FDA: Page
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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 -
Drug pricing — what you need to know
Controversy over rising drug prices has put industry on the defensive in recent years. In this Spotlight, BioPharma Dive explores the trends fueling the debate, as well as emerging responses.
By Lisa LaMotta • Aug. 15, 2017 -
Take two: Portola's reversal agent secures FDA review
Regulatory setbacks have kept Andexxa from market. But with a resubmission of the drug now accepted by the FDA, Portola hopes to secure approval by February.
By Jacob Bell • Aug. 15, 2017 -
Deep Dive
5 Trends influencing drug pricing
When pricing medications, drugmakers now weigh consumer outrage, negotiating power and calls for transparency.
By Jacob Bell • Aug. 14, 2017 -
FDA gives OK, Cel-Sci clinical hold finally lifted
Well into its second decade of clinical development, a Phase 3 study of Multikine inches forward.
By Suzanne Elvidge • Aug. 14, 2017 -
Prescribed Reading: Merger as a band-aid for biotech troubles
Multiple biotechs with ongoing problems discovered solutions this week by merging with privately held companies, which could offer a needed boost.
By Lisa LaMotta • Aug. 11, 2017 -
Trump says he will declare opioid crisis a national emergency
Details have not been released, but the order would likely free up funding for fighting the epidemic and give relevant agencies more leeway and resources.
By Shannon Muchmore • Aug. 11, 2017 -
Vernalis hit with second CRL this year
Rejection for CCP-08 is another setback for the British biotech's U.S. cough and cold franchise.
By Lisa LaMotta • Aug. 7, 2017 -
Dynavax dips as its hep B drug faces another setback
The FDA's request for more information on a planned, post-marketing study of Heplisav-B is pushing back an approval decision.
By Jacob Bell • Aug. 4, 2017 -
Jazz trumpets FDA approval of AML drug
Days after Celgene secured approval for its AML drug Idhifa, the FDA OK'd another treatment option for the aggressive blood cancer.
By Suzanne Elvidge • Aug. 4, 2017 -
Prescribed Reading: More portfolios reshuffled
Restructuring continued throughout the industry, as more companies attempt to cut costs or excess programs. Meanwhile, the FDA kept up its rapid pace of drug approvals.
By Lisa LaMotta • Aug. 4, 2017 -
FDA
J&J set back by negative panel vote for sirukumab
Safety concerns led an advisory panel to recommend the FDA reject the IL-6 blocker.
By Ned Pagliarulo • Aug. 3, 2017 -
Imbruvica finds new use as GvHD drug
AbbVie and J&J's blood cancer medication got an FDA go-ahead as a treatment for chronic graft-versus-host disease.
By Lisa LaMotta • Aug. 2, 2017 -
Kite first to file for CAR-T approval in Europe
In the U.S., however, Novartis looks set to secure the first approval for a CAR-T therapy, winning the unanimous support of a FDA advisory panel in July.
By Suzanne Elvidge • Aug. 2, 2017 -
Vertex wins new Kalydeco approval, ups sales forecast
A label expansion will increase the patient population treatable by Vertex's older cystic fibrosis drug, strengthening the biotech's position.
By Ned Pagliarulo • Aug. 1, 2017 -
FDA
GSK gets go-ahead for new Benlysta formulation
Approval brings the first self-injectable treatment for the most common form of lupus to market, according to the British drugmaker.
By Jacob Bell • July 26, 2017 -
Lilly, Incyte likely won't resubmit baricitinib until 2019
The companies expect it will be at least another 18 months before their arthritis drug makes it back in front of the FDA.
By Jacob Bell • July 25, 2017 -
5 orphan drugs receive EMA thumbs-up
Pfizer and Merck KGaA's Bavencio and Novartis' Rydapt were among the 11 drugs recommended for approval during the Committee for Medicinal Products for Human Use's July meeting.
By Jacob Bell • July 21, 2017 -
Prescribed Reading: Bolt-on deals for Sanofi
The big pharma tries to fill its pipeline, Vertex touts strong CF data and the FDA gives three approvals.
By Lisa LaMotta • July 21, 2017 -
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
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