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Roche leukemia drug extends lives; generic opioid dependence drug gets FDA nod


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Roche leukemia drug extends lives; generic opioid dependence drug gets FDA nod

Top news

* Roche Holding AG said its drug Gazyva, also marketed as Gazyvaro, extended the lives of people with a type of blood cancer better than the company's MabThera, also known as Rituxan, under a phase 3 study. The trial evaluated both cancer drugs, in combination with a chemotherapy drug called chlorambucil, in patients with previously untreated chronic lymphocytic leukemia, or CLL.

Meanwhile, AbbVie Inc.'s venetoclax, in combination with Rituxan, caused undetectable minimal residual disease — a state used to describe low-level disease — in 83% of 121 patients with CLL under a phase 3 trial called Murano. The patients who achieved uMRD also did not see their disease worsen for a median time of 13.8 months.

* The U.S. Food and Drug Administration approved the first generic versions of Indivior PLC's Suboxone film — a treatment for opioid dependence — from units of Mylan NV and Dr. Reddy's Laboratories Ltd.

U.S. FDA Commissioner Scott Gottlieb said the regulator plans to promote the development of better drugs for opioid use disorder and facilitate market entry of generic versions of approved drugs to help ensure broader access.

* Novartis AG said two phase 3 studies showed that its biosimilar drugs Zessly and Erelzi were just as effective and safe in treating rheumatoid arthritis compared to their reference therapies — even in patients who were originally on the branded counterparts and switched to the company's copies. Zessly and Erelzi are drug copies of Johnson & Johnson's Remicade and Amgen Inc.'s Enbrel, respectively.

The Swiss drugmaker hopes that the studies will convince doctors and patients that switching to their biosimilars will continue to deliver the same benefits.

* Kentucky's attorney general sued Walgreens Boots Alliance Inc. over what the state alleges is the company's dual role as a distributor and a pharmacy in fueling the opioid crisis by flooding the state with prescription painkillers.

On the policy front

* A bill aimed at combating anti-competitive practices used by brand-name drugmakers to impede generic rivals was advanced to the Senate floor by the chamber's Judiciary Committee. The legislation, known as the Creating and Restoring Equal Access To Equivalent Samples Act, would make it easier for generic-drug companies to sue brand-name biopharmaceutical makers when those manufacturers withhold samples of their medicines needed by their competitors to conduct required studies for U.S. approval.

* The U.S. Court of Appeals for the Federal Circuit has ruled that the U.S. government does not owe health insurers billions of dollars in payments from an Affordable Care Act provision. The federal appeals court, in a 2-1 decision, ruled against insurers Moda Health Plan Inc. and Land of Lincoln Mutual Health Insurance Co. who represented dozens of other companies that sought to recover $12 billion from the ACA risk corridor program.

* The U.K. government its relaxing its rules on immigration to facilitate the entry of more doctors and nurses from outside the European Union to work for the National Health Service, Reuters reported, citing a spokesman for U.K. Prime Minister Theresa May.

M&A and capital markets

* Sirtex Medical CEO said he expects the company's A$1.9 billion buyout by CDH Investments and China Grand Pharmaceutical to obtain regulatory nods in Australia and the U.S. despite diplomatic tensions with China, Reuters reported.

* Sweden-based Calliditas Therapeutics AB filed for an IPO on Nasdaq Stockholm, expecting gross proceeds of 650 million Swedish kronor. The company is selling 14,444,444 new shares at 45 kronor each to raise money for the clinical development of its kidney disease drug Nefecon.

* Verrica Pharmaceuticals Inc. priced its IPO of 5 million common shares at $15 apiece to raise gross proceeds of about $75 million.

Drug and product pipeline

* The U.K. National Institute for Health and Care Excellence rejected Kyowa Hakko Kirin Co. Ltd.'s Crysvita for treating children and young people with X-linked hypophosphatemia — a genetic disorder causing low phosphate levels in the blood — in a draft guidance. The U.K. price watchdog said it did not recommend the treatment for use due to price concerns.

* Novartis said its drug Jakavi significantly reduced the risk of blood clots and death in certain patients with polycythemia vera, a type of slow-growing blood cancer, compared to patients who received the current best available therapy under a comparison study. Polycythemia vera is a condition in which a sufferer's bone marrow produces too many red blood cells.

The findings are based on a comparison of patients in the company's phase 3 Response trial of Jakavi and a real-world Spanish patients registry called Gemfini.

* Switzerland's Molecular Partners AG said its drug MP0250, in combination with Takeda Pharmaceutical Co. Ltd.'s Velcade and dexamethasone, reduced the disease in 5 out of 8 patients with multiple myeloma, a type of blood cancer.

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* BeiGene Ltd. said its drug zanubrutinib reduced the disease in 86% of patients with mantle cell lymphoma, a type of blood cancer.

Operational activity

* Aptose Biosciences Inc. signed a licensing deal to develop and commercialize South Korea-based CrystalGenomics Inc.'s blood cancer drug CG-806 in China, including Hong Kong and Macau. CG-806 is a therapy for patients with acute myeloid leukemia, B-cell malignancies and other hematologic malignancies.

Other features

* Dementia patients who exercise regularly are just as likely to see their cognition worsen compared to those who do not work out, Reuters reported, citing a U.K. study.

* Eli Lilly & Co. CEO David Ricks told CNBC that he believes closing the gap between list prices and what consumers pay is a good idea to counter the rising prescription drug prices.

* CNBC also has a feature about how Google is exploring ways to use artificial intelligence in improving a patient's visit to the doctor, such as voice recognition to help physicians take notes.

The day ahead

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

In Asia, the Hang Seng was down 0.43% to 30,309.49, and the Nikkei 225 was up 0.50% to 22,851.75.

In Europe, around midday, the FTSE 100 slipped 0.75% to 7,707.44, and the Euronext 100 rose 0.15% to 1,076.62.

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