Pharmaceuticals
AstraZeneca to invest Rs 250 crore on expansion of its GCC in India
The facility currently occupies 334,000 square feet of office space at Ramanujan IT City, with plans to add approximately 180,000 square feet over the next six months to accommodate this expansion, creating AstraZeneca’s biggest global capability centre.
Alembic Pharma gets tentative nod from USFDA for Ivosidenib tablets
The company said Ivosidenib tablets are indicated for patients with newly diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Zydus Lifesciences gets tentative approval from USFDA for BP lowering drug
Zydus Lifesciences announced on Thursday that it has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic Azilsartan Medoxomil tablets, which are used to treat high blood pressure. The USFDA's tentative approval covers Azilsartan Medoxomil tablets in strengths of 40 mg and 80 mg.
Waiting for a wonder drug? The weight just got longer
Eli Lilly awaits India's approval to sell Tirzepatide, marketed as Mounjaro and Zepbound in the US. CEO David Ricks plans to launch the drug in India in 2025, pending supply. The SEC recommends approval for pre-filled pens and vials, contingent on a phase-IV trial. The Drug Controller General of India will finalize the decision.
Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility
"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA said.
EU approves Sanofi's Dupixent for 'smoker's lungs'
Sanofi and Regeneron received EU approval for broader use of Dupixent in treating chronic obstructive pulmonary disease (COPD), a significant step achieved faster than in the U.S. The EU Commission approved Dupixent for COPD patients not responsive to standard treatments, marking its expanded use beyond conditions like asthma and eczema.
Weekly-once insulin jab may soon come to India
A new weekly insulin dosage by Novo Nordisk, Insulin Icodec, is on the brink of approval in India, offering potential relief for those who require daily insulin injections. The Subject Expert Committee has recommended permitting the import and sale of this innovative product, expected to revolutionise the insulin market. While further studies are required, doctors anticipate improved patient compliance with this new treatment option.
Wockhardt aims to launch antibiotic with USD 25 bn mkt potential by early FY26
With strong financial backing and successful research, Wockhardt is poised for the launch of Zaynich, an antibiotic targeting high resistance levels globally. The company's strategic pricing and partnership approaches enhance its market penetration, setting the stage for a significant impact on the pharmaceutical industry.
India to make drugs for diabetes, obesity under PLI by 2026, says report
India plans to incentivize local manufacturing of GLP-1 drugs, crucial for treating diabetes and obesity, starting in 2026, as per a government official speaking to Reuters. These drugs, originally approved for diabetes treatment, are also used for obesity due to their ability to slow digestion and reduce appetite. Novo Nordisk's patent on semaglutide, a key ingredient in popular drugs like Wegovy and Ozempic, is set to expire in India by 2026. Indian companies are already preparing to manufacture these drugs under the government's production-linked incentive (PLI) scheme.
Risk-based audits of drug units to begin from July 1
The revised Schedule M, which is considered more stringent than the World Health Organization's (WHO) good manufacturing practices (GMP) in certain areas, was notified on December 28, 2023. Companies with turnover of over ₹250 crore will have to comply with the upgraded version of Schedule M, starting July 1, and the remaining others, which are largely micro, small, and medium enterprises (MSMEs), have been given a year's time to comply. Inspections on those firms will begin from January 1, 2025.
Must Watch
Indian regulator says 36% of inspected drug-making units had to be shut
India's drug regulator has ordered the closure of over 36% of its 400 drug manufacturing units since last year due to concerns over sub-standard cough syrups. The country, known as the world's pharmacy due to its large drug production, is working to restore confidence after the deaths of over 300 children worldwide linked to these syrups.
Indian Pharma exports: 'USD 10 billion opportunity up for grabs in off patent drug market by 2029'
A senior official of the Pharmexcil said drugs such as Merck's Pembrolizumab (Keytruda) whose revenue were at USD 25 billion and Bristol-Myers Squibb's Eliquis (Apixaban)-USD 12 billion, among others would be off-patented in the next few years.
India pharma units fare better in US checks in 2023
The drug regulator United States Food and Drug Administration (USFDA) has classified 13%, or 19 out of 145 inspections it carried out against Indian facilities, as Official Action Indication (OAI) in 2023, which is lower than the global average of 15% OAIs, according to a report by Indian Pharmaceutical Alliance and McKinsey & Company said.
Dr Reddy's to buy nicotine replacement brands from UK-based Haleon for $632 million
The portfolio to be acquired consists of Nicotinell, a global leader in the NRT category with an extensive footprint in over 30 countries spanning Europe, Asia including Japan, and Latin America, and local market-leading brand names of the product – Nicabate in Australia, Thrive in Canada, and Habitrol in New Zealand and Canada. The proposed acquisition will be inclusive of all formats such as lozenge, patch, gum as well as pipeline products, in all applicable global markets outside of the US.
Jubilant Pharmova's US arm prepays Rs 626 crore term loan
Jubilant Pharmova's US subsidiary secured a $75 million term loan, as of March 31, 2024, the company's gross debt stood at Rs. 3,414 crore and net debt at Rs. 2,457 crore. In FY24, the company reported revenue of Rs. 6,772 crore and a net profit of Rs. 195 crore. The net debt to Ebitda ratio improved from 2.93x to 2.48x.
US lawmakers questions FDAs drug inspection programme in India and China
Three top American lawmakers have raised concerns about the FDA's foreign drug inspection program in India and China. In a letter to FDA Commissioner Robert Califf, they highlighted inconsistencies in inspection outcomes from January 2014 to April 2024. Some inspectors reported no compliance issues in numerous inspections, while others found issues in almost every inspection. The lawmakers, Cathy McMorris Rodgers, Brett Guthrie, and Morgan Griffith, pointed out these discrepancies and called for an investigation into the skill and thoroughness of FDA inspectors to ensure rigorous and consistent inspections.
