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Roche Takes Natco to Supreme Court Over Generic Risdiplam Launch in India

Roche Takes Natco to Supreme Court Over Generic Risdiplam Launch in India

2025-10-16

Swiss pharma giant Roche has approached the Supreme Court of India to challenge a recent Delhi High Court ruling that allowed Natco Pharma to launch a generic version of Risdiplam, Roche’s breakthrough treatment for spinal muscular atrophy (SMA).

India Accuses Balaji Amines of Manufacturing Pharma-Grade Propylene Glycol Without Drug Manufacturing Licence

India Accuses Balaji Amines of Manufacturing Pharma-Grade Propylene Glycol Without Drug Manufacturing Licence

2025-10-16

In a fresh regulatory controversy, Indian authorities have accused Balaji Amines, a major chemical manufacturer, of producing pharmaceutical-grade propylene glycol (PG) without holding a valid drug manufacturing licence.

J&J to Spin Off Orthopedics Business, Raises 2025 Forecast

J&J to Spin Off Orthopedics Business, Raises 2025 Forecast

2025-10-16

Johnson & Johnson (J&J) has announced plans to separate its orthopedics unit into a standalone company, while simultaneously raising its 2025 full-year sales guidance.

Bayer’s Ambitious Gene & Cell Therapy Pipeline Eyes Parkinson’s, Oncology, Rare Diseases

Bayer’s Ambitious Gene & Cell Therapy Pipeline Eyes Parkinson’s, Oncology, Rare Diseases

2025-10-16

Bayer, via its subsidiary Viralgen (acquired through AskBio in 2020), is aggressively advancing a gene and cell therapy (CGT) portfolio targeting Parkinson’s disease, oncology, cardiovascular, rare conditions, and more.

Aspen Secures Approval to Market Lilly’s Mounjaro for Weight Loss in South Africa

Aspen Secures Approval to Market Lilly’s Mounjaro for Weight Loss in South Africa

2025-10-16

Aspen Pharmacare announced that it has obtained regulatory approval in South Africa to market Lilly’s Mounjaro (tirzepatide) for chronic weight management, expanding the indication beyond its prior authorization for Type 2 diabetes.

Bristol Myers Squibb Launches Mavacamten (“Kopozgo”) in India for Obstructive Hypertrophic Cardiomyopathy

Bristol Myers Squibb Launches Mavacamten (“Kopozgo”) in India for Obstructive Hypertrophic Cardiomyopathy

2025-10-16

Mumbai, October 13, 2025 — Bristol Myers Squibb (BMS) has launched its novel cardiovascular drug Mavacamten, under the brand name Kopozgo, in India.

The Oral GLP-1 Cage Match: Orforglipron vs Rybelsus

The Oral GLP-1 Cage Match: Orforglipron vs Rybelsus

2025-09-24

Eli Lilly’s once-daily oral GLP-1, orforglipron, outperformed Novo Nordisk’s oral semaglutide (Rybelsus) in a head-to-head diabetes study, reinforcing Lilly’s bid to lead in pills as well as injectables.

Sun Pharma’s Secret Sauce: Solve the Specific, Win the Market

Sun Pharma’s Secret Sauce: Solve the Specific, Win the Market

2025-09-24

India’s largest drugmaker underscores that precision—designing drugs to reduce side effects and improve delivery for very specific patient needs—beats scattershot expansion.

Sun Pharma’s Winning Formula: Precision Over Expansion

Sun Pharma’s Winning Formula: Precision Over Expansion

2025-09-24

India’s largest drugmaker Sun Pharma has carved out its niche by focusing on unmet patient needs rather than chasing every new market segment, according to founder and executive chairman Dilip Shanghvi.

NHU and Sinopec Advance Liquid Methionine Project

NHU and Sinopec Advance Liquid Methionine Project

2025-09-19

On September 5, NHU announced progress at its joint venture with Sinopec, Ningbo Zhenhai Refining & Chemical NHU Biotechnology Co., which has successfully produced qualified output from its 180,000 t/year liquid methionine project.

