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Vertex Scores FDA Nod for CF Combo Drug

The FDA approved Vertex Pharmaceuticals Inc.’s Symdeko (tezacaftor/ivacaftor and ivacaftor) for cystic fibrosis in patients ages 12 and older with two copies of the F508del mutation.

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Purdue Pharma Cuts More Than Half of U.S. Sales Staff

OxyContin maker Purdue Pharma LP is slashing its sales force in half as the company changes the marketing strategy for the chronic pain pill OxyContin amid the opioid abuse crisis.

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U.S. can sue UnitedHealth in $1 billion Medicare case, judge rules

A federal judge ruled the U.S. Justice Department can move forward with a lawsuit claiming UnitedHealth Group Inc. wrongly retained more than $1 billion from the government healthcare program Medicare.

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Germany’s CureVac wins new vaccine funding from Gates Foundation

German biotech firm CureVac secured more financial backing for vaccine development projects from its investor the Bill & Melinda Gates Foundation, working on jabs to prevent malaria and influenza.

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Novartis gains U.S. approval for delayed MS drug

Novartis’ Sandoz division won U.S. approval for a larger dosage of its Glatopa drug for multiple sclerosis patients, ending a costly delay that allowed rival generics makers to beat it to market.

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Charles River Acquires Global CRO

Charles River Laboratories, a contract research organization (CRO) with headquarters in Wilmington, Mass., is buying MPI Research for about $800 million.

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Opioid makers paid millions to advocacy groups: U.S. Senate report

Five opioid manufacturers including OxyContin maker Purdue Pharma LP paid more than $10 million to advocacy groups and doctors tied to them, many of whom amplified industry messages supporting the use of the painkillers, a U.S. Senate report.

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FDA Shaves Four Months Off Amicus’ Fabry Drug Review Date

The FDA accepted Amicus Therapeutics’ NDA for migalastat to treat Fabry disease in patients with amenable mutations.

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Sirenas, Bristol-Myers Squibb enter collaboration

Bristol-Myers Squibb will deploy Sirenas’ drug discovery platform against certain undisclosed challenging therapeutic targets to identify potential drug candidates.

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Eisai’s Phase III Trial Results of Anticancer Agent Lenvatinib in Hepatocellular Carcinoma Published in The Lancet

Eisai Co. Ltd. announced that the results of a Phase III study of its in-house discovered and developed anticancer agent lenvatinib mesylate in patients with hepatocellular carcinoma were published in the online version of The Lancet.

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Phase II Data Support Potential for Novel Anti-VEGF/Anti-Angiopoietin-2 Bispecific Antibody, RG7716, for People With Diabetic Macular Edema

Genentech announced encouraging results from the Phase II BOULEVARD study. In people with vision loss from diabetic macular edema, treatment with intravitreal RG7716 resulted in clinically meaningful and statistically significant improvements in visual acuity gains compared with ranibizumab alone.

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HealthMine Survey: Two-Thirds (65%) of U.S. Employees Say Top Performers in Their Company Are Just “Somewhat” Healthy

When asked to characterize the overall health of top performers in their companies, 65% of U.S. employees said they were just “somewhat” healthy.

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Organizers confirm 177 total norovirus cases at Pyeongchang

Pyeongchang Winter Olympics organizers (POCOG) said on Monday a total of 177 norovirus cases had been confirmed so far at the Games, but that the athletic delegations remained unaffected.

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OxyContin maker stops promoting opioids

OxyContin maker Purdue Pharma LP has cut its sales force in half and will stop promoting opioids to physicians, following widespread criticism of the ways that drugmakers market addictive painkillers.

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Roche wins UK watchdog’s nod for lymphoma drug

Britain’s healthcare watchdog NICE recommended Roche’s medicine Gazyvaro for previously untreated advanced follicular lymphoma patients after initially rejecting the medicine in 2017.

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Janssen Submits MAA for Apalutamide

J&J’s Janssen Pharmaceutical Companies submitted a Marketing Authorization Application to the EMA for apalutamide for non-metastatic castration-resistant prostate cancer.

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U.S. approves medical isotope system not based on bomb-grade uranium

The U.S. federal government approved a device made by a private company in Wisconsin that will allow the first domestic production of a medical imaging isotope in 25 years.

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Maryland sues Insys to enforce subpoena in opioid probe

Maryland’s attorney general filed a lawsuit seeking to enforce a subpoena the state sent Insys Therapeutics Inc. as part of a probe into allegations the drugmaker deceptively marketed a fentanyl-based cancer pain medicine.

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Olympics: IOC discussing norovirus outbreak, more cases reported

Olympic officials are discussing measures to combat the spread of a virus that causes vomiting and diarrhea after 42 new cases were confirmed at the Winter Games, a Korean Centers for Disease Control and Prevention (KCDC) official said.

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U.S. child mortality rates remain higher than in other wealthy nations

Even though infant and child mortality rates in wealthy nations have been steadily declining for decades, American children are still more likely to die than kids in other affluent countries, a U.S. study suggests.

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