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Regulatory
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China gives conditional nod to Zhongsheng’s COVID-19 oral pill

March 27, 2023
By Doris Yu
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).
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Enablement of genus claims gets its day in US high court

March 27, 2023
By Mari Serebrov
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.
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Regulatory actions for March 27, 2023

March 27, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Henlius, Incyte, Janssen, PTC.
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FDA Approved stamp with pills

Pharming’s PI3K-delta inhibitor, Joenja, wins first FDA nod in APDS

March 24, 2023
By Jennifer Boggs and Karen Carey
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.
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FDA’s human factors draft draws fire for introduction of ‘critical task’ concept

March 24, 2023
By Mark McCarty
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.
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Regulatory actions for March 24, 2023

March 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neurorpm, Syntheticmr.
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Shiver me LIMBER: Incyte’s once-a-day Jakafi meets rough seas with CRL from FDA

March 24, 2023
By Randy Osborne
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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Regulatory actions for March 24, 2023

March 24, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Aurion, Biogen, Cidara, Creative Medical Technology, Dyne, Incyte, Kite, Melinta, Olix, Ono.
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Regulatory actions for March 23, 2023

March 23, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Echosens, Tela Bio.
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China greenlights CSPC’s mRNA COVID-19 vaccine for emergency use

March 23, 2023
By Zhang Mengying
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China.
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