The U.S. FDA has approved the country’s first-ever respiratory syncytial virus (RSV) vaccine, Arexvy, from GSK plc. The adjuvanted vaccine is also the first for older adults anywhere on the planet. GSK now has a head start to vaccinate the U.S. market, but other big companies, such as Sanofi SA and especially Pfizer Inc., are in late-stage development and will pose strong challenges in the coming year. Pfizer’s PF-0692831/RSVpreF, an RSV vaccine for treating lower respiratory tract disease caused by RSV, has a priority BLA with a May 31 PDUFA date. Read More
Immunogen Inc. scored a major win in top-line data from the confirmatory phase III trial called Mirasol evaluating the approved antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx, “mirv”) vs. chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer (PROC). The victory led shares of the Waltham, Mass.-based firm to close May 3 at $12.26, a rise of $7.06, or 135%. Read More
In January, a Wall Street analyst predicted the U.S. FDA’s rejection of Eli Lilly and Co.’s application seeking accelerated approval of amyloid beta-targeting Alzheimer’s candidate, donanemab, would be a “mere footnote” in the drug’s development, a forecast confirmed in the wake of positive top-line phase III data showing donanemab significantly slowed cognitive and functional decline in people with early symptomatic disease. Read More
While the U.S. continues to call out other countries for weak enforcement of intellectual property rights, trade secret theft and forced technology transfers in the life sciences sector, some companies in the sector claim similar things are happening in the U.S. In its 2023 Special 301 Report, released April 26, the Office of the U.S. Trade Representative (USTR) noted “the growing need for trading partners to provide effective protection and enforcement of trade secrets.” Read More
The IPO market in Europe is firmly shut and not a single company went public in the first quarter of 2023. The impact of this is trickling down to limit access to venture capital for biotechs. Read More
Cellular Biomedicine Group Inc. (CBMG) licensed a pair of candidates for the treatment of non-Hodgkin lymphoma to Janssen Biotech Inc. for development outside of greater China. The candidates are anti-CD19 and CD20 bispecific CAR T-cell therapy C-CAR039 and anti-CD20 CAR T-cell therapy C-CAR066. Read More
Buoyed by the progress it has made with its lead integrin therapy for moderate to severe ulcerative colitis, MORF-057, which significantly reduced disease activity in a phase IIa trial, Morphic Therapeutic Inc. is raising $240 million in a public offering to further advance the candidate through the clinic. Read More
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New hires and promotions in the biopharma industry, including: Biophytis, Cerevel, Elite, Exscientia, Leniobio, Pharmajet, Rapt, Soligenix, Vaccentis, Xenetic. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Brightpath, Clavius, Cyclacel, Dianthus. Gain, Ionctura, Magenta, Moonlake, Nimmune, Rubedo, Sernova, SHL, Summit. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amolyt, Avadel, Boehringer Ingelheim, Elicera, Eloxx, Hyloris, Memo, Neurobo, Pharmather, Protara, Sirpant, Tenaya. Read More
