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Novartis MS drug beats Teva's in trial; Bayer could win retrial in Roundup case

Top news

* Novartis AG said Gilenya, in a late-stage study, worked better than Teva Pharmaceutical Industries Ltd.'s Copaxone in reducing the recurrence of relapsing remitting multiple sclerosis, or RRMS — a disease affecting the central nervous system by disrupting the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss. Both Gilenya and Copaxone are approved to treat RRMS.

* Bayer AG unit Monsanto Co. could win a new trial on the $250 million in punitive damages awarded by a jury over allegations that its weedkiller caused a former school groundskeeper's cancer, the Associated Press reported. During a hearing yesterday, San Francisco Superior Court Judge Suzanne Bolanos issued a tentative ruling for a new trial as she considers striking down the punitive damages, citing an insufficiency in "clear and convincing evidence of malice or oppression" by Monsanto.

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Bayer is also looking to sell its animal health unit as it streamlines businesses after the Monsanto acquisition in June, Bloomberg News reported, citing people familiar with the plans. Nothing has been finalized yet and the German pharmaceutical giant may decide to keep the business, the sources added.

On the policy front

* Democrats and fact-checkers were quick to respond to an op-ed by U.S. President Donald Trump, noting that nearly all of his statements contained misleading information about proposals for universal healthcare coverage. In an article published yesterday in USA Today, Trump said the Democrats intended to "outlaw private healthcare plans, taking away freedom to choose plans, while letting anyone cross our border."

* Just in time for Canada's legalization of marijuana, the Canadian Securities Administrators have asked cannabis companies to improve disclosure processes after a review of 70 companies — including the largest Canadian cannabis companies Canopy Growth Corp. and Tilray Inc. — revealed practices that would not properly inform investors. The CSA highlighted the lack of clear disclosures in 70 cannabis companies' financial reports in a notice issued yesterday.

* Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, warned of inevitable problems for U.K. drugmakers at the event of a no-deal Brexit, Reuters reported.

M&A and capital markets

* San Diego-based Ligand Pharmaceuticals Inc. completed the acquisition of U.K.-based drug discovery biotechnology company Vernalis PLC for about $42.3 million. The completion follows the approval of the acquisition by Vernalis shareholders.

Drug and product pipeline

* The U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee said AcelRx Pharmaceuticals Inc.'s opioid drug Dsuvia was safe and effective based on resubmitted data — prompting the company's shares to rise. AcelRX resubmitted a new drug application for drug-device combination Dsuvia in May after addressing concerns raised by the FDA in its rejection of the first application for the pain treatment.

* Celltrion Inc. and Teva said the U.S. FDA's Oncologic Drugs Advisory Committee unanimously voted to recommend the approval of their biosimilar — lower-cost versions of biologic therapies — of Roche Holding AG's blood cancer drug Rituxan. The panel voted 16-0 to back the Rituxan copycat CT-P10 for treating a nonaggressive form of B cell non-Hodgkin's lymphoma that has a high density of malignant cells expressing the CD20 protein.

* The U.S. FDA lifted the clinical hold on CRISPR Therapeutics AG and Vertex Pharmaceuticals Inc.'s experimental sickle cell disease treatment CTX001. The regulator also accepted the investigational new drug application for CTX001, a stem cell therapy being developed to treat severe hemoglobinopathies — a genetic defect that leads to abnormalities in the hemoglobin molecule in blood cells.

* Arbutus Biopharma Corp. is postponing an early stage study evaluating its hepatitis B drug AB-452 due to nonclinical safety findings. The therapy is designed to block the replication of the virus by destabilizing or decreasing the stability of the virus' RNA.

* Akorn Inc. said the U.S. FDA approved its abbreviated new drug application for bimatoprost ophthalmic solution to treat hypotrichosis — a condition of abnormal hair patterns, predominantly loss or reduction — of the eyelashes by increasing their growth, including length, thickness and darkness.

Operational activity

* Teva is nearing a sale of its manufacturing site at Kiryat Shmona in Israel to German company B. Braun Melsungen AG, FiercePharma reported, citing Israeli newspaper Calcalist. The plant, which makes plastic products for the pharmaceutical industry, employees about 200 people and could fetch the Israeli drugmaker up to $100 million, the head of the plant's union committee told the Israeli newspaper.

* Roche entered an agreement, valued at up to $760 million, to develop and commercialize Ionis Pharmaceuticals Inc.'s IONIS-FB-LRx medicine for a number of diseases, including an eye disorder. The companies will first develop IONIS-FB-LRx to treat geographic atrophy, the advanced stage of dry age-related macular degeneration.

Our features

New study links IVF process itself to higher chance of multiple births: The largest study ever of multiple pregnancies after a single embryo transfer during IVF has found that using thawed embryos or maturing the fertilized egg in the laboratory before implanting it could increase the risk of multiple births.

Amgen vs. Novartis: Enbrel patent fight will further shape biosimilar law: A biosimilar law fraught with ambiguities will once again be shaped by a fight between Amgen and Novartis over the autoimmune drug Enbrel.

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Other features

* Reuters has a feature about how having a type of irregular heartbeat can raise the risk of developing dementia and another about how about half of U.S. immigrants who have private insurance are paying more than they receive in benefits.

* CNBC writes about how Facebook's head of health research wants to help doctors better predict illnesses by giving physicians an insight into their patients' social lives.

* STAT has a feature about the potential of using artificial intelligence to develop medicines.

The day ahead

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

In Asia, the Hang Seng slipped 3.54% to 25,266.37, and the Nikkei 225 declined 3.89% to 22,590.86.

In Europe, around midday, the FTSE 100 was down 1.65% to 7,027.61, and the Euronext 100 fell 1.70% to 991.57.

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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