The days may be numbered for drug companies telling the FDA one thing to expedite approval and then telling the U.S. Patent and Trademark Office (PTO) something else to ensure they get a new patent.
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
The share price of Renovorx Inc. has spiked following FDA clearance for its Renovocath delivery system. Since the company announced the clearance, its stock (NASDAQ:RNXT) has climbed by more than 13%. Last month the company completed an IPO for approximately $16.6 million, issuing shares at $9-$11.
It was a busy week for the U.K.’s drugs regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA), which fast tracked decisions on novel drugs for cancer and eczema and made a ruling on booster COVID-19 jabs from Astrazeneca plc and Pfizer Inc. But even as Prime Minister Boris Johnson tweeted his support over the approval of Amgen Inc.’s cancer drug Lumykras, there are questions over the future of the regulator as it faces a round of job cuts because of a lack of funding following Brexit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cantargia, Mirror.
The COVID-19 pandemic has exerted a significant effect on enforcement in the U.S., but Ethan Davis of King & Spalding (K&S) said federal prosecutors have made use of several novel approaches to prosecution in the past year.
China’s Personal Information Protection Law (PIPL) will take effect on Nov. 1, 2021, making it harder for tech firms, including health care companies, to access and use consumers’ personal information. The PIPL was officially passed by the National People’s Congress on Aug. 20.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Madorra, Vonco Products.
Initial efforts at Humanigen Inc. to win an FDA emergency use authorization (EUA) for treating hospitalized COVID-19 patients with its monoclonal antibody, lenzilumab, have failed to gain the regulator's buy-in, sending company shares (NASDAQ:HGEN) down 47.3% to $7.97 on Sept. 9 after touching a 52-week low during the session, a reaction part of a volatile arc that has seen shares climb as high as $29.20 during the same time span.
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