While the FDA approved Zogenix Inc.’s Fintepla (fenfluramine), an oral treatment for patients ages 2 and older with seizures associated with Dravet syndrome, a rare, pediatric-onset form of epilepsy, the company stock continued its months-long struggle. Read More
Prevailing after an initial complete response letter from the FDA, Chiasma Inc. on June 26 has finally secured U.S. approval for Mycapssa, the first oral formulation of the acromegaly medicine octreotide to get a regulatory green light. Octreotide has until now only been available by injection. The drug was approved for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, both somatostatin analogues (SSAs). Read More
DUBLIN – Emer Cooke, named this week as the next executive director of the EMA, is the first woman to lead the organization since its creation in 1994. She is due to take up the post in November, but her appointment must first be ratified by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). She is due to present a statement to the group on July 13. Read More
The FDA sent a complete response letter (CRL) to Allergan plc, an Abbvie Inc. company, and Molecular Partners AG, of Zurich, Switzerland, regarding the BLA for abicipar pegol, their VEGF-A inhibitor-Darpin therapy for patients with wet age-related macular degeneration (AMD). Read More
LONDON – Two months after the launch, the World Health Organization (WHO) has laid out the spending plans for its push to accelerate development and production of COVID-19 vaccines, therapeutics and diagnostics. Read More
BEIJING – China this week approved both the country’s first mRNA vaccine candidate and its first recombinant protein subunit vaccine to begin clinical trials to fight COVID-19. Read More
A pair of upsized IPOs packed away cash by way of identical terms, with Boston-based Akouos Inc. and Fusion Pharmaceuticals Inc., of Hamilton, Ontario, separately selling 12.5 million shares at $17 each for $212.5 million in gross proceeds. Read More
Artiva Biotherapeutics Inc., of San Diego, has secured $78 million in series A financing to support its development of off-the-shelf universal NK cells for use in combination with monoclonal antibody therapy and tumor-targeting CAR-NK cell therapies. Read More
Technical challenges at the annual meeting of the International Society for Stem Cell Research (ISSCR) meeting led to at least one lively exchange of stem cell jokes in the chat box as the audience waited for talks to resume, including stem cell parental advice: “You can be anything you want when you grow up!” Read More
Deals tracked by BioWorld indicate a slight slowdown in activity moving from April to May, showing an 8% drop in the number of deals and a 43% drop in the disclosed deal values. Read More
BioWorld looks at translational medicine, including: A Tau-sand forms of tau?; P53 ‘glue’ gums up cancer cells; Shock and kill with less toxicity; Placental attachment theory. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alimentiv, Caiac, DBV, Diversigen, Helix, Hemogenyx, Medicinova, Novan, Siga, Vaxart. Read More
