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IPO
LB Pharma needed $350 million to advance a promising schizophrenia candidate at a time when the biotech markets were locked up tight. Fortunately, it wasn’t CEO Heather Turner’s first rodeo.
FEATURED STORIES
Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care.
Billions of dollars’ worth of cancer drugs are discarded each year. Manufacturers must refund Medicare for some of this waste. A data-driven approach offers a practical path to greater efficiency.
Sales of Merck’s longtime oncology blockbuster Keytruda will erode more starkly in about 2033 rather than 2029, predicts Bloomberg Intelligence, translating to some $22 billion more in revenue.
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Read our takes on the biggest stories happening in the industry.
FDA
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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The U.S. Department of Justice has slapped BioMarin Pharmaceutical with a subpoena in connection with its sponsored testing programs for the rare disease therapies Vivizim and Naglazyme.
Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.
The oral antibiotic, which is also in development for uncomplicated urinary tract infections, demonstrated non-inferiority to the most common treatment for gonorrhea.
Boehringer Ingelheim and Zealand Pharma’s dual glucagon/GLP-1 receptor agonist elicited significant topline Phase II results in metabolic dysfunction-associated steatohepatitis.
Approved earlier this month for children and adults with one or more food allergies, Xolair in a Phase III study reduced severe allergic reactions in patients suffering from multiple food allergies.
Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.
FDA
On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.
GSK terminated their collaboration with Vir to research, develop and commercialize the biotech’s monoclonal antibodies for the prevention, treatment, or prophylaxis of the influenza under a 2021 agreement.
The cancer space has been aflutter with notable approvals so far this year, but there are several more candidates with significant data expected over the next four months. BioSpace takes a closer look.
Thanks to the success of outgoing CEO Richard Gonzalez, biopharma executives will be studying for years to come how AbbVie navigated the decline of blockbuster Humira.