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Home » Topics » Regulatory

Regulatory
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Green approved stamp

Astellas wins first approval of Vyloy in gastric cancer in Japan

March 27, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
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New approach for PAH as Merck’s Winrevair wins FDA nod

March 27, 2024
By Jennifer Boggs
Merck & Co. Inc. is looking to a fast launch for sotatercept, its newly U.S. FDA-approved pulmonary arterial hypertension (PAH) drug. The agency cleared the drug, branded Winrevair, under priority review on its March 26 PDUFA date, marking the first in a new class of therapies the company has touted for its potential for disease modification.
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CINA ASPECTS

FDA clears Avicenna.AI tools focused on pulmonary embolism, stroke

March 27, 2024
By Shani Alexander
Avicenna.AI SAS received clearance from the U.S. FDA for two of its artificial intelligence (AI)-based solutions, Cina-Ipe and Cina-Aspects, which provide for the detection of pulmonary embolism (PE) and the assessment of stroke severity in CT scans, respectively.
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Abbott Labs Assert-IQ-AIQ

Abbott secures CE mark for Assert-IQ insertable cardiac monitor

March 27, 2024
By Annette Boyle
Abbott Laboratories landed CE mark for two versions of its Assert-IQ insertable cardiac monitor (ICM), one with a three-year battery life, the other lasting six years. Designed for long-term remote monitoring of individuals with abnormal heartbeats or at risk of developing arrhythmias, the device helps detect often-fleeting irregularities in heart rhythm to assist in diagnosis and care management.
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Microscope
Endocrine/Metabolic

UK clearance for phase I/II trial of Beam’s BEAM-302 for α1-antitrypsin deficiency

March 27, 2024
Beam Therapeutics Inc. has received clearance of its clinical trial authorization (CTA) application by the U.K.’s Medicines and Healthcare Products Regulatory Agency for BEAM-302, an in vivo base editor, as a potential treatment for patients with α1-antitrypsin deficiency (AATD).
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DNA in drug capsules, digital background
Neurology/Psychiatric

Atamyo’s gene therapy for LGMD2C/R5 cleared to enter clinic in Europe

March 27, 2024
Atamyo Therapeutics SAS has received clinical trial application (CTA) authorizations in Italy and France for ATA-200, its gene therapy for the treatment of γ-sarcoglycan related limb-girdle muscular dystrophy type 2C/R5 (LGMD2C/R5).
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Endocrine/Metabolic

Cinfina Pharma obtains IND clearance for PYY3-36 analogue CIN-110 for obesity

March 27, 2024
Cinfina Pharma Inc. has obtained FDA clearance of its IND application for CIN-110, a PYY3-36 analogue, allowing it to initiate a first in-human study in otherwise healthy subjects with obesity. CIN-110 is a stable and long-acting analogue of PYY3-36 being developed both as a monotherapy and for co-administration for obesity.
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Senate presses HHS on data breach that cost $7.5M

March 26, 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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Amgen fights state price control, as Enbrel ruled ‘unaffordable’

March 26, 2024
By Mari Serebrov
While some states are beginning to double down on the prices they pay for prescription drugs, the state of Colorado is taking it to a whole new level with its Prescription Drug Affordability Review Board that was empowered to set maximum prices of prescription drugs it considers “unaffordable.”
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EU flag, pills, syringe

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

March 26, 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.
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