Drugmaker

French drugmaker Servier sharpens India strategy, eyes ₹1,000 cr revenue

Servier is stepping up its India push to bring first-in-class and precision medicines, expand global clinical research participation and use India for manufacturing and GCC services

MNC drugmakers push for 10-year exclusivity period for trial data

Global pharma companies represented by OPPI are urging the government to grant 10 years of exclusivity over regulatory trial data for first filers of novel drugs

India and China begin discussions for a reverse-trade model for drugs

This would unlock export potential of $6 billion for Indian pharma companies

Lupin launches generic injection in US with 180-day exclusivity

Drug maker Lupin on Friday said it has launched a generic medication to treat schizophrenia in the US with 180 days of exclusivity. The company has launched Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials, with 180-day CGT exclusivity in the US, the Mumbai-based drug maker said in a statement. This follows the recent approval received from the US Food and Drug Administration (USFDA). This is the company's first product using proprietary technology from PrecisionSphere, the Long-acting Injectable (LAI) platform developed by its subsidiary Nanomi BV. Risperidone for extended-release injectable suspension is bioequivalent and therapeutically equivalent to the reference listed drug Risperdal Consta LAI. It is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder in adults. As per IQVIA MA

FDA's top drug regulator resigns after officials probe 'serious concerns'

The head of the Food and Drug Administration's drug centre abruptly resigned on Sunday after federal officials began reviewing serious concerns about his personal conduct, according to a government spokesperson. Dr George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services' Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned on Sunday morning. Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency, Hilliard said. The departure came the same day that a drugmaker connected to one of Tidmarsh's former business associates filed a lawsuit alleging that he made false and defamatory statements during his time at the FDA. The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a longstand

Highlights: Centre to force drugmakers to upgrade plants after fatal cough syrup crisis

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Lupin share price rises 3% as USFDA okays schizophrenia drug; details

Drugmaker Lupin said it has received the USFDA's approval for Risperidone for extended-release injectable suspension

US pharma tariffs unlikely to hit Indian drugmakers materially: Ind-Ra

Ind-Ra said US tariffs may cause only short-term pricing impact for Indian pharma as firms remain fortified by diversification, strong balance sheets, and global market positioning

Anti-rabies vaccine, immunoglobulin sales pick up as dog bite cases jump

Drugmakers aim to step up production by 15-20% in the near term

Schedule M rollout may face delay as MSMEs seek more time for upgrade

Small drugmakers seek a three-month extension to submit GMP compliance plans under revised Schedule M, raising concerns about delays in national rollout

TPG acquires 35% in SCHOTT Poonawalla, SII retains minority stake

SCHOTT Pharma keeps 50% stake in Indian JV as TPG joins with Novo Holdings to support global pharma supply chain growth; deal expected to close in H1 2025

Pfizer beats Q1 profit estimates on cost cut, strong sale of heart drug

It reported total revenue of $13.70 billion for the first quarter, compared with analysts' expectations of $13.91 billion, according to LSEG data

Drugmakers Mallinckrodt, Endo agree to merge in nearly $7 billion deal

Endo shareholders will get $80 million in cash and own 49.9 per cent of the combined company, while Mallinckrodt shareholders will own the rest for an enterprise value of $6.7 billion

Drugmaker Amgen to invest $200 million in India site: CEO Robert Bradway

Amgen announced its plans to open a "technology and innovation" site in India last year that is focused on increasing the use of AI and data science to support development of new medicines

Lilly forecasts 2025 profit above estimates on weight-loss drug strength

The forecast comes weeks after the drugmaker stunned investors with weaker-than-expected sales for its weight-loss drug Zepbound for the second straight quarter

Alivus Life Q3 results: Net profit rises to Rs 137 cr, revenue jumps 12%

The Mumbai-based company said its profit rose to Rs 137 crore (nearly $16 million) for the three months ended Dec. 31 from Rs 119 crore a year earlier

J&J to acquire drugmaker Intra-Cellular Therapies for $14.6 billion

The deal is the latest in a string of acquisitions by J&J as it looks to drive growth beyond 2025

Drugmaker Anthem Biosciences files draft papers for $397 million IPO

The Indian IPO market has been bustling this year, with over 300 companies having raised $17.5 billion as of mid-December, more than double the amount raised last year

This pharma company from Mumbai may be helping Putin get Nvidia AI chips

But this inconspicuous pharmaceutical company is part of a lucrative trade in leading-edge technology to Russia that has the US and its European allies worried at India's burgeoning role

EU approves Sanofi's Dupixent injection to treat chronic lung disease

The EU Commission approved Dupixent to treat chronic obstructive pulmonary disease (COPD) in patients that cannot be helped by standard inhaled drugs