Provention Bio Inc.’s diabetes candidate, teplizumab, is heading into a May 27 advisory committee meeting with a skinnier label than originally planned, which could signal a smoother path to approval. The positive briefing document the FDA put out Tuesday also suggested an approval path for what could be the first disease-modifying treatment available for type 1 diabetes (T1D).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acer, Ascletis, Asklepios, Idorsia, Janssen, Optimus, Pharmather, Provention, Sandoz, Scholar Rock, TG, Therapeuticsmd, TLC.
In seeming opposition to U.S. Trade Representative Katherine Tai’s support of a proposed compulsory World Trade Organization intellectual property (IP) waiver on COVID-19-related medical products, U.S. Vice President Kamala Harris signed onto the G20’s May 21 Rome Declaration that commits the member countries to work to defeat the pandemic within the current flexibilities of the TRIPS agreement by promoting voluntary IP licensing agreements, technology and knowledge transfers, and patent pooling on mutually agreed terms.
With the intense focus on developing COVID-19 diagnostics, sequencing tools, vaccines and treatments, the pandemic is having an outsized impact on the global development of drugs and devices to treat other diseases. Recent data show that more than 1,000 clinical trials worldwide remain disrupted by COVID-19, including 60% of the non-COVID-19 trials being conducted in the U.S., as funding and other resources continue to be directed toward ending the pandemic.
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Biomarin, Boehringer Ingelheim, Bristol Myers Squibb, Cansino, Kancera, Glenmark, J&J, Merck & Co., Regeneron, Scopus, Verastem.
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
DUBLIN – Skysona (elivaldogene autotemcel, Lenti-D), Bluebird Bio Inc.’s gene therapy for cerebral adrenoleukodystrophy, received a nod from the EMA’s Committee for Human Medicinal Products (CHMP) during its May meeting this week, paving the way for a formal European authorization in the coming weeks. It will constitute the first approval for the product. An FDA approval is some way behind – the company will not complete its BLA filing with the FDA until around midyear.
The EMA issued a positive scientific opinion on Glaxosmithkline plc (GSK) and Vir Biotechnology Inc.’s sotrovimab for early COVID-19 treatment. The Committee for Human Medicinal Products (CHMP)’s opinion concerns the monoclonal antibody’s use for adolescents ages 12 and older weighing at least 40 kg (88 pounds), plus adults. All must risk progressing to severe COVID-19 and not require oxygen supplementation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Alexion, Almirall, Astrazeneca, Athenex, Bayer, Bluebird, BMS, Eli Lilly, Genmab, Glaxosmithkline, Janssen, Larimar, Moderna, Myovant Sciences, Rhythm, Takeda, Vir.
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