In addition to safety questions about its COVID-19 vaccine, Johnson & Johnson is facing manufacturing challenges as a key partner, Emergent Biosolutions Inc., has yet to get FDA approval to manufacture or distribute the vaccine or its components in the U.S. That approval could be awhile in coming. On April 21, a day after completing its onsite inspection of Emergent’s Bayview plant in Baltimore, Md., the FDA released Form 483 from its inspection, revealing nine observations related to cross-contamination issues, lack of employee training and poorly designed and maintained facilities. Read More
The development of gene therapy has come a long way over the past two decades after getting off to a rocky start following the death of a young patient after being treated with an experimental therapy. Since that time continuing scientific progress has enabled the development of a robust product pipeline of promising therapies that could lead to, according to FDA estimates, 10 to 20 cell and gene therapy products a year within the next five years. The renaissance of the sector has also attracted record amounts of investment capital and significant business development. Read More
Versant Ventures has closed three new funds with an aggregate raise of $950 million to allocate to the next wave of innovative startups across North America and Europe. The money is new, but everything else is more or less unchanged. “It’s the same strategy, same team, same geography, same operational model,” Versant chairman and managing director Brad Bolzon told BioWorld. Read More
Casualties continue to accrue in Huntington’s disease, but drug developers continue their work in the challenging, fatal genetic disorder that afflicts an estimated 2.71 per 100,000 people globally. In March, Basel, Switzerland-based Roche Holding AG pulled the plug on its phase III Generation HD1 study with the antisense therapy tominersen, licensed from Ionis Pharmaceuticals Inc., of Carlsbad, Calif., in a tie-up that dates back to the spring of 2013. Roche subsidiary Genentech Inc. said the move was based on an independent data monitoring committee's preplanned look at the drug's risk-benefit profile. Read More
HONG KONG – Qilu Pharmaceutical Ltd. has inked a deal for the global rights to Peptron Inc.’s antibody-drug conjugate (ADC) candidate PAb-001-ADC for the treatment of various cancers. Seoul, South Korea-based Peptron stands to receive an up-front payment of $3 million and $539 million in milestone payments, as well as royalties. Read More
Genome editing startup Edigene Inc. closed a ¥400 million (US$62 million) series B+ round to expand its operation to more cities and advance its lead product ET-01 into clinical trials. The financing follows the $67 million series B that closed in October 2020. Read More
New hires and promotions in the biopharma industry, including: Cedilla, Cerevel, Dewpoint, Enveda, Humanigen, Lumos, Medicenna, Neximmune, Nimbus, Pharmaessentia, Psybio, Rayzebio, Replimune. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alterity Therapeutics, Atriva Therapeutics, China Biologic Products, Claritas, CMAX, Cybin, Enzychem, Excellthera, Hemoshear, Horizon, Marinomed, Moderna, Nasus, RDIF, Valneva, Willow. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Apic, Chiesi, Oasmia, Organicell, Pharvaris. Read More
