FDA: Page 43
-
Insulin drugmakers again come under Senate scrutiny
Eli Lilly, Novo Nordisk and Sanofi now face pressure on their pricing practices from several key Congressional committees, including Senate Finance.
By Ned Pagliarulo • Feb. 22, 2019 -
In unusual step, FDA pushes back against reports on questionable generic drug quality
A statement from agency chief Scott Gottlieb and CDER head Janet Woodcock defended their oversight of generic drugs imported from abroad.
By Ned Pagliarulo • Feb. 22, 2019 -
FDA to accept drug plant inspections by Poland, Slovenia
So far, the regulator has recognized health authorities in 22 EU countries, trusting information those agencies gather through GMP inspections.
By Ned Pagliarulo • Feb. 21, 2019 -
After accelerated approval, Merck's Keytruda fails in liver cancer study
The negative results raise questions about Keytruda's earlier OK, which was based on findings from a smaller Phase 2 trial.
By Andrew Dunn • Feb. 20, 2019 -
Roche gains quick review for two cancer drugs
Priority review from the FDA could mean entrectinb and polatuzumab vedotin join the ranks of Roche's oncology medicines later this year.
By Suzanne Elvidge • Feb. 19, 2019 -
FDA clarifies pathway for devices used in regenerative medicine
The final guidance document covers instruments, machines and implants used in conjunction with cell-based and gene therapies.
By Susan Kelly • Feb. 19, 2019 -
CMS unveils CAR-T proposal, with emphasis on patient outcomes
High price tags and a potential one-time administration have challenged CMS to figure out reimbursement for CAR-T cell therapies.
By Jacob Bell • Feb. 15, 2019 -
Novartis secures regulatory 'fast pass' in US OK for tropical disease drug
With the FDA's nod, Egaten is now the first approved therapy in the U.S. for an infectious disease caused by parasites found in contaminated food and water.
By Kristin Jensen • Feb. 14, 2019 -
J&J's esketamine wins backing of key advisory panel
Committee experts recommended the FDA approve the depression drug, giving cover for the agency to take a more flexible approach in its review.
By Ned Pagliarulo • Feb. 12, 2019 -
Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection
The agency will re-inspect a New Jersey manufacturing facility as part of a regulatory resubmission for the company's lead drug candidate.
By Andrew Dunn • Feb. 8, 2019 -
Approving J&J's new depression drug would be an unusual move for the FDA
Esketamine's clinical track record could raise questions about its efficacy, which will be a key topic during a joint advisory committee meeting next week.
By Jacob Bell • Feb. 8, 2019 -
FDA draft lays out submission paths for combo products
Commissioner Scott Gottlieb said the agency will develop additional guidances outlining specific premarket considerations for combo products.
By David Lim • Feb. 6, 2019 -
Key Senate committee pressures 7 big pharmas to testify
Pfizer, J&J and AbbVie are among the major drugmakers invited by Senate Finance to discuss drug pricing at a hearing set for Feb. 26.
By Suzanne Elvidge • Updated Feb. 5, 2019 -
Alkermes' depression drug turned back by FDA
A Complete Response Letter was expected, after an advisory panel last year recommended against approving the biotech's experimental antidepressant.
By Suzanne Elvidge • Feb. 4, 2019 -
Payers balk at HHS proposal to end federal PBM rebates
AHIP criticized the administration's plan as "well-intentioned but misguided." The payer lobby insisted rebate savings go directly to consumers, lowering premiums and cost-sharing.
By Shannon Muchmore • Feb. 1, 2019 -
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 -
Courtesy of Eli Lilly
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
Previous
