Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airway, Astellas, Biontech, Camurus, Diurnal, Gilead, Glaxosmithkline, Idorsia, J&J, Pfizer, Roche, Seagen, Takeda, Vertex, Vir.
Biopharmas raising money in public or private financings, including: Amplicore, Design, Edgewise, Gain, Gyroscope, Ikena, Phoremost, Summit, TFF, Universe, Windtree.
As the nonalcoholic steatohepatitis (NASH) space continues to bustle, Wall Street watches, scanning the horizon for promising new approaches while handicapping the odds for proven approaches.
If the March 25 vote from a joint FDA advisory committee meeting is anything to go by, the long and bumpy development road for Pfizer Inc.’s tanezumab, a nonopioid pain drug, may have just gotten longer and bumpier. In what was nearly a unanimous vote, the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee said the sponsor’s proposed risk evaluation and mitigation strategy (REMS) was not adequate to ensure the benefits of tanezumab in alleviating osteoarthritis pain outweigh its risks, which include further joint deterioration.
The animal world is full of species that can perform astonishing, and sometimes disgusting, feats. Take vultures, for example. “They eat this rotten meat that is full of pathogens and toxins, and they stay healthy,” Neta Raab told BioWorld. Raab is the co-founder and CEO of Wild Biotech Ltd., an Israeli startup that is seeking to understand gut microbiome contributions to these animal superpowers, and harness them for therapeutic use.
DUBLIN – Last May, a quartet of Dutch biotech industry veterans gathered for a socially distanced outdoor meeting in a private garden in Leiden to discuss what could be done to prevent the present COVID-19 fiasco from ever occurring on such a scale again. A new startup, Leyden Laboratories BV, emerged from that conversation, and it has just raised €40 million (US$47.3 million) in a series A round to develop broad-spectrum, self-administered, intranasal antiviral drugs to prevent infection.
LONDON – After the extraordinary public accusation by the National Institute of Allergy and Infectious Diseases that it published “outdated” information on the interim results of the phase III U.S. trial of its COVID-19 vaccine, Astrazeneca plc has rushed through the full primary analysis, showing 76% efficacy in preventing symptomatic disease. That is 3% lower than the headline figure in the interim data published on March 22. But with the confidence interval ranging from 68%-82%, it is consistent with the pre-specified interim analysis claim of 79% efficacy – and would appear to indicate the data safety monitoring board’s (DSMB) concern that the company, “may have provided an incomplete view,” was misplaced.
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