FDA: Page 73
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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The agency released two other draft guidance documents giving more clarity to the industry on medical product communications.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 -
JPM: Day 4 round-up
A host of biotechs, including Novavax and MannKind, brought the huge healthcare conference to a close on Thursday.
By Lisa LaMotta • Jan. 12, 2017 -
Prescribed Reading: Quiet before the storm
M&A was slow in 2016 and 2017 is off to a slow start. But the JP Morgan conference in San Francisco next week could put dealmaking back in full swing.
By Lisa LaMotta • Jan. 6, 2017 -
FDA releases guidance on electronic drug applications
The pharma industry may ditch paper drug applications sooner than it thinks, as the FDA pushes forward with a transition to electronic files.
By Jacob Bell • Jan. 5, 2017 -
Sanofi asked to pull vaccine ads in the Philippines
The country's Food and Drug Administration called on the French pharma to pull radio and television ads for its Dengue fever vaccine, Dengvaxia.
By Jacob Bell • Jan. 4, 2017 -
After FDA delays pneumonia antibiotic, Cempra's shares plummet
Some analysts contend the size and cost of the FDA's recommended safety study is impractical for the North Carolina-based biotech, likely sinking its lead product.
By Judy Packer-Tursman • Dec. 30, 2016 -
FDA
Biogen, Ionis gifted with approval for SMA drug
The FDA okayed the first SMA drug months ahead of its PDUFA date.
By Lisa LaMotta • Dec. 26, 2016 -
A look back: Top stories of 2016
2016 was a rollercoaster year full of clinical jackpots and busts, reorganizations, and dramatic economic and political twists. Here are some of the biggest headlines from the last 12 months.
By Jacob Bell • Dec. 26, 2016 -
Prescribed Reading: An uptick in year-end M&A
Several companies are striking deals to round out the year, while others are trying to bury bad data, and the FDA cracks down on manufacturing.
By Lisa LaMotta • Dec. 23, 2016 -
Teva pays up $520M to settle bribery charges
The Israeli generic drugmaker admitted to bribing foreign government officials in Russia, Ukraine and Mexico in a past effort to boost sales.
By Ned Pagliarulo • Dec. 22, 2016 -
FDA warns drugmakers on misleading marketing
Two companies were hit with warning letters last week for failing to disclose risks associated with their respective drugs.
By Ned Pagliarulo • Dec. 21, 2016
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