In one of the year’s biggest deals, Bristol Myers Squibb Co. (BMS) is buying Turning Point Therapeutics Inc. for about $4.1 billion to get at a potential cancer blockbuster, repotrectinib. The oral tyrosine kinase inhibitor, Turning Point’s lead asset, targets ROS1 and TRK in treating ROS1-positive metastatic non-small-cell lung cancer. Once the deal closes, BMS’ acquisition of Turning Point would be the second largest of the year. The biggest remains Pfizer Inc.’s purchase of San Diego’s Arena Pharmaceuticals Inc. for $6.7 billion in March. Read More
The world’s biggest cancer-focused conference began June 3 as more than 40,000 attendees are expected at the American Society of Clinical Oncology’s (ASCO) annual gathering. The conference is being held in live in Chicago and is also available virtually. Among the more than 2,500 abstract presentations in about 120 subject subcategories are potential breakthroughs in treating non-small-cell lung cancer from Immutep Ltd., Cullinan Oncology Inc. and Surface Oncology Inc. Each company has seen upticks in their stock value, some as much as 10%, during the week as the conference approached and their data are presented. Read More
As the American Society of Clinical Oncology (ASCO) meeting began, researchers discussed abstracts related to findings due to roll out during the course of the weekend event. On the table June 3 were primary results from the double‐blind, placebo‐controlled, phase III Shine study of Imbruvica (ibrutinib) from Abbvie Inc. and Johnson & Johnson (J&J) in combination with bendamustine‐rituximab and rituximab maintenance therapy as a first‐line treatment for patients ages 65 and over with mantle cell lymphoma. Read More
Affibody AB and its development partners, Acelyrin Inc. and Inmagene Biopharmaceuticals Co. Ltd., are accelerating plans to move the interleukin-17A inhibitor izokibep (formerly ABY-035) into phase III studies in psoriatic arthritis following better-than-expected phase II efficacy combined with an apparently clean safety profile. Read More
Drug and device makers are necessarily wary of any activities that could lead to prosecution under the False Claims Act (FCA), but seemingly innocuous activities are now fair game for federal prosecutors. The latest example is the FCA prosecution of Caris Life Sciences for filing claims for cancer tests outside the 14-day post-discharge window, and Mark Gardner, directing attorney at Gardner Law of Stillwater, Minn., told BioWorld that device makers should be on the alert because it appears that federal authorities are ramping up enforcement. Read More
Shares of Novavax Inc. dropped 19% after briefing documents released ahead of the U.S. FDA’s June 7 advisory committee raised concerns about risks of myocarditis associated with COVID-19 vaccine NVX-CoV2373, though reviewers also noted the vaccine could offer protection against the omicron variant. The stock (NASDAQ:NVAX) closed June 3 at $44.76, down $11.21. Read More
As multidisciplinary care extends survival and improves the quality of life for people with amyotrophic lateral sclerosis (ALS), can a host of new ALS drugs vying to slow its progression make a difference? Join the BioWorld Insider podcast as we discuss what the future of medicine may hold for ALS patients. Read More
New hires and promotions in the biopharma industry, including: Aravive, Bexion, Boundless, Celularity, Concarlo, Elevar, Gilead, Optinose, PDS, Scorpion, Tessera, Sana, Sarepta, Soricimed. Read More
New and updated preclinical and clinical data to be presented by biopharma firms at American Society of Clinical Oncology annual meeting, including: Epizyme, Intensity, Mereo, Transcenta. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alnylam, Ampio, Astrazeneca, Athersys, Biovaxys, Boehringer Ingelheim, Etirarx, Gilead, Hookipa, Immunocore, Innate, Nirvana, Pfizer, Resilience, Sanofi, Vaxart. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Aeglea, Algotx, Evofem, Gamida, Iaso, Innovent, Myovant, Opiant, PDS, Pfizer, Takeda. Read More
