Neumora Therapeutics Inc., a neuroscience startup aiming to launch precision medicines for brain diseases, said Oct. 7 it has raised more than $500 million, including a $100 million equity investment from Amgen Inc. and a series A financing led by Arch Venture Partners. The company launches with a portfolio of eight clinical, preclinical and discovery-stage programs from internal discovery efforts, the acquisitions of multiple private companies and a new license agreement with Amgen. Read More
Intergalactic Therapeutics Inc. is aiming for the stars with a nonviral gene therapy platform, backed with $75 million in series A financing from life sciences venture capital firm Apple Tree Partners. While management are tongue in cheek about the name of the company, they are serious about their mission to produce a next generation of gene therapies that overcome the issues associated with marketed adeno-associated virus-based products. Read More
If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients. Read More
With its topical gel for primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older, Brickell Biotech Inc. is gearing up to challenge Journey Medical Corp.’s Qbrexza (glycopyrronium), an anticholinergic agent contained in a single-use, pre-moistened, medicated cloth. Read More
With a growing number of deals worth $1 billion or more, 2021 values are slowly inching past 2020’s record year, as mergers and acquisitions also move higher, indicating a potentially stronger second half of the year. Read More
Data from two phase I studies from Prelude Therapeutics Inc. helped open the American Association for Cancer Research virtual International Conference on Molecular Targets and Cancer Therapeutics on Oct. 7 but tugged the company’s stock sharply downward. Read More
LONDON – The World Health Organization (WHO) is recommending the widespread rollout of Glaxosmithkline plc’s Mosquirix (RTS,S), the first malaria vaccine, following real-world evidence it is safe and can be integrated into routine immunization programs and existing malaria control measures. Read More
DUBLIN – Sapreme Technologies BV is taking a novel approach to the extraordinary inefficiency of intracellular delivery of macromolecular drugs by developing a series of compounds that can dramatically improve the rate with which drugs such as proteins and oligonucleotides can escape the endosome. Read More
FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels. Read More
Biopharmas raising money in public or private financings, including: Affyimmune, Amplo, Appili, Imophoron, Osmotica, Progenity, Pyxis, Theseus. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Brickell, Bristol Myers, Celltrion, Denali, G1, Genetx, Inhalon, Jounce, Minervax, Timber, Ultragenyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aicuris, Alx, Blade, Calliditas, Curative, Cytodyn, Debiopharm, Dexa, Evox, Flightpath, Genkyotex, Immunoprecise, Janssen, Johnson & Johnson, KGK, Mid-Atlantic, Moderna, Neurorx, Northwestern, Pierre Fabre, Psyched, Relief, Talem, Tryp. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Pfizer. Read More
