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When terminally ill Americans receive experimental medicines through so-called “compassionate use” programs, they typically only get these drugs after extensive tests for safety and effectiveness, a recent study suggests. “This means that sufficient evidence of safety and effectiveness has been…
The Medicines Development for Global Health (MDGH) and the World Health Organization Special Program for Research and Training in Tropical Diseases (TDR) have announced that the FDA has approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients 12 years of age and…
Valeant Pharmaceuticals' plans to grow its dermatology business hit a snag this week, when the specialty drug-maker disclosed that the FDA had declined to approve an experimental psoriasis treatment key to the unit's turnaround, according to a BioPharma Divereport.  The regulator issued a complete…
The FDA has approved pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. The indication is approved under the FDA’s accelerated approval regulations…
The Trump administration is expected to reveal what it has in store for association health plans today. The plans are aimed at small businesses and people who buy their own insurance. As the Associated Press reports, the new model association health plans will still have to cover people with pre-existing…
An editorial in the Columbus Dispatch of Ohio takes off the gloves when it comes to how PBMs do business. The editorial is a companion to investigative reporting by the newspaper concerning how CVS Caremark goes about its business saying that “for its middleman role in Ohio’s taxpayer-funded Medicaid…
Well, somebody has to pay. In April, Anthem began paying the manufacturers of breast pumps less for the devices, reports the St. Louis Post-Dispatch. The newspaper cites one of the manufacturers as saying that the insurer decided to pay 36% less, from $150 to $95 per device. The move represents one…
Eric H. Schultz, the president and CEO of Harvard Pilgrim for the past eight years, resigned today for behavior that he described in his resignation letter as “inconsistent with my personal core values and the company’s core values.” Full text of the letter is pasted in below. Boston media outlets…
Eli Lilly and AstraZeneca have announced that they will discontinue phase 3 trials of their BACE inhibitor lanabecestat for the treatment of Alzheimer's disease, according to a BioPharma Dive report. The AMARANTH study in early Alzheimer's disease, its extension study, as well as the DAYBREAK-ALZ trial…
The Trump administration is urging states to better use Medicaid for the delicate and difficult treatment of opioid-addicted and exposed infants, but did not offer any new outlets, according to a recent FierceHealthcare report. Congress, however, might be delivering on that front shortly. The Centers…
U.S. lawmakers fear the FDA is not doing enough to stop the flow of illegal drugs into the United States as the country works to combat the opioid epidemic, Reuters reports. Republican and Democratic members on the House Energy and Commerce Committee questioned whether the FDA’s criminal investigators…
The FDA has cleared a new auricular neurostimulation device (Drug Relief, DyAnsys, Inc.), to be used as an aid to reduce the symptoms of opioid withdrawal without narcotics. The device is available for providers to prescribe for use during opioid detoxification. The wearable device sends electrical…
A new study from University of Illinois at Chicago (UIC) researchers suggests that more than one-third of U.S. adults may be using prescription medications that have the potential to cause depression or increase the risk of suicide, and that because these medications are common and often have nothing…
In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Scott Gottlieb, MD, wants to speed approval times for rivals to promising new first-to-market medicines, Reuters reports. The FDA chief has made a commitment to speeding up approvals of cheap generic medicines,…
New research indicates that millions of Americans may need to talk to their doctor about taking different prescriptions of aspirin, statins, and blood pressure medications, according to a study led by Stanford researchers. Sanjay Basu, MD, PhD, and his colleagues have come up with new calculations to…

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