India's drug regulator has released draft guidelines for biosimilar drugs, inviting public comments within 30 days. These revised regulations, aligned with international standards, aim to establish stringent quality benchmarks for biosimilar research and manufacturing. The guidelines also emphasize minimizing animal testing, reflecting a commitment to ethical practices in drug development within the rapidly growing biosimilars market.

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 potential disruptions in API sourcing from China.

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.

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 rigor with flexibility, potentially waiving animal studies where sufficient clinical data exists.

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 psoriasis, and psoriatic arthritis.

US Health Secretary Robert F. Kennedy's plan to Make America Healthy Again faces challenges as government cuts eliminate over a dozen data-gathering programs tracking deaths and diseases. The CDC lost experts monitoring areas like abortions, lead poisoning, and violence. Critics warn that these cuts will hinder the ability to understand and address health issues effectively.

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%.

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.

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 options.

Dr. Reddy's Laboratories has expanded its partnership with Sanofi Healthcare to introduce Beyfortus, a novel drug preventing lower respiratory tract disease in newborns caused by RSV. Dr. Reddy's will exclusively promote and distribute Beyfortus in India, with a launch expected in the second quarter of the current fiscal year, following regulatory approval.

India's drug advisory board is considering restricting over-the-counter medication sales to prevent misuse and ensure patient safety. The proposal limits OTC sales to 27 drugs, including antipyretics and painkillers, with dosage and quantity restrictions. The board aims to increase accessibility while ensuring patient safety by excluding several currently available drugs and recommending smaller pack sizes for safe use.

Dr. Reddy's Laboratories and Lupin are recalling products in the US due to labeling and manufacturing issues. Dr. Reddy's is recalling an antiepileptic drug due to a labeling mix-up, where infusion bags were incorrectly labeled. Lupin Pharmaceuticals is recalling an antidepressant medication due to failed impurity specifications. The USFDA has classified Dr.

Eli Lilly's new oral weight-loss pill, orforglipron, shows promise in late-stage trials across countries like India and the US. Participants experienced an average weight loss of 7.2 kg with the 36 mg dose over 40 weeks. While less potent than injectable Wegovy, orforglipron offers a needle-free alternative, potentially easing distribution, especially in emerging markets.

Alembic Pharmaceuticals has received the United States Food and Drug Administration approval. The approval allows them to market Carbamazepine tablets in the US. This medication is a generic version of Tegretol Tablets. Carbamazepine tablets are anticonvulsants. They also treat pain from trigeminal neuralgia. The market size for these tablets is estimated at USD 32 million.

In a devastating incident, an Australian woman unknowingly carried and gave birth to another couple's baby due to a mix-up at a Monash IVF clinic in Brisbane. The clinic attributed the error to a human error during the embryo transfer process.

Donald Trump announced a forthcoming major tariff on pharmaceutical imports, aiming to incentivize drug companies to relocate operations to the U.S. He also stated he warned Taiwan Semiconductor Manufacturing Company (TSMC) about potential taxes if they didn't establish U.S. plants. Trump criticized the Biden administration's $6.6 billion grant to TSMC's U.S.