Spotlight On... Indian pharma to face U.S. headwinds, but growth to remain 'stable'; China FDA details 2015 device statistics; and more...

Indian pharma companies will face growing challenges in the U.S. as fewer big drugs will be losing their patents in the coming years with increased competition and a rise in regulatory scrutiny all set to create headwinds for generics makers, according to the Indian investor firm ICRA. Drugmakers in India have booked strong growth over the past 10 years--driven mainly by the U.S. market--on account of large brands going off patent and sizable organic and inorganic expansion. But the investor firm, a part of the Moody's group, warned that while things might get tough toward the end of the decade, there will be other sales opportunities in lieu of increased R&D expenditure and product pipeline comprising specialty drugs, niche molecules and complex therapies--meaning the growth outlook for Indian pharmaceutical companies will remain stable, if not spectacular. Release

> China FDA has released its 2015 annual report that lists medical device registrations, applications, reviews and approvals. Release

> Prosecutors in Shanghai are looking into milk powder packages sold via the internet and falsely bearing the brand of Abbott Laboratories ($ABT) and have arrested 6 suspects, China FDA said. Release

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> Mumbai-based Lupin Pharmaceuticals has named Kurt Nielsen as president of U.S.-based Lupin-Somerset with responsibility for the recently acquired Gavis-Novel Somerset business in New Jersey. Release

> Israel-based Oramed ($ORMP) has completed a Phase IIb study of an oral insulin candidate, ORMD-0801, and is awaiting topline results for the therapy licensed to Hefei Life Science & Technology Park Investments and Development for Mainland China, Hong Kong and Macau. Release

> Japan's Ministry of Health, Labour and Welfare (MHLW) has released detailed statistical reports on production by the pharmaceutical industry for 2013 and 2014 in English. 2013 release and 2014 release

> South Korea drugmakers are increasingly gaining access to the U.S. market. Report

> Hong Kong-based Ally Bridge Capital Partners has led a $150 million private placement for San Diego-based Sorrento Therapeutics ($SRNE) that includes its partner, Seoul-based Yuhan. Sorrento has four mAbs in post-Phase III development that were in-licensed in 2015 from China's Mabtech. Release

> U.S.-based BioChain, which operates units in Beijing, has bought China rights to a blood-based lung cancer diagnostic test from Berlin-based Epigenomics, building on a 2015 agreement for a colorectal cancer blood test. Specifics on payments and milestones were not disclosed. Release

> Seoul-based Hanmi Pharmaceutical, which has recently been white-hot on the licensing front, has announced plans to spend $200 million over a decade on drug manufacturing and R&D units in China's northeastern Yantai city, marking a major expansion in the country. Hanmi opened a plant and R&D operation in Beijing in 1996. Release

> China's State Council was updated on the investigation into illegal vaccine sales, China FDA said on its website citing a Xinhua story, noting "progress" on the case and vowing to "severely punish" anyone found guilty. Release (Chinese language)

> Researchers at the National Cancer Center, Tokyo, unveiled a plan for Boron Neutron Capture Therapy trials by next March, deploying the new radiation therapy on cancer cases considered the hardest to treat. Report

> India's clinical trial landscape has improved, the CEO of U.S.-based Quintiles ($Q), Tom Pike, told the Times of India in the southern tech hub of Bangalore, citing speedier approvals as an example. Report

> A diabetes-focused drug discovery pact was signed between India's Translational Health Science & Technology Institute and Hyderabad-based Revelations Biotech, aiming to use artificial intelligence to identify people in the pre-diabetes stage. Report

> China's State Council has stressed it wants to expand healthcare reforms to all urban public hospitals and smaller centers by fully abolishing markups of drugs bought on site with an initial increase to 200 cities covered by reforms from 100 earlier as well as new efforts at the county level. As well, it repeated aims to make critical disease insurance universal within a year. Report

> South Korea and Mexico officially recognized each country's pharmaceuticals qualification standards, aiding bilateral trade in the sector. Report

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