FDA: Page 65
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Clinical hold still in effect for Repros' oral drug
The drugmaker is now weighing a shift in focus to its vaginal drug delivery program for Proellex.
By Jacob Bell • July 17, 2017 -
Amgen osteoporosis drug rejected
A complete response letter is not an unexpected heartbreak for Evenity after Phase 3 data showed some worrying safety signals.
By Suzanne Elvidge • July 17, 2017 -
Prescribed Reading: Rumors, blood and history in the making
Rumors swirl about a new CEO at Teva, hemophilia drugs are getting exciting and the first CAR-T therapy could be coming.
By Lisa LaMotta • July 14, 2017 -
J&J's Tremfya approved, further crowding IL-inhibitor market
Tremfya, approved to treat plaque psoriasis, will directly compete with Novartis' Cosentyx and Eli Lilly's Taltz.
By Jacob Bell • July 14, 2017 -
FDA to expand REMS for opioids in effort to slow epidemic
As part of stepped-up efforts to address the crisis, FDA chief Scott Gottlieb announced plans to expand REMS requirements to immediate-release opioids.
By Suzanne Elvidge • July 14, 2017 -
FDA suggests 1-year delay on serialization rules for pharma supply chains
The regulators were concerned the industry would not be ready to comply with the Drug Supply Chain Security Act requirement, according to the draft guidance.
By Edwin Lopez • July 13, 2017 -
FDA panel unanimously backs approval of Novartis CAR-T
If approved later this year for an aggressive type of leukemia, Novatis' tisagenlecleucel would be the first CAR-T therapy OK'd for commercial use.
By Ned Pagliarulo • July 12, 2017 -
FDA
Woodcock: We need better biomarkers
The CDER director says precision medicine has come a long way, but biomarkers will bring the advances even further.
By Lisa LaMotta • July 12, 2017 -
Manufacturing problems once again stall Ocular's Dextenza
The eye drug developer received another complete response letter for its post-surgical pain treatment.
By Jacob Bell • July 12, 2017 -
Pfizer's Mylotarg resurrected for new chance at US market
The cancer drug may get a second chance after being pulled from the market several years ago when it failed to gain full approval.
By Lisa LaMotta • July 12, 2017 -
FDA changes tune on Amicus Fabry disease drug
The agency will let Amicus file for approval of migalastat with currently in-hand clinical data, walking back a demand for another Phase 3 study.
By Ned Pagliarulo • July 11, 2017 -
Safety issues for Novartis CAR-T therapy main focus of FDA
Documents released ahead of a key advisory meeting Wednesday show the agency is primarily concerned with the safety risks of what could be the first CAR-T therapy approved.
By Ned Pagliarulo • July 10, 2017 -
Prescribed Reading: I/O is the only game in town
Immuno-oncology dominates dealmaking, clinical trial data and regulatory action.
By Lisa LaMotta • July 7, 2017 -
Novo Nordisk recalls six batches of insulin cartridge holders
Affected holders could crack or break when exposed to certain chemicals, leading to delivery of lower insulin doses, the Danish drugmaker said.
By Ned Pagliarulo • July 6, 2017 -
FDA issues warning letter to Chinese heparin maker
The agency cited issues with the system suitability and data controls — among other things — at the Shandong Analysis and Test Center.
By Jacob Bell • July 6, 2017 -
3 Keytruda studies put on clinical hold after deaths
The FDA halt comes three weeks after Merck paused enrollment in the trials, which pair Keytruda with Celgene's Revlimid or Pomalyst in multiple myeloma.
By Ned Pagliarulo • July 6, 2017 -
Industry paid $8.2B to docs, hospitals last year
Roche, Novartis and Pfizer each spent more than $475 million in total 2016 payments, with fellow multinational drugmakers not far behind.
By Ned Pagliarulo • July 5, 2017 -
Gottlieb plans to clear orphan drug backlog
The new FDA Commissioner is trying to improve efficiency at the agency by plowing through the backlog of orphan drug designation requests.
By Lisa LaMotta • June 29, 2017 -
Coherus cuts staff after FDA red light
The California-based company will lay off employees after getting handed a rejection from the FDA for its Neulasta biosimilar.
By Lisa LaMotta • June 28, 2017 -
Novartis scores second biosimilar approval in two weeks
With several biosimilar approvals in Europe and the U.S., Sandoz is poised to make inroads into the blockbuster immunology drug market.
By Barbara Boughton • June 28, 2017 -
FDA's first steps in drug competition plan: get more generics approved
The agency rolled out a new list highlighting branded medicines that lack generic competition and updated protocols so copycat drugs can move to market faster.
By Jacob Bell • June 28, 2017 -
SEC charges ex-Ariad employees with insider trading
Two former senior staffers allegedly sold company stock, or tipped relatives to do the same, ahead of announcements about Ariad's drug Iclusig.
By Ned Pagliarulo • June 28, 2017 -
Esperion locks down regulatory pathway for cholesterol combo
The company is mapping out a late-stage bridging study for a pairing of its bempedoic acid with ezetimibe.
By Jacob Bell • June 27, 2017 -
Clarus resubmits oral hormone therapy to FDA
The small biotech again filed its testosterone replacement drug for approval, with the hope that new data will clear a path to market.
By Jacob Bell • June 27, 2017 -
Despite setbacks, Portola snags FDA OK for Bevyxxa
Although the anticoagulant missed its endpoint in a Phase 3 study, Portola was able to secure FDA backing with a second analysis.
By Suzanne Elvidge • June 26, 2017
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