FDA: Page 61
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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After being withdrawn in 2010, the cancer drug has been green lighted again with new dosing and a slightly different patient population.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 -
Roche lines up February decision date for hemophilia prospect
If approved, emicizumab could threaten both Shire and Novo Nordisk's respective hemophilia businesses.
By Ned Pagliarulo • Aug. 24, 2017 -
Pfizer secures patent in India for pneumonia vaccine
Aid groups expressed concern that the patent grant would limit access to the life-saving vaccine.
By Ned Pagliarulo • Aug. 23, 2017 -
Intra-Cellular swings up on latest go-ahead from FDA
The biotech secured a green light from the regulator to move forward with testing and a mid-2018 filing of its lead compound.
By Lisa LaMotta • Aug. 23, 2017 -
Cardiome shaken by FDA no-go on heart drug refiling
The Canadian drugmaker's stock fell by almost a quarter after disclosing the data package for Brinavess wasn't sufficient for a resubmitted New Drug Application.
By Jacob Bell • Aug. 22, 2017 -
Ironwood wins FDA approval for combo gout drug
The biotech expects the oral therapy to further grow its gout franchise, established last year with the acquisition of U.S. rights to Zurampic from AstraZeneca.
By Ned Pagliarulo • Aug. 21, 2017 -
Trump signs FDA user fee reauthorization into law
Congress effectively ignored the administration's demand to fund the regulator entirely through user fees and instead moved forward with a package already negotiated with industry.
By Suzanne Elvidge • Aug. 21, 2017
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