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Regulatory
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Green approved stamp

Pfizer’s Paxlovid becomes first COVID-19 oral pill approved in China

Feb. 15, 2022
By Doris Yu
China’s NMPA has given conditional approval to Pfizer Inc.’s COVID-19 oral pill Paxlovid (nirmatrelvir/ritonavir). The drug was approved for the treatment of adults with mild to moderate COVID-19 and a high risk of progression to severe disease. This includes the elderly, and people with chronic kidney issues, diabetes, cardiovascular, and chronic lung disease.
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Acute myeloid leukemia illustration

Cstone wins first nod for IDH1 inhibitor in China with AML approval

Feb. 15, 2022
By Doris Yu
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
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Magnifying glass, FDA concept image

Biosimilars no priority in US FDA pandemic inspections

Feb. 15, 2022
By Mari Serebrov
Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
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Architectural pillars

US Fed Circuit repeats wakeup call on generic carveouts

Feb. 15, 2022
By Mari Serebrov
The U.S. Federal Circuit’s denial Feb. 11 of an en banc rehearing in a case that could undermine label carveouts and slow the launch of generics is the topic of hallway chatter at this week’s annual conference of the Association for Accessible Medicines.
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Regulatory actions for Feb. 15, 2022

Feb. 15, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Axcella, Avion, Bavarian Nordic, Cidara.
Read More

Regulatory actions for Feb. 14, 2022

Feb. 14, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Datar Cancer Genetics, Motus GI, Sequana Medical.
Read More
Green approved stamp

Pfizer’s Paxlovid becomes first COVID-19 oral pill approved in China

Feb. 14, 2022
By Doris Yu
China’s NMPA has given conditional approval to Pfizer Inc.’s COVID-19 oral pill Paxlovid (nirmatrelvir/ritonavir). The drug was approved for the treatment of adults with mild to moderate COVID-19 and a high risk of progression to severe disease. This includes the elderly, and people with chronic kidney issues, diabetes, cardiovascular, and chronic lung disease.
Read More
Prescription drug bottle, pills shaped in $ sign

More US-approved biologics translates to higher Rx drug spend

Feb. 14, 2022
By Mari Serebrov
Even as the U.S. Congress continues to kick the can down the road on prescription drug pricing, pressure to finally confront the issue is increasing. But as lawmakers debate price controls via direct Medicare negotiations vs. innovation, along with inflationary caps on price increases, one factor often gets downplayed: the role biologics are playing in the country’s overall spend on prescription drugs. While generics account for 90% of the drugs prescribed in the U.S., the other 10% of drugs prescribed account for more than 80% of the annual spending, according to the Association for Accessible Medicines.
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Regulatory actions for Feb. 14, 2022

Feb. 14, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Biontech, Cytryx, Eli Lilly, Innovent, Journey Medical, Metacrine, Noema, Novavax, Pfizer, Pharmacyte, Roche, Spectrum, Veru, Y-mabs.
Read More
Eversense sensor and apps

Senseonics receives FDA approval for long-lasting Eversense E3 CGM

Feb. 11, 2022
By Annette Boyle
At long last, the FDA granted premarket approval to Senseonics Holdings Inc.’s fully implantable Eversense E3 continuous glucose monitoring (CGM), an implantable device that provides accurate glucose readings for six months. The CGM will be available in the U.S. through Senseonics’ commercial partner, Ascensia Diabetes Care Holdings AG, starting in the second quarter. In Europe, the previous generation Eversense XL is available today and the company plans to launch the E3 in the third quarter of 2022.
Read More
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