Spotlight On... Australia's biotech industry sings Korea's praises, asks for more tie-ups; India's Sun snaps up 14 Novartis drugs in Japan; and more...

There was a lot of back slapping at this year's Australian Clinical Trial Seminar, held last week, that aimed to showcase Australia's capabilities and strengths in the clinical trial industry. The events, part of a collaboration project between the Korea Health Industry Development Institute and trade group AusBiotech, saw AusBiotech's COO Glenn Cross tell the Korea Times: "(South) Korea is one of AusBiotech's priority countries in the Asian region. I would like to see increased collaboration between Korean and Australian companies, especially in the regenerative medicine area through this visit." He added: "Australia welcomes more investment from Korean venture capital into Australia and active research and development and marketing activities by Korean companies." This comes just a week after Korean biotech startups were given a new boost after the government announced they would be helped with extra funding and advice. Report

> Mumbai-based Sun Pharmaceutical Industries has entered the Japanese market by snapping up 14 prescription drug brands sold there by the local unit of Novartis ($NVS) for $293 million in cash with details of the products unavailable. Sales of around $160 million have already been reported. Release

> India's National Pharmaceutical Pricing Authority (NPPA) has set domestic price bands for generic licensed versions of Gilead Sciences' ($GILD) Sovaldi (sofosbuvir) at a top price of INR619.31 ($9.34) per tablet starting April 1, the Economic Times said, citing a gazette notification. The drug previously sold in a range of INR705 to INR900 a tablet. Report

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> India's NPPA has also cut ceiling prices on 103 drug formulation packs that cover therapies in HIV/AIDS, bacterial infections, tuberculosis and other diseases effective April 1, the Times of India said. Report

> Tokyo-based Eisai will sell AkaRx, and its sole pipeline asset, avatrombopag (AKR-501/E5501), to a U.S. private equity group, with terms not disclosed. The company is moving to focus on core pipeline areas of oncology and neurology. Eisai bought AkaRx for $255 million in 2010. Release

> The parent of Hong Kong-listed Luye Pharma Group is in the race to buy privately-held French drug firm Ethypharm in a deal that could fetch $800 million to $900 million, according to Bloomberg, with other potential interest from private equity firm Astorg Partners, Mundipharma, and unnamed China drug companies. Report

> China-based Citic Private Equity has invested an unspecified amount in Beijing New Journey Cancer Hospital, a 150-bed facility founded in 2011 using public and private capital with an aim to bring international cancer care expertise to the country. Report

> Zhenjiang-based private hospital chain Zhongmei Healthcare aims to raise $150 million in an initial public offering on the Hong Kong Stock Exchange in the second quarter, offering a 25% stake. Carlyle Group holds a 15.7% stake in Zhongmei. The offer comes as Hospital chain Human Health Holdings is looking to raise $15 million on the exchange as is Rici Healthcare by eyeing $250 million. Report

> Tokyo-based Asahi Kasei Pharma will co-develop and commercialize preclinical pain candidate ARRY-954 and other candidates with U.S.-based Array BioPharma that could see payments and milestones of as much as $76 million for Array with $12 million upfront, which will retain rights to all compounds subject to the collaboration for all indications outside of Asia. Release

> China FDA is getting an earful from the public on food and drug safety, China,org.cn says, with 770,000 complaints in 2015, a jump of nearly 37% with a central feature on companies that operate without a license that sell substandard or fake products. Report

> Japan's Kyoto University and privately-held German drugmaker Boehringer Ingelheim will collaborate to develop a treatment for hearing loss using regenerative therapy techniques developed at the university and led by Takayuki Nakagawa, a senior lecturer and member of an Inner Ear Research Group. Report

> Osaka-based Takeda Pharmaceutical and partner Lundbeck said they were disappointed after they received a complete U.S. FDA response letter requesting new clinical data on an additional efficacy claim for antidepressant Brintellix (vortioxetine) to treat cognitive dysfunction in adults with major depressive disorders. The move follows an 8 to 2 vote by the regulator's Psychopharmacologic Drugs Advisory Committee that the companies had provided evidence to support an efficacy claim. Release

