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Clovis ovarian cancer drug gets NICE nod; Takeda in sale talks with Stada, Acino

Editor's Note: Today's edition of the Daily Dose was published late due to technical issues. We apologize for the inconvenience.

Top news

* Clovis Oncology Inc.'s Rubraca received a recommendation from the U.K.'s National Institute for Health and Care Excellence to treat women with ovarian cancer, in a reversal of its earlier decision after the U.S.-based company cut the price of the drug. Women in the U.K. with relapsed ovarian, fallopian tube or peritoneal cancer that has responded to platinum-based chemotherapy can now be offered Rubraca, also known as rucaparib.

The medicine belongs to a class of drugs called PARP-inhibitors, which are targeted therapies that kill cancer cells by blocking enzymes that allow cells to repair DNA. Other PARP inhibitors include GlaxoSmithKline PLC's Zejula, or niraparib, and AstraZeneca PLC's Lynparza, also known as olaparib, both of which recently unveiled highly anticipated data showing a jump in survival for women with ovarian cancer without the disease progressing.

* Takeda Pharmaceutical Co. Ltd. is in advanced negotiations to sell its over-the-counter and prescription-drug assets in Russia to Germany's Stada Arzneimittel AG, which is owned by Cinven and Bain Capital, Bloomberg News reported. Tokyo-based Takeda is also nearing a deal to divest in assets in the Middle East and Africa to Switzerland's Acino International AG, which is owned by Nordic Capital and Avista Capital Partners, unnamed sources told the news outlet.

Takeda is also nearing selling its portfolio of over-the-counter and prescription drugs in emerging markets and western Europe in separate transactions in a bid to reduce and simplify its portfolio, Bloomberg News reported in September.

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* The U.S. Food and Drug Administration granted marketing authorization to OraSure Technologies Inc.'s test for the detection of Ebola virus antigens. The OraQuick Ebola Rapid Antigen test becomes the first rapid diagnostic test approved for the Ebola virus disease.

The Ebola outbreak in the Democratic Republic of the Congo is confined in a smaller area but also in "more rural and more insecure areas" with armed rebels, making the disease harder to eradicate, Michael Ryan, the executive director of the World Health Organization's health emergencies program, told reporters. The WHO said there were 14 confirmed infections last week — the lowest number in what is considered the world's second-largest Ebola outbreak, Reuters noted.

* French President Emmanuel Macron said donors from around the globe, including Microsoft Corp.'s co-founder Bill Gates, have pledged about €13.8 billion to fight AIDS, Reuters reported.

On the policy front

* After a U.S. district judge struck down work requirement policies in Kentucky and Arkansas three times in nine months, the federal government is looking to a U.S. appeals court to overturn the decisions and land a win for what has become a defining and controversial health policy of the Trump administration.

Judge James Boasberg for the U.S. District Court for the District of Columbia struck down the states' policies in March, writing that the U.S. Department of Health and Human Services did not adequately consider the impact the policies will have on beneficiaries. Boasberg pointed to thousands of people who lost coverage in Arkansas as evidence and said HHS Secretary Alex Azar's approvals were "arbitrary and capricious."

M&A and capital markets

* Chanticleer Holdings Inc., the owner and operator of restaurants including Hooters, reached a deal to combine with privately held cancer-drug maker Sonnet BioTherapeutics Inc. in a reverse merger. Under the definitive merger agreement, Sonnet shareholders will become the majority owners of the combined entity, a company operating as Sonnet and trading on Nasdaq under the ticker SONN.

* Germany's Merck KGaA said it acquired Wilbraham, Mass.-based FloDesign Sonics Inc., a private biotechnology company offering an acoustic cell processing platform to industrialize cell and gene therapy manufacturing. Financial terms were not disclosed.

* Vir Biotechnology Inc., an immunology company focused on treating serious infectious diseases, priced its IPO of 7,142,858 common shares at $20 apiece — the lower end of a previously announced range. Gross proceeds from the IPO are expected to reach about $142.9 million.

Operational activity

* Bayer AG unit Monsanto Co. is facing charges from Ross Wild, a farmer from New South Wales, Australia, alleging that the company's top-selling herbicide Roundup caused his non-Hodgkin's lymphoma, a type of blood cancer, Reuters reported. The German healthcare conglomerate, which is facing thousands of lawsuits in relation to Monsanto's glyphosate-based weedkiller, said it stands behind the safety of its products.

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* CSPC Pharmaceutical Group Ltd.'s shares slumped on speculation that butylphthalide, a substance used in one of the company's key medicines, has been included on the watch list in China's eastern Zhejiang province, Bloomberg News reported. The Chinese drugmaker's shares were down 6.10% to HK$16.02 as of market close Oct. 11. Butylphthalide is used in China to treat stroke, although it has not been proven effective in that indication.

* Alexion Pharmaceuticals Inc. and Stealth BioTherapeutics Corp. agreed to co-develop and commercialize Stealth's genetic disorder drug elamipretide. Newton, Mass.-based Stealth's elamipretide is being evaluated in late-stage studies for the treatment of genetic disorders including primary mitochondrial myopathy and Barth syndrome.

* United Therapeutics Corp. handed back the North American rights of inhaled drug-device combination product RT234 to Respira Therapeutics Inc. RT234 is being evaluated in a mid-stage study to treat pulmonary arterial hypertension — a rare, progressive disorder characterized by high blood pressure in the arteries of the lungs.

* Beacon Pharmaceutical, an affiliate of Beacon Capital LLC of New York, got one step closer last week to building a 150,000-square-foot bioscience research and development accelerator in Jupiter, Fla., after the town's council approved the company's site plan, S&P Global Market Intelligence reports.

The day ahead

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

In Asia, the Hang Seng climbed 2.34% to 26,308.44, and the Nikkei 225 rose 1.15% to 21,798.87.

In Europe, around midday, the FTSE 100 was up 0.60% to 7,210.66, and the Euronext 100 was up 0.83% to 1,085.79.

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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