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Home » Topics » Regulatory

Regulatory
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Invivyd’s COVID MAb Pemgarda gains US EUA with boxed warning

March 25, 2024
By Karen Carey
The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis.
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Magnifying glass, FDA concept image

Regeneron starts the week with two CRLs

March 25, 2024
By Lee Landenberger
The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab.
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Radiotherapy of cancer

China Grand Pharma advances radionuclide ITM-11 to phase III

March 25, 2024
By Tamra Sami
China’s National Medical Products Administration has cleared China Grand Pharmaceutical and Healthcare Holdings Ltd. to advance radiopharmaceutical agent ITM-11 (177Lu-edotreotide) to phase III trials in gastroenteropancreatic-neuroendocrine tumors
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Cloud/cybersecurity illustration

Senate presses HHS on data breach that cost $7.5M

March 25, 2024
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) was quite vocal in its statement regarding a recent hospital cybersecurity breach, but HHS recently suffered an undisclosed data breach that cost $7.5 million in taxpayer monies.
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Gears with regulatory words

FDA resubmits proposed ban of electrical stimulation devices

March 25, 2024
By Mark McCarty
The U.S. FDA has posted another proposed ban of the use of electrical stimulation devices (ESDs) for the treatment of self-injurious behavior, which revisits the controversy over their use by the Judge Rotenberg Center.
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CMS: Coverage of obesity drug Wegovy for cardiovascular events OK

March 22, 2024
Following the U.S. FDA’s March 11 approval of Novo Nordisk A/S’ glucagon-like peptide 1 receptor agonist, Wegovy (semaglutide), to reduce the risk of major adverse cardiovascular events such as heart attack and stroke, the Centers for Medicare & Medicaid Services (CMS) has issued guidance ensuring coverage.
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Zepbound

US CBO: Numbers don’t add up yet for Part D obesity drug coverage

March 22, 2024
By Mari Serebrov
When it comes to whether Medicare Part D should cover the new anti-obesity drugs, the U.S. Centers for Medicare & Medicaid Services and lawmakers may be caught between the math and public pressure.
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EU flag, pills, syringe

EMA’s CHMP backs new antibiotic, oral PNH drug in March meeting

March 22, 2024
By Jennifer Boggs
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria. If approved, Emblaveo would be among the first beta-lactam/beta-lactamase inhibitor combos cleared for use in Europe.
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FDA Approved seal
Biopharma regulatory actions and approvals February 2024

11 US approvals in February include biosimilar, treatments for frostbite, HIV

March 22, 2024
By Amanda Lanier
In February, the U.S. FDA greenlit 11 new drugs, a slight decrease from the 14 approvals seen in the same month the previous year but an increase from January’s tally of eight FDA approvals.
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Abiomed Impella

Abiomed recalls Impella devices citing risk of ventricle perforation

March 22, 2024
By Mark McCarty
The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement. The FDA noted that it has received 129 reports of serious injury and 49 reports of fatalities associated with these devices, but did not indicate whether device malfunction was the source of these adverse events. Abiomed advises customers that the device should be implanted “with special care” in patients during active cardiopulmonary resuscitation, and to review some updated warnings in the product’s instruction for use statement.
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