FDA: Page 40
-
Trump administration proposal takes aim at drug rebates
Billed by government officials as a sweeping reform, the plan aims to do away with price reductions paid by drugmakers to PBMs and insurers in Medicare.
By Ned Pagliarulo • Jan. 31, 2019 -
Mylan's Advair generic wins long sought-after FDA OK
Past rejections slowed Wixela Inhub's path to market, giving GSK ample time to prepare for the now-forthcoming competitive hit to its top respiratory drug.
By Suzanne Elvidge • Updated Jan. 31, 2019 -
Gottlieb teases real-world data emphasis for FDA in 2019
The agency head highlighted four priorities this year that focus on using and implementing real-world evidence and data.
By Suzanne Elvidge • Jan. 29, 2019 -
With 10th FDA OK, Imbruvica further expands in CLL
While the cancer drug appears poised for more growth, AbbVie's stock ticked down Monday in the wake of earnings last week that fell below expectations.
By Andrew Dunn • Jan. 28, 2019 -
FDA zeroes in on potential causes of blood pressure med contamination
Scientists at the FDA have developed new tests to detect NDMA impurities contaminating some valsartan and other angiotensin II receptor blockers.
By Suzanne Elvidge • Jan. 28, 2019 -
Advaxis hit with clinical hold for cervical cancer drug
The FDA flagged issues with Advaxis' chemistry, manufacturing and controls, handing the biotech another setback.
By Suzanne Elvidge • Jan. 24, 2019 -
FDA, EMA recommend against starting patients on Lilly's Lartruvo
Yet neither regulator has signaled Lartruvo's accelerated approval to be in question after a Phase 3 study failed to show a survival benefit.
By Kristin Jensen • Updated Jan. 25, 2019 -
Walgreens pays $270M to settle Medicaid fraud allegations
For years, the U.S. government alleges, the pharmacy giant routinely submitted false data to improperly secure federal reimbursement for insulin pens not needed by patients.
By Suzanne Elvidge • Jan. 23, 2019 -
FDA says user fees could run through February, as patient orgs raise alarm
While the FDA said it may be able to stretch money for drug reviews to Feb. 28, patients groups said the shutdown risks hindering access to new medicines.
By Andrew Dunn • Jan. 23, 2019 -
FDA approves third biosimilar of Roche's Herceptin
The go-ahead creates yet another threat to one of the Swiss pharma's top-selling franchises.
By Suzanne Elvidge • Jan. 22, 2019 -
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
Previous
