Top news
* China unveiled a list of potential winners for the expanded centralized procurement program, which further slashed prices for 25 selected drugs by 25%, according to a notice posted on a Shanghai city government website. Eli Lilly and Co., Sanofi and Dr. Reddy's Laboratories Ltd. are among the multinational drugmakers with products included in the list.
* Novartis AG said an internal investigation into manipulation of preclinical data on gene therapy Zolgensma was "drawn out" due to the "lack of cooperation" and "categorical denial" of the allegations by two now-former executives of its AveXis Inc. unit.
In a response letter to the U.S. Food and Drug Administration dated Aug. 23, the Swiss pharmaceutical giant said an employee of AveXis alleged that two AveXis senior executives "altered or instructed others to alter" certain data related to the preclinical testing that led to the internal probe's launch March 14.
The FDA opened a probe into Zolgensma in August after AveXis reported a data manipulation issue related to animal testing that was done to support the therapy's approval. Just over a week after the investigation was launched, Novartis said AveXis Head of Research and Development Allan Kaspar and Chief Scientific Officer Brian Kaspar were no longer with the company.
* Amgen Inc. is fostering its biosimilar pipeline to become a powerhouse in the fledgling U.S. copycat arena, building upon global sales that have doubled since the end of 2018. Taking advantage of these early stages of the U.S. biosimilar market is a good investment for Amgen and the healthcare system as a whole, Chad Pettit, an executive director for the company's biosimilar programs, told S&P Global Market Intelligence.
* Best Buy Co. Inc. is planning to enter the healthcare sector to offset the slow performance of its main business of selling laptops, televisions, phones and other gadgets, Bloomberg News reported. The electronics retailer plans to offer health-related products, including fitness machines and health-monitoring services, the news outlet added.
* Amazon.com Inc. launched Amazon Care, a virtual health clinic for its Seattle-based employees, CNBC reported. The app-based service allows employees and their families to consult with doctors or nurses through video calls and online messaging.
* Chinese tech companies Ping An Insurance (Group) Co. of China Ltd.-backed Ping An Healthcare and Technology Co. Ltd., along with Alibaba Group Holding Ltd. and Tencent Holdings Ltd., are using digital services such as mobile applications and online messaging to transform the country's healthcare system, Bloomberg News reported. Online healthcare in China is expected to become a 198 billion yuan industry by 2026, Bloomberg added, citing business and consulting firm Frost & Sullivan.
On the policy front
* Premiums for private healthcare insurance plans sold to seniors and Americans with disabilities under the Medicare Advantage program are expected to decline next year by 14% from 2019 rates, the Centers for Medicare and Medicaid Services, reported. Beneficiaries would also have about 1,200 more plan choices in 2020 versus 2018.
* CMS finalized $44 billion in Medicaid payment cuts for disproportionate share hospitals, facilities that serve a high volume of uninsured or Medicaid patients, which can result in hospitals having large amounts of uncompensated care.
* CMS Administrator Seema Verma said a federal court decision that dealt a blow to efforts to establish site-neutral Medicare payments is a cautionary tale of too much government control in the U.S. healthcare system. The court's decision to vacate the Medicare payment rate for certain outpatient facilities was a "setback" for the administration, which used site-neutral payments that it said helped curb unnecessary spending, Verma said.
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* As Tennessee attempts to become the first state to have a Medicaid block grant waiver approved by the Trump administration, legal experts expect the proposal to become locked up in court before it is ever implemented. The state's proposal would cap federal funding for Medicaid and grant the state extra flexibility to operate its program with little interference from the federal government.
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M&A and capital markets
* London's Amryt Pharma PLC said it completed the acquisition of Aegerion Pharmaceuticals Holdings Inc. from Vancouver, British Columbia-based Novelion Therapeutics Inc. The acquisition was conducted as part of funding and restructuring deals to help Aegerion recover from bankruptcy.
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Drug and product pipeline
* Acorda Therapeutics Inc.'s Parkinson's disease drug Inbrija won the European Commission's approval to treat adult patients experiencing so-called off periods, when the effects of an existing medication start to wear off in between doses, or symptoms of the disease reemerge.
* Novartis issued a recall of its heartburn medicines that contain ranitidine — a generic version of Sanofi's Zantac — from shelves in the U.S. due to the presence of the chemical N-nitrosodimethylamine, a probable carcinogen. The move comes after a worldwide distribution halt implemented by the company a week earlier.
* Bavarian Nordic A/S said the FDA approved its smallpox and monkeypox vaccine Jynneos for use in adults, including people with weak immune systems and eczema.
* Amgen Inc.'s cancer medicine Blincyto performed better than chemotherapy in treating children with B-cell acute lymphoblastic leukemia in two late-stage studies, dubbed 20120215 and AALL1331.
* UroGen Pharma Ltd. said its investigational blood cancer drug UGN-101 helped 59% of patients achieve remission after 12 weeks of treatment, the main goal of a late-stage study known as Olympus.
* Cumberland Pharmaceuticals Inc. received slightly more than $1 million in funding from the FDA's orphan-drug grant program for a mid-stage study evaluating ifetroban, a potential treatment of rare genetic neuromuscular disorder Duchenne muscular dystrophy.
Operational activity
* Rexahn Pharmaceuticals Inc. is evaluating strategic alternatives to enhance shareholder value and hired Oppenheimer & Co. Inc. as financial adviser. The Rockville, Md.-based biopharmaceutical company is considering an acquisition, merger, reverse merger, asset sales, licensing or other transactions and combinations.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng declined 1.28% to 25,945.35, and the Nikkei 225 was down 0.36% to 22,020.15.
In Europe, around midday, the FTSE 100 fell 0.86% to 7,227.91, and the Euronext 100 slid 1.32% to 1,074.14.
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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