> A venture between Takeda Pharmaceutical and Israel's Teva Pharmaceutical Industries ($TEVA) in Japan, Teva Takeda Yakuhin, has named Hiroshi Matsumori as CEO and president of Teva Pharma Japan. He will be based in Nagoya and start in his new role on April 25. Release

> Takeda Pharmaceutical has announced a multi-year effort on inflammatory bowel disease research with the University of Chicago and the Icahn School of Medicine at Mount Sinai in New York to aid in clinical work in the field. Release

> Japan's Ministry of Health Labor and Welfare (MHLW) endorsed two epilepsy treatments, the local unit of Sanofi's ($SNY) Sabril (vigabatran) developed with Alfresa Pharma and Eisai's Fycompa (perampanel). In other approvals, Meiji Seika Pharma's antipsychotic Sycrest (asenapine), a drug licensed from Merck ($MRK) was approved for schizophrenia as well as Alexion ($ALXN)'s Kanuma (sebelipase alfa) to treat rare genetic disorder lysosomal acid lipase deficiency. The approval sets up marketing and reimbursement pathways for the drugs. MHLW website

> GlaxoSmithKline ($GSK) won a marketing authorization nod for Nucala (mepolizumab) in Japan from the Ministry of Health, Labor and Welfare to treat bronchial asthma in patients with refractory asthma. Release

> The Global Health Innovative Technology Fund will invest $1.4 million to study a pair of potential malaria eradication tools--a vaccine that could block transmission of two species of the deadly disease and a rapid field test that can reveal a malaria infection in minutes. Release

> Johnson & Johnson's ($JNJ) Janssen Pharmaceuticals unit in Japan has applied to the Ministry of Health, Labor and Welfare (MHLW) for an additional indication for Imbruvica (ibrutinib) to treat relapsed or refractory mantle cell lymphoma. Release

> Johnson & Johnson's ($JNJ) Janssen Pharmaceuticals unit in Japan has filed an application with MHLW for approval of Stelara (ustekinumab) to treat moderate to severe active Crohn's disease. Release (Japanese language)

> Tokyo-based Taiho Pharmaceutical said it Phase III candidate, TAS-102, met the primary endpoint of demonstrating improvement in overall survival for patients with refractory mCRC who had already received approved standard therapies. Release

> Australia's Pharmaceutical Benefits Scheme (PBS) has cut prices on more than 400 prescription drugs, including oncology and cardiovascular therapies. Report

> The Drug Controller General of India (DGCI) has banned the manufacture of Liposomal Amphotericin B used to treat severe fungal infections, including meningitis, because of increased complaints of potential side effects on kidney and liver function. Report

> Japan Post will act as an intermediary between doctors, pharmacies and patients for prescription drug delivery initially in Tokyo, Sapporo and Nagoya, but will not handle online sales that remain banned in the country. Report

> Hyderabad-based Dr. Reddy's Laboratories ($RDY) has recalled 3,342 vials of Zoledronic Acid injections that were found as "sub-standard" by the U.S. FDA with questions raised on sterility because of defective seals. Report

> Japan's Pharmaceuticals and Medical Devices Agency has established an Asian Regulatory Training Center on April 1 that will offer training on regulations to regulatory colleagues in the countries that are part of the Association of Southeast Asian Nations with an aim to speed the approval process. MHLW website

> Hong Kong-based Ally Bridge Capital Partners joined a Series B round of funding for Beijing-based LinkDoc Technology, a company that gathers and analyzes oncology medical records in China for doctors. Release

> India's Supreme Court will reply in two weeks to a public interest lawsuit that seeks to half Ranbaxy Laboratories' license permission to make drugs, charging the firm has sold substandard drugs in India. The company is now owned by Mumbai-based Sun Pharmaceutical Industries. Report

> Tamil Nadu, Indian-based drug firm Strides Shasun has completed the acquisition of three brands of Sweden's Moberg Pharma for $10 million as it looks to strengthen its global OTC franchise. Report

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