The FDA has approved a second indication for plecanatide (Trulance, Synergy Pharmaceuticals Inc.): the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Plecanatide was already approved for the treatment of adults with chronic idiopathic constipation (CIC). The 3-mg…
Survival from cardiac arrest doubled when a bystander stepped in to apply an automated external defibrillator (AED) before emergency responders arrived, according to new research in the American Heart Association (AHA) journal Circulation. According to the AHA, of the more than 350,000 out-of-hospital…
The American College of Physicians (ACP) has issued new guidance that adults with type-2 diabetes can aim for an easier-to-achieve blood sugar target than what’s been used to guide treatment in the past, according to a Reuters report. But that advice is already controversial. Based on its review of…
Two federal agencies have acted to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases. The FDA has approved the RadioGenix System (NorthStar Medical Radioisotopes), a unique system for producing Technetium-99m (Tc-99m), the…
Patients with hard-to-treat episodic migraine experienced marked improvement in the phase 3B LIBERTY study of erenumab (Aimovig, Amgen), according to new trial results. The study assessed the efficacy and safety of erenumab 140 mg in patients with episodic migraine who had experienced two to four previous…
RAND Health researchers who studied how much U.S. medical practices were using electronic health records (EHRs) found only about a quarter using them to their full potential, while 39% of the practices were underusing EHRs. The study was funded under the Agency for Healthcare Research and Quality (AHRQ)…
A scientific analysis found stronger evidence that compounds in kratom have opioid properties, according to FDA Commissioner Scott Gottlieb, MD, who added that the agency has now received 44 reports of deaths linked to the Asian plant. In November 2017, the FDA warned the public not to use kratom (Mitragyna…
Elagolix (AbbVie) and low-dose hormone therapy reduced heavy menstrual bleeding among women with uterine fibroids in the phase 3 ELARIS UF-I study, with 68.5% achieving a clinical response compared with placebo (8.7%). Clinical response, measured by the alkaline hematin method, was defined as menstrual…
A federal judge in Delaware has overturned a jury’s verdict requiring Gilead Sciences to pay a record $2.54 billion because its hepatitis C drugs sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni) infringed a patent held by rival Merck & Company, according to a Reuters report. The verdict had…
The FDA has approved a new indication for durvalumab (Imfinzi, AstraZeneca)–– treating patients with unresectable stage III non–small–cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. Durvalumab becomes the first treatment approved to reduce the risk…
To keep rising health care costs in check, many health insurers have adopted a strategy known as “step therapy,” a policy requiring patients to try cheaper drugs first—and find them to be ineffective—before approving pricier medication. However, some health care experts contend the approach,…
Alirocumab injection (Praluent, Regeneron Pharmaceuticals/Sanofi) reduced the risk of major cardiac events by 15% among patients who had suffered heart attacks and other coronary events in the ODYSSEY OUTCOMES trial. The two companies have announced that they are willing to offer price breaks on the…
A new study makes a strong case for the importance of government support for basic research: Federally funded studies contributed to the science that underlies every one of the 210 new drugs approved between 2010 and 2016. Researchers at Bentley University scoured millions of research papers for mentions…
The Trump administration will allow states to test requiring some Medicaid recipients to work or participate in community activities such as volunteering or jobs training as a condition of eligibility for the government health insurance program for the poor. The Centers for Medicare and Medicaid Services…
In a late-stage study, a combination of experimental drugs—encorafenib and binimetinib (Array BioPharma, Inc.)—kept patients with advanced melanoma associated with a common gene mutation alive for nearly three years and twice as long as rival medicine vemurafenib (Zelboraf, Roche), according to…
