Industry News

AstraZeneca Pharma India Limited and Mankind Pharma Limited entered into an agreement for exclusive distribution of AstraZeneca's budesonide and formoterol fumarate dihydrate (inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) combination) brand Symbicort in India. AstraZeneca will retain the intellectual property rights to budesonide and formoterol fumarate dihydrate and will continue to be the Marketing Authorisation Holder (MAH) and import license.

Medical devices industry is considered as one of Indias sunrise sectors. India is amongst the worlds fastest emerging Medical Device market with exports from the sector growing steadily at a CAGR of around 14 percent since FY 2019-20. The market for medical device industry in India is currently estimated to be of the size of USD 11 billion and it is expected to cross USD 30 billion mark by 2050.

Strides Pharma Science Limited (Strides) announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Gabapentin Tablets USP, 600 mg and 800 mg, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC.

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.

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.

Lykos Therapeutics a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration has accepted its new drug application for midomafetamine capsules used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with post-traumatic stress disorder (PTSD). The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act target action date of August 11, 2024.