FDA: Page 59
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FDA clears orphan drug backlog ahead of schedule
The agency is now turning its attention toward addressing criticisms of the Orphan Drug Act and the loopholes potentially exploited by pharma.
By Jacob Bell • Sept. 12, 2017 -
Analyst: Intercept safety concerns overblown
Shares of the biotech fell after it issued a 'Dear Health Care Provider' letter.
By Lisa LaMotta • Sept. 12, 2017 -
Elizabeth Regan/BioPharma Dive
ESMO: Clovis seeking new indication on positive ARIEL3 data
Strong results in all types of advanced ovarian cancer patients has the biotech looking to expand the market for its PARP inhibitor.
By Lisa LaMotta • Sept. 8, 2017 -
Pfizer's EpiPen manufacturer warned by FDA
The agency found glaring issues with how the site handled quality control, complaints and defective auto-injectors.
By Jacob Bell • Sept. 8, 2017 -
Prescribed Reading: PD-1, CAR-T threatened by clinical holds
Highly innovative oncology technologies may be life-saving, but they have also raised major safety concerns.
By Lisa LaMotta • Sept. 8, 2017 -
FDA
Integration a key focus of FDA's new drug review model
Agency head Scott Gottlieb plans to create more integrated teams to boost information sharing between staff scrutinizing new drugs and those reviewing manufacturing facilities.
By Jacob Bell • Sept. 7, 2017 -
New PD-1 clinical holds raise more concerns for class
The FDA halted several trials from Bristol-Myers, AstraZeneca and Celgene after the deaths in Merck's Keytruda trials.
By Lisa LaMotta • Sept. 7, 2017 -
FDA warns drugmaker over misleading marketing of opioid
The regulator's letter to Cipher Pharmaceuticals is only the second warning issued by the Office of Prescription Drug Promotion this year.
By Ned Pagliarulo • Sept. 6, 2017 -
FDA delays review of Mylan and Biocon's Herceptin biosimilar
The companies had appeared set for a September approval after winning the backing of an FDA panel, but a final decision will now not come until December.
By Suzanne Elvidge • Sept. 6, 2017 -
Death in Cellectis CAR-T trial leads to clinical hold
Another patient death in CAR-T trials pushed the Food and Drug Administration to place two early trials on clinical hold.
By Lisa LaMotta • Sept. 5, 2017 -
Pfizer's Mylotarg gets a second shot at market
After being withdrawn in 2010, the cancer drug has been green lighted again with new dosing and a slightly different patient population.
By Lisa LaMotta • Sept. 1, 2017 -
Prescribed Reading: Get ready for CAR-T clash
The biggest deal of the year and a major approval were both based around CAR-T technology, setting up the market for a price war in the space.
By Lisa LaMotta • Sept. 1, 2017 -
FDA hits yet another Indian drugmaker with warning letter
Following a December inspection, the agency determined equipment maintenance and quality controls at a Hetero Labs manufacturing facility were inadequate.
By Jacob Bell • Aug. 31, 2017 -
FDA warns Florida stem cell clinic about GMP deviations
The FDA has warned U.S. Stem Cell Clinic about a host of issues, including violations of GMP.
By Suzanne Elvidge • Aug. 31, 2017 -
FDA
FDA issues second refuse-to-file letter in a week, this time to SteadyMed
Shares in SteadyMed dropped more than 40% on news the FDA wouldn't accept the company's application for its PAH treatment Trevyent.
By Jacob Bell • Aug. 31, 2017 -
Aveo wins European approval for cancer drug, triggering milestone payment
Per a licensing deal with EUSA Pharma, Aveo receives $4 million for winning EU approval of Fotivda — money it will reinvest into drug development.
By Jacob Bell • Aug. 30, 2017 -
In historic first, FDA approves Novartis CAR-T therapy
Approval of Kymriah, for treatment of an aggressive type of leukemia, marks a major advance for cell therapy even as its $475,000 price tag raises questions about value.
By Ned Pagliarulo • Aug. 30, 2017 -
MedCo gets FDA OK on antibacterial, boosting sale potential
The approval makes the antibiotics developer's infectious disease business more valuable, a plus given that the company is looking to sell the unit.
By Lisa LaMotta • Aug. 30, 2017 -
Courtesy of Eli Lilly
Lilly speeds up timeline for refiling of baricitinib
The drugmaker said it would resubmit the arthritis drug before the end of January 2018, much sooner than had previously been expected.
By Ned Pagliarulo • Aug. 30, 2017 -
FDA steps up oversight of cell therapies
The agency's enforcement aims to protect patients and promote genuine science.
By Suzanne Elvidge • Aug. 29, 2017 -
FDA
Acorda Parkinson's drug hits FDA roadblock
The regulator issued a refuse-to-file letter for the biotech's application, sending shares in the company spiraling.
By Lisa LaMotta • Aug. 29, 2017 -
Prescribed Reading: Biosimilars or biologics? Why not both?
A few small deals, plenty of stock movement on clinical trial results and several new therapies inch closer to market.
By Lisa LaMotta • Aug. 25, 2017 -
Samsung Bioepis locks down EU approval for Humira biosimilar
The Korean biosimilars developer has now won major market approvals for copycat versions of Enbrel, Remicade and Humira — three of the best-selling drugs in the world.
By Ned Pagliarulo • Aug. 24, 2017 -
US, EU advance collaboration efforts on manufacturing
The FDA has agreed to share more complete confidential information per the terms of a freshly inked agreement with other regulatory bodies.
By Jacob Bell • Aug. 24, 2017 -
FDA warns compounding pharmacy of wood contamination
An inspection of ImprimisRx last summer turned up a sample of drug product containing "fibrous material consistent with wood."
By Ned Pagliarulo • Aug. 24, 2017
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