Additional questions about a planned phase II/III trial of its COVID-19 DNA vaccine candidate and delivery device by Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., has prompted a partial clinical hold by the FDA. The delivery device reversibly opens small pores in the skin by using a brief electrical pulse. The action does not impinge upon Inovio’s ongoing phase I of the candidate, INO-4800, and is not due to any adverse events in the study, the company said. Inovio added that it plans to respond to the FDA in October and then await the FDA’s response that is due within the following 30 days. In the meantime, the company stock (NASDAQ:INO) struggled at midday as shares traded 26% lower.

GSK's Nucala wins FDA approval in HES, with Fasenra on its heels

A revised U.S. label for Glaxosmithkline plc's Nucala (mepolizumab) has expanded the first-in-class anti-IL-5 treatment's approval to hypereosinophilic syndrome (HES), a group of rare disorders associated with persistent eosinophilia. It's the first approval for HES patients in nearly 14 years, according to the FDA. But Astrazeneca plc's Fasenra (benralizumab), now in phase III for HES, may not be far behind.

Anti-infective drugs speed through clinical development and regulatory approvals

Anti-infective drugs approved over the last two decades were able to get through the clinical development process substantially faster than other drugs, according to a new report from the Tufts Center for the Study of Drug Development. Antiviral drugs led the class in speed, thanks in large part to quick clinical trials for hepatitis C drugs. Anti-infective drugs were also able to obtain decisions from the FDA faster than other drugs, partially due to the high frequency they were awarded special designations, such as fast track and breakthrough therapy designations.

Biopharm America: European money spigot wide open in pandemic

Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities.

Ena Respiratory launches with AU$11.7M series A as it heads toward clinic with COVID-19 nasal spray

PERTH, Australia – Australia’s largest health care venture capital firm, Brandon Capital, announced the launch of Australian biotech company Ena Respiratory Pty Ltd., which has developed a nasal treatment to boost the natural immune system to fight common colds and flu and has proved successful in reducing COVID-19 viral replication. The Melbourne, Australia-based company has developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for topical delivery via nasal spray to target the primary site of most respiratory infections, including influenza and SARS-CoV-2. The pegylated TLR 2/6 agonist, INNA-051, reduced viral replication by up to 96% in an animal study in ferrets led by Public Health England.

Zai Lab nabs $761M via secondary listing in Hong Kong

HONG KONG – U.S. listed Chinese biotech company Zai Lab Ltd. has raised $761 million in its secondary listing on the Hong Kong stock exchange. The issue price was set at HK$562 (US$72.50) per share, and the stock opened at HK$613.5 per share, up 9.16%, with a market cap of HK$52.724 billion. Samantha Du, the founder and CEO of Zai Lab, told BioWorld that proceeds will be used for R&D activities in relation to its product portfolio and internal discovery efforts, enhancing the commercialization capabilities of Zejula (niraparib), Optune and other candidates, exploring new global licensing and collaboration opportunities, and as working capital and general corporate purposes.

Regulatory front: U.S. Rx importation from Canada closer to reality

The U.S. pathway for legally importing certain prescription drugs from Canada to take advantage of lower prices is closer to opening for business with the FDA issuing a final rule and guidance on making it happen. Scheduled for publication in the Oct. 1 Federal Register, the rule would allow states, tribes and, in future circumstances, pharmacists and wholesalers to submit importation plans to the FDA for approval. The rule will become effective 60 days after publication. Of course, importation could become moot should President Donald Trump’s most-favored nation drug pricing or congressional efforts to impose Medicare direct negotiations go into effect.

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