FDA: Page 63
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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 -
Expanded label boosts AstraZeneca and Merck's Lynparza
Securing a broader indication for earlier treatment of ovarian cancer should help Lynparza fend off competition from rival PARP inhibitors.
By Ned Pagliarulo • Aug. 18, 2017 -
Pfizer locks down US approval for Besponsa
The drug is the first CD22-targeting antibody-drug candidate to gain approval for a specific population of acute lymphoblastic leukemia patients.
By Suzanne Elvidge • Aug. 18, 2017 -
House Democrats to probe 'skyrocketing' prices for MS meds
Two top Democrats on the House Oversight Committee plan to investigate the pricing strategies of seven leading drugmakers in the space.
By Ned Pagliarulo • Aug. 17, 2017 -
Mylan finalizes $465M settlement for EpiPen
The payment, though, is just a fraction of the $1.3 billion the U.S. government says it may have overpaid for the epinephrine autoinjectors.
By Jacob Bell • Aug. 17, 2017 -
FDA flags drugmaker's testing of potentially poisonous powders
The agency took a dim view of Homeolab USA's manufacturing processes, including those for its belladonna-containing powder blend.
By Jacob Bell • Aug. 17, 2017 -
Biocon pulls EU application for Herceptin biosimilar
The European Medicines Agency informed Biocon it would need to re-inspect the Indian manufacturer's drug product facility, triggering the withdrawal.
By Suzanne Elvidge • Aug. 17, 2017 -
Sponsored by ZS Associates
Adapting to industry changes: Moving to an agile operating structure
With new field roles being introduced, a new challenge emerges: How will these roles report up into the organization?
By Karan Dhundia co-wrote this blog post with Jude Konzelmann • Aug. 17, 2017
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