Sun Pharmaceutical Industries plans a USD 100 million investment to commercialize innovative products this fiscal year, focusing on its specialty business. The company will launch Unloxcyt and Leqselvi, while seeking a partner for MM-II development. Sun Pharma anticipates mid-to-high single-digit consolidated topline growth for FY26 and expects R&D...
US FDA approves Moderna's next-gen COVID vaccine for adults 65 or older
Moderna's updated COVID-19 vaccine has received FDA approval for individuals aged 65 and older, marking the first endorsement under stricter regulatory guidelines. The vaccine is also authorized for those between 12 and 64 who have underlying health conditions that increase their risk. This approval signifies a step forward in protecting vulnerable...
Big fat legal war bursts out ahead of Novo Nordisk's Wegovy launch
Novo Nordisk has filed a lawsuit in Delhi High Court. The suit aims to stop Dr Reddy's Laboratories and OneSource from selling semaglutide in India. Semaglutide is the active ingredient in Wegovy. The court has restrained the Indian companies from selling the drug domestically. However, they can still manufacture and export it. The next hearing is...
Daiichi comments continue to damage interests: IHH Unit
Northern TK Venture, a subsidiary of IHH Healthcare, has increased its legal claim against Daiichi Sankyo. The claim is now for ₹11,800 crore. NTK alleges Daiichi Sankyo blocked its 2018 open offer for Fortis Healthcare. Daiichi Sankyo denies these claims. NTK seeks damages and an injunction against Daiichi Sankyo's statements. The next court hearing...
Fortis Open Offer: Daiichi Sankyo's 'misleading' statements continue to damage interests, says NTK
IHH Healthcare's subsidiary, NTK, accuses Daiichi Sankyo of damaging its interests through misleading statements regarding the Fortis Healthcare open offer. NTK has increased its damages claim against Daiichi Sankyo to JPY 200 billion, alleging obstruction of the open offer's completion.
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Flush expired, unused opioids down the toilet, says regulator
Drug regulatory authority mandates disposal of unused opioid drugs and painkillers. This action aims to prevent misuse and health risks. Central Drugs Standard Control Organisation has listed 17 harmful medicines for disposal. Some drugs should be flushed, while others can be collected through 'drug take back' programs. Unscientific disposal causes...
India gears up to reboot ICU standards, fix doctor drain, and cash in on global med travel
India is developing a structured critical care framework to bridge infrastructure and human resource gaps. Led by NITI Aayog, the initiative will define resource allocation, patient prioritization, and standards for critical care units nationwide. This aims to improve domestic healthcare and attract medical tourists, addressing current imbalances and...
Novartis offers payment plan for high-cost heart medicine
Novartis introduces a financing scheme with Pine Labs for its cholesterol-lowering drug, Sybrava (inclisiran), in India, aiming to broaden access by offering zero-interest EMI options. This strategy addresses the drug's high cost, previously ₹1.2 lakh per injection, and involves partnerships with Mankind Pharma, JB Pharma, and Lupin to expand market...
Quadria's third fund nets $1 billion, to deploy 60% in India
Quadria Capital, an Asia healthcare-focused private equity firm, has successfully raised $1.07 billion for its third fund, surpassing its initial $800 million target. The oversubscribed fund will allocate approximately 60% of its capital to India, with the remainder invested in ASEAN countries. This fund also marks the first time Quadria Capital has...
Lupin inks licensing deal to supply biosimilar ranibizumab in Latin America
Lupin, an Indian drug maker, partners with SteinCares. The agreement focuses on ranibizumab's commercialisation. Latin America, excluding Mexico and Argentina, is the target. SteinCares will handle regulatory aspects. Lupin will manufacture the biosimilar drug. This collaboration aims to improve retinal care access.
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VC funding, influencers power India’s health supplements craze amid lingering safety concerns
Fast forward to 2025, and a whole new market has emerged — gummies to enhance your hair health, powders to boost collagen, liquid for gut, pills for women’s perimenopause hormonal imbalance, magnesium tablets for better sleep, testosterone boosters, capsules with calming properties and vegan versions of all these.
