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Home » Topics » Regulatory

Regulatory
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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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AI-generated image for cancer cells observed under a microscope
Immuno-oncology

Bioatla’s anti-Nectin-4 ADC gains IND clearance

May 7, 2024
Bioatla Inc. has received FDA clearance of its IND application for BA-3361, a conditionally active biologic (CAB)-Nectin-4 antibody-drug conjugate (ADC) for the treatment of multiple tumor types.
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Cancer cell and DNA
Cancer

IND clearance for Eisbach’s allosteric ALC1 inhibitor EIS-12656

May 7, 2024
Eisbach Bio GmbH has announced FDA clearance of its IND application for EIS-12656, a first-in-class orally bioavailable and blood-brain barrier-penetrant allosteric inhibitor of ALC1 (CHD1L), a key molecular machine in DNA repair. Enrollment will open in the second quarter in a phase I/II trial in patients with genetically defined advanced solid tumors, including patients progressing under PARP inhibitor treatment.
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Musculoskeletal

Vyne’s BD2-selective BET inhibitor cleared by FDA for phase I

May 7, 2024
Vyne Therapeutics Inc. has received IND clearance from the FDA allowing it to initiate a first-in-human phase Ia study of VYN-202, an oral small-molecule BD2-selective BET inhibitor for autoimmune diseases.
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