DR. REDDY'S LABORATORIES, INC.
🇺🇸United States
USFDA Issues Form 483 with Two Observations for Dr. Reddy's New York API Facility
• The U.S. Food and Drug Administration completed a Good Manufacturing Practice inspection at Dr. Reddy's Middleburgh API facility in New York, resulting in two observations via Form 483.
• The inspection was conducted from May 12-16, 2025, with Dr. Reddy's committing to address the observations within the stipulated timeline set by regulators.
• Form 483 is issued when FDA investigators observe conditions that may constitute violations of the Food Drug and Cosmetic Act, potentially affecting the company's manufacturing compliance status.
Dr. Reddy's to Launch Sanofi's Beyfortus in India for RSV Prevention in Infants
• Dr. Reddy's Laboratories has secured exclusive rights to promote and distribute Sanofi's novel RSV drug Beyfortus (nirsevimab) in India, expanding their existing vaccine partnership.
• Beyfortus, a monoclonal antibody administered as a prefilled injection, prevents respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
• The drug, already approved in major markets including the EU, US, and China, received marketing authorization from India's CDSCO in June and is expected to launch in the second quarter of the current fiscal year.
Gland Pharma Secures USFDA Approval for Acetaminophen Injection for Pain Management
• Gland Pharma has received USFDA approval for Acetaminophen Injection (10 mg/mL) in 500mg/50mL and 1000mg/100mL bag formulations for pain management.
• The injectable product is indicated for mild to moderate pain management in patients 2 years and older, and for moderate to severe pain when used with opioid analgesics.
• With US sales of approximately $55 million for the twelve months ending February 2025, Gland Pharma plans to launch the product through a marketing partner soon.
Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors
• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes.
• As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage.
• Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.
Senores Pharmaceuticals Acquires 14 ANDAs from Dr. Reddy's in $421M Market Opportunity Deal
• Gujarat-based Senores Pharmaceuticals has strategically acquired 14 Abbreviated New Drug Applications from Dr. Reddy's Laboratories, with 13 already FDA-approved and one pending approval.
• The acquired portfolio represents a significant US market opportunity of approximately $421 million according to IQVIA data, spanning multiple therapeutic areas including controlled substances.
• The acquisition, funded through IPO proceeds, aims to strengthen Senores' presence in US regulated markets and expand distribution across government, retail, and specialty clinic sectors.
Mankind Pharma Advances Novel Oral Anti-Obesity Drug in Phase 2 Trials
• Mankind Pharma has developed a pioneering GPR109 agonist as the world's first potential small-molecule oral treatment for obesity, currently advancing through Phase 2 trials in Australia.
• The innovative drug offers advantages over existing injectable peptide treatments like Wegovy and Mounjaro, requiring no food-related restrictions and providing a more convenient oral administration route.
• Phase 1 results have shown promising outcomes, with Phase 2 trial results expected by the end of the year, positioning Mankind Pharma for a potential breakthrough in the global obesity treatment market.
Abivax's Phase 3 Ulcerative Colitis Trial Nears Completion with 82% Enrollment
• Abivax's ABTECT Phase 3 trial for obefazimod in ulcerative colitis has reached 82% enrollment, with 1,003 of 1,224 participants now recruited.
• Top-line results from the 8-week induction phase are expected in Q3 2025, while 44-week maintenance data is anticipated in Q2 2026.
• A New Drug Application (NDA) submission is planned for the second half of 2026, contingent on positive clinical outcomes from the trial.
• Abivax reports sufficient cash runway to cover the ABTECT induction trial readout and operations into Q4 2025.
FDA Accepts Alvotech and Teva's Biosimilar Application for Golimumab (AVT05)
• The FDA has accepted the BLA for AVT05, a biosimilar to Simponi/Simponi Aria (golimumab), marking the first such acceptance in the U.S.
• AVT05 is intended for inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
• The FDA's decision on AVT05 is expected in Q4 2025, potentially offering a cost-saving alternative for patients.
• Clinical studies have demonstrated comparable efficacy, safety, and immunogenicity between AVT05 and the reference golimumab.
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