Focus on Brazil: In pursuit of the Zika vaccine

BioPharma Dive spoke with Nuno Antunes, PhD, an analyst at Decision Resources Group, about the potential costs of the Zika pandemic and what Brazil’s regulatory authority and top pharma company are doing to solve the problem.

By Nicole Gray • Jan. 27, 2016

Roche investigating off-label Avastin use after 15 Indian patients hospitalized

Roche has emphatically reiterated Avastin is not approved for intraocular use in either India or the United States. 

By Nicole Gray • Jan. 26, 2016

Amgen wins big with Kyprolis expansion in US and Repatha approval in Japan

The expanded indication for Kyprolis broadens the biotech's initial November 2012 accelerated approval.

By Nicole Gray • Jan. 25, 2016

UPDATED: Feds to reportedly unveil new findings of 'serious deficiencies' at Theranos lab

The Wall Street Journal continues its series of investigative reports centering on the embattled blood testing firm, this time asserting that CMS will soon publicly release a report finding serious violations at a Theranos facility in Newark, California. And it could have consequences for the firm's already-strained partnership with Walgreens.

By Sy Mukherjee • Jan. 25, 2016

Bristol-Myers' Opdivo notches two key regulatory victories in US, UK

Following NICE's endorsement of Opdivo for use against skin cancer, the melanoma drug won expanded approval for advanced melanoma in combination with Yervoy. 

By Ned Pagliarulo • Jan. 25, 2016

Drug firms like J&J cautious on FAAH inhibitors in wake of trial death in France

On January 15, six patients who were being tested with Bial's developmental FAAH inhibitor were seriously harmed, one of whom later died. Janssen subsequently suspended its own (separate) FAAH trial.

By Nicole Gray • Jan. 21, 2016

Biden pushes Cancer MoonShot to corporate leaders in Davos, pitches faster approvals

Vice President Joe Biden focused on how to expedite the drug approval process for promising cancer drug combinations. 

By Nicole Gray • Jan. 21, 2016

Shkreli & Valeant's interim CEO to face down Congress in pricing testimony next week

House Oversight Committee ranking member Rep. Elijah Cummings (D-MD) has been gunning for the recently-arrested biopharma gadfly and Canadian pharma giant for a while now.

By Sy Mukherjee • Jan. 20, 2016

Multiple violations cause production halt at Mylan-owned Agila's Polish plant

A regulatory filing by the Polish Main Pharmaceutical Inspectorate (GIF) revealed 29 GMP violations at an Agila-operated facility in the country. 

By Ned Pagliarulo • Jan. 20, 2016

Watchdog report spotlights significant failures in FDA postmarket drug tracking

The report from the Government Accountability Office found that roughly a quarter of the drugs approved by the FDA used an expedited review pathway. However, the FDA lacks sufficiently robust data systems to track postmarket safety issues with those drugs, according to the GAO. 

By Ned Pagliarulo • Jan. 20, 2016

Off-label use of Avastin in India hospitalizes 15, sales halted in two states

Roche's Avastin is commonly used off-label to treat wet age-related macular degeneration (AMD), but the FDA has not approved it for that purpose. 

By Nicole Gray • Jan. 19, 2016

Novartis' psoriasis mega-blockbuster hopeful Cosentyx nabs 2 new indications

The FDA has expanded its approval of Cosentyx to include the treatment of ankylosing spondylitis and psoriatic arthritis in adults. 

By Ned Pagliarulo • Jan. 19, 2016

Samsung Bioepis scores first-ever Enbrel biosim approval in EU

Benepali is now approved in Europe for treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis.

By Nicole Gray • Jan. 19, 2016

FDA harshly criticizes Sarepta's Duchenne drug just one day after rejecting BioMarin's

It looks to be a fairly devastating week for the Duchenne muscular dystrophy (DMD) patient community. Sarepta shares opened down more than 56%.

By Nicole Gray , Sy Mukherjee • Jan. 15, 2016

Behind the scenes at the FDA: Why they ultimately approved Addyi

In this week’s issue of the New England Journal of Medicine, Dr. Hylton Joffe and his colleagues at the FDA provide insight into the technical process of approving a drug—and some eye-opening facts about the controversial female libido pill Addyi.

By Nicole Gray • Jan. 15, 2016

WHO declares Liberia free of Ebola, ending West African outbreak

Liberia has gone 42 days, or two incubation periods, after the last confirmed patient tested negative for Ebola. 

By Ned Pagliarulo • Jan. 14, 2016

Pay-for-delay deals continue to fall following FTC court victory

The number of pay-for-delay deals has declined by almost 50% since 2012.

By Nicole Gray • Jan. 14, 2016

Warning letters reveal some of the FDA's biggest problems with Indian drugmakers

Nearly a third of the warning letters issued by the FDA's Center for Drug Evaluation and Research stemmed from violations of safe manufacturing practices at India-based facilities. 

By Ned Pagliarulo • Jan. 13, 2016

FDA flags manufacturing deficiencies of Chinese drug supplier

The warning letter from the FDA reveals Zhejiang Hisun Pharmaceutical had been the subject of 61 complaints from 2012 to 2014.

By Ned Pagliarulo • Jan. 13, 2016

Roche and AbbVie move promising CLL drug towards finish line

Venetoclax (formerly ABT-199) was designated a breakthrough therapy, making it eligible for an expedited six-month review by the FDA.

By Nicole Gray • Jan. 13, 2016

Health committee sends Califf FDA nom to full Senate as Sanders mulls hold

Senator Sanders issued a statement following the voice vote reiterating his opposition to Robert Califf's nomination for FDA Comissioner. 

By Ned Pagliarulo • Jan. 12, 2016

Lawmakers urge NIH to combat high drug prices with patent overrides

The National Institutes of Health has the power to require drugmakers to out-license drug patents which have benefited from federal funds. 

By Nicole Gray • Jan. 12, 2016

FDA accepts Sanofi/Regeneron application for RA drug

A decision is expected on the anti-interleukin 6 med sarilumab by October 30. 

By Nicole Gray • Jan. 11, 2016

Medical marijuana clinics open in New York with strict restrictions

Eight medical marijuana dispensaries opened their doors this week, making New York the 23rd state, along with Washington D.C., to launch a medical marijuana program. 

By Nicole Gray • Jan. 8, 2016

Zydus Cadila slapped with FDA GMP violation letter

The warning letter flagged monitoring issues at two plants in the Indian state of Gujarat. 

By Nicole Gray • Jan. 7, 2016