Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 4
Drug Approval
Drug Approval | 25 December 2023

Eugia's East Windsor facility gets 10 observations from USFDA

The plant is yet to start commercial operations

Drug Approval
Drug Approval | 23 December 2023

Zydus Lifesciences' API site in Ahmedabad. receives 6 observations from USFDA

This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023

Drug Approval
Drug Approval | 23 December 2023

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients

Drug Approval
Drug Approval | 20 December 2023

FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults

Drug Approval
Drug Approval | 20 December 2023

Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection

Drug Approval
Drug Approval | 18 December 2023

Zydus receives USFDA approval USFDA to initiate Phase II clinical trial of ZYIL1 for Parkinson's disease

Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation

Drug Approval
Drug Approval | 18 December 2023

Lupin receives tentative USFDA approval for Sitagliptin Tablets

Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus

Drug Approval
Drug Approval | 18 December 2023

Zydus receives final approval from the USFDA for Lacosamide Tablets

Lacosamide is indicated to treat partial-onset seizures

Drug Approval
Drug Approval | 17 December 2023

Zydus receives final USFDA approval for Cyclophosphamide Capsules USP, 25 mg and 50 mg

Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell

Drug Approval
Drug Approval | 17 December 2023

Lupin receives USFDA approval for Allopurinol Tablets

The product will be manufactured at Lupin's Pithampur facility in India

Drug Approval
Drug Approval | 14 December 2023

Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD

Drug Approval
Drug Approval | 13 December 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting

Drug Approval
Drug Approval | 12 December 2023

Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto

The CVMP recommends the product for approval for the treatment and persistent killing of fleas

Drug Approval
Drug Approval | 10 December 2023

Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis

Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections

Drug Approval
Drug Approval | 09 December 2023

European Commission approves Pfizer’s Elrexfio for multiple myeloma

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial

Drug Approval
Drug Approval | 09 December 2023

Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease

Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment

Drug Approval
Drug Approval | 08 December 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions

Drug Approval
Drug Approval | 07 December 2023

Zydus receives final approval from the USFDA for methylene blue injection

Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product

Drug Approval
Drug Approval | 07 December 2023

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa

Drug Approval
Drug Approval | 06 December 2023

Granules India received ANDA approval for Sildenafil for oral suspension

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million

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