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Sign-up pace slows in third week of 2018 Obamacare enrollment

The pace slowed in the third week of enrollment for 2018 Obamacare individual insurance as nearly 800,000 people signed up through the federal government website HealthCare.gov, down about 75,000 people from the previous week, a U.S. government agency reported.

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AmerisourceBergen settles U.S. government probe

A unit of AmerisourceBergen Corp. – one of the largest U.S. drug wholesalers – agreed to pay $625 million to resolve a U.S. government probe involving pre-filled syringes.

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U.S. FDA approves first two-drug HIV regimen in win for GSK

The U.S. Food and Drug Administration approved the first two-drug regimen to treat HIV, aimed at lessening the side effect burden of current treatments that combine three or four medicines.

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Ardelyx to Ditch Phase III Hyperkalemia Drug

Ardelyx decided to shutter development of RDX7675 – an experimental medicine for hyperkalemia – including the onset-of-action trial and Phase III studies.

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Stanford, NCI Researchers Discover New CAR-T Target With Early Study Data

Researchers at Stanford University School of Medicine with the National Cancer Institute have identified another cancer-surface molecule, CD22, and begun trials on B-cell acute lymphoblastic leukemia patients using an immuno-oncology approach similar to CAR-T.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse

“As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. …”

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EMA moving to Amsterdam

Drugmakers are racing to implement Brexit contingency plans to prepare for a jolt to their regulatory system as the EMA is uprooted from London to Amsterdam.

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J&J multiple myeloma drug succeeds in first-line combination study

Johnson & Johnson’s blockbuster multiple myeloma drug Darzalex when added to a standard therapy regimen reduced the risk of disease progression or death by 50 percent compared with the standard therapy alone in patients not previously treated for the blood cancer, according to released data.

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Roche, AbbVie leukemia drug superior to older medicine in study

Patients with a type of leukemia that had relapsed who received the new drug Venclexta in combination with Rituxan went significantly longer without the disease worsening than those treated with Rituxan and Treanda, according to interim results from a pivotal late-stage study released on Tuesday.

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Cytokinetics abandons ALS drug after failed trial, shares tank

Cytokinetics Inc. will stop developing one of its treatments for ALS – which afflicts Stephen Hawking – after the drug failed in a late-stage trial, sending the company’s shares tumbling about 35 percent.

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