Even as U.S. lawmakers continue to push back against the rising price of prescription drugs and patients with life-threatening diseases clamor for access to new treatments, the FDA is considering a step that could increase the cost and lengthen the development time of therapies targeting non-small-cell lung cancer and perhaps other solid tumors.
A new collaboration with Dren Bio Inc. means Novartis Pharma AG has negotiated two of the biggest deals of 2024, with its parent company Novartis AG signing a third. Privately held Dren is getting $150 million up front and the chance to ultimately bring in $2.85 billion. The $150 million up-front payment includes a $25 million equity investment.
The July 25 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) could impact the future development of immune checkpoint inhibitors, such as Astrazeneca plc’s Imfinzi, to treat patients with non-small-cell lung cancer (NSCLC) both before and after surgery. Although much of the discussion will focus on an sBLA for Imfinzi (durvalumab), the committee will be asked to vote on whether the FDA should require that new trial design proposals for perioperative regimens for resectable NSCLC include adequate within-trial assessment of the contribution of the treatment phase to efficacy results.
After reaching a height in 2021, seed and series A rounds have fallen in recent years, and 2024 is no exception, although amounts raised are tracking slightly ahead of last year. On July 23, the numbers were given a boost when two new companies – namely Dover, Del.-based Brenig Therapeutics Inc. and Boston-based Third Arc Bio Inc. – raised $65 million and $165 million, respectively, in series A financings. A third new company, Abiologics Inc., also received $50 million in initial funding.
The 2024 meeting of the International AIDS Society (IAS), which is being held in Munich this week, began with the announcement of another curative bone marrow transplant. The new case brings the total number of patients cured of HIV via a bone marrow transplant up to 7 since “Berlin patient” Timothy Ray Brown became the first such person in 2007.
The U.S. FDA advised Agenus Inc. to conduct a phase III trial for its immunotherapy combination, botensilimab (bot) and balstilimab (bal), instead of seeking accelerated approval based on phase II data, sending company shares plunging by 58.8% July 18.
Lotte Biologics Co. Ltd. broke ground on its contract development and manufacturing organization (CDMO) plant at its Songdo Bio Campus in Incheon, South Korea, on July 3 to grow its production capacity and set “a new standard” for Korean CDMOs in the global market.
Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma.
Through a global rights agreement with Futuregen Biopharmaceutical Co. Ltd., Abbvie Inc. continues to build its immunology portfolio to help offset losses from Humira as biosimilars tighten their grip on the mega-blockbuster.
Amgen Inc. is looking to position inebilizumab as the first therapeutic specifically for treating immunoglobulin G4-related disease (IgG4-RD), a rare, immune-mediated condition that can affect multiple organs, after yielding what Leerink Partners analyst David Risinger called “exceptional” phase III results.
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