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The biggest winners--and losers--in the 2015 race for new drug approvals Let's start with the good news.

CommentsJohn Carroll2016-01-05 17:13 Read   292

In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs.

FDA 2015: A Look Back (and Ahead) – Part 1: Medical Product Innovation

RegulatorStephen M. Ostroff, M.D.2016-01-04 09:59 Read   164

As the year draws to a close, I want to reflect on FDA’s many accomplishments in these previous 12 months, the last nine of which it has been my pleasure to serve as Acting Commissioner.

Chimerix shares crash as antiviral flops and deaths spike in first PhIII challenge

TrendChimerix2015-12-29 14:03 Read   206

 High hopes for Chimerix's antiviral turned into a bad case of data shock Monday morning after the biotech revealed that brincidofovir had failed its first Phase III study.

Bristol-Myers Squibb Announces Regulatory Update for Opdivo (nivolumab) in Advanced Melanoma

RegulatorBristol-Myers Squibb2015-11-29 22:41 Read   455

Bristol-Myers Squibb Company today announced that the U.S. FDA has issued a Complete Response Letter for its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.

Amgen's First Biosimilar Biologics License Application For ABP 501 Submitted To U.S. Food And Drug Administration

R&DAmgen2015-11-27 13:49 Read   567

Amgen today announced the submission of a Biologics License Application (BLA) with the United States (U.S.) Food and Drug Administration (FDA) for ABP 501, a biosimilar candidate to Humira® (adalimumab).

Pfizer, Allergan agree on $150B-plus megamerger: WSJ

EVENTSWSJ2015-11-23 16:06 Read   313

The agreement's been made: The boards at Pfizer and Allergan have ratified a megamerger--worth more than $150 billion--that will create the world's biggest pharma company

CHMP recommends EU approval for UCB’s new drug brivaracetam for people with epilepsy

TrendUCB2015-11-23 14:04 Read   515

CHMP recommendation based on Phase 3 data showing brivaracetam significantly reduced the frequency of seizures in patients aged 16 years and older with uncontrolled partial-onset seizures.

UCB receives positive EU CHMP opinion for CIMZIA® (certolizumab pegol) to treat severe, active and progressive rheumatoid arthritis in DMARD-naïve patients

TrendUCB 2015-11-23 12:41 Read   615

UCB has announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending extending the European Union marketing authorization for the use of CIMZIA® in the treatment of severe, active and progressive RA in DMARD-naïve adult patients.

Merck Announces Initial Results for KEYTRUDA® (pembrolizumab) with Novel Immunotherapy Combinations from Three Investigational Studies Presented at the Society for Melanoma Research International Congress

EVENTSMerck2015-11-23 10:44 Read   631

Merck, today announced findings from three studies investigating the use of KEYTRUDA(pembrolizumab), the company’s anti-PD-1 therapy, in combination with three other immunotherapies – epacadostat, IMLYGICTM (talimogene laherparepvec), and ipilimumab – in patients with advanced melanoma.

BioMarin Announces Data Analysis Demonstrating Consistent Efficacy of Kyndrisa™ (drisapersen) in Comparable Patients Across Three Randomized Studies

EVENTSBioMarin2015-11-23 09:36 Read   488

BioMarin Pharmaceutical Inc. today announced data analysis for Kyndrisa demonstrating consistent evidence of efficacy in comparable patients across three randomized, placebo-controlled studies that were conducted contemporaneously.

AstraZeneca, Sanofi swap 210,000 compounds in no-cash deal

EVENTSAstraZeneca2015-11-22 22:01 Read   488

AstraZeneca and Sanofi have exchanged 210,000 compounds from their respective libraries in a no-cash, no-strings-attached deal.

Biogen and Samsung's Enbrel biosimilar wins EMA nod for EU approval

EVENTSBiogen,2015-11-21 21:49 Read   499

Enbrel is one of the world's best-selling drugs with nearly $9 billion in global sales last year shared by Pfizer ($PFE) in Europe and Amgen ($AMGN) in the U.S. But competition is hot on its heels in the guise of biosimilars. And in the newest attack, a copycat version of the anti-TNF med from Biogen ($BIIB) and Samsung has been recommended for approval in Europe.