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  • BMS medicine for Crohns disease fails in clinical trial

    Bristol Myers Squibb announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. The study did not meet its primary endpoint of clinical remission at Week 12.

  • FDA approves Merck’s WINREVAIR

    Merck known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. WINREVAIR was previously granted Breakthrough Therapy Designation by the FDA.

  • Akebia receives FDA approval of Vafseo (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease

    Akebia Therapeutics, Inc a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

  • Novartis Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria (PNH)

    Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Fabhalta® (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia.

  • AstraZeneca to acquire Fusion to accelerate the development of next-generation radioconjugates to treat cancer

    AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments.

  • AstraZeneca Pharma India Ltd and Mankind Pharma partner to accelerate access to asthma medicine for patients in India

    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.

  • Rising of Indian Medical Device Industries

    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 receives USFDA approval for Gabapentin Tablets USP, 600 mg and 800 mg

    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.

  • Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for Clobetasol Propionate Ophthalmic Suspension 0.05%

    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 receives FDA approval for the AGENT Drug-Coated Balloon

    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.

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