Enforcement Report - Week of September 13, 2023
Enforcement Report - Week of March 15, 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the local Ethics Committee have approved Initiator Pharma’s clinical trial application (CTA) for Phase I trial to evaluate pain-reducing effects.
Averitas Pharma, Inc., a subsidiary of GRT US Holding, Inc. and member of the Grünenthal Group, announced today that the supplemental New Drug Application (sNDA) for QUTENZA for the treatment of neuropathic pain associated with diabetic peripheral neuropathy has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set a goal date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2020.
MORRISTOWN, New Jersey, Dec. 18, 2019 /PRNewswire/ -- Averitas Pharma, Inc., a subsidiary of GRT US Holding, Inc. and member of the Grünenthal Group, announced today that the supplemental New Drug Application (sNDA) for QUTENZA for the treatment of neuropathic pain associated with diabetic peripheral neuropathy has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set a goal date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2020.
Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-addictive therapies for the treatment of chronic pain, today announced that the U.S. Patent and Trademark Office has issued a composition of matter patent (Patent No. 10,493,047) entitled “Stable Aqueous Capsaicin Injectable Formulations and Medical Uses Thereof,” which provides coverage for the formulation of capsaicin used in the company’s CNTX-4975 product candidate. The patent describes and claims an aqueous, injectable, ready-to-use formulation of capsaicin.
Centrexion Therapeutics has restarted its attempt to list on the Nasdaq. The Jeff Kindler-helmed biotech pulled the plug on a planned IPO late last year but now hopes to find investors more amenable to its bid to raise money for a phase 3 pain program.
AACHEN, Germany and MORRISTOWN, New Jersey, November 14, 2018 /PRNewswire/ -- Grünenthal announced today that it has acquired the US-based pharmaceutical company Averitas Pharma, thereby extending its commercial footprint to the United States.
Grünenthal, the science-focused pharmaceutical company based in Germany, announced today that it has acquired additional global commercial rights for the dermal pain patch Qutenza® (8% capsaicin) from Acorda Therapeutics, Inc (USA). Grünenthal is now the sole owner of Qutenza® worldwide, including the US, Latin America, Asia and Australia. Grünenthal had already acquired exclusive commercial rights for Europe, Middle East and Africa in December 2016.
Enforcement Report - Week of May 30, 2018