FDA: Page 62
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Who will host the EMA? A brief guide to the leading contenders
Nineteen cities have bid to become the regulatory agency's new home, now that Brexit has forced the European Medicines Agency to relocate from London.
By Suzanne Elvidge • Sept. 27, 2017 -
FDA targets illegal online pharmacies as part of global crackdown
In a recent enforcement effort, the U.S. regulator sent 13 warning letters to the operators of 401 websites peddling illegal or counterfeit medicines.
By Suzanne Elvidge • Sept. 27, 2017 -
J&J, Roche among companies selected for FDA digital health pilot
The regulator hopes to improve how it reviews digital medical devices, aiming to streamline the path to market for new health tools.
By Jeff Byers • Sept. 26, 2017 -
FDA
Intellipharmaceutics receives painful FDA rejection
The agency said it needs more data demonstrating extended-release oxycodone's abuse deterrence profile.
By Jacob Bell • Sept. 25, 2017 -
Following negative adcomm, J&J's sirukumab rejected
The rheumatoid arthritis drug, which has already lost GSK support, gets a thumbs down from the regulator.
By Suzanne Elvidge • Sept. 25, 2017 -
Prescribed Reading: Consolidation, clinical holds and landmark results
The FDA continues its clinical hold spree for PD-1/L1s, consolidation is rampant in the CDMO space and RNAi may become a reality very soon.
By Lisa LaMotta • Sept. 22, 2017 -
Korean drugmaker used employees to test potentially harmful ointment, FDA says
Firson Co. Ltd. is one of two Asian pharma manufacturers recently flagged by the agency for manufacturing violations.
By Jacob Bell • Sept. 21, 2017 -
Split adcomm vote leaves Pfizer's Sutent in limbo
An FDA advisory panel voted six in favor, six against a new indication for the drugmaker's cancer med.
By Jacob Bell • Sept. 19, 2017 -
GSK's respiratory business boosted by lung drug approval
The three-in-one inhaler should help GlaxoSmithKline stay competitive in respiratory disease as rival therapies erode sales of its blockbuster drug Advair.
By Ned Pagliarulo • Sept. 19, 2017 -
Samsung Bioepis first to secure EMA backing for Herceptin biosimilar
A final decision on marketing authorization will be made by the European Commission in the coming months.
By Ned Pagliarulo • Sept. 15, 2017 -
Amgen, Allergan win first approval of cancer biosimilar in US
The drug, which will be marketed as Mvasi, is a biosimilar version of Roche's top-selling biologic Avastin.
By Ned Pagliarulo • Sept. 14, 2017 -
FDA calls for industry input on continuous manufacturing guidelines
Biopharmas largely haven't adopted the speedier and more adaptable approach to drug manufacturing, relying instead on tried-and-true batch production methods.
By Ned Pagliarulo • Sept. 14, 2017 -
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
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