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Novartis, Lilly win in breast cancer; GSK, AstraZeneca cut ovarian cancer risk

Top news

* New data presented separately by Novartis AG and Eli Lilly and Co. at the European Society for Medical Oncology showed that women with the most common type of breast cancer — hormone receptor-positive, or HR+, and human epidermal growth factor 2-negative, or HER2- — live longer when treated earlier with a class of drugs known as CDK4/6 inhibitors, or cyclin-dependent kinase inhibitor, and AstraZeneca PLC's Faslodex.

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* The U.K.'s two biggest drugmakers, AstraZeneca and GlaxoSmithKline PLC, both reported highly anticipated data showing targeted treatment with PARP inhibitor drugs significantly extended survival in women with ovarian cancer without the disease progressing. The results open up the possibility of new treatment options for the fifth most common cancer in the world.

AstraZeneca's Paola-1 study of Lynparza taken in combination with Roche Holding AG's Avastin was shown to cut the risk of disease progression or death by 41% in ovarian cancer patients with and without the genetic BRCA mutation. The announcement was followed by results of GSK's Prima study of Zejula as maintenance treatment in women with newly diagnosed ovarian cancer that showed a 38% drop in disease progression or death compared with placebo.

* Paris-based Sanofi plans to slash about 200 jobs involving sales, regulatory affairs and operations in Japan, Reuters reported, citing a person familiar with the matter. Sanofi Japan intends to roll out a voluntary retirement program, according to a company representative.

ESMO conference

* Bristol-Myers Squibb Co. said its blockbuster immunotherapy Opdivo, in combination with Yervoy, beat chemotherapy in extending the lives of patients with advanced non-small cell lung cancer. According to the final results of a late-stage study, called CheckMate -227, the two-year survival rate for patients who received the combo was 40%, compared to 33% for those who underwent chemotherapy.

In July, topline results of the CheckMate -227 trial showed Opdivo failed to best chemotherapy in extending overall survival in non-small cell lung cancer patients whose tumors expressed a certain protein called PD-L1.

* Amgen Inc. said its KRAS inhibitor AMG 510 showed tumor stopping and reducing capabilities in an early-stage study consisting of patients with non-small cell lung cancer, colon cancer and appendix cancer.

* Merck & Co. Inc. said a combination of Keytruda and chemotherapy resulted in more remissions than chemotherapy alone in a late-stage study, named Keynote-522, in patients with early-stage triple-negative breast cancer.

* GlaxoSmithKline said a combination of its experimental drug GSK3359609 and Merck & Co.'s Keytruda helped reduce tumors in patients with head and neck squamous cell carcinoma who took part in an early-stage study.

* Eli Lilly's experimental drug selpercatinib shrank thyroid cancers in patients whose cancers have abnormalities in the rearranged during transfection kinase, according to data from an early-stage study.

* Roche said its medicine Tecentriq, when used as an initial therapy, was better than chemotherapy in improving overall survival in certain patients with advanced non-small cell lung cancer, according to data from a late-stage study.

* Seattle Genetics Inc. said its drug tucatinib, combined with Roche Holding AG's Herceptin, shrank tumors in patients with HER2-positive, RAS wild-type colorectal cancer that has spread across the body, data from a mid-stage study showed.

On the policy front

* President Donald Trump will "tout" his healthcare agenda during an Oct. 3 speech at The Villages retirement community in Florida, the White House said, though it is unclear if the address will be used to reveal the plan he has repeatedly promised. Trump is also expected to sign an executive order affecting the Medicare program, White House spokesman Judd Deere told S&P Global Market Intelligence.

* The U.S. Senate approved the delay of $4 billion in Medicaid payment cuts for disproportionate share hospitals, pushing the start date back from Oct. 1 to Nov. 22. The delay was a provision of the continuing resolution the Senate passed Sept. 26 to avoid a government shutdown. The move came just three days after the Centers for Medicare and Medicaid Services finalized the Oct. 1 start date.

* Bangladesh's Directorate General of Drug Administration banned the use of heartburn medicine ranitidine as the agency probes into the possibility that the popular therapy contains a cancer-causing chemical called N-nitrosodimethylamine, Reuters reported. Ranitidine, which is sold by French drugmaker Sanofi as Zantac, is also under review by U.S. and EU regulators and has been recalled by companies such as Swiss drugmaker Novartis.

CVS Health Corp., which owns U.S. retail pharmacy chain CVS Pharmacy, also suspended the sale of Zantac and other ranitidine products due to the potential carcinogen presence.

M&A and capital markets

* Swedish Orphan Biovitrum AB (publ) will acquire Dova Pharmaceuticals Inc. for a potential consideration of up to $915 million. Sobi will launch a tender offer for all outstanding Dova shares, offering the target company's shareholders a total consideration of $29 per share, based on certain conditions.

* Conglomerate CK Hutchison Holdings Ltd. will lose control of Hutchison China MediTech Ltd. as it plans to reduce its stake in the Hong Kong-based pharmaceutical company to 49.9% from 51.1%.

* In yet another delay in Roche's takeover of Spark Therapeutics Inc., the Swiss drugmaker is again extending the tender offer period to acquire all Spark shares for $114.50 apiece, or $4.3 billion in cash. The offer will now expire at 5 p.m. ET on Oct. 30, unless further extended. The company had already extended the offer period several times from its initial April 3 deadline.

* Allergan PLC received a request for more information from the U.S. Federal Trade Commission with regard to its pending $84.2 billion acquisition by AbbVie Inc., although the company did not disclose what the FTC was investigating. The companies said they are cooperating with the FTC, and they still plan to complete the merger in 2020.

Drug and product pipeline

* Roche said the U.S. Food and Drug Administration expanded the marketing approval for Genentech Inc.'s Rituxan to treat children ages two years or older who are affected by granulomatosis with polyangiitis and microscopic polyangiitis, two rare kinds of blood vessel disorders.

* Novartis' investigational triple combination therapy QVM149 was better than its other inhaled treatment QMF149 in improving the lung function in certain patients with uncontrolled asthma — the main goal of a late-stage study known as Iridium.

Meanwhile, QMF149 helped improve the lung function of certain asthma patients better than corticosteroid alone, meeting the main goal of a late-stage trial called Palladium.

Operational activity

* Mylan NV agreed to pay $30 million to the U.S. Securities and Exchange Commission to settle a complaint alleging the company failed to inform investors that a 2014 U.S. Department of Justice inquiry into its EpiPen pricing could result in a loss.

* Mallinckrodt PLC reached a definitive settlement agreement with Ohio's Cuyahoga and Summit Counties in relation to allegations that the U.K. drugmaker helped fuel the U.S. opioid epidemic. Mallinckrodt will pay $24 million in cash and provide $6 million in generic products, including addiction treatment products.

* Speaking at a Sept. 26 S&P Global climate risk conference in New York City, Novartis' head of climate, James Goudreau, told a room of investors, CEOs and others that the company's views on climate change risks are constantly evolving — and one emerging threat is the loss of biodiversity.

The day ahead

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

In Asia, the Hang Seng lost 0.33% to 25,954.81, while the Nikkei 225 dropped 0.77% to 21,878.90.

In Europe, around midday, the FTSE 100 slipped 0.25% to 7,407.99, and the Euronext 100 shed 0.06% to 1,092.48.

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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The European Society for Medical Oncology is holding its 2019 scientific meeting in Barcelona, where more than 3,900 study abstracts have been submitted for review by oncology professionals from around the world.