The U.S. COVID-19 vaccine program is at risk of “booster fatigue,” which will undermine public confidence in the vaccines, several members of the CDC’s Advisory Committee on Immunization Practices (ACIP) said April 20 as they met to discuss the future of the vaccines. Rather than relying on boosters, “we need to use our expertise to advocate for something that’s better,” something that resolves the ill effects of COVID-19, whether it’s mild or severe, said Lynn Bahta, an immunization program clinical consultant for the Minnesota Department of Health. Read More
Arcturus Therapeutics Holdings Inc. reported that ARCT-154, its self-amplifying mRNA COVID-19 vaccine, showed efficacy of 55% against infection and 95% efficacy against severe disease, meeting the primary and key secondary endpoints of the ongoing phase I/II/III trial. While the company’s stock (NASDAQ:ARCT) regained much of its initial 25% drop to close the day, investors continue to await further data to determine where Arcturus’ vaccine will fit in with available COVID-19 vaccines. Read More
Abbvie Inc. is stepping away from a 2016 deal with Bioarctic AB to develop alpha-synuclein antibodies for treating Parkinson’s disease, originally valued at up to $775 million. Bioarctic said it plans to stay the course without its big-pocketed partner. Bioarctic’s stock (Stockholm:BIOA-B) fell 14.6% to SEK90 (US$9.40) on April 20. Read More
Windtree Therapeutics Inc.’s positive top-line data from the phase II study called Seismic, testing istaroxime in cardiogenic shock (CS), a form of sudden heart failure (HF), add “a lot of interesting strategies and options” with the compound, also in development for acute HF, said CEO Craig Fraser. Read More
Shares in Medincell SA dropped 29.1% Apr. 20 on news that the U.S. FDA slapped a complete response letter (CRL) on an NDA for an extended release, long-acting formulation of risperidone, which it is co-developing with Teva Pharmaceuticals Industries Ltd. as a maintenance treatment for schizophrenia. Read More
Satellite Biosciences Inc. has become the latest biotech to emerge from stealth, backed with more than $110 million in VC financing to develop bioengineered tissues that fix damaged tissues or organs. With former Novartis executive Dave Lennon leading as CEO, the Cambridge, Mass.-based company is hoping to find therapies for hard-to-treat diseases. Read More
After several delays due to COVID-19, Canada is on track to implement, within a few months, its first major changes to its Patented Medicines Regulations in more than 30 years. One change coming July 1 is a new basket of comparator countries that will be used to determine whether a drug’s Canadian price is excessive. Read More
Genequantum Healthcare Co. Ltd. will work with Aimedbio Inc. to co-develop an antibody-drug conjugate (ADC) to treat brain and other cancers, working toward an IND filing in 2023. Read More
New hires and promotions in the biopharma industry, including: Acrivon, Ambys, Enochian, Hookipa, Medipharm, Merck, Treadwell, Vaxxas, Vigil. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acadia, Amgen, Beigene, Bioage, Biorestorative, Clover, Cyclacel, Kempharm, Moderna, Neuraly, Synaptogenix, TFF, Urovant.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aclipse, Aptinyx, Benevolentai, Diamyd, Dragonfly, Endevica, Heat, Hoth, Neuropore, Nextcure, PDS, Pharmacyte, Soligenix, Therapeutic Solutions. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adicet, Astrazeneca, Axsome, Aytu, Daiichi Sankyo, Hansa, Innovative Cellular, Merck, Navidea, Novavax, NTC, Ribomic, Serum Institute, Takeda.. Read More
