Pharma News

A drug used to treat altitude sickness - as well as glaucoma, epilepsy, heart failure and seizures - may also offer significant gains for patients with a fast-growing brain tumor known as glioblastoma, according to a study.

McMaster University researchers have developed a new theory on Huntington's disease which is being welcomed for showing promise to open new avenues of drug development for the condition.  Huntington's disease is caused by a mutation in the gene that makes the protein called huntingtin.

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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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.

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.

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.

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).

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.

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.

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.