Pharmaceuticals
Bharat Biotech credited ICMR, NIV as Covaxin co-inventors after missing them initially: Government
Responding to Trinamool Congress member Sougata Roy, who had asked whether the government took any punitive action against the company for not mentioning the names of ICMR and NIV in the patent application, the Union Health and Family Welfare Minister gave a detailed reply. There was a joint Memorandum of Understanding (MoU) between ICMR, NIV and Bharat Biotech for the development of Covaxin, he said.
Sanofi gets drug regulator nod to market RSV therapy in India
French drugmaker Sanofi announced on Thursday that it has received approval from India's Central Drugs Standard Control Organization (CDSCO) to market its novel therapy, Beyfortus, in India. The therapy is aimed at protecting newborns and infants from respiratory syncytial virus (RSV).
Zydus gets Mexican regulatory approval to market cancer treatment product
The product is used in the treatment of breast cancer and advanced gastric cancer. Breast cancer has become the most diagnosed cancer in Mexico, overtaking prostate and colorectal cancers, the company added. Developed in-house by the research team at the Zydus Research Centre (ZRC), the Trastuzumab biosimilar was launched in 2016 in India under the brand name Vivitra. Since then, an estimated 1 lakh patients have been treated with the therapy, the company added.
Govt plans crackdown on lookalike drug brands
According to people in the know, the government is likely to consider as valid only the brand names which were approved first by the regulator. Other same or similar sounding and lookalike brands will not be allowed to be marketed. Drug makers will soon be asked to upload formulation details along with the brand names of their products on the government's portal.
Drug MNCs for keeping patient aid plan out of trade margin formula
The Organisation of Pharmaceutical Producers of India (OPPI) recommended excluding Patient Assistance Programmes (PAPs) from Trade Margin Rationalisation to maintain affordability for patients. They noted that PAPs are crucial for providing access to expensive drugs, especially for oncology and rare diseases. OPPI also sought exemption for patented and orphan drugs from government-set price controls and opposed post-patent price cuts.
Cipla expects to commence supplies to US from China plant later this year
Cipla plans to start supplying from its China facility to the US market by the second half of the current fiscal year, following USFDA approval. The company is resolving regulatory issues with its domestic plants and focusing on new therapeutic areas and tech-based solutions. Cipla is also addressing antimicrobial resistance and expanding its digital health initiatives.
Textiles and pharma PLI schemes likely to see longer product list
The cabinet was set to decide on expanding the production-linked incentive (PLI) schemes in sectors like textiles, food processing, and pharmaceuticals to include more products. Meanwhile, the budget for PLI schemes increased to `16,092 crore for FY25. Textile PLI might see a lower investment threshold, with more man-made fabric products and apparel possibly being added.
Mankind to use debt, internal accruals to fund BSV buyout
Mankind Pharma announced a ₹13,630 crore acquisition of Bharat Serums and Vaccines (BSV) to be funded through internal accruals and a mix of debt and equity. This strategic move will make them leaders in the gynaecology-fertility segment. The acquisition aligns with their goal to expand in high-potential areas and is expected to boost earnings from the second year.
Cipla's North America business revenue hits record high in Q1 at $250 million
Cipla's North American business achieved a record $250 million revenue in Q1 FY25, a 13% year-on-year growth. The company's branded prescription business in India grew 10%, while overall India growth was offset by trade generics softness. Cipla's South Africa revenue grew 19% YoY in local currency terms. Net profit rose 17.4% to Rs 1,178 crore.
Sun Pharma gets US FDA nod for its specialty drug against baldness
Sun Pharma announced FDA approval of Leqselvi (deuruxolitinib) 8 mg tablets for severe alopecia areata, marking a major milestone after acquiring Concert Pharmaceuticals for $576 million. The drug, with a five-year marketing exclusivity, boosts Sun Pharma's specialty business. Shares rose 2.58%. Clinical trials showed significant hair regrowth in patients
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Sun Pharma's drug to treat alopecia areata gets USFDA nod
Sun Pharmaceutical Industries Ltd announced that the USFDA has approved its drug LEQSELVI (deuruxolitinib) for treating adults with severe alopecia areata. The approval is based on Phase 3 clinical trials involving 1,220 patients. LEQSELVI provides a new treatment option for patients with significant hair loss due to this autoimmune disorder.
Mankind trumps EQT-ADIA to buy BSV for $1.67 bn
This is the largest acquisition by Mankind Pharma, India’s 4th largest pharma company by market share. A formal announcement regarding the deal is likely by this week.
Mankind Pharma is frontrunner in Bharat Serums bid
Mankind Pharma is in talks to acquire Bharat Serums & Vaccines Ltd., a biopharmaceutical company with brands like Manforce Condoms and Prega News pregnancy tests. The target company could be valued at around $1.5 billion. Advent International, which acquired a majority stake in Bharat Serums in 2019, is looking to exit and return liquidity to investors.
Australia's Mayne Pharma sues Indian drugmaker Sun Pharma over patent infringement
Mayne Pharma sued India's Sun Pharma for allegedly infringing patents on IMVEXXY, a drug for menopause-related vaginal pain. The lawsuit was filed after Sun Pharma sought FDA approval for a generic version. This action might delay FDA approval for Sun Pharma by 30 months under the Hatch-Waxman Act.
Budget 2024: Cancer patients get relief but senior citizens missed the attention
The Union Budget 2024, while significantly increasing health sector funding to ₹90,959 crore, failed to address the BJP’s poll promise of including senior citizens above 70 in Ayushman Bharat-PMJAY. The budget features customs duty exemptions for three cancer drugs and changes to basic customs duty for X-ray equipment. Reactions from healthcare leaders underscore the budget's focus on improving accessibility and infrastructure. However, the omission of the senior citizens' health cover highlights a key unfulfilled promise, leaving a gap in comprehensive healthcare improvements.
Govt mulls dropping quality tests for cough syrups from developed market-approved plants
The proposal, which follows a representation from a stakeholder, suggests that testing at the prescribed laboratory may be waived for cough syrups being exported to the US, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and Switzerland.
