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Gavel and FTC logo

Metaltronica prods FDA over risk classification for tomosynthesis

May 8, 2024
By Mark McCarty
It’s no surprise to hear that industry’s view of a device’s inherent risk differs from that of the U.S. FDA, a disparity that came to surface in a new citizen petition from Metaltronica SpA of Pomezia, Italy. The company petitioned the agency to down-classify digital breast tomosynthesis system to class II, a move that would align the risk classification with full-field digital mammography and ease the premarket path for future digital breast tomosynthesis applications.
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Magnifying glass, FDA concept image

FDA’s Califf downplays utility of advisory committee voting process

May 8, 2024
By Mark McCarty
In a May 8 Senate hearing, U.S. FDA commissioner Bob Califf described the agency’s advisory committee process as a useful source of information, but Califf reassured members of the Senate that the FDA is not intent in doing away with advisory hearing votes altogether.
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Colon cancer illustration

FDA greenlights Geneoscopy’s Colosense colorectal cancer screening test

May 8, 2024
By Annette Boyle
This time a positive result for a cancer screening test brought good news, as Geneoscopy Inc. secured U.S. FDA approval for its RNA screening test for colorectal cancer. The agency based its decision on strong results from the phase III CRC-PREVENT trial in its approval of the noninvasive test for use in individuals aged 45 years and older with average risk for the disease.
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Blood pressure gauge, ECG and medication
Cardiovascular

Sanegene Bio’s SGB-3908 cleared to enter clinic in China for hypertension

May 8, 2024
Suzhou Sanegene Bio Inc.’s clinical trial application for SGB-3908 injection, an siRNA drug for the treatment of hypertension, has been accepted in China by the National Medical Products Administration (NMPA)’s Center for Drug Evaluation (CDE).
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Breast cancer cells.
Cancer

FDA clears IND for Biotheryx’s CDK4/6 degrader for breast cancer

May 8, 2024
Biotheryx Inc. has gained FDA clearance for its IND application for BTX-9341, a novel cyclin-dependent kinase 4/6 (CDK4/6) bifunctional degrader.
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Stolen Schedule III study drug leads to US FDA scolding

May 7, 2024
By Mari Serebrov
The theft of 110 units of a study drug containing a Schedule III controlled substance resulted in a warning letter from the U.S. FDA. Addressed to the clinical investigator, Kevin Bender, of the Tamarac, Fla.-based DBC Research Corp., the May 2 letter should serve as a reminder to all trial investigators handling controlled substances.
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Coin inserted into Australian map

Australia investing AU$1.89B for new research, clinical trials

May 7, 2024
By Tamra Sami
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund.
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Jacobio seeks China approval of second-line KRAS lung cancer drug

May 7, 2024
By Marian (YoonJee) Chu
China and U.S. biotech Jacobio Pharmaceuticals Group Co. Ltd.’s shares (HKEX:1167) rose nearly 20% after it filed an NDA in China on May 6 for its independently developed KRAS G12C inhibitor, glecirasib (JAB-21822), to treat lung cancer.
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FDA icons and doctor

US FDA relying ever more on standards as pressure on EtO mounts

May 7, 2024
By Mark McCarty
The U.S. FDA and industry have been in scramble mode for some time to address the Environmental Protection Agency’s actions on ethylene oxide, but some manufacturers must also deal with other regulators’ perceptions of what constitutes an acceptable method of sterilization.
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Regulatory icons

Mexico’s COFEPRIS adds SaMD to definitions in revised labeling rule

May 7, 2024
By Mark McCarty
Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms.
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