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Regulatory
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Lungs wireframe illustration

US FDA approves J&J’s Rybrevant-Lazcluze combo for lung cancer

Aug. 21, 2024
By Marian (YoonJee) Chu
The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor called Lazcluze (lazertinib) as a first-line combination treatment to treat select non-small-cell lung cancers.
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TRAUMAGEL Hemostatic Gel

Cresilon Traumagel wins FDA greenlight

Aug. 21, 2024
By Annette Boyle
Cresilon Inc. secured U.S. FDA clearance for Traumagel, a hydrogel that stops potentially life-threatening bleeding in seconds. Cresilon designed the product for use by the U.S. military, first responders and medical professionals to swiftly and effectively stop bleeding from traumatic wounds
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Blood cells and bacteria

Algodx receives FDA clearance for early sepsis detection software

Aug. 21, 2024
By Shani Alexander
Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.
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MHRA logo

UK MHRA launches AI airlock program for artificial intelligence

Aug. 21, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency enacted its AI Airlock program for artificial intelligence – the agency’s branding for its regulatory sandbox for this type of medical software.
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Laptop displaying FDA logo

FDA hit with second lawsuit over LDT final rule

Aug. 21, 2024
By Mark McCarty
The U.S. FDA’s effort to regulate lab-developed tests was predictably controversial, but the final rule drew a second lawsuit, this time from the Association for Molecular Pathology.
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Doctor and patient consultation

Patient perspective: Cost of Medicare negotiations not in dollars

Aug. 20, 2024
By Mari Serebrov
While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.
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Green approved stamp
Biopharma regulatory actions and approvals July 2024

July FDA approvals target Alzheimer's, myeloma and wet AMD

Aug. 20, 2024
By Amanda Lanier
The U.S. FDA approved 17 drugs in July, down from 28 in June, which marked the third-highest month in BioWorld’s records. On average, the FDA approved approximately nearly 19 drugs per month so far in 2024, compared to 16 per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
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Red and white blood cells

Ascentage moves BCL-2 inhibitor into fourth phase III

Aug. 20, 2024
By Tamra Sami
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
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Australia flag with microscope, test tubes

Pfizer urges Australia to establish clear vision for life sciences

Aug. 20, 2024
By Tamra Sami
Pfizer Inc. is calling on the Australian government to establish priorities for the life sciences sector to attract more investment into research, clinical trials and manufacturing in Australia. The new report recommends that the government issue a life sciences vision akin to the one issued by the U.K. in 2021 to make the country more competitive to attract investment.
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Wegovy available in Australia; hefty price likely to deter use

Aug. 20, 2024
By Tamra Sami
In the wake of shortages for Novo Nordisk A/S’ Ozempic (semaglutide), Australia’s Therapeutic Goods Administration has announced that Wegovy, which has the same active ingredient, is now available in Australia and is advising prescribers to stop prescribing Ozempic off-label for weight loss.
Read More
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