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BioWorld - Thursday, June 30, 2022
Home » Topics » Regulatory

Regulatory
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SCOTUS: US HHS wrong in reducing reimbursement to 340B hospitals

June 15, 2022
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The U.S. Supreme Court shot down a rule June 15 that allowed the Department of Health and Human Services (HHS) to sharply reduce Medicare reimbursement for Part B drugs to hospitals participating in the 340B prescription drug discount program.
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Regulatory actions for June 15, 2022

June 15, 2022
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anchordx, Ibex, Ricoh.
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Regulatory actions for June 15, 2022

June 15, 2022
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Attgeno, Cellenkos, Eli Lilly, Incyte, Innovent, Moderna, Nammi, Outlook, Stealth, Tremeau.
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2022 FDLI Annual Meeting

Califf says his return to FDA will bring changes to supply chain issues

June 14, 2022
By Mark McCarty
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U.S. FDA Commissioner Robert Califf offered the keynote address at this year’s annual meeting of the Food and Drug Law Institute (FDLI), revisiting recent events that have roiled the agency’s staff and reputation. Califf made a point of emphasizing the need for new statutory authorities in connection with the supply chains for FDA-regulated products, and remarked that his return to the agency will not be a reversion to the norm in this context.
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Person using Eksonr

Ekso steps up with FDA clearance for exoskeleton use in MS

June 14, 2022
By Annette Boyle
No Comments
Ekso Bionics Holdings Inc. added a new indication for its robotic Eksonr exoskeleton with a U.S. FDA 510(k) clearance for use of the mobility device in patients with multiple sclerosis (MS). The green light for MS follows clearances for stroke and spinal cord rehabilitation in 2016 and acquired brain injury (ABI) in 2020.
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Child being evaluated using Earlipoint system

FDA greenlights Earlitec autism diagnostic tool

June 14, 2022
By Catherine Longworth
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The U.S. FDA has granted clearance for Earlitec Diagnostics Inc.’s Earlipoint evaluation tool for the diagnosis and assessment of autism spectrum disorder (ASD) in children aged 16-30 months. The eye-tracking technology utilizes Dynamic Quantification of Social-Visual Engagement (DQSVE), which captures a child’s moment-by-moment looking behavior. The clearance was based on positive results from two studies in which more than 500 children were enrolled.
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Syringe and COVID-19 vaccine vials as question mark

COVID-19 IP waiver on the line at WTO conference

June 14, 2022
By Mari Serebrov
No Comments
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
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China in red on globe

Everest wins first approval in China for breast cancer drug Trodelvy

June 14, 2022
By Doris Yu
No Comments
Everest Medicines Ltd. has picked up its first marketing approval in China for Trodelvy (sacituzumab govitecan), a medicine licensed from Gilead Sciences Inc. It was approved to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
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US flag, Department of Health and Human Services flags

EU, US to strengthen cooperation on health

June 14, 2022
By Mari Serebrov
No Comments
The European Commission and the U.S. Department of Health and Human Services (HHS) recently signed an arrangement to strengthen their cooperation on preparedness and response to public health threats.
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FDA Approved seal

Lilly’s Olumiant approved by FDA for treating alopecia

June 14, 2022
By Lee Landenberger
No Comments
Eli Lilly and Co. crossed the line in front of three strong competitors with the U.S. FDA’s approval of Olumiant (baricitinib) as a first-in-disease systemic treatment for severe alopecia areata. Two of those three are, like Olumiant, JAK inhibitors and have recent phase III data to run by the FDA.
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