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- Read more about Speeded-Up Drug Approval Process Will Boost Biologics Market
The US Federal Drug Administration is aiming to cut the time-to-market and the development costs for new drugs. This will help drive growth in the market for biologics, where over 1000 drugs are currently under development, to 9.6% year on year from its recent rate of 5.4%. Unlike small-molecule drugs that are manufactured through organic or inorganic chemical synthesis, biologics are manufactured by living cells. Biologics are more complex, fragile and difficult to manufacture than small molecules. They cost more to bring to market than the $2 billion average to develop a new drug, despite a trend to outsource development to contract research organizations.

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- Read more about FDA approves novel device for treating breathing difficulty from severe emphysema
The U.S. Food and Drug Administration approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema.
- Read more about CDSCO proposal to include all implantable medical devices & other high end equipment under the definition of 'drug'
The Central government has moved forward with its plan to bring all implantable medical devices and other critical medical equipment under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics (D&C) Act 1940 to ensure quality and reliability.
- Read more about Oxytocin manufacturing ban for domestic use to come into effect from 1st July 2018
The Ministry of Health and Family Welfare has restricted the manufacture of Oxytocin formulations for domestic use to public sector only from 1st July 2018. It has also banned the import of Oxytocin and its formulations.
From 1st July 2018, no private manufacturer will be allowed to manufacture the drug for domestic use.
- Read more about EMA and European Commission Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).
- Read more about MoU between India and Norway to extend health cooperation
Ministry of Health and Family Welfare signed a Memorandum of Understanding (MoU) with the Norwegian Ministry of Foreign Affairs, Government of Norway to extend the cooperation within health sector through the Norway India Partnership Initiative (NIPI) for a period of three years starting from 2018 to 2020, here.
- Read more about CDSCO held meeting on introducing ‘trace and track’ mechanism for top 300 brands
The Central Drugs Standard Control Organisation (CDSCO) has taken step to introduce an effective “trace and track” mechanism on top 300 brands, which would be included in the initiative. The top 300 brands were identified on the basis of moving annual total (MAT) data.
- Read more about Importance of India and Africa Strategic Partnerships to Build Health Innovations for Universal Health Coverage (UHC)
In an endeavour to encourage health innovations in India and Africa, a conclave was organised by the Public Health Foundation of India (PHFI), Amref Africa, the Institute of Development Studies, UK (IDS UK), Indian Institute of Public Health Gandhinagar in partnership with NITI Aayog. This event was hosted at the GE Healthcare Centre in Bengaluru.
- Read more about NIH plans to end funding for Moderate Alcohol and Cardiovascular Health trial
The National Institutes of Health plans to end funding to Moderate Alcohol and Cardiovascular Health (MACH) trial. National Institute of Alcohol Abuse and Alcoholism (NIAAA) funding for the MACH trial will end within the next few months following completion of an orderly closeout.
- Read more about Retail prices of 22 formulations revised by NPPA under DPCO, 2013
The National Pharmaceutical Pricing Authority (NPPA) has revised retail prices of 22 formulations under Drugs (Prices Control) Order, 2013 in a notification dated 12 June 2018.