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

Regulatory
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FDA final guidance for non-CGM devices holds HbA1c threshold for rescue medication

May 13, 2022
By Mark McCarty
No Comments
The U.S. FDA posted a final guidance for feasibility and early feasibility studies for non-traditional devices for type 2 diabetes, a document that is largely unchanged from the draft. This in the eyes of some stakeholders is precisely the problem as the final guidance retains a set point for rescue medication that some in industry believe is inappropriate for a study that does not seek to establish device effectiveness.
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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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Regulatory actions for May 13, 2022

May 13, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic.
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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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Heartcare receives NMPA approvals for medical devices to treat stroke

May 12, 2022
By Doris Yu
No Comments
Shanghai Heartcare Medical Technology Corp. Ltd. received marketing approvals for three medical devices designed for stroke, namely its left atrial appendage (LAA) occluder, the aspiration catheter, and the support catheter.
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Embold Fibered Detachable Coil

Boston Scientific receives FDA clearance for the Embold coil

May 12, 2022
By David Godkin
No Comments
The Embold fibered detachable coil developed by Boston Scientific Corp. to obstruct or reduce the rate of blood flow during therapeutic treatment in the peripheral vasculature, has won FDA 510(k) clearance.
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Wysa Ltd.’s chatbot

FDA grants breakthrough device designation for Wysa digital therapy

May 12, 2022
By Annette Boyle
No Comments
Wysa Ltd.’s artificial intelligence-based digital therapy received FDA breakthrough device designation for adults with chronic musculoskeletal pain, depression and anxiety. The device delivers cognitive behavioral therapy (CBT) via a digital companion or conversational agent on a smartphone.
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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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