Spotlight On... Ono Pharma developing new diagnostic for potential Opdivo patients; Japanese researchers create new iPS cell line; BioAtla in line for $70M; and more...

Japan's Ono Pharmaceutical is planning to develop a new diagnostic tool to determine whether more cancer patients will benefit from the cancer drug Opdivo. The company has put together a team of 6 researchers to ID cancer biomarkers; it has already found one marker that "determines how well a patient could respond to the drug." Opdivo was approved in Japan in 2014 for melanoma treatments and in 2015 for lung cancer. A Nikkei report said the company earned $21 million from Opdivo sales in 2014 and that a new diagnostic tool could increase sales. The approach differs from conventional treatments because it looks for patients with specific genetic codes, but this entails a "companion diagnostic" to ID benefits and side effects. Report

> India's efforts to become a global power in drug discoveries "is bound to fail" if the country does not work to improve its drug manufacturing practices, a top official said. Report

> San Diego-Beijing biotech BioAtla is slated to get a total of $70 million in payments and equity investment from Beijing-based Sinobioway Group this year related to a programs selected for development in collaboration deal to develop CAB antibody therapeutics. BioAtla signed a potential $1 billion deal with Pfizer ($PFE) in December covering CAB. Release

> Japanese researchers have created a line of cells that can develop into induced pluripotent stem cells they hope will help spur new developments in regenerative treatments. Report

> The government of India has extended the dates for companies to place track and trace systems on drug shipments. Report

> Hisamitsu Pharmaceutical subsidiary Noven said it has appointed Jeff Mihm as CEO, John Choi as CFO and Michael Greene as general counsel. Release

> Japan's Eisai said it has appointed Hiroyuki Kobayashi as chief medical officer. Release

> India's Ministry of Health and Family Welfare is proposing to raise fees charged to drug companies for new registrations, manufacturing and licenses, and for clinical trials. Report

> U.S.-based Lixte Biotechnology has licensed the Asian rights of its lead anti-cancer compound, LB-100 to Taipei Medical University for a clinical trial in exchange for unspecified milestones and royalties. The candidate is aimed at hepatocellular carcinoma treatment. Release

> Vancouver-based Cardiome said a subsidiary has signed an agreement with Seoul-based Chong Kun Dang Pharmaceuticals to sell onset atrial fibrillation treatment Brinavess in South Korea. Release

> Japan's Ministry of Health, Labor and Welfare may approve resumed shipments of hepatitis B vaccine Bimmugen by the Chemo-Sero-Therapeutic Research Institute, or Kaketsuken, early this year in case of shortages, a MHLW spokesman said. In December, Japan suspended shipments of 7 types of Kaketsuken products linked to record-keeping fraud. MHLW website

> Panelists at the annual Indian Science Congress called on domestic companies and researchers to strive for Good Laboratory Practices in the pursuit of drug discoveries and manufacturing standards. Report

> Mumbai-based Cipla has signed an agreement with U.S.-based BioQ for post-operative pain treatment Ropivacaine registration and sales in India. Release

> The Mumbai-based Tata Memorial Hospital will apply for clinical trial approval to join the UK-based "Add-Aspirin" global drug clinical trials to study whether the analgesic has any role in preventing recurrence of the most common cancers. Report

> Mumbai-based Lupin has launched its contraceptive Tri-Lo-Marzia tablets in the U.S., a generic of Janssen Pharmaceuticals' Ortho. Report

> Mumbai-based Glenmark Pharmaceuticals won a tentative nod from the U.S. Food and Drug Administration to sell a generic version of Sanofi-Aventis cardiovascular drug Multaq in the U.S. Report

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