FDA: Page 44
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As shutdown stalls IPOs, companies mull creative paths to market
Biotechs in the process of going public are considering legal workarounds to bypass a hamstrung SEC, but the Nasdaq appears to be proceeding warily.
By Andrew Dunn • Jan. 18, 2019 -
Aimmune drug application confusion leaves investors searching for answers
The ongoing government shutdown derailed Aimmune's filing for its peanut allergy drug. But tweets from FDA chief Scott Gottlieb raise questions of whether the biotech and the agency are on the same page.
By Ned Pagliarulo • Jan. 18, 2019 -
Immunomedics sheds $1B in value as FDA rejects drug candidate
The company's 37-year push to win its first drug approval was expected to reach an end. Instead, a Complete Response Letter has left analysts frustrated.
By Andrew Dunn • Jan. 18, 2019 -
FDA advisers split on Lexicon-Sanofi diabetes drug
The panel could not agree on whether the benefits outweigh the risks of what could be the first oral anti-diabetic drug in the U.S. for Type 1 patients.
By Suzanne Elvidge • Jan. 18, 2019 -
FDA finalizes guidance on development of antimicrobial tests
The document is intended to improve coordination between drug and diagnostic developers.
By Nick Paul Taylor • Jan. 18, 2019 -
AmerisourceBergen subsidiary laying off hundreds at compounding plant
The company will cut about half its workforce at a Tennessee-based facility, which has been suspended due to concerns flagged by the FDA last year.
By Suzanne Elvidge • Jan. 17, 2019 -
Elizabeth Regan/BioPharma Dive
7 biopharma trends to watch in 2019
Intensifying political pressure, surging cancer drug investment and the rise of pharma chief digital officers are among the factors which look set to shape the industry's next 12 months.
By Ned Pagliarulo • Jan. 17, 2019 -
FDA advisory panel recommends Amgen's Evenity, with conditions
Chances for approving Amgen's bone drug are looking more positive the second time around, although the committee asked for post-market studies.
By Suzanne Elvidge • Jan. 17, 2019 -
FDA to bulk up cell and gene therapy staff, growing with the field
Two FDA leaders said the development of cell and gene therapies has reached "a turning point," leading to new agency plans to keep pace with research.
By Andrew Dunn • Jan. 16, 2019 -
Brexit deal collapse keeps U.K. pharmas in limbo
As the March leave date gets ever closer, pharmas operating in the U.K. and Europe are calling for measures to be taken to prevent medicine delays.
By Suzanne Elvidge • Jan. 16, 2019 -
Amgen's osteoporosis drug faces safety scrutiny from FDA
Wall Street analysts expect the drug to secure a thumbs up from an FDA advisory panel later this week, but note any approval could be limited in scope.
By Suzanne Elvidge • Jan. 15, 2019 -
FDA review of Aimmune drug put on hold due to government shutdown
Regulators won't begin reviewing Aimmune's peanut allergy drug until agency funding is restored, an uncertain delay likely to weigh on the biotech.
By Ned Pagliarulo • Updated Jan. 15, 2019 -
Deep Dive
How a 'regulatory dead zone' may be holding up copycat insulin
The FDA has talked up biosimilars' potential impact on the insulin market, but changing regulations have complicated matters for would-be competitors.
By Andrew Dunn • Jan. 14, 2019 -
EPA: Pharmaceuticals in reverse supply chain are hazardous waste
A new regulation could prompt uncertainty as players in the pharmaceutical supply chain evaluate compliance.
By Gary Wollenhaupt • Jan. 14, 2019 -
FDA expands excepted activities as government shutdown drags on
As days stretch into weeks, Commissioner Scott Gottlieb and his agency are battling to not let the shutdown hurt food and drug safety.
By Suzanne Elvidge • Jan. 14, 2019 -
Teva hands over $135M to settle claims of inflated drug prices
A lawsuit dating back to 2005 alleges Teva and 46 other companies published inflated drug prices that ultimately caused Illinois to overpay for medications.
By Suzanne Elvidge • Jan. 14, 2019 -
Louisiana launching 'Netflix model' in Medicaid for hep C drugs
The state is looking for a pharmaceutical partner on a project that will cap state spending for the expensive liver disease treatments.
By Les Masterson • Jan. 14, 2019 -
FDA to beef up Sentinel postmarket safety system
The agency unveiled a new plan to expand and strengthen the system by adding new data types and recruiting more collaborators to the network.
By Susan Kelly • Jan. 11, 2019 -
J&J raises prices as Dems introduce bills aimed at lowering drug costs
Drug pricing reform has bipartisan support, but that hasn't stopped pharma from enacting hikes — in part because such moves have been vital to growth.
By Jacob Bell • Jan. 11, 2019 -
Akorn's drug pipeline 'held hostage' with FDA warning letter
The agency detailed numerous violations against the generic manufacturer's plant in Decatur, Illinois.
By Kristin Jensen • Jan. 10, 2019 -
FDA warns it won't be long before user fee funding runs dry
With no end in sight to the shutdown, Commissioner Scott Gottlieb said drug and medical device user fee programs have one to two months of funding left.
By Jacob Bell • Jan. 9, 2019 -
Elizabeth Regan/BioPharma Dive
Portola boosted by FDA nod for new Andexxa manufacturing
Roll-out of the reversal agent has been hampered by supply issues. Portola hopes its second-generation production process can give Andexxa a lift.
By Suzanne Elvidge • Jan. 2, 2019 -
Our 10 best stories of 2018
Pharma boards, cell therapy, AI and cancer drug ads feature in BioPharma Dive's top articles of the past 12 months.
By Ned Pagliarulo • Dec. 21, 2018 -
Courtesy of Merck & Co.
Merck's Keytruda faces delay in first-line approval decision
Keytruda already owns three approvals in frontline lung cancer, but will now have to wait three more months to find out the FDA's decision on a fourth.
By Suzanne Elvidge • Dec. 21, 2018 -
Lynparza boosted by key approval, trial success
An FDA OK for Lynparza as a first-line maintenance therapy in ovarian cancer should give AstraZeneca and Merck a leg up in the PARP inhibitor market.
By Suzanne Elvidge • Dec. 20, 2018
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