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Home » Topics » Regulatory

Regulatory
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US FDA grants fast track to Moebius-Sun’s knee OA pain injection

Sep. 10, 2024
By Marian (YoonJee) Chu
The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.
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Pharos PHI-101

Pharos Ibio wins MFDS orphan drug designation for AML drug

Sep. 10, 2024
By Marian (YoonJee) Chu
South Korean artificial intelligence-based drug developer Pharos Ibio Co. Ltd. said that the Ministry of Food and Drug Safety (MFDS) granted an orphan drug designation for PHI-101, a second-line therapy for acute myeloid leukemia (AML).
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Glenmark settles US civil price-fixing allegations

Sep. 10, 2024
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
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De novo key on keyboard

Digital products lead FDA’s de novo parade for September

Sep. 10, 2024
By Mark McCarty
The U.S. FDA posted a series of de novo decisions Sept. 9, including a digital diagnostic for chronic kidney disease progression by Renalytix AI Inc., of New York, and a digital therapy device for management of fibromyalgia symptoms by Swing Therapeutics Inc., of San Francisco.
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Virtual IP display

FDA draws a fine line on disclosure for third-party servicers

Sep. 10, 2024
By Mark McCarty
The U.S. FDA’s final guidance for device remanufacturing was the result of a nearly decade-long policy examination, and the agency’s Sept. 10 webinar highlighted a few key questions. The FDA’s Angela Krueger said the agency “always encourages transparency” on the part of manufacturers to ensure device safety and performance but said the FDA does not endorse disclosure of trade secrets in providing information on device servicing.
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Results of Type A meeting at heart of insider trading allegation

Sep. 9, 2024
By Mari Serebrov
Another biopharma employee got caught up in insider trading allegations, this time following a positive sponsor meeting with the U.S. FDA.
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Antibiotic resistant bacteria inside a biofilm

Adcom tries to balance risk for the many with benefit for the few

Sep. 9, 2024
By Mari Serebrov
With antimicrobial resistance growing to many first-line antibiotics, a key concern in the U.S. FDA’s approving an oral penem like Iterum Therapeutics International Ltd.’s tablet combining sulopenem etzadroxil and probenecid is that it could become a first-line, go-to drug in treating uncomplicated urinary tract infections and, possibly, more serious infections off-label.
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US FDA grants fast track to Moebius-Sun’s knee OA pain injection

Sep. 9, 2024
By Marian (YoonJee) Chu
The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.
Read More
FemChec

Femasys Femchec receives FDA clearance

Sep. 9, 2024
By Annette Boyle
Femasys Inc. checked off a box on the way to launch of its Fembloc non-surgical birth control method with U.S. FDA clearance of Femchec. An enhanced version of the Femvue product used to diagnose fallopian tube abnormalities, Femchec enables confirmation of successful blockage of the fallopian tubes to prevent pregnancy without use of radiation.
Read More
Chronos

Germitec gains FDA de novo clearance for UV-C disinfection tech

Sep. 9, 2024
By Shani Alexander
Germitec SA received U.S. FDA de novo clearance for Chronos, its chemical-free, ultraviolet-C-based disinfection device for endocavitary and external ultrasound probes. The technology will help to protect patients and aid health care professionals in tackling cross-contaminations in U.S. hospitals, Vincent Gardès, CEO of Germitec, told BioWorld.
Read More
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