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Dr Reddy's gets 2 observations from USFDA for Telangana API plant
Dr. Reddy's Laboratories received a Form 483 with two observations following a GMP inspection by the USFDA at its API manufacturing plant (CTO-5) in Miryalaguda, Telangana. The inspection, conducted from May 19 to May 24, 2025, identified potential violations of the Food Drug and Cosmetic Act. The company plans to address the concerns within the given...
China’s India Headache: The growing pharmaceutical industry
Indian CDMOs are strategically expanding through acquisitions in the US and Europe, driven by global pharma's nearshoring trend and a desire to diversify from China. These companies are investing in advanced technologies and specialized capabilities, particularly in biologics and complex chemistry, to capture a larger share of the global market.
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Venus Remedies gets Ukrainian GMP renewal certification
Venus Remedies has received renewed GMP certification from Ukraine. This certification applies to its Baddi facility. It covers cephalosporin, non-cephalosporin, and oncology production lines. The company aims to strengthen its presence in Ukraine and PIC/S markets. This will facilitate international growth. The Ukrainian pharmaceutical market is expected...
Waive risk-based inspections, urges MSME pharma body
Laghu Udyog Bharati requests the government to waive risk-based inspections for companies upgrading their facilities. The association seeks an extension for Schedule M implementation for smaller firms. Concerns arise over inspections being conducted like raids. LUB highlights the role of MSMEs in supplying medicines during Covid. They request special...
Sun Pharma to invest $25 mn in Pharmazz Inc; raises stake to 22.7 pc
Sun Pharmaceutical Industries Ltd will invest up to USD 25 million in Pharmazz Inc, increasing its stake to 22.7%. This investment triggers the conversion of a previous agreement. Sun Pharma gains an option to negotiate licensing of Sovateltide for developed markets and already holds exclusive rights for emerging markets. Pharmazz is developing drugs...
Alembic Pharma gets USFDA nod for generic high blood pressure treatment drug
Alembic Pharmaceuticals announced that it has secured final approval from the USFDA for its generic amlodipine and atorvastatin tablets, used for treating hypertension. The approval covers multiple strengths of the tablets, therapeutically equivalent to Pharmacia and Upjohn Co LLC's Caduet. With this approval, Alembic now has a cumulative total of...
Zydus working on single pen device for adjustable Semaglutide doses
Zydus Lifesciences is innovating a single-device for semaglutide. This device can deliver multiple strengths of the drug. It targets both diabetes and obesity. Clinical trials are underway in India. Zydus plans a day 1 launch in India. They will explore partnerships for emerging markets. The device aims to improve patient convenience. Some companies...
Many MSME pharma firms making substandard drugs, CDSCO data shows
Data from the CDSCO reveals that numerous MSME pharmaceutical companies in India are producing substandard drugs, failing to meet safety standards. Inspections have uncovered issues with infrastructure, quality management, and manufacturing processes. A significant percentage of MSMEs have faced stop production orders due to these quality concerns,...
Neuberg, Star Imaging in joint venture to expand integrated diagnostics across Maharashtra
Neuberg Diagnostics and Star Imaging have partnered to expand integrated diagnostic centers across Maharashtra, aiming to unify radiology, pathology, wellness, and genomics for improved accuracy and faster diagnoses. This joint venture will establish a comprehensive, technologically advanced network, launching new centers in key cities like Pune and...
Bharat Biotech's cholera vaccine successfully completes Phase-III trials
Bharat Biotech's oral Cholera Vaccine, Hillchol, has successfully completed phase III clinical trials, demonstrating non-inferiority against Ogawa and Inaba serotypes in Indian adults and children. The study involved 1,800 participants across various age groups and ten clinical sites in India. With a production capacity of 200 million doses, Hillchol...
