Category: Regulatory
PharmaSignal — Regulatory
FDA issues complete response letter to Replimune’s RP1 for melanoma
Pharmaceutical Business Review
The decision affects Replimune’s lead product candidate, which is based on a genetically engineered herpes simplex virus intended to stimulate an anti-tumour immune response.
FDA issues complete response letter to Replimune’s RP1 for melanoma
Pharmaceutical Technology
The FDA has issued a complete response letter to Replimune’s biologics license application concerning the RP1 therapy.
FDA hands another rejection to Replimune’s melanoma therapy
Pharmaphorum
Replimune has had its advanced melanoma treatment RP1 turned down by the FDA for a second time, prompting job losses.
Bayer wins MHRA approval for Kerendia in heart failure
PharmaTimes
New authorisation offers additional option for patients with lvef 40%
GSK again pulls application for leucovorin, touted by FDA as potential autism treatment
BioSpace
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to…
FDA seeks permanent future for rare pediatric priority review vouchers
Pharmaceutical Technology
The rare disease framework has had a turbulent past few years, with the FDA looking to create regulatory stability.
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
BioSpace
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.
MSD secures EC clearance for Keytruda combination therapy for ovarian cancer
Pharmaceutical Technology
MSD has received the EC approval for Keytruda along with paclitaxel, with or without bevacizumab, as a treatment for PD-L1-positive ovarian cancer.
Eli Lilly wins FDA approval for weight loss pill, tees up Novo rivalry
Pharmaceutical Technology
Lilly’s product, known under the brand name Foundayo, has a clear route to early blockbuster status.
FDA approves Lilly obesity pill, triggering battle with Novo Nordisk
BioPharma Dive
Foundayo could erase the Wegovy pill s four-month head start as the two drugmakers clash on a debate of efficacy and convenience.
Lilly bags FDA okay for Wegovy pill rival orforglipron
Pharmaphorum
Eli Lilly has claimed US approval for oral GLP-1 agonist orforglipron, setting up a market clash with Novo Nordisk’s first-to-market Wegovy pill.
Eli Lilly’s Oral Obesity Pill Approved, Kicking Off Renewed Novo Rivalry
BioSpace
The FDA approved Eli Lilly’s orforglipron–to be known as Foundayo–on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.
FDA approves new high dose Spinraza regimen for SMA
FDA Ties Amgen’s Rare Inflammatory Disease Drug to Eight Deaths, Dozens of Liver Injuries
BioSpace
The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile.
IO Shuts Down Following Regulatory Roadblocks
BioSpace
The FDA advised IO Biotech last year to hold off on filing an approval application for its cancer vaccine Cylembio, pointing to a failed Phase 3 study in frontline advanced melanoma.
EMA seeks input on virtual alternative to animal test
Pharmaphorum
EMA delivers a milestone in the replacement of animals in drug testing with the qualification of a virtual model for repeat-dose toxicity studies.
FDA, after turbulent year, leaves drugmakers guessing on its direction
BioPharma Dive
Constant leadership changes and erratic decision-making have left the biopharmaceutical industry feeling its chief regulator is as unpredictable as it s ever been.
Agios mulls early FDA filing for sickle cell therapy
Pharmaphorum
Agios is planning to file its sickle cell disease candidate mitapivat with the FDA under the accelerated pathway within the next few months.