Topic:

Regulatory

Latest Headlines

Latest Headlines

AZ approval for Tagrisso in Japan a big change to NSCLC treatment options in Asia

The Japan approval of AstraZeneca's Tagrisso (osimertinib), a first-in-class drug used to treat non-small cell lung cancer (NSCLC), represents a potential major change in treatment options in the country and brings on a comparison with the state-of-play with therapies available in China.

FDA cites Lupin Indian facilities for what drugmaker calls 'minor' issues

India's Lupin said in a Bombay Stock Exchange filing on Tuesday that it had received four observations for two plants at its Mandideep site following a two-week inspection by the FDA in February.

Biocon wins key Japan approval for Lantus biosimilar

Japan has approved a new biosimilar of Sanofi's blockbuster Lantus (insulin glargine) as its creator Biocon chalks up a much-needed win after a tough 2015.

India releases guidelines on biosimilar approval, manufacturing

India's Central Drugs Standard Control Organization and the Department of Biotechnology have published guidelines on biosimilars that detail the regulatory path to marketing authorization.

Natco plant closed during floods written up by FDA

Yet another Indian drugmaker has had plants written up by the FDA for not hitting manufacturing standards. This time it is Natco, which said it got Form 483s for its pharmaceutical formulations facility at Kothur, near Hyderabad, as well as an API plant at Manali, near Chennai, which it had to close in December because of flooding in the area.

Lundbeck upgrades ArisGlobal regulatory and safety IT system

Danish drug developer Lundbeck has upgraded to the latest version of ArisGlobal's regulatory and safety platform. The decision, which follows a review of the alternatives, will see Lundbeck move to a fully outsourced hosted system, a model it thinks will lower its upgrade and maintenance costs while freeing it to focus on its core business.

Prosecutors heap more woe on OBI Pharma as 'insider trader' investigation deepens

The bad news just keeps coming for Taiwan's biotech firm OBI Pharma as the country's prosecutor has released new information alleging that the daughter of the head of Taiwan's lead science research agency did in fact sell some of her company stock just three months before it announced the failed trial of its lead cancer drug.

A second Indian vaccine maker under WHO scrutiny raises concern

India's second vaccine maker to get bad marks and stern words in a World Health Organization (WHO) notice this month has come at a bad time not only for offender Ahmedabad-based Cadila Healthcare, but also for a prequalification system essential to global programs.

China FDA sets out GCP guide for medical devices to take effect in June

China FDA has unveiled guidelines on medical device clinical trial supervision and management that will take effect in June, marking the latest effort in the field to ensure quality and safety standards for multinational and domestic products.

UPDATED: China FDA vows to fix vaccine supply 'gaps' in remarks at Boao Forum

China FDA repeated that it will root out any "gaps" in the regulation of vaccines exposed in a case of illegal sales of products in Shandong province, using a public forum to vow a tough response.