Aman Mehta appointed Managing Director of Torrent Pharma
Torrent Pharmaceuticals has appointed Aman Mehta, son of current chairman Samir Mehta, as Managing Director, effective August 1, 2025. This move marks the third-generation leadership taking charge, building upon the legacy of founder Uttambhai Nathalal Mehta. Aman's experience includes successful integration of acquisitions and strategic roles across...
IHH Healthcare increases damages claim against Daiichi Sankyo to Rs 11,800 cr over Fortis acquisition dispute
IHH Healthcare's indirect subsidiary, Northern TK Venture Pte Ltd, has significantly increased its damages claim against Daiichi Sankyo to approximately Rs 11,800 crore. This revision follows Daiichi Sankyo's alleged interference with IHH's bid to acquire a larger stake in Fortis back in 2018. The increased claim accounts for losses and reputational...
Domestic drug companies in a sweet spot as global players look beyond insulin
Indian drug companies are increasing their presence in the insulin market. They are competing with multinational corporations. Affordable insulin and more type 1 diabetes cases are helping them. Domestic companies accounted for 25% of the market. Multinational companies are shifting focus. This shift creates opportunities for Indian companies. Lupin...
India's orthopaedic and cardiac implant sector to touch $4.5-5 bn by FY28: Report
India's implant sector is set for significant growth. The orthopaedic and cardiac implant market may hit USD 5 billion by FY28. Domestic manufacturers are expanding rapidly. They are outpacing foreign companies. Government initiatives and healthcare improvements are fueling this surge. Zydus Lifesciences and Alkem Laboratories are investing in this...
Non-AI organisations won't make it to 2050, says Diogo Rau
Eli Lilly's Diogo Rau emphasizes the critical role of AI in the pharmaceutical industry's future, predicting that companies not investing in AI now may not survive by 2050. Rau highlights AI's potential in drug discovery, including designing proteins and identifying promising molecules. He notes the challenge of limited datasets and the importance...
Dr Reddy's gets 2 observations from USFDA for New York API plant
Dr. Reddy's Laboratories announced that the USFDA issued a Form 483 with two observations after a GMP inspection of its API manufacturing facility in Middleburgh, New York. The inspection, conducted between May 12-16, 2025, identified potential violations of the Food Drug and Cosmetic Act.
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'Irrational' fixed dose combos harmful, may face ban: Expert panel
Several personal care products containing ingredients like aloe vera, jojoba oil, and orange oil are likely to be banned in India. An expert committee has deemed these fixed-dose combinations (FDCs) as irrational and potentially harmful to human health.
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Piramal Pharma to stay away from prescription business in India: Nandini Piramal
Piramal Pharma is not planning to re-enter the domestic prescription formulations business, according to chairperson Nandini Piramal. Instead, the company will focus on its consumer healthcare business, potentially acquiring OTC portfolios or brands, and explore targets in its global complex hospital generics business. Piramal Pharma will continue...
Generic pharma companies unlikely to be impacted by Trump's order to cut Rx drug prices: Report
A report suggests Indian generic drug companies may not be affected by US President Donald Trump's order. The order aims to lower US prescription drug prices. It will match them to those of other developed nations. The 'Most-Favoured-Nation' price model will be introduced. This model will cover Medicare and Medicaid. The order may face legal challenges.
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Biocon plans ₹4,500-cr QIP to raise stake in Biologics unit: Kiran Shaw
Biocon is planning a ₹4,500 crore fundraise to increase promoter stake in Biocon Biologics and convert structured venture debt into equity, aiming to improve profitability. The company is also considering a merger with its parent company as an alternative to an IPO due to market uncertainties.
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Donald Trump’s order to lower prices may benefit generics, says Cipla CEO
Cipla anticipates that Donald Trump's order to lower US drug prices could favor generic drug companies like itself. The company reported a strong Q4 performance with a 30% increase in net profit. Cipla is optimistic about growth in India, particularly in the weight-loss drug market, and is exploring both organic and inorganic expansion opportunities.
