The U.S. Health Resources and Services Administration (HRSA) ordered six drug companies May 17 to immediately resume providing 340B discounts to contract pharmacies without restrictions and to credit or refund overcharges stemming from those restrictions.
Multinational players are changing the way they look at China as a source for innovation as it accelerates efforts in areas such as digital health in pursuit of desire to make a global impact. At the Chinabio Partnering Forum, panelists representing Pfizer Inc., Merck & Co. Inc., Sanofi SA and Johnson & Johnson all shared what they have witnessed there and how they’re already tapping China-sourced innovations.
Respiratory syncytial virus, which puts millions of otherwise healthy infants in the hospital each year, could soon face a new foe. Top-line results from a phase III test of the extended half-life monoclonal antibody nirsevimab, developed by Astrazeneca plc and Sanofi SA, found it reduced lower respiratory tract infections requiring medical attention due to the virus in both healthy preterm and term infants.
LONDON – C4X Discovery Holdings plc has out-licensed its preclinical oral interleukin-17 (IL-17) inhibitor to Sanofi SA in a potential €414 million (US$493.4 million) deal. Under the terms of the agreement, Sanofi is paying €7 million up front and a further €11 in short-term preclinical milestones, with the balance to follow on reaching development, regulatory and commercialization milestones.
In a move that Sanofi SA said will bring it an mRNA-based research platform with applications in oncology, immunology and other diseases, the company has acquired Tidal Therapeutics Inc. for $160 million up front and up to $310 million in milestone payments. The preclinical startup, led by Merrimack Pharmaceuticals Inc. and Torque Therapeutics Inc. co-founder Ulrik Nielsen, is based in Cambridge, Mass.
Shares of mRNA therapeutics specialist Translate Bio Inc. (NASDAQ:TBIO) fell 30.9% to $17.76 on March 18 over concerns about a new interim analysis of phase I/II data for its cystic fibrosis (CF) candidate, MRT-5005. Several dosing regimens of the inhaled candidate failed to improve a key measure of lung function vs. placebo, in contrast to an earlier readout on other doses tested in the ongoing study, called Restore-CF.
Libtayo (cemiplimab-rwlc) became the first PD-1 therapy to score a phase III win in cervical cancer, a pleasing development not only for investors in Regeneron Pharmaceuticals Inc. and partner Sanofi SA but for patients with the stubborn disease.
Months of talks between Johnson & Johnson (J&J) and Merck & Co. Inc. about a COVID-19 vaccine manufacturing partnership came to fruition March 2 with the Biden administration hailing the deal as an “unprecedented historic” agreement between two long-time rivals.
Aside from its place in the history books as a global pandemic that nearly locked down the world, COVID-19 could have a lasting, more positive legacy of finally opening U.S. biopharmaceutical clinical trials to greater diversity.
The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit agrees Amgen patents lack enablement; HC nudging along with regulatory modernization plan; EMA: No Sputnik application yet.
