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

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/kZ5qovn
via IFTTT

Read More

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 psoriasis, and psoriatic arthritis.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/AlgfezL
via IFTTT

Read More

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, which is witnessing significant investment and expansion.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/aGsn7ht
via IFTTT

Read More

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 matter in detail before a decision is made.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/pZ592OC
via IFTTT

Read More

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%.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/6BeDcRs
via IFTTT

Read More

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.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/2xhg1db
via IFTTT

Read More

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 options.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/YsUp51L
via IFTTT

Read More