Category: News

April 8, 2024

The decision came right after the US regulator also cleared Bristol-Myers Squibb and 2seventy bio’s rival CAR-T Abecma as a third-line therapy for relapsed or refractory multiple myeloma, moving the cell therapies much earlier in the treatment pathway from their […]

March 29, 2024

Some pain-relieving skin products contain potentially harmful doses of the numbing agent lidocaine and should be avoided, the U.S. Food and Drug Administration warns. These creams, gels, sprays and soaps are marketed for topical use to relieve the pain of […]

March 1, 2024

The number of contractors and subcontractors involved in the supply chain for finished goods can be high, and their relationships very complex, particularly when goods are shipped by air or sea. Depending on the scope of the activity (e.g., whether […]

February 29, 2024

When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to […]

February 28, 2024

The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]

February 27, 2024

The round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]

February 26, 2024

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]

February 20, 2024

If approved, Vyvgart Hytrulo (efgartigimod alfa) will be the first drug in the FcRn blocker class to treat CIDP, a rare autoimmune disease of the peripheral nervous system that causes fatigue, muscle weakness, and loss of feeling that can lead […]

February 15, 2024

The US regulator has cleared Aurlumyn (iloprost) injection from CiVi Biopharma subsidiary Eicos Sciences as a treatment for severe frostbite, caused by prolonged exposure to extreme cold, after a priority review. The incidence of severe frostbite injury in the US […]

February 14, 2024

LianBio had a busy end to 2023. In October, the biotech sold its marketing rights to the heart medicine mavacamten in Asian countries to Bristol Myers Squibb for $350 million. Not long after, the company received an unsolicited bid from […]

February 6, 2024

To hear venture capitalist Alex Morgan tell it, investors shouldn’t be in the business of predicting trends. “There’s often a public perception that we’re in the prediction game,” said Morgan, a partner at Khosla Ventures who oversees the firm’s biotechnology […]

February 2, 2024

If the biologics license application (BLA) is approved, afami-cel will become the first engineered T-cell therapy for solid tumours and the first effective treatment option for advanced synovial sarcoma in more than a decade, according to the Anglo-American company. Synovial […]

January 31, 2024

Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, […]

January 8, 2024

In 2028, Merck faces the possible loss of market exclusivity for its biggest product, Keytruda, which accounted for nearly half of its pharmaceutical revenue over the first nine months of 2023. Aiming to maintain its market share, Merck has been […]

January 8, 2024

Applesauce fruit puree pouches under recall and investigation for toxic lead levels may also contain another toxin, chromium, according to an update released Friday by the U.S. Food and Drug Administration (FDA). The products under recall are WanaBana, Weis and […]

January 5, 2024

A California-based company has raised tens of millions of dollars to support its mission of bringing an ecstasy-based therapy to patients with post-traumatic stress disorder. MAPS Public Benefit Corp. formed a decade ago as a subsidiary of the Multidisciplinary Association […]

January 3, 2024

Goldman’s foray into the biotech world shows continuing investor appetite in the venture capital arena, even while the public biotech market remains tepid. The last year featured a number of new VC fund launches, including from Dimension, Cure Ventures, Yosemite, […]

January 2, 2024

The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and […]

December 14, 2023

The route – which is being piloted for two years – allows drugs deemed to be innovative and with a major medical benefit by the Haute Autorité de Santé (HAS) to be made eligible for reimbursement by French social security […]

December 7, 2023

Colorado officials say their plan to import cheaper medicines from Canada has been stymied by opposition from drugmakers and inaction by the Biden administration, according to a state report obtained by KFF Health News. The Dec. 1 report, prepared for […]