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Home » Topics » Regulatory

Regulatory
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FDA Approved stamp

Lilly gets accelerated FDA nod for next-gen BTK inhibitor in MCL

Jan. 27, 2023
By Jennifer Boggs
Mantle cell lymphoma (MCL) patients developing resistance to existing BTK inhibitors now have a new treatment option, with the U.S. FDA’s accelerated approval of Jaypirca (pirtobrutinib) from Eli Lilly and Co.’s oncology unit, Loxo@Lilly. It is indicated for use in adults with relapsed or refractory disease who have received at least two lines of systemic therapy, including a BTK inhibitor.
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Dupixent

EMA says yes to Sanofi/Regeneron’s dermatitis drug, no to Ipsen’s bone disease contender

Jan. 27, 2023
By Caroline Richards
Where European regulatory decisions were concerned, there was good news and bad news for pharma today as Sanofi SA and Regeneron Pharmaceuticals Inc. got the go-ahead for expanded approval of Dupixent (dupilumab) in pediatric atopic dermatitis patients whilst Ipsen SA’s ultra-rare bone disease drug palovarotene was left off the shelf as efficacy data failed to impress.
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Australian flag on laptop screen with health professional

Australia begins first independent review of its health technology assessment process

Jan. 27, 2023
By Tamra Sami
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
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Regulatory actions for Jan. 27, 2023

Jan. 27, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Infinity Neuro.
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Regulatory actions for Jan. 27, 2023

Jan. 27, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Centessa, Daewoong, Daiichi, Discgenics, Lapix, Syros, Valeo.
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Judge's gavel with US flag

US GAO report highlights growing use of third-party funding in product liability litigation

Jan. 26, 2023
By Mark McCarty
Makers of medical devices and pharmaceuticals face a significant risk of product liability litigation, but the use of third-party funding of such lawsuits is a novelty in the U.S. relative to some other Western nations. Nonetheless, a new report by the U.S. Government Accountability Office (GAO) makes clear that third-party litigation funding (TPLF) is an increasing common practice that seeks to include uninjured parties in mass tort litigation, thus endangering the fortunes of those who invest in life science companies.
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China grapples with regulating online drug sales

Jan. 26, 2023
By Tamra Sami
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
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FDA vaccine illustration

VRBPAC backs simplification of COVID-19 vaccines

Jan. 26, 2023
By Mari Serebrov
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
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Chinese flag, pills

China adds 111 new drugs to NRDL, focus on innovation

Jan. 26, 2023
By Zhang Mengying
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
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Regulatory actions for Jan. 26, 2023

Jan. 26, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Cidara, Fabre-Kramer, Immuron, Inhibikase, Oncotelic, Poxel, Tango.
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