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US FDA cracks down on data fraud; 2 EU wins for Roche's Tecentriq in lung cancer

Top news

SNL ImageUS FDA Acting Commissioner Ned Sharpless
Source: U.S. Food and Drug Administration

* The U.S. Food and Drug Administration warned that it will be vigilant against companies that may try to slip fraudulent data into their marketing applications and warned that any company caught deliberately falsifying data will be punished, Ned Sharpless, the agency's acting commissioner, said Sept. 5 at Research!America's Straight Talk forum in Washington.

Sharpless did not identify any company that has engaged in fraudulent behavior, but in early August, the FDA reported that Novartis AG had submitted manipulated preclinical animal data in its application for its $2.1 million gene therapy Zolgensma — a charge now being investigated by Congress.

Also at the conference, Robert Redfield, director of the Centers for Disease Control and Prevention, urged more investment in the core capabilities required to address the nation's public health needs, such as data and data analytics, laboratory capacity, and the workforce.

* The European Commission approved Roche Holding AG's medicine Tecentriq, in combination with chemotherapy, as an initial treatment for two lung cancer types: extensive-stage small cell lung cancer and non-squamous non-small cell lung cancer. The approvals were based on positive results from late-stage studies, dubbed IMpower133 and IMpower130.

* AstraZeneca PLC and Microsoft Corp. are collaborating to set up AI Factory for Health, a health technology incubator in France for startups, Bloomberg News reported. While the U.K.-based drugmaker will provide clinical expertise and healthcare data, among others, Microsoft will offer the services of its cloud platform, Azure.

* A study suggests that older Americans who have home healthcare via traditional Medicare plans may have access to higher quality services, compared to those who opt for private plans under Medicare Advantage, Reuters reported.

* Japan's Sumitomo Dainippon Pharma Co. Ltd. will pay about $3 billion to acquire a 10% equity stake in Roivant Sciences Ltd. and ownership interests in five of its biopharmaceutical companies. Sumitomo will also have options to acquire up to an additional six companies.

On the policy front

* The Medicare Payment Advisory Commission supported expanding the Centers for Medicare and Medicaid Services' authority to use competitive bidding strategies for all durable medical equipment, prosthetics, orthotics and supplies. MedPAC, which advises Congress about potential payment rate and policy changes for Medicare, also supported expanding the competitive bidding program to other aspects of Medicare, including services and treatments.

M&A and capital markets

* IFM Therapeutics Inc. said its subsidiary IFM Due entered into an exclusive option agreement worth about $840 million with Novartis to develop therapies for cancer and severe inflammatory disorders. Under the agreement, the Swiss drugmaker would make fixed payments in exchange for the option to acquire IFM Due.

* Hong Kong-based private equity firm PAG acquired a 58% stake in Hisun BioRay Biopharmaceutical, a unit of Chinese drugmaker Zhejiang Hisun Pharmaceutical Co. Ltd., for $540 million, Endpoint News reported.

* OncoCyte Corp. is acquiring a 25% stake in Razor Genomics in the form of its preferred stock for a cash payment of $10 million. Razor markets a test to identify early-stage lung cancer patients who are at high risk versus low risk of death within five years after surgery.

Drug and product pipeline

* Global Blood Therapeutics Inc.'s experimental therapy voxelotor was accepted for review by the U.S. FDA to treat sickle cell disease — a lifelong inherited blood disorder caused by a mutation in the oxygen-carrying blood component called hemoglobin.

* Japanese drugmaker Takeda Pharmaceutical Company Ltd. is recalling all doses of its thyroid medicine Natpara in the U.S. due to potential contamination issues in the injection cartridge.

Operational activity

* Novartis is selling its Chinese manufacturing site, Suzhou Novartis, excluding its technology and drug development assets, to Zhejiang Jiuzhou Pharmaceutical Co. Ltd. for 790 million Chinese yuan, Morningstar reported.

* Sun Pharmaceutical Industries Ltd. is undergoing a financial audit, as ordered by India's securities market regulator. The Securities and Exchange Board of India has asked the drugmaker to launch a forensic audit of its financial statements for three fiscal years until March 31, 2018, due to alleged irregularities and lapses in its corporate governance standards.

* Theragnostics Inc. said it received intellectual property rights from AstraZeneca to develop radionuclide-labeled PARPi therapies for diagnosing cancer.

* Endo International PLC finalized the settlement of two Ohio lawsuits regarding its opioid marketing activities and will pay a total of $10 million to Ohio's Summit and Cuyahoga counties.

* Zafgen Inc. said it initiated a strategic review, including an acquisition, merger, business combination, in-licensing or other strategic transaction. The company said there is "low probability" of resolving the clinical hold on its experimental diabetes product ZGN-1061 in the near term.

* CannTrust Holdings Inc. laid off about 180 people, or about 20% of its workforce, as part of a restructuring. The move is expected to result in annual cash savings of about $9 million for the company.

The day ahead

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

In Asia, the Hang Seng rose 0.66% to 26,690.76, and the Nikkei 225 rose 0.54% to 21,199.57.

In Europe, around midday, the FTSE 100 was down 0.8% to 7,265.62, and the Euronext 100 was down 0.18% to 1,080.49.

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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