Two days after the U.S. FDA announced approval of gene therapy Lenmeldy (atidarsagene autotemcel), making it the first treatment option for rare disease metachromatic leukodystrophy, Orchard Therapeutics and parent firm Kyowa Kirin Co. Ltd. disclosed the wholesale acquisition price of $4.25 million for the one-time treatment, which edges out hemophilia B gene therapy Hemgenix (etranacogene dezaparvovec) to become the world’s most expensive drug.
Scottsdale, Ariz.-based Renovacare Inc., has come to terms over allegations that the company engaged in what the Securities and Exchange Commission (SEC) said was a pump-and-dump scheme designed to defraud the company’s investors. The initial SEC complaint dated May 28, 2021, alleges that Renovacare and company executives began making misleading statements to investors as far back as July 2017, making this yet another cautionary tale of duplicitousness in life science startups.
Laboratory Corporation of America Holdings expanded its blood biomarker test portfolio for Alzheimer’s disease, making its pTau217 test available by prescription in the U.S. as well as for research globally. The standalone test can also be used in monitoring patients undergoing treatment for the neurodegenerative disease.
The U.S. FDA has followed up on reports of problematic syringes made by several companies in mainland China, recommending that U.S. suppliers, consumers and health care organizations stop using these products unless no alternatives are available. The agency said it has issued warning letters to three of these companies, at least one of which appears to have been the supplier of Monoject syringes that have been the subjects of recent FDA recalls.
About six months after Johnson & Johnson (J&J) returned rights to the compound, oral Tryvio (aprocitentan) won FDA clearance for Idorsia Ltd. Given once daily at a 12.5 mg dose, Tryvio is indicated for hypertension in combination with other blood pressure drugs in patients whose condition is not adequately controlled.
Real life economics, not functionality, is the standard for determining a relevant antitrust market for distinct versions of a prescription drug, the U.S. Court of Appeals for the Second Circuit said as it schooled a lower court and handed Regeneron Pharmaceuticals Inc. a win in its ongoing litigation with Novartis AG and Vetter Pharma International GmbH over the prefilled syringe market for eye drugs Eylea (aflibercept) and Lucentis (ranibizumab).
Validating Fusion Pharmaceuticals Inc.’s radiopharmaceutical technology and manufacturing capabilities, Astrazeneca plc offered to buy the firm for $2 billion up front in cash, plus a contingent value right that could raise the total deal value by another $400 million.
The U.S. FDA has approved Beigene Co. Ltd.’s Tevimbra (tislelizumab-jsgr) as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that did not include a PD-1 inhibitor. A humanized IgG4 anti-PD-1 monoclonal antibody, tislelizumab is designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.
Samsung Life Science Fund, created jointly by Samsung Biologics Co. Ltd., Samsung Biopeis Co. Ltd. and Samsung C&T Corp., said it invested in Waltham, Mass.-based antibody-drug conjugate (ADC) developer Brickbio Inc. on March 18, as its fifth biotech investment.
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