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Roche's breast cancer drug Kadcyla beats Herceptin; Medicare to hike rates

Top news

* Roche Holding AG said Kadcyla is better than Herceptin in lowering the risk of disease recurrence in early breast cancer patients, meeting the main goal of a late-stage study. The Swiss drugmaker was studying Kadcyla in a phase 3 trial known as Katherine which enrolled patients with HER2-positive breast cancer.

* Just three days before Medicare open enrollment is set to begin, the Centers for Medicare and Medicaid Services announced an increase to premium and deductible rates for Medicare parts A and B. The new rates issued by the CMS on Oct. 12 will go into effect Jan. 1, 2019. Open enrollment for the federally run healthcare program begins Oct. 15 and ends Dec. 7.

* Danish pharmaceutical company Novo Nordisk A/S, which recently announced a restructuring of its research operations, said that Ludovic Helfgott is to join the company from AstraZeneca PLC and take charge of its hemophilia and human growth hormone franchise. He will take up the position as head of the Biopharm unit and a member of Novo Nordisk's executive management — which reports to CEO Lars Fruergaard Jørgensen — on April 3, 2019, and will be based in Zurich.

* EU authorities are bolstering supervision over Chinese drugmaker Zhejiang Huahai Pharmaceutical Co. Ltd., after the European Medicines Agency and the U.S. Food and Drug Administration found that the company's manufacturing facility for heart medicine valsartan was not in compliance with good manufacturing practices.

* In the Democratic Republic of the Congo, the latest Ebola outbreak in the eastern region has led to the death of 125 people, with more people getting the disease at a faster rate, Bloomberg News wrote, citing the country's health ministry. The outbreak could last at least three or four months more and could spread to neighboring countries Uganda or Rwanda, a senior World Health Organization official told Reuters.

* The number of individuals who were confirmed to have been infected with the Zika virus in Jaipur, India, rose to about 55 from 22 a week earlier, as the peak tourist season approaches, Reuters reported, citing the local health department. Although there is no vaccine for the virus yet, Japanese drugmaker Takeda Pharmaceutical Co. Ltd. is among the companies developing one.

M&A and capital markets

* Canopy Growth Corp. is acquiring ebbu Inc., an Evergreen, Colo.-based hemp research company. The Canadian medical cannabis company will pay C$25 million in cash and issue 6,221,210 common shares to ebbu, as well as up to C$100 million based on the achievement of certain milestones within two years after deal closing.

* Innovent Biologics Inc. expects to raise as much as $422 million through its Hong Kong IPO, Reuters reported, citing three sources. The biotechnology company set a price range of HK$12.5 per share to HK$14 per share for the offering, giving it a valuation of about $2 billion, the sources said.

* India's Dr. Reddy's Laboratories Ltd. agreed to sell its active pharmaceutical ingredients manufacturing unit in Jeedimetla, Hyderabad, to Therapiva Pvt. Ltd. The transaction, financial terms of which were not disclosed, is part of Dr. Reddy's efforts to streamline manufacturing operations and improve cost structures, according to a news release.

* The Green Organic Dutchman Holdings Ltd. said Aurora Cannabis Inc.'s milestone option to buy an additional 8% stake in the company expired. Aurora, which recently applied to list on the NYSE, still has the right to buy up to 20% of Green Organic Dutchman's premium organic cannabis from two facilities being constructed in Canada.

Drug and product pipeline

* The U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee recommended AcelRx Pharmaceuticals Inc.'s under-the-tongue opioid Dsuvia for approval. Dsuvia is a sufentanil sublingual tablet designed to reduce dosing errors that can be associated with intravenous drugs.

* Chugai Pharmaceutical Co. Ltd.'s nerve disease drug satralizumab significantly reduced relapses in patients suffering from an autoimmune disease of the nervous system, a late-stage study showed. The phase 3 trial, called SAkuraSky, enrolled 83 patients with neuromyelitis optica spectrum disorder — a rare, lifelong and debilitating autoimmune disease of the central nervous system.

* TG Therapeutics Inc. said a midstage trial of ublituximab showed that the medicine was safe and effective in treating multiple sclerosis. The New York-based biopharmaceutical company evaluated ublituximab, also known as TG-1101, in a phase 2 trial to treat relapsing, or returning forms of multiple sclerosis — a disabling disease of the brain and central nervous system.

Operational activity

* Bayer AG CEO Werner Baumann is considering to outsource some of the German agrochemical company's drug research activities to reduce costs amid lagging growth at its pharmaceuticals business, Reuters reported, citing Bayer's works council.

* Israel's Teva Pharmaceutical Industries Ltd. lost an appeal to regain four patents on its blockbuster multiple sclerosis drug Copaxone, reaffirming marketability of generics from Mylan NV and Novartis AG generics unit Sandoz.

* Merck & Co. Inc. terminated a collaboration deal with South Korea-based Samsung Bioepis to market a biosimilar version of Sanofi's Lantus, a long-acting insulin intended to lower blood sugar in diabetes patients, FiercePharma reported. Lantus, whose patent is set to expire in 2020, would still need to compete with Eli Lilly and Co. and Boehringer Ingelheim's biosimilar Basaglar, as well as Mylan and Biocon Ltd.'s Semglee.

Our features

Capitol Checkup: 'It's healthcare, stupid,' in 2018; progress on cheaper drugs: Healthcare has either outranked or tied even with the economy as Americans' most important concern ahead of the midterm elections; meanwhile, the U.S. Food and Drug Administration broke a new record for generic drug approvals.

Bausch Health sheds Valeant's legacy by building an R&D future: Joseph Papa took the helm of Valeant Pharmaceuticals amid a stock price plummet and $32 billion in debt. Now, the newly renamed Bausch Health Cos. Inc. is on the rebound under his leadership, climbing to a market value exceeding $8.5 billion.

Pricing, patent risks haunt strong Q3, but US FDA approvals offer silver lining: As pharma companies prepare to report earnings, pricing freezes and patent expirations are a source of concern, but a glut of recent drug approvals offer a shot in the arm.

SNL Image

Bose's entry into hearing aids foreshadows new regulations, entrants: The U.S. Food and Drug Administration's Oct. 5 approval for the consumer electronics company's first-of-its-kind "self-fitting" device is a step toward introducing over-the-counter hearing aids that are less costly.

Other features

* A report by investigators at the U.S. Department of Health and Human Services found "widespread and persistent problems related to denials of care and payment in Medicare Advantage," The New York Times wrote.

* The looming European patent expiry of the world's best-selling medicine Humira would leave AbbVie Inc. open to generic competition from several drugmakers such as Amgen Inc. and Biogen Inc., the Financial Times noted.

The day ahead

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

In Asia, Hang Seng dropped 1.38% to 25,445.06, while the Nikkei 225 fell 1.87% to 22,271.30.

In Europe, around midday, the FTSE 100 shed 0.06% to 6,991.79, and the Euronext 100 dropped 0.38% to 985.06.

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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