Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease. In February, the agency’s Vaccines and Related Biological Products Advisory Committee voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation. Read More
Having banked almost $775 million since its inception in 2019, Eikon Therapeutics Inc. closed three transactions to beef up its pipeline and raised nearly $106 million in a series C round. And the dealmaking will continue, said Alfred Bowie, chief financial officer. “We still have well over a half-billion in cash on our balance sheet,” he told BioWorld. “We’re active.” The new funds “add more fuel to the fire,” and let the company “make sure we aren’t cannibalizing some of the funding we’ve raised to help push forward the internal pipeline,” which is “advancing very nicely.” Read More
Immutep Ltd. announced an AU$80 million (US$52.1 million) capital raise that consists of a AU$50 million placement and a AU$30 million entitlement offer to eligible shareholders to fund clinical programs for lead candidate eftilagimod (IMP-321, efti), a lymphocyte activation gene-3 (LAG-3) fusion protein and major histocompatibility complex class II agonist that stimulates both innate and adaptive immunity for treating cancer. Read More
Hookipa Pharma Inc. is looking to raise about $50 million in a public offering to further advance its lead immunotherapy candidate, HB-200, into a pivotal phase III trial in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) for the first-line treatment of recurrent or metastatic head and neck cancer associated with human papillomavirus (HPV) 16. Read More
The U.S. House of Representatives has passed an agreement with the Biden administration on the debt ceiling, a deal that does not affect mandatory spending programs such as Medicare. However, the agreement, which still must gain the Senate’s stamp of approval, appears to eliminate any chance of yet more monies for the National Institutes of Health or the FDA, two programs of intense interest for companies in the life sciences. Read More
Lonza Group Ltd. has acquired Synaffix BV, the developer of a widely partnered set of tools for generating antibody-drug conjugates (ADCs), for €100 million (US$108 million) up front plus up to €60 million more in milestones. Read More
With False Claims Act (FCA) whistle-blower lawsuits multiplying amid the complexity of regulations that often are unclear, the U.S. Supreme Court provided some clarity as to what constitutes a false claim in a unanimous opinion handed down June 1. But it’s not what the biopharma and med-tech industries were hoping for. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abilita, Ariceum, Cleave, GE Healthcare, Genfit, Impact, Medigene, Mei, Merck & Co., Novan, Nykode, Philogen, Seal Rock, Theragnostics. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Aridis, Ascentage, Cocrystal, IGM, Pepgen, Pharmazz, Precigen, Rocket. Read More
