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Invokana Reduces Cardiac Problems in Diabetes Patients

Canagliflozin (Invokana, Janssen Pharmaceutical) significantly reduced the risk of cardiovascular death or hospitalization for heart failure in patients with type-2 diabetes at high cardiovascular risk in an exploratory analysis from the CANVAS clinical program, according to a presentation at the American…
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OxyContin Maker Stops Promoting Opioids, Cuts Sales Staff

OxyContin maker Purdue Pharma LP says it has cut its sales force in half and will stop promoting opioids to physicians following widespread criticism of the ways that drug makers market addictive painkillers, Reuters reported. The drug maker is informing doctors that its sales representatives will no…
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House Passes Right-to-Try Legislation on Second Attempt

The second time proved to be the charm for the U.S. House of Representatives to pass right-to-try legislation that would provide terminally ill patients access to experimental drugs without the approval of the FDA, according to a BioSpace article. The House approved a second bill with a 267–149 vote…
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Study: Short-Term Increase in Inhaled Steroids Won’t Prevent Children’s Asthma Flare-Ups 

Researchers have found that temporarily increasing the dosage of inhaled steroids when asthma symptoms begin to worsen does not effectively prevent severe flare-ups and may be associated with slowing a child’s growth, challenging a common medical practice involving children with mild-to-moderate asthma.…
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Blincyto Indication Expanded to Include Certain Leukemia Patients at Increased Risk for Relapse

The FDA has granted accelerated approval to blinatumomab (Blincyto, Amgen) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen…
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New Drug Candidate Aids Macular Edema Linked to Uveitis

A first-in-class medication being developed to treat back-of-the-eye diseases achieved positive results in the pivotal phase 3 PEACHTREE trial, the developer has announced. Among patients with macular edema associated with noninfectious uveitis, 47% of those treated every 12 weeks with suprachoroidal…
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AMA Survey: Patient Clinical Outcomes Shortchanged by Prior Authorization

More than nine in 10 physicians (92%) say that prior authorizations programs have a negative impact on patient clinical outcomes, according to a new physician survey released by the American Medical Association (AMA). The survey results further bolster a growing recognition across the entire health…
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Barbershop-Based Study Lowers Blood Pressure in African-American Men

African-American men lowered their high blood pressure to healthy levels when aided by a pharmacist and their barber, according to a study from the Smidt Heart Institute. The findings were published in the New England Journal of Medicine and presented as a late-breaking clinical trial at the American…
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Cabometyx Wins Indication for Previously Untreated Advanced Kidney Cancer

The FDA has approved a new indication for cabozantinib tablets (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer in adults. The FDA’s priority review and approval were based on results from the randomized phase 2 CABOSUN…
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Health, Medical Groups Sue FDA Over E-Cigarette Rule Delay

Seven public health and medical groups have filed a lawsuit challenging an FDA decision that they said would allow e-cigarettes to remain on the market for years without regulatory review, Reuters reports. The lawsuit, filed in federal court in Greenbelt, Maryland, argued the FDA in August improperly…
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Federal Panel Calls for Urgent Action to Align Cancer Drug Prices With Value

Urgent action must be taken to address the dramatic rise of cancer drug prices and to better align prices with value, according to a report released by the President's Cancer Panel. The panel's report, Promoting Value, Affordability, and Innovation in Cancer Drug Treatment, found that while some cancer…
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Justice Department Seeks Role in Opioid Settlement Talks

The Justice Department is seeking court permission to participate in settlement negotiations aimed at resolving lawsuits by state and local governments against opioid manufacturers and distributors, according to a Reuters report. The Justice Department said in a brief that it wanted to participate in…
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Judge Orders Former Drug Exec Shkreli to Give Up $7.36 Million

A federal judge in New York on Monday ordered Martin Shkreli, the former drug company executive convicted of defrauding investors, to forfeit $7.36 million in assets, which could include a Picasso painting and a one-of-a-kind album by the Wu-Tang Clan. U.S. District Judge Kiyo Matsumoto in Brooklyn…
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Roche’s Tecentriq Notches Third Cancer Cocktail Trial Win

Roche’s immunotherapy atezolizumab (Tecentriq) has racked up a third trial win in combination with other cancer drugs, a boost for the Swiss drug-maker as it seeks to muscle in on space dominated by Merck and Bristol-Myers Squibb, according to a Reuters report. A late-stage study, called IMpower131,…
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FDA Slams Duodenoscope Makers Over Failure to Complete Studies

The FDA has  issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices. As part of an ongoing effort to prevent…
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