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BioWorld - Monday, May 16, 2022
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
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FDA Approved stamp

Lilly’s Mounjaro first to win US FDA approval for GLP-1 and GIP dual agonist

May 13, 2022
By Lee Landenberger
No Comments
Six weeks ahead of its June 26 PDUFA date, the U.S. FDA has approved a priority NDA for Eli Lilly and Co.’s Mounjaro (tirzepatide), an injectable treatment for adults with type 2 diabetes (T2D). The once-weekly, first-in-class medicine activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which leads to improved blood sugar control. The potential market is massive, as 462 million people across the planet have T2D. The numbers have been growing 1.4% annually as the population ages and grows more obese.
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WTO logo

WTO waiver proposal a surprise to US Congress

May 13, 2022
By Mari Serebrov
No Comments
News that the U.S. Trade Representative (USTR) had signed off on a compromise World Trade Organization (WTO) proposal to waive IP rights for COVID-19 vaccines caught Congress by surprise earlier in early May. Now, some members, both Democrats and Republicans, are reminding USTR Katherine Tai that she has an obligation to consult with Congress on such trade issues.
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Regulatory actions for May 13, 2022

May 13, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lava, Rockwell, Salarius, Stealth.
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US FDA rejects UCB psoriasis drug Bimzelx, citing facility inspection issues

May 13, 2022
By Richard Staines
No Comments
UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection observations” that must be resolved before approval. Shares in Brussels-based UCB (Brussels:UCB) fell 13.6% following the announcement that the FDA had rejected Bimzelx for treatment of adults with moderate to severe plaque psoriasis.
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Riddle me this: How are COVID-19 vaccines like smartphones?

May 12, 2022
By Mari Serebrov
No Comments
The commercial success of COVID-19 mRNA vaccines has other companies in the space “looking in the attic, so to speak,” to see if they have any patents they can assert against components of the vaccines so they can get a percentage of the sales, Aziz Burgy, a patent attorney, told BioWorld. Given the global spread of the pandemic and how quickly it came on, the vaccines have generated billions of dollars in sales in a short period of time, and other companies want a share, he said. He compared today’s patent infringement cases against the vaccine producers to the litigation seen in the early days of the smartphone revolution when other high-tech companies scrambled for a piece of Apple’s and Samsung’s profits.
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US NIH COVID-19 technologies going global

May 12, 2022
By Mari Serebrov
No Comments
In an effort to increase global access to COVID-19 technologies, the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool finalized a licensing agreement May 12 with the U.S. NIH for research tools, early stage vaccines and diagnostics.
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Regulatory actions for May 12, 2022

May 12, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Ascletis, Cue, Eli Lilly, Immuron, Incyte, Iterum, Kiromic, Regulus, Spine, Veru.
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U.S. Capitol building, Washington D.C.

FDA user fee legislation passes first hurdle in House of Representatives

May 11, 2022
By Mark McCarty
No Comments
The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House.
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US lawmakers question budget fulcrum for ARPA-H, NIH

May 11, 2022
By Mari Serebrov
No Comments
With its focus on transformative high-risk, high-reward research to drive biomedical breakthroughs, the new Advanced Research Projects Agency for Health (ARPA-H) may be a good concept, but it shouldn’t come at the expense of increased investment in basic research at the NIH, according to the bipartisan leadership of U.S. House appropriators.
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Regulatory actions for May 11, 2022

May 11, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Eisai, Gilead, Kadmon, Moleculin, Neogene, Novo Nordisk, Turning Point, Zai Lab.
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