Industry News

26 June 2024

USDA approves Merck Animal Health’s NOBIVAC NXT Canine Flu H3N2

NOBIVAC NXT is a revolutionary, first-of-its-kind vaccine technology for companion animals that leverages RNA-particle technology, allowing for a precise immune response to protect against a wide range of viral and bacterial pathogens.

25 June 2024

EMA approves Biocon Biologics’ New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites

Biocon Biologics Ltd , a global, fully integrated biosimilars company and a subsidiary of Biocon Ltd, has received approval from the European Medicines Agency to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies mAbs drug substance facility at Bengaluru.

17 June 2024

Alembic Pharmaceuticals announces USFDA approval for Icatibant Injection

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Icatibant Injection

14 June 2024

Torrent Pharma enters into Non-Exclusive Patent Licensing agreement with Takeda Pharma to Commercialize its Novel Gastrointestinal Drug in India

Torrent Pharmaceuticals Limited announced that it has entered into a non-exclusive patent licensing agreement with Takeda to commercialize Vonoprazan in India. Vonoprozan is a novel potassium-competitive acid blocker (P-CAB), used for the treatment of acid related disorders - Gastroesophageal Reflux Disease (GERD). Torrent will market Vonoprazan under its own trademark, Kabvie.

13 June 2024

Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules USP,

Glenmark has received final approval by the United States Food and Drug Administration USFDA for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent1 to Nexium.

6 June 2024

Torrent Pharmaceuticals to market Vonoprazan of Takeda in India

Torrent Pharmaceuticals has entered into a non-exclusive patent licensing agreement with Takeda to commercialize Vonoprazan in India.

27 May 2024

Advance DoE Workshop 2024 : A Testament to the Power of Collaboration, education, and innovation

An exclusive Advance DoE Workshop 2024 hosted by Eminence Business Media, concluded with resounding success, inspiring participants with valuable insights to enhance their experimental design and optimization skills.

15 May 2024

Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV).

10 May 2024

FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

Patients were randomized (1:1) to receive either tisotumab vedotin 2 mg/kg intravenously every 3 weeks or investigator’s choice of chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed, until unacceptable toxicity or disease progression.

8 May 2024

Gland Pharma receives approval for Edaravone Injection

Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Bags.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Radicava Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL) of Mitsubishi Tanabe Pharma Corporation.

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USDA approves Merck Animal Health’s NOBIVAC NXT Canine Flu H3N2

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