The FDA and the CDC have jointly paused the further rollout of Johnson & Johnson Co.’s COVID-19 vaccine while they investigate six rare clotting cases in adults between the ages of 18 and 48. The CDC is convening a meeting of its Advisory Committee on Immunization Practices this morning to further review the six cases of cerebral venous sinus thrombosis (CVST), which coincided with thrombocytopenia or low levels of blood platelets. This follows a report on April 9 from the EMA’s Pharmacovigilance Risk Assessment Committee of “thromboembolic events” – blood vessel blockage due to clot formation – in individuals who had received COVID-19 Vaccine Janssen. As of April 12, more than 6.8 million doses of J&J’s COVID-19 vaccine had been administered.

Senti enters a $645M deal with Spark

Senti Biosciences Inc. stands to receive more than $645 million in up-front, opt-in and milestone payments through a new collaboration and option agreement with Spark Therapeutics Inc. Spark will apply South San Francisco-based Senti’s gene circuit technology to develop therapies targeting cells in the CNS, the eye and liver, while Senti handles the design, building and testing of cell type- and disease specific-synthetic promotors. Spark has the option to exclusively license synthetic promotors to use in developing gene therapy products. Spark will also have the option to conduct preclinical, clinical and commercialization duties for any candidates incorporating Senti’s licensed synthetic promotors.

Theseus Pharmaceuticals raises $100M series B for pan-variant kinase inhibitors

Theseus Pharmaceuticals Inc., a startup developing new tyrosine kinase inhibitors to overcome treatment-resistant cancer mutations, has raised $100 million in a series B financing led by Foresite Capital. Co-founded at the health care investment firm Orbimed with former Ariad Pharmaceuticals Inc. scientists who pioneered the development of pan-variant kinase inhibitors, the company's lead candidate is THE-630, a next-generation pan-variant KIT inhibitor for the potential treatment of refractory gastrointestinal stromal tumors.

Adcom to explore islet for diabetes relief

The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will be venturing into new territory April 15 in which it not only has to consider whether the benefit of Celltrans Inc.’s donislecel is clinically meaningful, but it also will have to define the indication. Donislecel, or cadaveric allogenic pancreatic islet cells, is being proposed as a treatment for “brittle type 1 diabetes,” which has not been specifically defined, according to the FDA. While the agency said it believes the number of trial participants freed from insulin might support the efficacy of the therapy, it questioned the duration of insulin independence that would be considered clinically meaningful. It also has questions about the characterization of the product, given the current “state of knowledge in the field of islet transplantation.”

China launches policies to encourage innovation, but pricing and payment remain pain points

SHANGHAI – China’s regulatory environment has evolved to encourage drug innovation, but despite remarkable progress, mounting pricing pressure from the government and a weak insurance sector remain as barriers. Those challenges, and progress to date, were a key focus for the 900 attendees at the 2021 China Pharmaceutical Innovation 100 Summit on April 10 in Shanghai.

Plx’s low-dose liquid aspirin pill with improved GI profile entering market soon

Sparta, N.J.-based Plx Pharma Inc. plans to launch next quarter the 81-mg and 325-mg doses of Vazalore, its liquid-filled aspirin capsule. About 43 million adults in the U.S. are at risk of cardiovascular events and many take low-dose aspirin as preventive care, but may quit because of gastrointestinal side effects. Vazalore uses Plx’s PLxguard drug delivery platform, ensuring that the drug bypasses the stomach and is released in the small intestine. Vazalore will go up against clopidogrel, first approved for Bristol Myers Squibb Co. as Plavix in 1997.

Australia lays out medical product manufacturing priorities to shore up future supply chains post-pandemic

PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience.

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