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Roche's Tecentriq meets goals in lung cancer study; J&J halts Darzalex trials

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Roche's Tecentriq meets goals in lung cancer study; J&J halts Darzalex trials

Top news

* Roche Holding AG said the phase 3 IMpower 130 study of Tecentriq plus chemotherapy met its main goals, helping people with advanced, nonsquamous non-small cell lung cancer live significantly longer compared to chemotherapy alone. The combination treatment also reduced the risk of disease worsening or death, compared to chemotherapy alone.

* Johnson & Johnson is ending two clinical trials for Darzalex — one for lung cancer and another for blood cancer — following a review by a data monitoring committee.

The committee recommended the termination of a phase 1b/2 study of Darzalex plus Roche Holding AG's Tecentriq in patients with previously treated non-small cell lung cancer after determining that the combination did not provide benefits over Tecentriq alone. The committee also found an increase in mortality-related events among patients in the combination arm of the study, which is called Callisto/LUC2001.

On the policy front

* Health and Human Services Secretary Alex Azar has been summoned to Capitol Hill to explain how President Donald Trump plans to lower the prices of prescription drugs in the U.S. and what role the White House expects Congress to play in that effort.

U.S. Food and Drug Administration Commissioner Scott Gottlieb invited senior executives from major internet search engines, social media platforms, domain name registries and online marketplaces to join him and other groups for a one-day summit to discuss ways to collaboratively take stronger action to combat the U.S. opioid crisis by reducing the availability of the drugs sold illicitly online.

Meanwhile, The Senate Judiciary Committee last week last week advanced five bills aimed at addressing the U.S. opioid crisis, while members of the chamber's Finance Committee introduced another 22 pieces of related legislation.

* Marc Short, the White House director of legislative affairs, said HHS chief Azar and U.S. FDA head Gottlieb cannot be blamed if the promise by congressional leaders that the right-to-try legislation would save lives fails to be borne out. Gottlieb initially expressed concern that the legislation's "life-threatening disease or condition" criteria was too broad.

M&A and capital markets

* Germany-based seed company KWS Saat SE is offering to buy Bayer AG's vegetable seed business, Reuters reported, citing KWS Chief Executive Hagen Duenbostel. Bayer previously agreed to sell the seed business to BASF SE as part of its $62.5 billion acquisition of Monsanto Co.

* Myriad Genetics Inc. agreed to acquire California-based genetic screening and DNA analysis service provider Counsyl Inc. for $375 million.

* Alibaba Group Holding Ltd. agreed to sell part of its Tmall Pharmacy business to its Hong Kong-listed subsidiary Alibaba Health Information Technology Ltd. in exchange for HK$10.6 billion of newly issued shares in the latter company.

Drug and product pipeline

* The U.S. FDA accepted Loxo Oncology Inc.'s application for its drug larotrectinib as a therapy for patients with solid tumors harboring an NRTK gene fusion — genetic alterations that can cause tumor growth. The regulator also granted priority review for the drug, which Loxo co-develops with Bayer.

* GlaxoSmithKline PLC and Innoviva Inc. are seeking approval from the Japanese Ministry of Health, Labour and Welfare to approve its triple drug inhaler therapy called Trelegy Ellipta for treating patients with chronic obstructive pulmonary disease.

* China's Luye Pharma Group Ltd. entered a collaboration and license deal with privately held Elpis Biopharmaceuticals Corp. to develop novel anticancer therapies. The partnership will focus on discovery and development of dual-target chimeric antigen receptor T cell therapies and biologics, or medicines derived from living organisms.

Operational activity

* Sun Pharmaceutical Industries Ltd. said net profit for the fiscal year ended March 31 fell to 21.62 billion Indian rupees from 69.64 billion rupees in the year-ago period. India's biggest drugmaker expects low double-digit percentage growth in revenue for fiscal 2019, helped by the launch of several specialty drugs and potential regulatory clearance for its Halol plant.

* The European Commission is planning to change intellectual property rules to make it easier for generic-drug makers to export therapies to countries where they are not covered by extended patent protection, Reuters reported.

Other features

* The Wall Street Journal reported on the growing number of lawsuits Johnson & Johnson has been facing over claims that its baby powder causes mesothelioma, a cancer of the lining of the lungs that is tied to asbestos exposure.

* The Wall Street Journal also has a feature about how blockchain technology could help iron out the way that electronic medical data is shared among doctors, insurers, patients and hospitals, and how it could contribute to affordable healthcare.

* Reuters writes about how U.S. doctors are arguing that improved access to affordable healthcare for women can improve the health of all Americans, not just women.

* Nepal reported an outbreak of a severe form of bird flu among backyard ducks near the country's capital, Reuters reported, citing the World Organization for Animal Health.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.

In Asia, Hang Seng lost 1.00% to 30,484.58, while the Nikkei 225 fell 0.55% to 22,358.43.

In Europe, around midday, the FTSE 100 dropped 1.36% to 7,625.13, and the Euronext 100 shed 1.16% to 1,054.14.

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