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BioWorld - Monday, June 5, 2023
Home » Topics » Regulatory

Regulatory
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Regulatory actions for May 31, 2023

May 31, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Amylyx, Beigene, Bristol Myers Squibb, Inhibrx, Iovance, Janssen, Lexicon, Metriopharm, SK, Valneva.
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Regulatory actions for May 30, 2023

May 30, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABK Biomedical, Blue Earth, Cepheid, Concept Medical, Establishment Labs, Pulse Medical, Quantalx.
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Fraud blocks under magnifying glass

US surgeon agrees to pay $43M for unperformed vascular procedures

May 30, 2023
By Mark McCarty
No Comments
Most enforcement activities in the U.S. related to physician participation in fraud deal with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) reported recently that it has snared a much bigger fish.
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FDA wraps up morcellation containment bag guidance, containment use still down

May 30, 2023
By Mark McCarty
No Comments
The U.S. FDA has issued a final guidance for non-clinical performance testing for tissue containment bags used during power morcellation procedures, and the FDA had recommended in 2020 containment bags always be used during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published last year suggested that most of these procedures are not done with these containment systems, possibly because the rate of procedure-related complications is considerably higher when containment is used.
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U.K. flag on stethoscope

Reports says UK government needs to speed up approval of med-tech devices

May 30, 2023
By Shani Alexander
No Comments
The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of Brexit, according to a report.
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Lilly out of suit alleging spread between list, net insulin pricing is fraud

May 30, 2023
By Mari Serebrov
No Comments
Eli Lilly and Co. is paying $13.5 million to bow out of a class action lawsuit that claimed the list price of several insulin analogue products was fraudulent. Lilly also committed to capping the monthly patient out-of-pocket cost at $35 for its insulin products for at least four years, bringing the total value of the settlement, announced May 26, to more than $500 million, according to the attorneys who filed the class action on behalf of patients in 2017.
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Cardiovascular illustration

Lexicon gets FDA sugar, targets HF ‘sweet spot’ with newly approved Inpefa

May 30, 2023
By Randy Osborne
No Comments
With rising rates of disease and established guidelines for treatment, officials at Lexicon Pharmaceuticals Inc. have “the wind at our backs” as they go about commercializing Inpefa (sotagliflozin) for heart failure (HF), after the drug was cleared late May 26 by the U.S. FDA, said CEO Lonnel Coats. Shares of The Woodlands, Texas-based Lexicon (NASDAQ:LXRX), which had risen significantly after hours on word of the Inpefa go-ahead, closed May 30 at $2.90, down 28 cents. Regulators gave their nod to the inhibitor of renal sodium-glucose co-transporter 2 (SGLT2) and intestinal SGLT1 with a broad label across the full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes.
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Demand for obesity drugs a golden opportunity for counterfeits

May 30, 2023
By Mari Serebrov
No Comments
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore.
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India ramps up testing requirements after contaminated cough syrup exports

May 30, 2023
By T.V. Padma
No Comments
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
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Bayer’s PI3K inhibitor cleared in China for follicular lymphoma

May 30, 2023
By Doris Yu
No Comments
Bayer AG’s copanlisib was approved in China for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It is the first indication approved in the country for copanlisib, which is entering a market with room to grow but marked by some domestic competition.
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