Biogen Inc. expects to begin shipping the company’s newly approved Alzheimer’s drug Aduhelm in about two weeks and has prepared more than 900 healthcare centers for the intravenous infusion treatment.
U.S. regulators on June 7 approved Biogen Inc.’s aducanumab as the first treatment to attack a likely cause of Alzheimer’s disease despite controversy over whether the clinical evidence proves the drug works, sending the company’s shares soaring.
Preliminary data from Annovis Bio’s Phase II study of ANVS401 shows significant cognitive improvements in Alzheimer’s patients after only one month of treatment.
Biogen reported that the company’s gene therapy, cotoretigene toliparvovec, failed to hit the primary endpoint of the Phase II/III XIRIUS trial for X-linked retinitis pigmentosa (XLRP).
Biogen Inc. exercised the company’s option to acquire TMS-007, an investigational drug for acute ischemic stroke, from TMS Co. Ltd.
Biogen and Capsigen forged a strategic collaboration to engineer novel adeno-associated virus (AAV) capsids that have the potential to become transformative gene therapies that treat underlying genetic causes of various central nervous system and neuromuscular disorders.
In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form.
Topline results from a Phase II study show SAGE-324, Sage Therapeutics’ investigational oral neuroactive steroid GABAA receptor positive allosteric modulator, significantly reduced tremor score in adult patients with essential tremor.
The U.S. Food and Drug Administration approved Biogen Inc.’s new intramuscular injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis.
RNAi-focused Atalanta Therapeutics launched with $110 million in combined Series A funding and collaboration deals with Genentech and Biogen to address diseases related to the central nervous system, including Huntington’s, Alzheimer’s and Parkinson’s diseases.