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Regulatory
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U.K. flag and capsules

UK pharma criticizes looming rise in revenue clawbacks

Feb. 24, 2023
By Caroline Richards
Plans by the U.K. government to claw back from pharma companies another 3.1% of the proportion of the drugs they sell to the National Health Service have been heavily criticized by the pharmaceutical industry as sending the “worst possible signal” to global investors. The Department of Health and Social Care announced in a consultation in December that it planned to increase the statutory scheme payment percentage from 24.4% to 27.5% starting April 1, 2023.
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Fraud blocks under magnifying glass

Pharma exec and cousin charged with securities fraud

Feb. 24, 2023
The SEC and the U.S. Attorney’s Office for the Southern District of New York charged a former pharmaceutical executive and his cousin Feb. 23 with the insider trading of Eastman Kodak Co. stock prior to a COVID-19 partnership with the U.S. government to support the launch of Kodak Pharmaceuticals.
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Regulatory actions for Feb. 24, 2023

Feb. 24, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Areteia, Bioatla, Enlivex, Ips Heart, Merck, Moderna, Octapharma, Regeneron.
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Ahead of schedule, a hemophilia A drug from Sanofi receives FDA approval

Feb. 23, 2023
By Lee Landenberger
The U.S. FDA has approved the priority BLA for Sanofi SA’s hemophilia A treatment nearly a week before its Feb. 28 PDUFA date. The approval is for efanesoctocog alfa, a recombinant factor VIII (rFVIII) therapy – the company has managed to partially incorporate rFVIII into the drug’s brand name, Altuviiio. The price per dose was not released by the company.
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PMD 200 platform in operating room

Medasense gets FDA nod for its nociception technology

Feb. 23, 2023
By Annette Boyle
Medasense Biometrics Ltd. received U.S. FDA marketing authorization for its PMD-200 patient monitor with nociception level index (NOL) technology that monitors patients’ physiological response to pain during surgery. NOL uses a multi-parametric sensor platform combined with artificial intelligence (AI) algorithms to generate a ‘signature of pain’ for patients under anesthesia who are also receiving opioids and other analgesics.
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US CMS refuses to budge on coverage of Alzheimer’s drugs

Feb. 23, 2023
By Mari Serebrov
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies approved to treat Alzheimer’s.
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Regulatory actions for Feb. 23, 2023

Feb. 23, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Innovation Zed, Medasense Biometrics, Mologic, Remidio.
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Regulatory actions for Feb. 23, 2023

Feb. 23, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Alimera, Cognition, Erydel, Fapon, GSK, Pfizer, PTC, Sage, Seagen, Viiv, Vir.
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Product recall concept image

GE Healthcare recall for imaging systems addresses potentially fatal detector collapse

Feb. 22, 2023
By Mark McCarty
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
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US ITC’s exclusion order favors Alivecor over Apple, but order held pending appeal of IPR

Feb. 22, 2023
By Mark McCarty
Alivecor Inc. has nudged the U.S. International Trade Commission (ITC) into issuing a limited exclusion order for products by Apple Inc. that are said to violate patents held by Alivecor, but there is one more stage gate to go for Alivecor. The ITC order notes that the exclusion won’t go into force until resolution of an inter partes review (IPR) involving the two firms, a process that could devour as much as a year and a half before a resolution is available.
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