On news that drove shares up by 36% on Sept. 3, San Carlos, Calif.-based Vaxcyte Inc. priced a $1.3 billion follow-on offering a day later. It is the fourth highest amount raised through a follow-on offering of shares in BioWorld’s records, as well as the second largest financing of all types for 2024, behind New York-based Pfizer Inc.’s $3.1 billion global sale of shares in March.
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
GSK plc and Flagship Pioneering Inc. have entered a collaboration to discover and develop a portfolio of therapeutics and vaccines for respiratory and immunology indications.
Curevac AG is casting off the deadweight of its pandemic push to translate its mRNA technology into a marketed COVID-19 vaccine, in a new €1.45 billion (US$1.6 billion) deal in which GSK plc will acquire full rights to infectious disease vaccines the two were co-developing.
In reviving another case involving drug label carveouts, the U.S. Court of Appeals for the Federal Circuit insisted that its June 25 decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will not kill so-called skinny labels that allow generics to come to market when some of the brand’s indications still have patent protection.
Even though the U.S. FTC recently claimed a court victory in its campaign to shut down the listing of device patents for drugs in the FDA’s Orange Book, 80% of the listings targeted in the commission’s first round of warning letters remain in place more than seven months later.
Becoming the first pneumococcal conjugate vaccine specifically designed for adults 18 and older, Merck & Co. Inc.’s 21-valent candidate, Capvaxive (V-116), gained U.S. FDA approval on its June 17 PDUFA date. The Rahway, N.J.-based company expects to take significant market share based on positive phase III findings from the Stride-3 trial. Analysts have estimated the product could reach $2 billion in annual global sales.
GSK plc’s interleukin-5 (IL-5) portfolio got boost as depemokimab, an ultra-long-acting biologic targeting IL-5, hit its endpoints in two phase III trials in severe asthma, setting up potential filings for the first therapy that could allow patients a six-month dosing schedule.
GSK plc has identified cyclic GMP-AMP synthase (MB21D1; cGAS) inhibitors and their prodrugs reported to be useful for the treatment of systemic lupus erythematosus or lupus nephritis.