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US govt order to have nil impact on Indian pharma players, says Cipla
Umang Vohra of Cipla says that the US order to lower drug costs will likely target branded drugs. He believes generic drug prices are already competitive. Vohra also states that potential US tariffs on pharmaceutical imports are not expected to significantly impact Cipla's business. He mentions that discussions between the US and Indian governments...
Lupin launches generic version of kidney disorder treatment drug in US
Lupin Ltd has launched generic Tolvaptan tablets in the US, after receiving USFDA approval. These tablets, with strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, are bioequivalent to Jynarque and indicated for slowing kidney function decline in adults with ADPKD. Lupin holds exclusive first-to-file status, granting them 180-day generic drug exclusivity.
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Trump drops the price bomb, Indian pharma may feel aftershock
President Trump's plan to lower US prescription drug prices by aligning them with other countries could impact Indian pharmaceutical companies, which heavily rely on the US market for revenue. While primarily targeting innovator drugmakers, the move may squeeze Indian generic firms, potentially leading to margin pressure and strategic adjustments.
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India has not accepted 'data exclusivity' demand by UK to protect generic drug firms
India has declined the UK's request for a 'data exclusivity' clause in their free trade agreement to safeguard its domestic generic drug industry. This decision mirrors a previous rejection of a similar demand from the EFTA bloc. The move aims to protect the flourishing generic drug sector, a key player in India's exports, from potential restrictions...
Trump's drug order sparks concern for India's pharma policy: GTRI
Donald Trump's "Most Favored Nation" pricing rule, aimed at significantly lowering U.S. drug prices, is expected to have global repercussions. The move could pressure pharmaceutical companies to seek higher revenues in markets like India, potentially impacting its pharmaceutical policies.
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Biocon plans $150-million capex in two years
Biocon plans a $150 million capital expenditure, allocating $100 million to biologics, primarily enhancing Malaysian capacities, and $50 million to generics. Fueled by strong generics growth and biosimilar progress, Q4 net profit surged 153%. The company launched key medications in the US and UK, focusing on peptide portfolios and biosimilars for future...
Dr. Reddy's eyes aspirational goal to be in top five in the Indian market
Dr. Reddy's Laboratories is prioritizing innovative product launches through strategic partnerships to achieve a 15-16% growth in the Indian market. The company's focus includes expanding its portfolio with new products, growing existing brands, and strengthening its consumer health segment. Recent successes include the launch of toripalimab and upcoming...
FDC recalls over 60,000 bottles of ophthalmic solution in US
FDC Ltd is recalling over 60,000 bottles of Timolol Maleate Ophthalmic Solution, a generic glaucoma medication, in the US market. The USFDA reported the recall, initiated on April 18, is due to a defective container issue where the bottle's spike was lodged in the nozzle, preventing solution dispensing.
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Zydus gets USFDA nod for generic drug to treat multiple sclerosis
Zydus Lifesciences has secured USFDA approval to market Glatiramer Acetate Injection, a generic version of Copaxone, for treating relapsing forms of Multiple Sclerosis. Developed with Chemi S.p.A. and manufactured in Europe, the drug addresses a market with USD 719 million in annual sales in the US. This approval highlights Zydus' dedication to providing...
Generic versions of key diabetic drug in market double in a month
Post patent expiry, numerous Indian companies launched generic versions of Empagliflozin. The market witnessed a surge in brands and players in April. This makes diabetes drugs more affordable for Indian patients. Prices have dropped significantly, increasing access. Doctors are optimistic about the future. More patent expirations will further benefit...
Mounjaro is now a heavyweight in weight-loss fight
Mounjaro, a weight-loss drug by Eli Lilly, saw a huge jump in sales after its India launch. Sales of Mounjaro injections increased significantly in April. Doctors are observing its effectiveness and side effects on Indian patients. Obesity is prevalent in India. Affordability and tolerance are key factors. Studies suggest constipation is a common side...
