FDA: Page 63
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FDA
May day: Amgen, Novartis lock down lead for CGRP
The FDA gave a May 17 target action date for erenumab, a calcitonin gene-related peptide that the drugmakers plan to market under the name Aimovig.
By Jacob Bell • July 21, 2017 -
Merck's Lantus follow-on gets tentative thumb's up
A second follow-on biologic of Sanofi's blockbuster insulin Lantus has now gotten approval from the FDA, dealing another blow to the French drugmaker.
By Suzanne Elvidge • July 21, 2017 -
Case study: How a trade deal will affect pharma R&D, supply chains
Canada's recent drug patent reform shows how modern trade deals go beyond tariff reduction to push for regulatory changes that benefit certain industries.
By Edwin Lopez • July 20, 2017 -
Significant cGMP violations at Tubilux Pharma
Regulators are keeping their eyes on Italian ophthalmology company Tubilux.
By Suzanne Elvidge • July 20, 2017 -
Gilead adds fourth drug to HCV arsenal
The FDA gave the OK for another Sovaldi-based hepatitis C regimen from the big biotech.
By Lisa LaMotta • July 18, 2017 -
Puma granted broad label for neratinib after FDA OK
The biotech gets a green light for its breast cancer drug, despite serious side effects and concerns raised by an advisory committee.
By Lisa LaMotta • July 18, 2017 -
First gene therapy could hit the market in January
Spark Therapeutics has landed a January user fee goal date for its gene therapy for a rare form of blindness.
By Lisa LaMotta • July 17, 2017 -
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
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