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Psychedelic drug- brain illustration

EMA reconsiders psychedelics for mental health disorders

May 8, 2024
By Nuala Moran
The EMA’s chief medical officer has expressed disquiet that Europe has fallen behind in the development of psychedelic drugs as approved therapies for mental disorders, saying they should be given “a second chance.”
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Indian President Droupadi Murmu

India launches Immunoact’s homegrown NexCAR19 for cancer

May 8, 2024
By Tamra Sami
India’s first indigenous CAR T therapy is expected to cost around $50,000, nearly one-tenth of the price of top-selling CAR Ts in the U.S. India President Droupadi Murmu officially launched Immunoadoptive Cell Therapy’s (Immunoact) NexCAR19 (actalycabtagene autoleucel), a CD19-targeted CAR T, and dedicated it to the nation in April 2024.
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Meeting illustration

US FDA adcoms turn the corner on pandemic

May 8, 2024
By Mari Serebrov
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
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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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