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

Number of violation letters issued by FDA hits all-time low

Over the last two years, the FDA's Office of Prescription Drug Promotion (OPDP) issued only 20 letters. 

By Nicole Gray • Jan. 7, 2016

Biotech startup Vtesse granted FDA breakthrough designation for orphan NPC drug

Vtesse has been working on a potentially first-of-its-kind treatment for Niemann-Pick Type C1 Disease, a genetic disease affecting one in 100,000 to 150,000 children. 

By Ned Pagliarulo • Jan. 6, 2016

ACCME vs. PharmedOut: How credible is CME in the age of Addyi?

Dr. Adriane Fugh-Berman, director of PharmedOut, has argued that most CME is commercially driven. 

By Nicole Gray • Jan. 6, 2016

Gilead grabs priority review for pangenotype hep C combo; Hep B med shown to be safe

The combo, which includes the megablockbuster Sovaldi, won priority review just as the biotech announced its experimental hep B drug was proven as effective and safer than its current med. 

By Ned Pagliarulo • Jan. 6, 2016

Rat study finds link between neural tube defects and low PCSK9 levels

If the results hold, they could raise concerns about taking PCSK9 inhibitors during pregnancy. 

By Nicole Gray • Jan. 5, 2016

New UK program gave 500 melanoma patients early access to Merck's Keytruda

Keytruda had been accepted into the UK's new Early Access to Medicines Scheme back in March of 2015. 

By Nicole Gray • Jan. 4, 2016