Byondis BV is gearing up for a U.S. filing of an antibody-drug conjugate (ADCs) in advanced HER2-positive breast cancer, but CEO Marco Timmers has grand plans to partner up with big pharma and expand into other diseases.
In a bid to bring more drug manufacturing back to the U.S. and to ensure an adequate supply of essential medicines, even in public health emergencies, the U.S. Department of Health and Human Services is forming a public-private consortium on advanced manufacturing and the onshoring of domestic production.
During a conference call with investors, Biogen Inc. officials defended the price of Aduhelm (aducanumab) for Alzheimer’s disease (AD), with CEO Michel Vounatsos saying the $56,000 per year price tag was based on “the value it is expected to bring to patients, caregivers, and society.”
Novo Nordisk A/S will this month launch its weekly weight loss glucagon-like peptide-1 injection Wegovy (semaglutide) at the same monthly cost as its older daily shot Saxenda (liraglutide), following FDA approval in overweight and obese adults.
By granting accelerated approval for Biogen Inc.’s Aduhelm (aducanumab) for Alzheimer’s disease (AD), the FDA is “essentially confirming that the beta-amyloid hypothesis has been validated,” Mizuho analyst Salim Syed said in an alert to investors. Shares of Cambridge, Mass.-based Biogen (NASDAQ:BIIB) closed $395.85, up $109.71, or 38.3%, as Wall Street hailed the first new AD therapy to reach the market since 2003.
A day before its June 5 PDUFA date and three months after its original PDUFA, Ryplazim (plasminogen, human-tvmh), from Liminal Biosciences Inc., won FDA approval for treating plasminogen deficiency type 1 hypoplasminogenemia, becoming the first approved therapy for the rare genetic disorder.
Following years of testing against a lengthy roster of viral foes, Chimerix Inc.'s Tembexa (brincidofovir) has finally won FDA approval as a medical countermeasure against smallpox.
In February 2020, when Redhill Biopharma Ltd. acquired the peripherally acting mu-opioid receptor antagonist (PAMORA) Movantik (naloxegol) from Astrazeneca plc, new prescriptions were dropping. But that picture has turned around after about nine months of promotion, with strong reimbursement trends for the product, and Redhill may have positioned itself to become a leader in the gastrointestinal (GI) space.
The U.S. Federal Trade Commission (FTC) is turning the biopharma industry’s claim about rebates on its ear, saying some rebates paid to pharmacy benefit managers and third-party payers are an anticompetitive tool drug companies use to maintain their U.S. market power.
A lawsuit filed last year challenging a federal rule and certification allowing certain drugs to be imported from Canada should be dismissed because no drug companies have been harmed yet, nor are they likely to be any time soon, the Biden administration said in a motion seeking dismissal of the suit.
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