Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we're going to do everything we can to resolve these issues quickly, and as safely as possible,” he said during an April 29 conference call on first-quarter financial results. Read More
LONDON – The latest tranche of data from an array of large-scale COVID-19 studies running in the U.K. provides real-world evidence that vaccines have a dramatic effect in preventing hospitalization and death, but that there are a very small number of vaccine failures. The data cover 3,842 people who received a vaccine and subsequently were admitted to the hospital between Dec. 8, 2020, when the national vaccination rollout began, and the data cutoff of April 10, 2021. Read More
Vaccitech plc and Werewolf Therapeutics Inc. opened the last day of April with contrasting IPOs. Both priced mid-range, with Vaccitech raising $110.5 million, similar to Werewolf's $120 million haul. However, American depository shares of Vaccitech (NASDAQ:VACC), co-developer of Astrazeneca plc’s COVID-19 vaccine, fell 17.1% to $14.10 from a $17 open, while shares of cancer therapy developer Werewolf (NASDAQ:HOWL) boomed – until they didn't – climbing to $24 before closing about where they started, at $16.10. Read More
HONG KONG – As it advances into its first full year of commercialization in China, Zai Lab Ltd. raised $857.5 million through the sale of American depositary shares (ADS) and ordinary shares, exceeding its initial aim of $750 million. “We continue to execute with speed and excellence across all areas of our platform,” Samantha Du, the CEO of Zai Lab, told BioWorld. That includes business development, clinical development – “we currently have 40-plus ongoing and planned trials this year” – along with commercial expansion and global pipeline advancement. Read More
The FDA slapped Leo Pharma A/S’ BLA for IL-13 inhibitor tralokinumab with a complete response letter (CRL), making it the latest atopic dermatitis candidate to hit a regulatory setback in the U.S., following delays for three oral JAK inhibitor drugs earlier this month. Read More
Using advanced intravital microscopy to visualize immune cell movement within the tissues, investigators at the Peter Doherty Institute for Infection and Immunity, Melbourne have discovered that the neurotransmitter noradrenaline produced by the sympathetic nervous system causes a dramatic paralysis of immune cell movement. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB, Eloxx, Mesoblast, Phathom, Scynexis, Synairgen, Tessa, Treadwell, Vifor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AKL, Alkermes, Centivax, Fera, Ibsa, Mereo, Nicox, Novavax, Scipher, Sola. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Biocryst, Biomarin, Biontech, BMS, Eagle, Hikma, Janssen, Legend, Leo, Pfizer, Praxis Precision Medicines, Therapeutic Solutions International, Xeris. Read More
