A year after FDA refusal, Celgene resubmits ozanimod for review

The multiple sclerosis drug is one of six therapies Bristol-Myers and Celgene are counting on to deliver future sales if shareholders OK their $74 billion deal.

By Ned Pagliarulo • March 26, 2019

FDA knocks back diabetes drug from Sanofi, Lexicon

The companies did not detail any reasoning behind the FDA's rejection of Zynquista, a dual SGLT 1 and 2 inhibitor designed to treat Type 1 diabetes.

By Andrew Dunn • March 22, 2019

Novo uses a PRV to submit oral semaglutide to FDA

The much-anticipated submission of the first oral GLP-1 agonist has gone ahead, boosted by Novo's recently purchased priority review voucher.

By Suzanne Elvidge • March 21, 2019

FDA's Gottlieb defends agency response to valsartan contamination

Responding to questions at an event this week, the outgoing FDA chief also pointed to forthcoming regulations aimed at improving oversight of manufacturing process changes.

By Ned Pagliarulo • March 21, 2019

Jazz gets OK for sleep drug, avoids black box warning

Solriamfetol, a treatment for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea, should launch in mid-2019, Jazz said.

By Andrew Dunn • March 21, 2019

Soon to depart, Scott Gottlieb keeps focus on greater drug competition

Increasing competition remains the outgoing FDA commissioner's remedy for drug market failures, which persist despite heightened public scrutiny.

By Ned Pagliarulo • March 20, 2019

Roche's Tecentriq secures another immunotherapy first

The drug is the first immunotherapy approved for first-line small cell lung cancer, and the first new initial treatment option for the cancer type in decades.

By Ned Pagliarulo • March 19, 2019

Aimmune's peanut allergy drug finally gets an approval timeline

An FDA decision could come by late January 2020 — about a year after Aimmune filed the oral therapy, called AR101, with the agency.

By Suzanne Elvidge • March 19, 2019

Biohaven pays $105M for GW Pharma's priority review voucher

The purchase speeds up the regulatory timeline for Biohaven's oral CGRP drug — and could help it leapfrog Allergan's rival therapy, currently under review.

By Andrew Dunn • March 19, 2019

Approval decision delay seen as positive for Karyopharm

The FDA pushed back its target decision date by three months and, in somewhat of a surprise, Wall Street analysts and the market cheered the news.

By Andrew Dunn • March 15, 2019

FDA's Gottlieb calls for greater adoption of new clinical trial tools

The outgoing agency chief expressed frustration with limited industry use of study methods he sees as enabling faster and more effective clinical testing.

By Ned Pagliarulo • March 15, 2019

Key drugs from Merck, Roche win wider EU approvals

Label expansions for Hemlibra and Keytruda give the respective pharmas wider markets for their therapies.

By Kristin Jensen • March 14, 2019

Senate calls on PBMs to give 'patients an explanation,' following pharma CEO hearing

The Senate Finance Committee invited Cigna, CVS, Humana, UnitedHealth's OptumRx and Prime Therapeutics to testify next month.

By Shannon Muchmore • Updated March 19, 2019

FDA approves valsartan generic amid probe into impurities

The agency is prioritizing generic applications for the commonly used high blood pressure drug to counteract a shortage caused by manufacturer recalls.

By Suzanne Elvidge • March 13, 2019

NCI Director Ned Sharpless to become acting FDA commissioner

President Trump will name Sharpless, currently the director of the National Cancer Institute, as acting FDA head, HHS Secretary Alex Azar said Tuesday.

By Ned Pagliarulo , Andrew Dunn • Updated March 12, 2019

Unblinded: Scott Gottlieb on biosimilars' precarious moment and the gene therapy boom

The outgoing FDA chief spoke with BioPharma Dive a day before his surprise resignation, detailing how drugmaker "shenanigans" have evolved and weighing in on gene therapy's inflection point.

By Andrew Dunn • March 12, 2019

Pfizer's Herceptin biosimilar gets FDA approval as US entry nears

Trazimera is the fourth biosimilar cleared in the U.S. of Roche's top-selling cancer drug, which is already facing copycat competition abroad.

By Andrew Dunn • March 12, 2019

Sanofi's dengue vaccine gets mixed review from FDA panel

The committee voted narrowly against recommending U.S. approval for the French pharma's target population ranging from 9 to 45 years old, but supported it for a narrower age group.

By Andrew Dunn • March 8, 2019

FDA walks back plan to alter generic names of already approved biologics

Introduction of biosimilars in the U.S. has forced the FDA to evaluate how best to distinguish biologic products, a regulatory process with broader implications than it might seem.

By Ned Pagliarulo • March 7, 2019

How Scott Gottlieb changed the FDA

The agency head, who will leave after two years on the job, departs with a legacy as an outspoken leader who pushed the agency forward on several fronts.

By Andrew Dunn • March 6, 2019

5 takeaways from Scott Gottlieb's surprising FDA departure

The FDA chief's exit spurs a number of questions for the pharmaceutical industry, including who will replace him and why he's leaving.

By Jacob Bell • March 6, 2019

FDA Commissioner Scott Gottlieb resigning, to leave in one month

Gottlieb led the agency for nearly two years, winning plaudits as an effective commissioner. His resignation surprised many in D.C. and in industry.

By Ned Pagliarulo , Andrew Dunn • March 5, 2019

Aimmune has its answer on peanut drug's status, but how FDA proceeds still unclear

The biotech says it will know in one month whether the FDA has accepted its drug application, which was derailed by the 35-day government shutdown.

By Ned Pagliarulo • March 1, 2019

Akorn's Amityville plant draws critiques from FDA

Inspectors from the agency flagged maintenance, testing and record-keeping issues at the New York plant, adding to the company's recent woes.

By Kristin Jensen • Feb. 28, 2019

Gottlieb pledges device, drug reviews will be on time post shutdown

The FDA chief's testimony follows introduction of a bill to allow the agency to accept new device applications and fees during a government shutdown.

By David Lim • Feb. 28, 2019