New top-line data from Scholar Rock Holding Group’s phase II Topaz trial of apitegromab (SRK-015) in patients with type 2 and type 3 spinal muscular atrophy generated enough proof-of-concept results for the company to plan on initiating a phase III for later this year. But the 12-month data didn’t stop the Cambridge, Mass.-based company’s stock (NASDAQ:SRRK) from struggling mightily on April 6 as shares closed 20.3% lower at $35.97 each. Read More
Mineralys Therapeutics Inc., a Philadelphia-based company developing an aldosterone synthase inhibitor in-licensed from Mitsubishi Tanabe Pharma Corp. (MTPC), has raised $40 million in series A funding to complete a phase II proof-of-concept study in hypertension for the candidate, known as MLS-101. Read More
LONDON – The largest study to date, involving 236,379 confirmed cases, shows that 1 in 3 survivors of COVID-19 was diagnosed with a neurological or psychiatric condition within six months of contracting the infection. For 13% of those patients, it was their first such diagnosis. Read More
Plans for a late-stage test of Valneva SE's COVID-19 vaccine candidate, clinical progress on a different vaccine from Novavax Inc. and advancement for two midstage therapies targeting the virus made clear April 6 that industry efforts to battle the pandemic remain in high gear. Read More
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.” Read More
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ABL, Aptinyx, Astrazeneca, Azafaros, Azurrx, Daiichi Sankyo, Dilafor, Dynavax, Enzychem, I-Mab, J&J, Molecular Partners, Neurorx, Novartis, Novavax, Opiant, Pinteon, Relief, Scholar Rock, Turning Point, Union, Valneva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AB Science, Amarin, Ampio, Ani, Boehringer, Catalent, Checkmate, Hoth, Janssen, Kuros, Ionis, Maxwell, Moderna, Ose, Oryzon, Oxford Biomedica, Progenity, Rational Vaccines, Valeo, Yumanity. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Bioniz, Gan & Lee, Huyabio, Landos, Mitoimmune, Ortho Regenerative, Tarus. Read More
