 10:15 AM

Allergan, a global pharmaceutical company, has agreed to acquire Kythera Biopharmaceuticals, a Westlake Village, Calif.-based biopharmaceutical company, in a cash and equity transaction valued at $75 per Kythera share, or approximately $2.1 billion, subject to the fulfillment of certain customary conditions.

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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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