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FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
FEATURED STORIES
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Amylyx Pharmaceuticals shared news that the FDA has extended the review period for AMX0035, a combination drug treatment with the potential to treat patients with ALS.
The results showed that insulin icodec is as non-inferior to Sanofi’s insulin glargine, Lantus, potentially bringing another major competitor into the insulin space.
Acelyrin, Affibody AB and Inmagene Biopharmaceuticals presented positive Phase II data for izokibep in psoriatic arthritis, while Aurinia’s Lupkynis hit post-hoc treatment targets in lupus nephritis.
Four life sciences companies posted previews of their respective programs ahead of the American Society of Clinical Oncology (ASCO) annual meeting on June 5, 2022.
Shares of Cleveland-based Athersys, Inc. are plunging Friday after the company announced a strategic restructuring that will result in the slashing of 70% of its workforce.
Pfizer’s Paxlovid shows benefits for vaccinated and unvaccinated patients for COVID-19, ages 65 and up while the White House indicates children under five could receive COVID vaccines by June 21.
Sanofi will study its SAR444245 in combination with Immunocore’s KIMMTRAK in HLA-A*02:01 positive patients with advanced unresectable or metastatic skin cancers.
In order to stay afloat while maintaining a competitive edge, many life science companies are going to have to get creative in order to keep up with rising salaries and inflation.
Biogen and Ionis Pharmaceuticals have announced results from the Phase III VALOR trial and an open-label extension (OLE) trial of tofersen.
Proxygen partnered with Germany-based Merck to jointly identify and develop molecular glue degraders for clinical research.