Receiving a second complete response letter (CRL) from the U.S. FDA for gefapixant to treat refractory and unexplained chronic cough – an indication for which there are no approved treatments in the U.S., Merck & Co. Inc. said it is reviewing the agency’s feedback to determine the next steps, if any, for the oral selective P2X3 receptor antagonist.
Nearly four years after the COVID-19 pandemic closed government offices and sent federal employees home to work remotely, the U.S. FDA is returning to some semblance of normalcy, with its drug and biologics centers expanding in-person face-to-face industry meetings to include all PDUFA and BsUFA meeting types, beginning Jan. 22.
Pharma companies facing the pricing pressures unleashed by the U.S. Inflation Reduction Act will find little respite in European markets in 2024, as governments erect higher market access hurdles around pricing and reimbursement in a bid to constrain drug budgets.
Following the decision of Australia’s Therapeutic Drugs Administration to allow prescribing of MDMA for post-traumatic stress disorder and psilocybin in treatment-resistant depression from July 2023, and with U.S. FDA approval of MDMA for treating PTSD expected in 2024, the EMA is under increasing pressure to set out a path to approval for psychedelics.
Calliditas Therapeutics AB’s full approval from the U.S. FDA for Tarpeyo (budesonide) delayed release capsules in immunoglobulin A nephropathy (IgAN) revived speculation about competitor Travere Therapeutics Inc. which, like Calliditas, has gained accelerated approval for its prospect.
Glaukos Corp. brought home a nice year-end gift for investors with a broad U.S. FDA approval for the Idose TR. Indicated for use in patients with primary open-angle glaucoma or ocular hypertension across the full range of disease severity, the device/drug combo provides continuous release of a prostaglandin analog that reduces intraocular pressure via a titanium device implanted through a corneal incision for up to three years.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Quidelortho, Ulrich Medical.
The FDA has awarded orphan drug designation to Ocelot Bio Inc.'s lead candidate OCE-205 for the treatment of ascites due to all etiologies except cancer. Ocelot Bio plans to initiate clinical studies of OCE-205 in refractory ascites next year.
Iama Therapeutics Srl has obtained clinical trial application (CTA) clearance from the Italian Medicines Agency (AIFA) to initiate a first-in-human phase I study of IAMA-6, an orally administered small-molecule therapeutic targeting NKCC1 for the treatment of autism and epilepsy.
Given the challenges of generating chemistry, manufacturing and control information on the compressed timelines used in the EMA’s Priority Medicines scheme and the U.S. FDA’s breakthrough therapy designation program, the two regulators published a joint question-and-answer document discussing quality and good manufacturing practice aspects of applications for both programs, which are aimed at speeding development of innovative products to address unmet medical needs.
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