Regulation

July 23 Quick Takes: FDA wants more data from Incyte on retifanlimab

Incyte Corp. (NASDAQ:INCY) may have to wait on results from the confirmatory POD1UM-303 study of retifanlimab before FDA will approve the intravenous PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal...

July CHMP recommendations: Data Byte

Among CHMP’s positive opinions this month is a recommendation for Nexviadyme avalglucosidase alfa, a long-term recombinant human GAA replacement therapy by the Genzyme unit of Sanofi (Euronext:SAN; NASDAQ:SNY), to treat Pompe disease. Meanwhile, Roche (SIX:ROG;...

New NASDAQ listings see mixed performance

Three newly public biotechs raised more than $500 million since Thursday’s market close, and saw varied first-day performance ranging from single-digit gains to double-digit losses.  After a brief slowdown in 2Q21, IPOs began to pick...

July 16 Quick Takes: ROCK brings Kadmon first win at FDA; plus Merck, Moderna, Alexion, HIFs and more

The first approval for Kadmon Holdings Inc. (NYSE:KDMN) — Rezurock belumosudil for third-line chronic graft-versus-host disease (cGVHD) — marks FDA’s first approval of a small molecule ROCK2 inhibitor....

ICER panel unanimously rebuffs Aduhelm

In another setback for Biogen and Eisai, ICER’s California Technology Assessment Forum on Thursday voted 15-0 that the evidence is not adequate to demonstrate the net health benefit of Aduhelm plus supportive care is superior...

July 15 Quick Takes: FDA panel rebuffs FibroGen CKD program; plus PAQ, Galapagos, Adlai Nortye and Ablynx-LabGenius

In light of concerns over roxadustat’s cardiovascular safety risks, FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13-1 against approval of the oral HIF-PH inhibitor to treat anemia in chronic kidney disease patients not dependent...

FDA questions roxadustat’s safety ahead of Thursday adcom

During Thursday’s meeting to discuss FibroGen’s NDA for roxadustat, FDA’s Cardiovascular and Renal Drugs Advisory Committee plans to discuss whether the candidate’s cardiovascular safety risks could be addressed by modifying dosing or treatment monitoring protocols, and...

Aduhelm: a tangled plot; plus INTREPID pandemic planning: a BioCentury podcast

A revised label and a request for an investigation by Acting FDA Commissioner Janet Woodcock are the latest tangles in the controversy over the approval of Alzheimer’s drug Aduhelm. In the latest BioCentury This Week...

New Aduhelm label disregards Biogen’s call for diagnostic

The revised Aduhelm label released Thursday calls for initiating therapy in early stage Alzheimer’s patients, which is consistent with clinical trial data and is in accord with statements from Biogen and Eisai. Unlike the clinical...

CHMP’s recommendations for June

Along with a positive opinion for Opdivo nivolumab to treat adult patients with esophageal or gastroesophageal junction cancer, Bristol Myers Squibb Co. (NYSE:BMY) also received a recommendation from EMA’s CHMP for conditional approval of BCMA CAR T...

FDA expediting two more anti-amyloid therapies for Alzheimer’s

After its accelerated approval of Biogen’s aducanumab, FDA is moving quickly to expedite development of two more anti-amyloid mAbs, with Lilly’s donanemab looking like it could be the first in the indication...

Amyloid analysis — stress testing FDA’s logic on a surrogate endpoint for Alzheimer’s: a BioCentury podcast

Documents released by FDA Tuesday to resolve arguments over the agency’s decision to grant accelerated approval to Biogen’s aducanumab have done the opposite, fueling rather than settling a contentious...

FDA cites patient, caregiver risk tolerance as factors in Alzheimer’s approval

FDA’s decision to grant accelerated approval to aducanumab was influenced by conversations with Alzheimer’s patients and caregivers who said they were willing to accept uncertainty about its benefit, according...

FDA’s rationale for amyloid surrogate endpoint sure to spark controversy

Documents released by FDA summarizing its review of Biogen’s aducanumab do little to settle the dispute over the drug’s efficacy, rehashing rather than resolving the litany of arguments on either side....

Amyloid stands out among surrogate endpoints, and not in a good way: Data Byte

Among the 15 surrogate endpoints upon which FDA has granted accelerated approvals in the last five and half years, β-amyloid clearance appears to be the most weakly supported. Ninety nine (87%) of the...