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Home » Topics » Regulatory

Regulatory
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Regulatory actions for July 21, 2022

July 21, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Belite, Celcuity, Daewoong, Eiger, Genmab, Karyopharm, Novavax, Oncopeptides, Peptilogics, Poolbeg, PTC, Qu, Rheos, Rhythm, Samsung, Soleno, Sorrento, Vivus, Wugen.
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IFPMA looks beyond IP to prepare for future pandemics

July 20, 2022
By Mari Serebrov
After political leaders across the globe made patents and other intellectual property (IP) safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
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US court kills patents for tissue rejection in organ transplant patients

July 20, 2022
By Mark McCarty
The effects of U.S. Supreme Court case law on patents are well demonstrated, but the latest victims of patent jurisprudence are directed toward a critical need for desperately ill patients. The Court of Appeals for the Federal Circuit ruled that several claims found in three patents licensed to Caredx Inc., of Brisbane, Calif., are ineligible due to a purported lack of inventiveness under Section 101 of the Patent Act, an outcome that sustains what some believe is a trend in case law that is hostile toward diagnostic patents in the U.S.
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Scientist injecting vaccine into Earth

Biopharma shares vision for pandemic preparedness, trial diversity

July 20, 2022
By Mari Serebrov
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
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Regulatory actions for July 20, 2022

July 20, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Apellis, Astrazeneca, Avadel, Daiichi, Destiny, Gilead, Incyte, Moderna, Viking.
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Digital 3-D illustration of Japan's flag, light effects

J-Tec’s autologous cultured cartilage receives full MHLW approval after 7 years

July 19, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
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Woman receiving COVID-19 vaccine

ACIP sees opportunity for Novavax in vaccine hesitancy

July 19, 2022
By Mari Serebrov
Although it’s a latecomer to the COVID-19 pandemic in the U.S., there is a wedge of opportunity for Novavax Inc.’s adjuvanted protein-based vaccine among the 10% of the U.S. adult population that has yet to get a first jab.
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Regulatory actions for July 19, 2022

July 19, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuronetics.
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J-Tec’s autologous cultured cartilage receives full MHLW approval after 7 years

July 19, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. 
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China in red on globe

Simcere’s CDK4/6 inhibitor gains nod for myelosuppression in China

July 19, 2022
By Doris Yu
China’s NMPA gave the green light to Simcere Pharmaceutical Group Ltd. for Cosela (injectable trilaciclib hydrochloride) as a treatment to decrease the risk of chemotherapy-induced myelosuppression. It is intended for adult patients with extensive-stage small-cell lung cancer (ES-SCLC), before they undergo a platinum/etoposide-containing regimen.
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