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BioWorld - Wednesday, June 25, 2025
Home » Topics » Regulatory

Regulatory
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US FDA rejects UCB psoriasis drug Bimzelx, citing facility inspection issues

May 13, 2022
By Richard Staines
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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China in red on globe

Heartcare receives NMPA approvals for medical devices to treat stroke

May 12, 2022
By Doris Yu
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
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 U.S. 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
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
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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COVID-19 research illustration

US NIH COVID-19 technologies going global

May 12, 2022
By Mari Serebrov
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
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Cepheid, Medmira, Remedee Labs, Wysa.
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Regulatory actions for May 12, 2022

May 12, 2022
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
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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Green traffic light

Neuronetics wins FDA nod for Neurostar TMS for OCD

May 11, 2022
By Meg Bryant
The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD).
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