Shares in Bavarian Nordic A/S fell sharply after its development partner Johnson & Johnson terminated collaboration and license agreements in hepatitis B virus (HBV) and human papillomavirus (HPV). Shares in the Danish company (OMX:BAVA) fell nearly 13% to DKK 115.75 (US$16.39) following the announcement. The partnerships, with J&J’s Janssen pharma unit, began with a $187 million tie-up in 2014, to develop an Ebola vaccine that is now approved in the EU. That led to an $171 million HPV vaccine research agreement in December 2015 and an $879 million deal covering HIV-1 and HBV research in 2017. Read More
Aspen Neuroscience Inc. has closed a series B financing of $147.5 million. The funds will help get its autologous neuron replacement candidate into a phase I/IIa study for Parkinson’s disease. Privately held Aspen has been talking about initiating the phase I/IIa clinical trial since at least 2019. But in April 2022, it came a lot closer to reality. That’s when the company launched its first patient screening studies at several sites in the U.S. Now, the trial-ready cohort study is designed to screen potential participants for the study. Read More
With 47% fewer biopharma financings than last year, investors who were once enthused over the industry’s potential in combatting the deadly SARS-CoV-2 virus appear to be taking a step back. So far in 2022, the industry has raised $18 billion across 346 financings through the first week of May. By the same time in 2021, it had raised three times that amount, $53.9 billion through 651 transactions. Read More
Shares in Oxurion NV dropped 40.3% percent May 9 on news that one of its two clinical-stage assets, THR-687, failed to demonstrate efficacy in a phase II trial in diabetic macular edema (DME). The candidate, a small-molecule pan integrin receptor antagonist, failed to demonstrate efficacy in Part A of the trial, called Integral, in which treatment-naïve patients received one of two doses of THR-687. Read More
Askgene Pharma Inc., which less than two weeks ago reported positive initial data from an ongoing phase I/II trial testing its claudin 18.2-targeting candidate, ASKB-589, added $20 million in a series A round, intended to advance the company’s clinical pipeline and support further development of its Smartkine cytokine drug platform. Read More
Even though at least two different U.S. district courts have ruled that the 340B enforcement letters the Department of Health and Human Services’ (HHS) Health Resources and Services Administration has sent to biopharma companies violate the Administrative Procedures Act, the agency continues to send the letters, along with threats of civil money penalties, to companies that place restrictions on the 340B discounts to contract pharmacies. Read More
The U.S. FDA’s efficacy bar for COVID-19 vaccines for the youngest children may be lower than the 50% required for the adult vaccines, according to Peter Marks, director of the agency’s Center for Biologics Evaluation and Research.< Read More
In a draft guidance released May 9, the U.S. FDA described the benefit-risk principles it uses when conducting quality-related assessments of chemistry, manufacturing and controls (CMC) information submitted as part of a new drug application, biologics license application or supplement. Read More
New hires and promotions in the biopharma industry, including: ADC, Adimab, Bausch Health, Clearmind Medicine, Eli Lilly, Epiendo, Genenta, Marengo, Seagen, Ventyx, XNK. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acer, Amylyx, Anthos, Citius, Evofem, KVK-Tech, Relief, Scilex, Sen-Jam, Sorrento. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aqilion, Aracari, Brii, Compass, Cumberland, Gain, IGM, Insilico, Jemincare, Neurelis, Orion, Psybio, Verity, Virpax. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Johnson & Johnson, Myovant, Pfizer. Read More
