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Novo Nordisk's diabetes pill meets study goal; UCB's 2017 profit rises YOY

Top news

* Danish drugmaker Novo Nordisk A/S said its diabetes pill semaglutide, sold as Ozempic in injection form, improved the blood sugar of people with type 2 diabetes under a late-stage trial.

* Novo Nordisk's Ozempic injection was included in Express Scripts Holding Co.'s 2018 formulary, a list that establishes the main products covered by private insurers, enabling the drug to better compete with Eli Lilly and Co.'s Trulicity, Reuters reported.

* Brussels-based UCB SA said full-year profit attributable to shareholders reached €753 million, up from €520 million in 2016. Core EPS was €4.82, up from €3.19 in the preceding year.

* The Copenhagen, Denmark-based drugmaker Genmab A/S reported an increase in 2017 operating income and revenue versus 2016, partially offset by increased operating expenses.

On the policy front

* Government policies and programs like Medicare and Medicaid are dampening competition and artificially driving up the prices of prescription medicines, the White House said in its Feb. 21 Economic Report of the President. The Trump administration said it was focused on correcting policies that hinder drug price competition.

* Robert Weaver, President Donald Trump's nominee to become director of the Indian Health Service, dropped out of consideration for the job, a spokeswoman for the U.S. Department of Health and Human Services told The Wall Street Journal. Weaver's withdrawal comes amid controversy over his work experience claims and financial struggles.

* U.S. Food and Drug Administration Commissioner Scott Gottlieb said the addiction problem in the U.S. is migrating to substances that his agency would not have suspected five or 10 years ago to be agents used to get high, such as the anti-diarrhea drug Imodium and the botanical substance kratom.

M&A and capital markets

* Summit, N.J.-based Celgene Corp. secured U.S. antitrust clearance for its $9 billion acquisition of biotech company Juno Therapeutics Inc. — a developer of chimeric antigen receptor T cell therapies.

Drug and product pipeline

* U.S.-based Loxo Oncology Inc.'s cancer drug larotrectinib recorded a shrinkage in tumor size across three clinical trials for patients whose cancers have a specific genetic mutation.

* U.K.-based GW Pharmaceuticals PLC's add-on therapy for focal seizures failed to meet the main goal in a phase 2a trial.

* Australia's Mesoblast Ltd said 69% of children with acute graft versus host disease were able to keep the disease at bay with the company's cell therapy MSC-100-IV, or remestemcel-L. Graft versus host disease is caused by genetic incompatibility between transplanted cells and their recipient.

Operational activity

* An increasing number of patients receiving Regeneron Pharmaceuticals Inc.'s top-selling eye drug Eylea have reported side effects, such as a pain and a sharp decline in sight, over the past six months, prompting a warning from the American Society of Retina Specialists. However, the U.S. FDA deemed a recall unnecessary, Bloomberg News reported.

* A federal judge ruled in favor of the FDA in Amgen Inc.'s pediatric exclusivity case for kidney treatment Sensipar, backing the agency's decision not to grant a six-month period of marketing exclusivity for pediatric uses of the drug, intended to treat secondary hyperparathyroidism.

* Sangamo Therapeutics Inc. and Gilead Sciences Inc. will collaborate to develop cell therapies for cancer using Sangamo's zinc finger nuclease technology platform. Under the deal, Gilead will pay Richmond, Calif.-based Sangamo $150 million up front, along with up to $3.01 billion in potential milestone payments.

* A majority of Greek lawmakers voted to set up a parliamentary committee to investigate the Novartis AG bribery case, which involves 10 former ministers including former Prime Minister Antonis Samaras and current Central Bank Governor Yannis Stournaras, Reuters reported.

* The Philippine's Department of Health is planning to sue Sanofi after it twice refused to pay back 3.5 billion Philippine pesos to the government for the French drugmaker's dengue fever vaccine Dengvaxia, which is under investigation, the Philippine Daily Inquirer reported.

Our features

* Indian regulator signals it may let US stent companies exit market: India's National Pharmaceutical Pricing Authority said in a statement that it will "not disallow" applications by overseas stent manufacturers to withdraw their products.

* Lawmakers, government target actions, plan hearings to address US opioid crisis: When House and Senate lawmakers return to Capitol Hill next week from their February break, efforts to confront the opioid epidemic will be among their top priorities, committee leaders said.

Other features

* A "stronger" European research area should emerge after the U.K. exits the EU, with greater collaboration from member states and neighboring nations, according to top European scientists' recommendations in a report by London-based Wellcome Trust, one of the continent's largest research funders. They said the U.K., however, may have to pay more to access European research programs post-Brexit than it does now, the Financial Times reported.

* Scientists called for more antidepressants to be offered to more than a million additional individuals after they were found to be effective in the largest study of its kind, The (U.K.) Times wrote.

* Swiss biotech CRISPR Therapeutics AG will face an uphill task recruiting patients in a study to test its treatment for sickle cell disease — a genetic disorder that predominantly strikes African-Americans in the U.S. — due to a history of unethical research studies on the community, STAT News noted.

The day ahead

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

In Asia, the Hang Seng fell 1.48% to 30,965.68, and the Nikkei 225 was down 1.07% to 21,736.44.

In Europe, around midday, the FTSE 100 was down 0.92% to 7,214.69, and the Euronext 100 fell 0.48% to 1,018.76.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.