Topic:

Manufacturing

Latest Headlines

Latest Headlines

Onyx Scientific expands again as GMP demand grows

Onyx Scientific is set to increase the size of its U.K.-based site by more than 30% as it enjoys the spoils of a lucrative 2015.

Amgen says it's awaiting reimbursement details after Japan Repatha nod

Amgen said that the approval for Repatha (evolocumab) in Japan filed by Amgen Astellas Biopharma K.K., a joint venture with Tokyo-based Astellas Pharma, could be launched within months pending reimbursement details.

Sinovac Biotech gets GMP stamp from CFDA for hand, foot and mouth vaccine

Beijing-based Sinovac Biotech has secured its good manufacturing certificate from the China FDA, placing it on track to sell the Enterovirus 71 (EV71) vaccine to prevent hand, foot and mouth disease.

India's Wockhardt knocked again by U.S. FDA

Mumbai-based drugmaker Wockhardt is once again in the crosshairs of the U.S. Food and Drug Administration (FDA) after the American regulator found the pharma giant was hiding the results from failed tests on drugs and deleting the resulting data from computer systems at a plant in western India, according to a report by Reuters.

GSK's Avodart goes off patent in Korea, generics rise to challenge

Drugmakers in South Korea are moving in to take market share from GlaxoSmithKline, which saw its prostatic hyperplasia and hair loss medication treatment Avodart (dutasteride) go completely off-patent.

Key Southeast Asia markets show strong potential punch in 2016

Outside of the main markets in China, Japan and India in Asia are closely followed plays in Indonesia, Thailand, Malaysia and Vietnam with the last two among 11 nations that signed the Trans-Pacific Partnership trade pact.

Japan's Chiyoda plans on big growth in drug plant building

Tokyo-based general contractor Chiyoda, which recently won a $42 million contract to build a production plant for injectable cancer drugs, plans to compete for more such business as its energy-related projects start to slow due to the low price of oil.

Indian drug firms may finally put quality at top of management agenda

India faces the coming year still mired in a long list of U.S. FDA manufacturing compliance failures that have snared the top generics makers and overshadowed domestic reform efforts--but that might change drastically.

AMRI signs a trio of deals in R&D, manufacturing and marketing

Contract drug developer AMRI bolstered its client roster with three new agreements making use of its R&D, manufacturing and marketing divisions.

Deal in Russia could cause Pfizer, GSK to lose contracts

A unit of Rostec, Russia's state corporation, has inked a pact with the Serum Institute of India to locally produce several vaccines in Russia, the Pharma Letter reports, a development that could bring about "significant losses" for Pfizer and GlaxoSmithKline in the country.