Investigational new drug applications for oncology in China may see a 60-day deadline for approvals, placing the country on a path already followed by other major Asian countries for rapid early-stage decisions.

Industry sources said that in a meeting held by the China FDA's Center for Drug Evaluation this month, the agency told clinical researchers and company executives that a pilot plan is on the drawing board for oncology products because of growing interest and therapeutic need.

Takeda Pharmaceutical has recieved expanded commercialization and technology access rights related to Nanotherapeutics' Vero cell technology platform, a cell culture-based platform for vaccine production which Nanotherapeutics acquired from Baxalta, formerly Baxter International's BioScience division.

WuXi PharmaTech's small-molecule process development and manufacturing subsidiary Shanghai SynTheAll Pharmaceutical has received its first approval from the Japan PMDA for the manufacture of the GMP intermediate of a branded commercial drug.

STA is among the Chinese contract manufacturing organizations to have received approval to supply active pharmaceutical ingredients (APIs) and GMP intermediates for branded commercial drugs from regulatory agencies in the United States, Canada, the European Union, Switzerland, China, Japan, Australia, and New Zealand.

Australia based Anteo Diagnostics has decided to acquire DIAsource ImmunoAssays, (DIAsource), a global specialty diagnostics company based in Belgium. DIAsource is a vertically-integrated specialty diagnostics company that develops, manufactures, markets and distributes clinical diagnostics products in the fields of endocrinology, especially bone metabolism, fertility, cardiovascular and oncology.

Researchers in Korea have determined the possibility that adult mesenchymal stem cells (MSCs) may extend healthy life and lifespan by intravenous injections.

Professor Kim from Chungbuk National University and Dr. Ra from Biostar, as a joint research team, announced that the discovery was published in International Journal of Medicine, 'Stem Cells Translation Medicine' (IF 5.7) on August 27, 2015.

Japan' Daiichi Sankyo's domestic subsidiary, Daiichi Sankyo Espha Co Ltd. has obtained approval for partial changes concerning a supplementary indication of their synthetic broad-spectrum oral antibacterial agents, Cravit Tablets 250mg and 500mg, Granules 10% (Levofloxacin hemihydrate). These drugs are marketed by Daiichi Sankyo, and Levofloxacin Tablets 250mg DSEP and 500mg DSEP, Granules 10% DSEP, marketed by Daiichi Sankyo Espha, for the treatment of pulmonary and other tuberculosis disorders.

According to a recent report released by IMS Consulting for the Pharmaceutical Healthcare Association of the Philippines (PHAP), the country's pharmaceutical industry is projected to grow by 4.5 percent annually over the next five years reaching P164 billion in 2018 from P146 billion in 2014.

The report elaborated that pharmaceutical manufacturing sector ranked in the top 22 percent of the 240 sectors in the Philippines when measured by total output, with the pharmaceutical market estimated to grow by 4.5 percent year-on-year over the next five years. 

A wide-ranging development plan targeting Taiwan's biotechnology-based economy is set to kick off next year, according to Premier Mao Chi-kuo Aug. 19.

Focusing on agriculture, biomedicine, food, health care and medical instruments, the 10-year initiative will potentially expand the scale of the local bioeconomy to NT$4 trillion (US$123.2 billion) in 2026.

Echo Therapeutics, Inc. (NASDAQ: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, today announced that, after numerous consultations with the Chinese government, its strategic partner, Medical Technologies Innovation Asia (MTIA), Ltd., believes that Echo's locally produced needle-free CGM products will be designated as a Class 2 medical device. Class 2 medical devices have a review period of 90 working days after filing submission with the Medical Device Evaluation Center of the China Food and Drug Administration (CFDA).  A formal and final designation from the CFDA is determined only at the time of submission.

The Biotechnician-What are you planning on acquiring from the Curative deal in China, and what is the future of the purchase?

Douglas-Curative Medical is a leading provider of non-invasive ventilation (NIV) and sleep-disordered breathing (SDB) medical devices in China, with strong local R&D manufacturing, sales and marketing capabilities. We have signed a definitive agreement to invest in this innovation-led, high growth company so that we can accelerate the development of China’s sleep and respiratory care markets. Curative will retain their name and branding, and Jason Sun will continue as Curative’s leader. Initially, ResMed and Curative will be strategically aligned but operationally independent. Curative and ResMed customers will continue to receive the same high quality customer service and both the companies’ product lines will be fully supported.