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Illustration of DNA strand next to lungs
Respiratory

Intellia receives UK regulatory clearance for gene insertion therapy

July 31, 2024
Intellia Therapeutics Inc. has received clearance from the U.K. Medicine and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of NTLA-3001 for the treatment of α1-antitrypsin deficiency (AATD)-associated lung disease.
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3D illustration showing presence of tumor inside prostate gland

Telix launches AU$650M bond offer, FDA accepts imaging NDA

July 30, 2024
By Tamra Sami
The U.S. FDA accepted Telix Pharmaceuticals Ltd.’s new drug application for TLX-007-CDx, a new cold kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer.
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EU flags in front of the Berlaymont building

A CHMP thumbs up for Astellas’ Claudin18.2 zolbetuximab

July 30, 2024
By Tamra Sami
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
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FDA Approved stamp with pills

Sun Pharma’s JAK inhibitor for severe alopecia gets US FDA nod

July 30, 2024
By Lee Landenberger
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
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Medicare puzzle

Industry supportive of new DRG code for combination of procedures

July 30, 2024
By Mark McCarty
The U.S. CMS proposed a series of changes to the Medicare series of codes for diagnostic-related groups, and device makers had pointed remarks about some of those proposals.
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U.S. FDA headquarters

US FDA eyes overhaul of guidance for maxillofacial systems

July 30, 2024
By Mark McCarty
The U.S. FDA proposed to overhaul guidances for maxillofacial systems that accumulated at least 18 years' of dust, in an effort to keep up to date with modern medical technology.
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NICE says no to Enhertu, blames price

July 30, 2024
By Mari Serebrov

For the first time in six years, the U.K.’s National Institute for Health and Care Excellence (NICE) is refusing to recommend a breast cancer treatment. It cited price as the issue.


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WHO preps for human avian flu spread with mRNA vaccine project

July 30, 2024
By Mari Serebrov
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
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Leqembi

EMA’s CHMP issues thumbs-down on Alzheimer’s drug Leqembi

July 30, 2024
By Nuala Moran
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.
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Monoclonal antibody illustration

European Commission approves Cstone PD-L1 sugemalimab in NSCLC

July 30, 2024
By Tamra Sami
The European Commission has approved Cstone Pharmaceuticals Ltd.’s PD-L1 monoclonal antibody, sugemalimab, in combination with platinum-based chemotherapy for first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
Read More
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