Pharma News

Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-operative inflammation and pain following ocular surgery.

Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue.

Bayer has acquired the exclusive marketing rights for acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH and BridgeBio Europe B.V.. Acoramidis is a highly potent and selective small molecule, orally administered transthyretin (TTR) stabilizer for the treatment of patients suffering from ATTR CM, a progressive fatal disease presenting as an infiltrative, restrictive cardiomyopathy resulting in heart failure.

Studies at MIT and elsewhere are producing mounting evidence that light flickering and sound clicking at the gamma brain rhythm frequency of 40 Hz can reduce Alzheimer’s disease (AD) progression and treat symptoms in human volunteers as well as lab mice.

Heart disease researchers have identified a group of patients in whom international guidelines on aspirin use for heart health may not apply.

In a study published in the renowned medical journal Circulation, the findings of a review of data from three clinical trials challenge current best practice for use of the drug for primary prevention of heart disease or stroke - otherwise known as atherosclerotic cardiovascular disease.  

In a significant diplomatic development, Nicaragua has become the first Spanish-speaking nation to officially recognize the Indian Pharmacopoeia (IP) or Indian Pharma standards. This development follows the signing of a Memorandum of Understanding (MoU) on Pharmacopoeia Cooperation between the Governments of India and Nicaragua. The ceremony, held in Nicaragua's capital, saw the signing of the MoU by Dr Sumit Seth, the Indian Ambassador to Nicaragua, and Dr Martha Reyes, Nicaragua's Minister of Health.

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.

Takeda and Biological E. Limited (BE), a leading India-based Vaccines and Pharmaceutical Company, today announced a strategic partnership to accelerate access to QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) multi-dose vials (MDVs). These doses will ultimately be made available for procurement by governments in endemic countries by 2030 at the latest to support National Immunization Programs.

Roche Pharma launches ocrelizumab in India, six years after global release. Ocrelizumab is an FDA-approved CD20-directed humanized monoclonal antibody indicated to treat adult patients with primary progressive or relapsing multiple sclerosis.