Aster DM Healthcare to invest Rs 480 cr to set up new hospital in Bengaluru
Aster DM Healthcare will invest Rs 480 crore to establish a 430-bed multispecialty hospital in Sarjapur, Bengaluru. The hospital, spanning 4 lakh sq ft, will be developed in two phases, with 300 beds operational by the second half of FY27 and the remaining 130 beds by FY29.
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Trump's new executive orders may hit Indian Pharma exports, reshape global drug supply chains: Report
The recent executive orders on pharma issued by President Donald Trump are expected to create significant challenges for Indian pharmaceutical companies, especially those operating in the U.S. generic drug market, according to a report by Nuvama Research.
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Trump's prescription: Indian drug units may face stricter check-ups
Following President Trump's executive order, the Indian pharmaceutical industry anticipates a surge in unannounced inspections by the US FDA, causing concerns about compliance and potential trade barriers. Experts suggest that companies should diversify their business and invest in innovation to mitigate risks associated with increased scrutiny and...
TPG to acquire 35% stake in SCHOTT Poonawalla from Serum Institute of India
TPG Growth is set to acquire a 35% stake in SCHOTT Poonawalla from Serum Institute of India, with Novo Holdings co-investing. This deal aims to bolster the drug containment firm's growth in India and globally. Serum Institute will retain a minority stake, while SCHOTT Pharma remains the controlling stakeholder, leveraging TPG's healthcare expertise.
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Revised rules for biosimilar drugs enter the final stretch
The Indian government is refining biosimilar drug regulations, aligning with global standards to ensure stringent quality in research and manufacturing. These revised 'Guidelines on Similar Biologics' prioritize minimizing animal testing, advocating for in-vitro studies and the 3R principles (replace, reduce, refine). The aim is to balance regulatory...
Biocon Biologics secures multiple market access agreements in US for Yesintek
Biocon Biologics' Yesintek, a biosimilar to Stelara, has secured significant market access in the US, covering over 100 million lives. Multiple formularies, including Express Scripts, Cigna, and UnitedHealthcare, will include Yesintek starting in 2025. This approval expands affordable treatment options for Crohn's disease, ulcerative colitis, plaque...
Manipal, IHH, EQT & others eye Sahyadri Hospitals in Rs 5,000 crore bidding war
Manipal Hospitals, IHH Healthcare, and Blackstone-owned Quality Care India are among the frontrunners vying for Sahyadri Hospitals, Maharashtra's largest hospital chain, with bids ranging from ₹4,500-5,000 crore. Ontario Teachers’ Pension Plan Board is divesting the chain amid a wave of PE-led consolidation in India's rapidly growing healthcare sector,...
Panel to take a call on doorstep medicine delivery
India's drug advisory body is considering the future of doorstep medicine delivery, initiated during the Covid-19 pandemic. The All-India Organisation of Chemists and Druggists is urging the government to withdraw the notification, alleging misuse by digital platforms and prioritizing profit over patient safety. A sub-committee will now examine the...
With weight-loss drugs, going under the knife may lose edge
The introduction of weight-loss medications like Mounjaro and Wegovy in India may lead to a decrease in bariatric surgeries as obese individuals with a BMI of 30-35 may opt for drugs first. While surgeries can result in 70-80% weight loss, drugs offer a less invasive option, though potentially less effective at 15-20%.
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Alembic gets USFDA nod for generic drug
Alembic Pharmaceuticals secured USFDA approval to market generic Ticagrelor tablets, 90 mg, aimed at preventing heart attack and stroke. They also received tentative approval for the 60 mg version. The approved drug is equivalent to AstraZeneca's Brilinta, with the 90 mg tablet having a market size of over USD 1 billion.
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Opioid Tapentadol may be put under Narcotics Act to curb its access
The government is planning to regulate Tapentadol under the Narcotic Drugs and Psychotropic Substances Act. This follows concerns about its misuse and exports to West Africa. The move aims to control its availability. The Narcotics Control Bureau and police will oversee its movement. Tapentadol is a pain management drug with limited alternative treatment...