* German pharma giant Bayer AG will consider selling some of its consumer health brands and will discuss options for its animal health business at a supervisory board meeting this week, Reuters reported, citing people close to the matter.
* A combination of Bristol-Myers Squibb Co.'s immunotherapies Opdivo and Yervoy failed to help patients survive significantly longer than placebo in a late-stage small cell lung cancer trial for patients whose disease has spread. The phase 3 study, called CheckMate-451, combined Opdivo's PD-1 inhibition with Yervoy's ability to jumpstart the immune system to fight tumor cells.
Opdivo is an immuno-oncology drug that blocks the PD-1 arm of healthy cells from latching onto a tumor cell's arm, thus stopping the spread of the disease. Yervoy is an anti-CTLA-4 therapy that strengthens the immune system and prompts T cells to fight cancer.
* Loxo Oncology Inc. and Bayer's Vitrakvi, also known as larotrectinib, received an accelerated approval from the U.S. Food and Drug Administration to treat adults and children whose cancer tests positive for a type of mutation known as a gene fusion in a gene called the neurotrophic receptor tyrosine kinase, or NTRK.
The approval is based on data from three clinical studies, which showed that after taking Vitrakvi, 75% of the patients saw a reduction in their tumor size with cancer types including thyroid, colon, lung and melanoma. Vitrakvi is the only drug available to treat tumors expressing the NTRK gene fusion, including mammary analogue secretory carcinoma, a cancer of the salivary glands; and cellular or mixed congenital mesoblastic nephroma, a tumor affecting the kidney.
Bayer set the drug's price tag at $32,800 per month, or about $393,000 annually.
* Sandoz, Novartis AG's generics unit, received marketing authorization from the European Commission for Ziextenzo, its biosimilar to Amgen Inc.'s Neulasta. Biosimilars are lower-cost copies of biologic medicines made by other companies.
Like Neulasta, Ziextenzo is indicated for use in reducing the duration of neutropenia — the lack of a type of white blood cells called neutrophils — and related fever in patients receiving chemotherapy for malignancies, excluding those with chronic myeloid leukemia and myelodysplastic syndromes. The European Medicine Agency's Committee for Medicinal Products for Human Use recommended Ziextenzo for approval in September.
On the policy front
* The Trump administration wants to give private insurance companies that sell drug plans under the federal government's Medicare program the power to restrict coverage of medicines for cancer, mental illness, HIV/AIDS and other diseases in an attempt to save money. The idea is to give the plans leverage to negotiate cheaper prices with biopharmaceutical companies and drive more competition to lower out-of-pocket costs for program beneficiaries, Centers for Medicare and Medicaid Services Administrator Seema Verma told reporters.
The proposal, unveiled yesterday, would apply to the so-called six classes of protected drugs under the Medicare Part D program, which covers prescription medicines sold at the pharmacy counter for seniors and disabled Americans. Currently, Medicare Part D plans are required under the 2003 Medicare Modernization Act to cover at least two drugs in each therapeutic class — medicines that treat the same disease or condition.
* The U.S.-China Economic and Security Review Commission, in a report, said Chinese authorities are not doing enough to stop the entry of synthetic opioid fentanyl and related chemicals into the U.S., Bloomberg News reported. In October, President Donald Trump signed a 660-page bill into law aimed at addressing the crisis.
* The U.S. Centers for Disease Control and Prevention said acute flaccid myelitis, a rare, polio-like disease, has affected 116 people in the U.S. — the most since 2016, Reuters reported. Acute flaccid myelitis causes weakness and paralysis in a patient's limbs.
M&A and capital markets
* Regulators have given their final approval for the pending acquisition of Aetna Inc. by CVS Health Corp. The deal's closing is expected to take place on or about Nov. 28, subject to the satisfaction of all other closing conditions.
* Indian drugmaker Sun Pharmaceutical Industries Ltd. agreed to buy Japan's Pola Pharma Inc. for an equity consideration of about US$1 million. Pola Pharma, whose portfolio is mainly composed of dermatology products, is a unit of Pola Orbis Holdings Inc., a maker of personal and beauty products.
Drug and product pipeline
* GW Pharmaceuticals PLC's marijuana-based treatment Epidiolex reduced the frequency of seizures in a late-stage study of children with a rare form of epilepsy. Epidiolex, the first U.S. FDA-approved cannabinoid anti-epileptic treatment, is also the first FDA-approved treatment for Dravet syndrome, a rare and severe genetic epileptic condition that begins in infancy.
* G1 Therapeutics Inc. said its drug trilaciclib improved lung cancer therapy outcomes more than placebo in a mid-stage trial. Topline data from a phase 2 study showed that giving trilaciclib to previously untreated patients with small cell lung cancer, in addition to chemotherapy and Roche Holding AG's Tecentriq, reduced the clinically relevant consequences of myelosuppression — decreased bone marrow activity, and a known side effect of chemotherapy and Tecentriq.
* Zafgen Inc. said the U.S. FDA placed a clinical hold on the launch of the first U.S. clinical trial for its lead experimental product ZGN-1061 — citing a possible cardiovascular safety risk for the potential type 2 diabetes drug. The Boston-based company will continue a phase 2 study of ZGN-1061 outside the U.S., with plans to report topline data from the study in early 2019.
* Perrigo Co. plc received tentative approval from the U.S. FDA for the first generic version of Sun Pharmaceutical Industries Ltd.'s plaque psoriasis lotion amid a patent lawsuit over the product. The tentative approval means that the product meets all safety, efficacy and manufacturing quality standards for marketing in the U.S. but must wait for any patent or legal issues to be resolved before it can launch.
* Rocket Pharmaceuticals Inc. will pay Regenxbio Inc. $7 million to acquire exclusive global rights to develop and market gene therapies to treat Danon disease, a rare neuromuscular and cardiovascular disease, using Regenxbio's NAV technology. The Rockville, Md.-based biotechnology company's NAV technology uses adeno-associated virus vectors to transport genes into cells and is in development for a broad pipeline of experimental drugs in multiple therapeutic areas.
* Zymeworks Inc. and BeiGene Ltd. entered a collaboration and licensing deal to develop the former's ZW25 and ZW49 HER2-targeted bispecific antibodies, which are investigational therapies for certain cancers. Under the deal, BeiGene will pay Zymeworks $40 million up front for both therapies, along with milestone payments.
US FDA considers restructuring primary medical device approval process: The U.S. FDA is considering policy changes that would require medical device makers to compare their products to more modern devices when seeking approval through the FDA's 510(k) pathway.
* U.K. Biobank, a database of patients' health and genetic data, is expected to generate as much as £250 million in investments from government, nonprofit and business sources as the U.K. looks to beef up its life-sciences sector amid its exit from the EU, Bloomberg News writes.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng dropped 0.17% to 26,331.96, while the Nikkei 225 rose 0.64% to 21,952.40.
In Europe, around midday, the FTSE 100 shed 0.06% to 7,031.47, and the Euronext 100 fell 0.34% to 967.88.
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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