Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Brainstorm Cell, Cyclerion, Genentech, Incyte, Iovance, Oncology.
Mergers and acquisitions in the U.S. have been under tremendous regulatory pressure over the past two years, a trend that seems likely to continue for the foreseeable future. However, Lina Khan, chairwoman of the U.S. Federal Trade Commission (FTC), said in a March 27 public forum that the agency will not wait for airtight cases to pursue legal remedies in part because the perfect case does not always arise, but also because the courts can be provoked into validating a novel legal theory even if the court does not ultimately side with the FTC.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femdx Medsystems, Getinge.
China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd. RAY-1216 is a peptidomimetic inhibitor of SARS-CoV-2 main protease (Mpro), which is also known as a 3C-like protease (3CLpro).
A lot of eyes and ears were tuned to the U.S. Supreme Court’s March 27 argument in Amgen Inc. v. Sanofi SA with its focus on how much enablement is necessary in broad genus patent claims.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Henlius, Incyte, Janssen, PTC.
Pharming Group NV’s stock skyrocketed March 24 on news that the U.S. FDA approved Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS) for those ages 12 and older. The nod, which came a few days ahead of the March 29 PDUFA date, sent shares (NASDAQ:PHAR) up 33%, or $3.69, to end the day at $14.96.
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neurorpm, Syntheticmr.
Incyte Corp.’s bid for a once-daily vs. twice-daily version of the Janus kinase inhibitor Jakafi (ruxolitinib) was foiled, at least temporarily, by a complete response letter (CRL) from the U.S. FDA.
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