FDA: Page 88
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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 -
FDA
Deep DiveBehind 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 -
Deep Dive
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
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 -
Montgomery County Planning Commission
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 -
FDA oncology chief Pazdur scrutinized over cancer drug approvals after wife's death
After facing criticism for a slow process, drug approval times have declined by one month at the FDA over the past three years—a period concurrent with Mary Pazdur's battle with cancer and eventual death.
By Nicole Gray • Jan. 4, 2016 -
Deep Dive
The year ahead: 11 execs & experts predict what's in store for biopharma in 2016
With a record-setting year behind us, we can only imagine what’s ahead for the industry in the coming months. Fortunately, industry execs and experts from Sanofi, Boehringer, Bain, amfAR, Novocure, and others shared some of their own predictions with BioPharma Dive.
By Nicole Gray • Jan. 4, 2016 -
FDA approves 2015's 45th new drug, AstraZeneca's gout med
Zurampic (lesurinad) is indicated for treatment of hyperuricemia, often associated with gout.
By Nicole Gray • Dec. 23, 2015 -
Deep Dive
11 biopharma execs & experts look back on 2015: A record year for record-breaking
We spoke with bigwigs from Sanofi, the Biosimilars Council, Novocure, Accenture, Bain, amfAR, Boehringer Ingelheim, and more on what they considered the most significant events that drove biopharma this past year.
By Nicole Gray • Dec. 22, 2015
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