LONDON – Positive interim data from the U.S. trial of Astrazeneca plc’s COVID-19 vaccine have added yet more evidence it is effective in older adults and quelled concerns about serious thrombotic events that led countries in Europe to pause use of the vaccine earlier this month. Overall, the vaccine showed 79% efficacy in preventing symptomatic COVID-19, and was 100% effective in preventing serious disease and hospitalization. The effect was comparable across different ethnicities and age groups, with 80% efficacy in participants over 65 years of age. The analysis is based on 141 cases of COVID-19 infection. Read More
With the December PDUFA date already blown, Pfizer Inc. is headed into a day-and-a-half FDA advisory committee meeting this week to make the case for 2.5-mg tanezumab, a potential first-in-class treatment in the U.S., partnered with Eli Lilly and Co. Inc., for chronic pain due to moderate to severe osteoarthritis. Read More
Aura Biosciences Inc., a company developing a virus-like drug conjugate (VDC) for the potential treatment of a type of rare ocular cancer, has closed an oversubscribed $80 million financing. Read More
While historical data suggest venture capital rounds will eventually dip below the peak years, biopharma financings completed in recent months indicate the dollars are continuing to climb in 2021. Read More
HONG KONG - Bispecific antibody startup Epimab Biotherapeutics Inc. has completed a $120 million series C financing, bringing it closer to a potential IPO next year. The Shanghai-based company said the new funds would help it move its EGFR/cMET-targeted bispecific candidate, EMB-01, into phase II testing this year, as well supporting the advancement of other clinical candidates and an expansion of its pipeline. Read More
As the firm doubles down on a therapy for the rare and terrible lung disease called autoimmune pulmonary alveolar proteinosis (aPAP), Savara Inc. met with little trouble raising money, disclosing March 15 a public offering that grossed $130 million. Read More
Three companies set terms for their IPOs that, if launched, will go far in maintaining the year’s already powerful momentum. Largest of the three comes from Design Therapeutics Inc., which looks to raise net proceeds of $209.1 million to fund its Friedreich’s ataxia program through IND studies and a phase I trial. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: MHRA resumes some onsite inspections; Kyprolis discount opens door to U.K. coverage; HHS delays Trump ‘Sunset’ rule. Read More
New and updated preclinical and clinical data presented by biopharma firms at the ENDO 2021, the Endocrine Society's annual meeting, including: 89bio, Amolyt, Biomarin, Bridgebio, Chiasma, Clarus, Crinetics, Lumos, Neurocrine, Strongbridge, Rezolute, Rhythm, Theratechnologies. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chiasma, Clarus, Crinetics, Lumos, Neurocrine, Strongbridge, Rezolute, Rhythm, Theratechnologies. Read More