AstraZeneca Targets Year-End Filing for Novel Hypertension Drug Baxdrostat

AstraZeneca Targets Year-End Filing for Novel Hypertension Drug Baxdrostat

2025-08-31

AstraZeneca plans to submit baxdrostat for regulatory review by the end of 2025, aiming for potential approvals in 2026 starting in the U.S. and EU.

Aficamten Beats Metoprolol in Obstructive HCM, Strengthening Case Ahead of FDA Decision

Aficamten Beats Metoprolol in Obstructive HCM, Strengthening Case Ahead of FDA Decision

2025-08-31

Cytokinetics’ aficamten improved symptoms and cardiopulmonary performance more than metoprolol in a 175-patient head-to-head study of obstructive hypertrophic cardiomyopathy (oHCM), with detailed data unveiled at the ESC Congress (Madrid).

FDA Clears Sanofi’s Wayrilz (rilzabrutinib) for Adult ITP; U.S. Launch in September

FDA Clears Sanofi’s Wayrilz (rilzabrutinib) for Adult ITP; U.S. Launch in September

2025-08-31

The U.S. FDA approved Sanofi’s BTK inhibitor Wayrilz (rilzabrutinib) to treat adult persistent or chronic immune thrombocytopenia (ITP) who failed prior therapies—a milestone from Sanofi’s $3.7B Principia acquisition.

Glenmark Recalls Over 110000 Bottles of BP and COPD Drugs in US Due to Safety Concerns

Glenmark Recalls Over 110000 Bottles of BP and COPD Drugs in US Due to Safety Concerns

2025-08-24

Glenmark Pharmaceuticals has announced a voluntary recall in the US, pulling more than 88,000 bottles of Carvedilol (a high blood pressure drug) and 22,656 bottles of Theophylline (used for COPD) from the market.

Parliamentary Panel Urges Expanded Price Controls as Dozens of Cancer Drugs Remain Unregulated

Parliamentary Panel Urges Expanded Price Controls as Dozens of Cancer Drugs Remain Unregulated

2025-08-24

A recent report from India’s Parliamentary Committee on Petitions warns that a large proportion of cancer medicines are still not subject to official price ceilings, leaving many treatments unaffordable for patients.

Novo Nordisk Reports Theft of Six Drug Batches in India Authorities Warn of Severe Patient Safety Risks

Novo Nordisk Reports Theft of Six Drug Batches in India Authorities Warn of Severe Patient Safety Risks

2025-08-24

Danish pharma giant Novo Nordisk has confirmed the theft of six batches of its products—including insulin brands Ryzodeg and Fiasp, and weight-loss drug Wegovy—during transit from its Bhiwandi hub to several Indian cities.

EFSA Reaffirms Safety of E948 Oxygen and E949 Hydrogen in All Foods No Health Risks Detected

EFSA Reaffirms Safety of E948 Oxygen and E949 Hydrogen in All Foods No Health Risks Detected

2025-08-22

On August 7, 2025, the European Food Safety Authority (EFSA) announced that oxygen (E 948) and hydrogen (E 949) remain safe as food additives across all food categories, including products for infants and young children.

EFSA Confirms Safety of Vitamin E TPGS as Food Additive New Opinion Covers Multiple Use Levels

EFSA Confirms Safety of Vitamin E TPGS as Food Additive New Opinion Covers Multiple Use Levels

2025-08-22

On August 11, 2025, the European Food Safety Authority (EFSA) announced its expert panel has found no safety concerns for Vitamin E polyethylene glycol succinate (TPGS) as a food additive at proposed use levels.

Indian Pharma Urges US to Exempt Generics as 50 Percent Tariffs Loom National Security Probe Sparks Supply Fears

Indian Pharma Urges US to Exempt Generics as 50 Percent Tariffs Loom National Security Probe Sparks Supply Fears

2025-08-22

India’s pharmaceutical sector is calling on the US government to exclude generic drug imports from a sweeping national security investigation that could trigger major supply disruptions and price spikes.

Haryana’s Drug Crackdown Gets Massive Public Support State Launches Podcast to Boost Community Involvement

Haryana’s Drug Crackdown Gets Massive Public Support State Launches Podcast to Boost Community Involvement

2025-08-22

Haryana’s Narcotics Control Bureau is seeing unprecedented public backing in its ongoing battle against drugs, according to Director General O P Singh.

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