After spending decades developing targeted chemotherapy and bringing a dozen or so compounds into the clinic, Fusion Pharmaceuticals Inc. Chief Scientific Officer Christopher Leamon switched careers to focus on radio-oncology because he saw the need for “a really strong bomb to target cancer to get it to respond.” That was radiotherapy, said Leamon, who was one of the scientific founders of Endocyte Inc., which Novartis AG acquired. Read More
If its challenges can be overcome, radioligand therapy is poised to change the way many cancers are treated. It is also likely to become an example of how scientific advances, once they are translated successfully, can enable further insights in a bench-to-bedside-to-bench loop. David Piwnica-Worms, professor and chair of cancer systems imaging at The University of Texas MD Anderson Cancer Center, predicted that as radioligand therapy expands, many questions will be answered about both radiation biology and the interaction of radiation with the immune system more specifically. Read More
The Advanced Medical Technology Association (Advamed) and the Biotechnology Innovation Organization (BIO) have teamed up on a friend-of-the-court brief for the U.S. Supreme Court’s upcoming hearing on twin cases that examine the question of a defendant’s state of mind when filing claims with federal health programs. Advamed and BIO argue that the existing judicial approach is critical to ensuring that companies in the life sciences are not subject to treble damages when acting reasonably in connection with products reimbursed by federal health programs, adding that an overturn of existing judicial practice would stifle innovation at the cost of patient access to life-saving medical therapies. Read More
As Seagen Inc. preps for a merger, the U.S. FDA awarded accelerated approval to the company’s big-selling Padcev (enfortumab vedotin). The approval is for a combination therapy with Merck & Co. Inc.’s Keytruda (pembrolizumab) as a first-line treatment for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy. Read More
Scorpion Therapeutics Inc. has out-licensed two of its small-molecule EGFR inhibitors to Pierre Fabre SA in exchange for a $65 million up-front fee and could also earn up to $553 million in potential milestone payments, plus royalties on net sales. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) has scaled back the list of Medicare Part B drugs facing the new inflation rebate under the Inflation Reduction Act for the first quarter of 2023. Read More
A few weeks after Gossamer Bio Inc. said it was pausing enrollment in a phase Ib/II study of CNS-penetrant BTK inhibitor GB-5121 in relapsed/refractory CNS lymphoma, citing the drug’s risk/benefit profile observed to date and a prioritization of resources, the company is dropping the drug’s development entirely. Read More
Innate Pharma SA inked a licensing deal that grants Takeda Pharmaceutical Co Ltd exclusive worldwide rights to research and develop antibody-drug conjugates using a panel of selected Innate antibodies against an undisclosed target, with a primary focus in celiac disease. Read More
Adcendo ApS has added a further €31 million (US$33.6 million) to its series A round, providing the means to take its lead antibody-drug conjugate (ADC) through to clinical proof of concept in the treatment of sarcoma. Read More
The U.S. NIH once again faces questions about its oversight of certain research. In the latest round, the U.S. Government Accountability Office called on the agency to do more to ensure that foreign facilities conducting NIH-funded animal research are compliant with U.S. standards and policy regarding animal care and use, as well as international standards. Read More
To help drug manufacturers comply with the technical requirements of RCD 753/2022 and other related standards regarding proof of a drug’s safety and efficacy, Brazil’s Anvisa issued three new guidelines for submitting registration requests for new or innovative synthetic and semi-synthetic drugs. Read More
New hires and promotions in the biopharma industry, including: Acasti, Aicuris, Arkuda, Biogen, Entrada, Flamingo, Legend, Mitsubishi Tanabe, Quantro. Read More
Biopharmas raising money in public or private financings, including: Cure Ventures, Diamond, Mosaic, OS Therapies, Psyence, Recce, Redhill, Viking. Read More
