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Bayer hit by Roundup trial loss; US FDA approves 1st postpartum depression drug

Top news

* In a second trial involving Monsanto Co.'s weedkiller Roundup, a jury in California concluded that a man developed cancer after using the company's top-selling product, The Wall Street Journal reported. Monsanto, which is now owned by Germany's Bayer AG, has been sued by about 8,000 plaintiffs in U.S. state and federal courts for injuries resulting from its glyphosate-based herbicide.

The six-person jury in the U.S. District Court in San Francisco will now move to the second phase of the trial to assess whether Monsanto should be held liable, according to the news outlet. Bayer's shares slumped 12.51% to €60.98 as of 12:27 p.m. Frankfurt time on March 20, 2019.

* The U.S. Food and Drug Administration approved Sage Therapeutics Inc.'s Zulresso as the first treatment for a form of depression that occurs following childbirth. Zulresso, or brexanolone, was given the green light to treat postpartum depression, in which women may experience symptoms such as sadness or loss of interest in previously enjoyed activities and a decreased ability to feel pleasure. Symptoms might also include cognitive impairment, feelings of worthlessness or guilt as well as thoughts of suicide.

The Zulresso injection, which is administered as a continuous intravenous infusion over 60 hours, carries a boxed warning regarding serious risks, including excessive sedation or sudden loss of consciousness.

* Merck KGaA and Pfizer Inc. discontinued the late-stage trial of Bavencio in certain patients with ovarian cancer. The late-stage trial, named Javelin Ovarian PARP 100, was evaluating the effectiveness and safety of Bavencio, or avelumab, in combination with chemotherapy followed by maintenance therapy of Bavencio and Pfizer's Talzenna, in patients with ovarian cancer that has spread to nearby tissue or lymph nodes, or to other sites of the body.

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On the policy front

* Departing FDA Commissioner Scott Gottlieb said he was confident he is leaving the agency in good shape, though he acknowledged some work he had hoped to tackle in his less than two years on the job will be left unfinished. At a March 19 forum in Washington hosted by the nonpartisan think tank the Brookings Institution, Gottlieb revealed his last working day at the FDA will likely be April 5, a month after he resigned. One of his last duties will be getting grilled on April 3 by House and Senate lawmakers on Capitol Hill about the administration's proposed fiscal 2020 budget.

* The European Federation of Pharmaceutical Industries and Associations called on European leaders to increase efforts to ensure the supply of drugs after the U.K. exits the EU, the Financial Times reported. The Brussels-based trade group, which represents the pharma sector in Europe, said medicines and medical devices that are quality tested in the U.K. should be approved for use in the rest of the continent to protect public health post-Brexit.

* China's rapid economic growth is linked to a rise in the number of overweight children and adolescents, according to research published in the journal The Lancet Diabetes & Endocrinology. Improvements in socioeconomic markers were also linked to reductions in stunting and thinness.

M&A and capital markets

* Pfizer acquired a 15% equity interest in Vivet Therapeutics and it secured an exclusive option to acquire all of the shares in the privately held French biotechnology company, which focuses on gene therapies for metabolic diseases. The companies will jointly develop VTX-801, Vivet’s proprietary treatment for Wilson disease, a rare, chronic and potentially life-threatening liver disorder.

Drug and product pipeline

* The U.S. FDA placed a partial hold on all trials evaluating AbbVie Inc. and Roche Holding AG's medicine Venclexta to treat a type of blood cancer called multiple myeloma, following several deaths.

North Chicago, Ill.-based AbbVie said a higher proportion of deaths was reported in patients receiving Venclexta, or venetoclax, compared to the control arm of a phase 3 trial dubbed Bellini, even though the study met its primary objective at an earlier date.

Operational activity

* Johnson & Johnson and Sientra Inc. received warning letters from the FDA for failing to comply with requirements of certain approvals for their silicone gel-filled breast implants. According to the U.S. drug agency, J&J unit Mentor Worldwide LLC failed to enroll the required number of patients in the post-approval study for its MemoryShape breast implant.

* The FDA issued a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products with claims to treat multiple conditions. According to the regulator, the products, which were labeled as homeopathic, claimed to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions — despite the lack of evidence that they are safe or effective.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, Hang Seng declined 0.49% to 29,320.97, while the Nikkei 225 gained 0.20% to 21,608.92.
In Europe, around midday, the FTSE 100 fell 0.14% to 7,313.56, and the Euronext 100 dropped 0.28% to 1,050.20.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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