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Roche has announced that the Phase 3 IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS).

The FDA has approved erenumab-aooe (Aimovig, Amgen, Inc.) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Erenumab is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

The FDA has approved lofexidine hydrochloride (Lucemyra, US WorldMeds LLC) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While lofexidine may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days.

The FDA has approved Retacrit (epoetin alfa-epbx, Hospira, Inc.) as a biosimilar to Epogen (epoetin alfa, Amgen, Inc.) and Procrit (epoetin alfa, Janssen) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with human immunodeficiency virus infection.

The surge in U.S. kids taking medication for attention-deficit/hyperactivity disorder (ADHD) is having an unintended side effect, a new study suggests: more children and teens are overdosing on these drugs.

The FDA has approved avatrombopag (Doptelet, AkaRx, Inc.) tablets to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use. 

The FDA has approved an expanded indication for fingolimod (Gilenya, Novartis) to treat relapsing multiple sclerosis (MS) in children and adolescents 10 years of age and older. This is the first FDA approval of a drug to treat MS in pediatric patients.

The Department of Justice has joined whistleblower litigation accusing Insys Therapeutics, Inc., of trying to generate more profit by paying kickbacks to doctors to prescribe powerful opioid medications, Reuters reports.

The FDA has approved the use of daratumumab (Darzalex, Genmab) in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

A new discovery shows that opioids used to treat pain, such as morphine and oxycodone, produce their effects by binding to receptors inside neurons, contrary to conventional wisdom that they acted only on the same surface receptors as endogenous opioids, which are produced naturally in the brain.

Days after President Donald Trump delivered a speech on prescription drug prices that was notably light on criticism of the pharmaceutical industry, his health secretary on Monday struck a far more aggressive tone, warning that the administration would be “turning on the pressure” on drug makers, according to a STAT report.

Kymriah (tisagenlecleucel), the landmark cell therapy Novartis brought to market last year, has gained a new indication that puts it in direct competition with Yescarta (axicabtagene ciloleucel), a rival treatment from Gilead Sciences, according to a recent BioPharma Dive article.

The FDA has approved dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and is BRAF V600E mutation-positive. Both drugs are Novartis products.

The FDA has permitted marketing of Hemospray (Wilson-Cook Medical, Inc.), a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.

The FDA has approved Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution, Salix Pharmaceuticals, Ltd.), a lower-volume (1-L) polyethylene-glycol–based bowel preparation.

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