Keyword: Aimmune Therapeutics
In a 7-2 vote, an FDA panel backed Aimmune’s peanut allergy treatment for approval. It desensitizes patients with increasing doses of peanut protein.
In documents, the FDA stressed the difference between allergic reactions to the treatment and allergic reactions due to accidental exposure to peanuts.
Mary Rozenman, Ph.D., signs on from Aimmune as Insitro's CFO and chief business officer and Pfizer veteran Keith James, Ph.D., joins as SVP of drug discovery.
Aimmune has confirmed that the government shutdown will delay the FDA’s review of AR101, its oral immunotherapy for peanut allergy.
The FDA shutdown is holding up human trials for Aimmune's egg allergy program and may delay approval for its oral immunotherapy for peanut allergy.
The French biotech pulled the BLA after talks with the agency revealed gaps in the manufacturing and quality-control sections of the filing.
Results from Aimmune’s phase 3 trial of AR101 for peanut allergy have been published and bode well for its planned FDA filing next month.
Two years after Nestlé Health Science poured $145 million into Aimmune, the company is boosting its total investment in the biotech to $273 million.
The trial's size and AnaptysBio’s analysis of the data leave scope for questions about the results and their implications for the anti-IL-33 antibody.
Aimmune plans to file for FDA approval by the end of 2018 to give patients a way to protect themselves against accidental exposure to peanut protein.