FDA: Page 73
-
FDA
Marathon stokes drug pricing flames after DMD approval
Marathon Pharmaceuticals' approved drug is a corticosteroid already widely used off-label for Duchenne muscular dystrophy and a high price tag is already causing outrage.
By Judy Packer-Tursman • Feb. 10, 2017 -
Amgen secures FDA approval for hormone drug
The approval should help ease the threat Amgen faces as generics move in on the company's older drug for a similar indication.
By Jacob Bell • Feb. 8, 2017 -
Mylan to pay $96.5M to settle pay-for-delay lawsuit
Cozy pay-for-delay deals between branded drugmakers and their generic competitors have come under closer scrutiny in recent years.
By Judy Packer-Tursman • Feb. 7, 2017 -
Checkpoint inhibitors set to face off in bladder cancer
Bristol-Myer's Opdivo will soon challenge Roche's Tecentriq in bladder cancer, but rivals Merck and AstraZeneca are moving quickly to compete.
By Suzanne Elvidge • Feb. 7, 2017 -
UK cost watchdog says Pfizer's Ibrance too pricey
NICE issued draft guidance last week judging the breast cancer drug to not be cost effective, even with data showing a progression free survival benefit.
By Suzanne Elvidge • Feb. 6, 2017 -
Prescribed Reading: A week dominated by politics and earnings
Pharma's sit down with President Trump was a hot topic in earnings calls this week as markets tried to gauge the new administration's approach to the industry.
By Lisa LaMotta • Feb. 3, 2017 -
Teva wins FDA approval for Advair copy
But the Israeli generics giant lost a Copaxone patent case in U.S. district court the same day, spelling trouble ahead for the company's most lucrative drug.
By Judy Packer-Tursman • Jan. 31, 2017 -
Amgen's Humira biosim clears EMA regulatory hurdle
The EMA also disclosed in its monthly update that Novartis had withdrawn an application for approval of its Neulasta biosimilar.
By Jacob Bell • Jan. 30, 2017 -
Regulus hits further setbacks as clinical hold upheld
Stock dropped by 20% after hours on Friday following an FDA request for more data on the microRNA-targeting drug RG-101.
By Suzanne Elvidge • Jan. 30, 2017 -
Regeneron drops $720M to buy New York HQ
The biotech has leased the space for years, but will now cement its presence in the state by buying the property outright.
By Judy Packer-Tursman • Jan. 26, 2017 -
FDA
FDA report stresses importance of Phase 3 testing
Several rumored candidates for FDA chief under President Trump have previously criticized the FDA approval process as being too slow.
By Judy Packer-Tursman • Jan. 25, 2017 -
Q4 was a mixed bag for pharma. Will 2017 be the same?
A new report from BioPharm Insight highlights an uptick in fourth quarter IPOs, but Trump's criticism of the industry makes the outlook for 2017 murky.
By Jacob Bell • Jan. 25, 2017 -
Endo reaches deal with FTC over pay-for-delay allegations
The federal agency had accused the Irish pharma of paying off rivals to keep generic copies of two of its top pain drugs off the U.S. market.
By Ned Pagliarulo • Jan. 23, 2017 -
Merck pays $625M to settle patent battle with Bristol, Ono
In another twist to the two companies' rivalry, Merck will pay up to clear the patent dispute.
By Jacob Bell • Jan. 23, 2017 -
FDA
Deep Dive
Biosimilars: What's in a name?
The FDA recently finalized naming conventions for biosimilars, putting in place an important piece of the regulatory framework for the copycat biologics.
By Ned Pagliarulo • Jan. 23, 2017 -
FDA gives go-ahead to Synergy's constipation drug
Facing a crowded market, the company’s CEO asserts that Synergy has “the right strategic vision and the right launch plan” for Trulance.
By Judy Packer-Tursman • Jan. 22, 2017 -
Prescribed Reading: A new era in pharma
Trump is in, Califf is out, Bristol-Myers foregoes any possible lead in lung cancer and the FDA made its mark.
By Lisa LaMotta • Jan. 20, 2017 -
Bristol-Myers nixes hopes of early filing for Opdivo combo
The pharma's shares tumbled by nearly 10% Friday morning on news it won't seek accelerated approval in first-line lung cancer for its Opdivo/Yervoy pairing.
By Ned Pagliarulo • Jan. 20, 2017 -
FDA details thinking on off-label communications
The agency released two other draft guidance documents giving more clarity to the industry on medical product communications.
By Ned Pagliarulo • Jan. 19, 2017 -
McKesson Corp. pays $150M in record settlement with DOJ
The federal government had alleged McKesson failed to report suspiciously large orders of controlled substances such as oxycodone and hydrocodone.
By Suzanne Elvidge • Jan. 19, 2017 -
FDA
Chinese API supplier lands in hot water with FDA
Suzhou Pharmaceuticals lacked a quality unit for starters, leading the FDA to ban the company from exporting to the U.S.
By Ned Pagliarulo • Jan. 18, 2017 -
FDA spells out expectations on biosimilar interchangeability
Days after publishing guidance on biosimilar naming, the FDA is back at it again this week with important new recommendations on interchangeable biologic products.
By Ned Pagliarulo • Jan. 18, 2017 -
FDA
FDA delays decision on Lilly and Incyte's arthritis drug
Review of baricitinib will be extended by three months in order for the FDA to review new data submitted by Lilly.
By Suzanne Elvidge • Jan. 17, 2017 -
Tesaro plans speedy response to CRL for nausea drug
The drugmaker disclosed last week the FDA had requested more details on manufacturing practices, an area where an increasing number of applications have fallen short.
By Suzanne Elvidge • Jan. 13, 2017 -
FDA issues long-awaited guidance on biosimilar naming
With the biosimilar field set to grow dramatically, what to call the copycat drugs has been in debate.
By Ned Pagliarulo • Jan. 12, 2017
Previous
