New hires:
Deerfield Agency, a 2023 MM+M Agency 100 honoree, hired Sam Cannizzaro as its first chief creative officer.
Deka Biosciences appointed Stanley Frankel, M.D., FACP as interim chief medical officer and as a member of its scientific advisory board.
IPG Health added Jessica Specker as executive director of global content solutions and Jack Vance as managing director of data and activation at IPG Health and SOLVE(D).
Pragma Bio tapped Dr. Mohamed Donia to serve as a scientific co-founder and chief scientific officer.
Executive elevations:
CMI Media Group promoted Leanne Smith to be its EVP of data strategy and governance.
Commercial-stage ophthalmic technology company Centricity Vision elevated Leonard Borrmann to CEO.
Board appointments:
Former Secretary of Commerce Wilbur Ross joined the board of biotech Coya Therapeutics.
Purple Biotech named Dr. Yael Margolin to its board of directors.
Deka Biosciences also named Stuart Chaffee, PhD as an independent director to the board.
1910 Genetics appointed Dr. Shaan C. Gandhi, head of strategic partnerships for Pfizer Ignite, as an independent board director.
Clinical stage immune-oncology company Cytovation appointed Ellen Lubman, MBA to its board of directors.
TC BioPharm formed a commercial development division, which will be led by Dr. Lauren Bor, PhD.
Specialty vaccine company Valneva transitioned from the company’s two-tier governance model to a one-tier model led by a board of directors.
Departures:
Amy Abernethy, the president of product development and chief medical officer at Verily, will leave the company at the end of the first quarter.
FDA:
The FDA announced the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will expand in-person face-to-face industry meetings (with a hybrid component), to include all Prescription Drug User Fee Act, Biosimilar User Fee Act and Over-The-Counter Monograph Drug User Fee Program meeting types.
The FDA also warned consumers of illegally marketed diabetes treatments and fraudulent pharmacies.
Merck said the agency approved Welireg, an oral hypoxia-inducible factor-2 alpha inhibitor, to treat patients with advanced renal cell carcinoma.
The agency placed a clinical hold on three CAR-T candidates from CARsgen Therapeutics.
Checkpoint Therapeutics said the agency declined to approve its experimental therapy to treat a type of advanced skin cancer, citing issues related to a third-party contract manufacturer.
The agency approved US WorldMeds’ new drug application for the use of eflornithine as a therapy for high-risk patients with neuroblastoma.
Layoffs:
San Francisco-based genetic data startup Invitae cut its headcount by more than 200 employees.
Deals:
GSKstruck a deal worth up to $1.7 billion with China-based Hansoh Pharma to pick up the rights to an antibody-drug conjugate (ADC), HS-20093, which is being investigated in cancer.
In a transaction valued up to $848 million that includes a $60 million up front payment, Compugen agreed to sell exclusive rights to Gilead Sciences for later stage development and commercialization of Anti-IL 18 binding protein antibodies.
First Wave BioPharma signed a non-binding term sheet for a business combination with ImmunogenX.
Teva Pharmaceutical announced an exclusive license agreement with Biolojic Design to develop a potential novel antibody-based therapy for the treatment of atopic dermatitis and asthma.
Spatially Health, a Miami-based health technology company, partnered with VBCare Network, a value-based provider network serving Medicaid and Medicare beneficiaries in Arizona.
Absci announced a strategic research and development partnership with PrecisionLife to develop an AI-enabled drug pipeline.
Funding rounds:
San Francisco–based venture capital firm Pivotal bioVenture Partners closed its second fund, with $389 million in capital commitments to support the development of novel medicines.
Biotech royalty aggregator XOMA Corporation entered into a non-dilutive, non-recourse, royalty-backed loan for up to $140 million of capital with certain funds managed by Blue Owl Capital.
Sudo Biosciences raised $116 million in a Series B financing round.
Fractyl Health filed for a $100 million IPO.
Totus Medicines closed a $66 million Series B funding round and named Nassim Usman, PhD as president and CEO.
Hybrid weight-inclusive primary care company Knownwell raised $20 million in a Series A funding round led by A16Z with participation from existing investors including Flare Capital Partners.
Industry news:
GSK announced a combination of its cancer drugs Zejula and Jemperli, when used as a maintenance therapy following Jemperli plus chemotherapy, met the main goal of a late-stage trial to treat a certain type of endometrial cancer.
Moderna inaugurated its first African manufacturing site in Kigali, Rwanda.
Shorla Oncology and Eversana announced the U.S. commercial launch of Jylamvo, an oral methotrexate solution approved by the FDA.
Verrica Pharmaceuticals’ development and commercialization partner, Torii Pharmaceutical, reported positive top-line results from its Phase 3 trial of its potential treatment for molluscum contagiosum in Japan.
The Muscular Dystrophy Association hit its $100 million fundraising milestone with longstanding partner Acosta Group.
Edgewise Therapeutics launched an educational website dedicated to the Becker muscular dystrophy community.
Mirum Pharmaceuticals said data from a Phase 2 trial for its potential biliary atresia treatment Livmarli didn’t meet either its primary or secondary endpoints.
