Top news
* Amgen Inc. and Allergan PLC's biosimilar medicine ABP 798 worked as well as Roche Holding AG and Biogen Inc.'s blockbuster Rituxan in a second clinical trial, this time in patients with a type of B-cell non-Hodgkin lymphoma, the most common type of blood cancer. The companies said they look forward to working with regulatory agencies to bring the treatment to patients.
* The U.K.'s drug price watchdog opted not to back GW Pharmaceuticals PLC's cannabis-based drug Epidiolex for treating difficult to control epilepsies. It said it will work with the company to address the issues raised, including cost. The cannabidiol therapy became the first marijuana-based medicine to be approved by the U.S. Food and Drug Administration in 2018.
* About 20 mayors in France have banned glyphosate — the main ingredient in Bayer AG's weedkiller Roundup — from their municipalities, defying the French government, which plans to allow the chemical's continued use for now, Reuters reported.
* The World Health Organization said accelerated research and development in new tools to prevent and treat malaria is vital to eradicating the disease. The agency noted that less than 1% of funding for health R&D investment goes toward developing tools to tackle malaria.
* The Philippines Department of Health upheld a decision by the country's Food and Drug Administration to revoke Sanofi's certificates of product registration for dengue vaccine Dengvaxia. The agency cited the French company's continued failure to submit post-approval requirements. It said Dengvaxia's efficacy was not the issue but rather Sanofi's complete disregard of FDA regulations. Dengvaxia has been involved in previous controversies in the Philippines over its usage.
On the policy front
* The Trump administration is seeking to loosen certain privacy requirements for patients with a history of addiction to make it easier for doctors to share information and improve care. The rules, known as 42 CFR Part 2 regulations, have been in place for more than four decades. They predate other privacy requirements implemented under the Health Insurance Portability and Accountability Act of 1996, Health and Human Services Secretary Alex Azar told reporters.
M&A and capital markets
* India's Glenmark Pharmaceuticals Ltd. is in talks to sell a minority stake — between 25% and 30% — of its newly spun off Glenmark Life Sciences Ltd. for about $150 million to private equity firm PremjiInvest. The drugmaker values the division, which supplies active pharmaceutical ingredient products, at between $600 million and $700 million.
Drug and product pipeline
* Roche Holding AG's immunotherapy medicine Tecentriq was approved in Japan for expanded use to treat extensive-stage small cell lung cancer. The drug was first approved in the country in January 2018 to treat non-small cell lung cancer that has advanced, recurred or cannot be removed through surgery.
* Retrophin Inc. lost about 25% of its market value on Aug. 22 after it reported that its medicine fosmetpantotenate failed to meet the main goal in a late-stage study of patients with a type of rare nervous system disorder. The company evaluated the safety and efficacy of fosmetpantotenate against placebo in the phase 3 trial, dubbed Fort, to treat pantothenate kinase-associated neurodegeneration.
* GlaxoSmithKline PLC said a trial of GSK2857916 showed that its medicine helped certain patients with a type of multiple myeloma, a blood cancer. The trial, named Dreamm-2, included patients whose cancer had returned and were resistant to prior treatment.
Operational activity
* Eli Lilly and Co. won support from a Chicago-based arbitration panel on a complaint filed by French drugmaker Adocia SA over the companies' prior collaboration on a rapid-acting insulin. Lilly had walked away from an agreement with Adocia to develop ultra-rapid insulin BioChaperone Lispro in January 2017, prompting the latter to seek arbitration.
* PerkinElmer Inc. Chairman and CEO Robert Friel will retire from the Waltham, Mass.-based life sciences company Dec. 29 and will be replaced by Prahlad Singh, the company's current president and COO.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng rose 0.50% to 26,179.33, and the Nikkei 225 increased 0.40% to 20,710.91.
In Europe, around midday, the FTSE 100 was up 0.57% to 7,169.09, and the Euronext 100 was up 0.42% to 1,049.99.
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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