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AstraZeneca's Imfinzi gets China nod; EU greenlights Amgen-UCB osteoporosis drug

Top news

* AstraZeneca PLC said its medicine Imfinzi was approved by China's National Medical Products Administration to treat patients with stage 3 non-small cell lung cancer whose tumors cannot be removed through surgery. Imfinzi is already approved for treating patients with this particular type of lung cancer in over 54 countries, including the U.S., EU and Japan.

* The European Commission approved Amgen Inc. and UCB SA's osteoporosis medicine Evenity in postmenopausal women at high risk of fracture. The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the drug for approval in October, having originally rejected it in June.

* The U.S. Food and Drug Administration has struggled for more than a decade with language barriers when inspecting foreign drug manufacturing facilities and frequently relies on translators provided by the companies under examination, raising questions about impartiality and accuracy of information, a government investigator told lawmakers.

One FDA inspector had to resort to using a translation application on their phone to interpret information and interviews while conducting an inspection at a drug facility in China, Mary Denigan-Macauley, director of healthcare at the Government Accountability Office, said at a Dec. 10 hearing.

* McKesson Corp. and retail pharmacy chain Walgreens Boots Alliance Inc. agreed to form a joint venture that will merge their respective pharmaceutical wholesale businesses in Germany. McKesson and Walgreens will respectively own 30% and 70% of the JV, whose aim is to advance patient-centric services.

* Google LLC's co-founder Larry Page is quietly funding efforts to fight influenza, TechCrunch reported. Page is funneling funds from his charitable foundation to a private company focused on combating flu, while a second company receives funding to develop a universal flu shot.

* Moody's said the global healthcare industry's outlook for 2020 is mainly stable as payers' efforts to reduce costs counterbalances a rising utilization of healthcare products and services. The rating agency expects demand for healthcare products and services to remain strong in 2020 due to aging populations in mature markets and better access to healthcare in the emerging markets.

Meanwhile, Fitch Ratings also upgraded its 2020 outlook for U.S. not-for-profit hospitals and health systems from a negative outlook to stable.

M&A and capital markets

* Correvio Pharma Corp. is exploring strategic alternatives after a U.S. FDA committee voted against the company's irregular heartbeat drug Brinavess. The Vancouver, British Columbia-based company said it is planning to reduce its operating costs outside its core commercial business in Europe and has formed a transaction committee within its board for that purpose.

* Alphamab Oncology shares closed at HK$13.50 apiece, up 32.4% from their issue price of HK$10.20 per share on Dec. 12, their first day of trading in Hong Kong. The Suzhou, China-based drugmaker sold 179,403,000 shares to raise about HK$1.71 billion.

Drug and product pipeline

* LEO Pharma A/S said its eczema treatment tralokinumab met the main goal in three late-stage clinical trials, but analysts were left wondering why the company waited a year to post results that lacked details. Lebrikizumab previously belonged to Roche Holding AG but was off-loaded to Dermira after the therapy missed the goals of a clinical trial in asthma.

* Gilead Sciences Inc. filed for approval with the U.S. FDA for its investigational cancer therapy KTE-X19 to treat mantle cell lymphoma, a rare cancer of the white blood cells. KTE-X19 is not yet been approved anywhere in the world but has previously received a breakthrough-therapy tag from the FDA and a priority medicine designation from the European Medicines Agency.

* Avenue Therapeutics Inc. submitted an application seeking U.S. approval of its formulation of injectable tramadol, an opioid medicine that has been in use for decades and sold under many brand names worldwide.

* Miragen Therapeutics said it will reduce the sample size of its mid-stage study of cancer drug candidate cobomarsen to about 30 patients from 126 patients and lay off some employees as part of a broader restructuring strategy. The biotechnology company is evaluating cobomarsen as a treatment for patients with cutaneous T cell lymphoma — a rare skin cancer — in a phase 2 trial called Solar.

* Xeris Pharmaceuticals Inc.'s ready-to-use glucagon medicine improved post-meal low blood sugar in patients who have undergone a weight loss surgery during a phase 2 clinical trial.

* Results from an early-stage study showed that a medicine derived from psilocybin mushrooms, commonly known as magic mushrooms, has a potential to treat depression, the Financial Times reported. Trial participants who took the drug — made by mental health startup Compass Pathways — at a higher dose experienced hallucinations, euphoria and altered moods, without having any serious untoward medical occurrences.

Operational activity

* Alkermes PLC received a warning letter from the U.S. FDA regarding its print advertisements for opioid dependence treatment Vivitrol, which did not disclose the most serious risks associated with taking the drug. The regulator requested that the Dublin-based company immediately halt its Vivitrol advertisements containing misleading information and come up with a plan to disseminate accurate information about Vivitrol to consumers who may have received the previous advertisements.

* Sienna Biopharmaceuticals Inc., which previously filed for Chapter 11 bankruptcy protection, said the U.S. Bankruptcy Court for the District of Delaware approved the sale of its assets, including intellectual property, related to its experimental drug SNA-001. The company will auction assets related to its experimental hair removal treatment for $1.7 million cash.

* Amgen's board declared a $1.60 per share dividend for the first quarter of 2020, a 10% increase from what the company paid in each of the prior four quarters.

The day ahead

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

In Asia, the Hang Seng increased 1.31% to 26,994.14, while the Nikkei 225 was up 0.14% to 23,424.81.

In Europe, around midday, the FTSE 100 increased by 0.49% to 7,251.27, and the Euronext 100 increased by 0.04% to 1,123.59.

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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