Alector Inc. Chief Operating Officer Shehnaaz Suliman said her company’s deal with Glaxosmithkline plc (GSK) – worth as much as $2.2 billion – “allows us to expand into indications that we have been quite thoughtful about doing, but in a more expeditious manner. This is really an opportune time to continue to explore the biology of these programs across multiple indications.” Read More
DUBLIN – Investment in European biotechnology slowed dramatically during the second quarter, as the funding frenzy of the first three months of the year gave way to a very solid but a less spectacular performance. Collectively, European firms engaged in drug discovery and development raised $3.358 billion in disclosed transactions during the second quarter, down 46% from the $6.195 billion raised during the first quarter. Read More
Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease. Read More
An ongoing FDA review of Iterum Therapeutics plc's NDA for a bilayer tablet containing sulopenem etzadroxil and probenecid for uncomplicated urinary tract infections (uUTI) has uncovered "deficiencies that preclude the continuation" of talks on labeling and postmarketing requirements, the company said. The revelation, less than four weeks before the NDA's July 25 PDUFA date, "throws an on-time approval into serious doubt," making Iterum's receipt of a complete response letter "a reasonably likely scenario," H.C. Wainwright analyst Ed Arce wrote. Read More
Arrowhead Pharmaceuticals Inc. said it voluntarily paused a phase I/II study of its RNAi candidate for treating cystic fibrosis (CF) out of an “abundance of caution” while considering its next steps. “This may delay our pulmonary program a bit, but it’s just part of drug development,” said Christopher Anzalone, Arrowhead’s CEO. The halt was prompted by signals of local lung inflammation found in an ongoing chronic toxicology study in rats. Read More
New hires and promotions in the biopharma industry, including: Bioasis, Cidara, Eledon, Medivir, Oncternal, Plexxikon, Solid, Stramsen, Tempest. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adlon, Alzamend Neuro, Hutchmed, Ildong, Immunic, Jazz, Lupin, Mesoblast, Puma, Prometic, Scpharmaceuticals. Read More
