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Replimune’s resubmission for RP1 for melanoma comes after the departures of FDA leaders in place at the time of the drug’s first two rejections. The FDA expects to hold an advisory committee meeting in late July.
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Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.”
Formed by Sofinnova Partners and former Sanofi executive Frédéric Marrache, Bionyra Pharma emerged from stealth Monday with an initial focus in inflammatory bowel disease and atopic dermatitis.
About two months into CEO Belén Garijo’s new tenure, Sanofi’s R&D chief has departed, with Xaira’s chief medical officer set to take charge of the pharma’s pipeline.
As uniQure prepares its closely watched Huntington’s disease gene therapy for FDA review, the biotech is also making waves in chronic epilepsy with another gene therapy that Stifel says is off to a “promising start.”
Eli Lilly plans to use BioArctic’s technology to shuttle an undisclosed drug candidate into the brain. The pharma hasn’t specified which neurodegenerative disease it will target.
Insilico Medicine and SK Biopharmaceuticals will use generative AI to develop novel therapies for unspecified neuroimmune disorders.
AbbVie will add Apogee’s IL-23 blocker to its current immunology stalwarts Skyrizi and Rinvoq, which have helped the pharma ride out the steep patent cliff left behind from mega-blockbuster drug Humira.
Nura Bio will use the series B financing to carry two neuroprotective drug candidates through early- to mid-stage clinical studies, one targeting ALS and the other for a broader neurological profile.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.