Tag Archives: approve

Novartis slaps $2M-plus price tag on newly approved gene therapy Zolgensma—and cost watchdogs approve

Industry watchers have been speculating for months about just how high Novartis would price gene therapy Zolgensma on approval—and just how payers would cover it. And with the FDA’s green light, they now have an answer. The Swiss drugmaker will roll out the drug, a one-time treatment for pediatric patients less than 2 years of… Read More »

5 state AGs push judge to approve CVS-Aetna merger agreement

Dive Brief: Five attorneys general representing California, Florida, Hawaii, Mississippi and Washington are urging a federal judge to approve the settlement agreement the U.S. Department of Justice struck with CVS Health and Aetna that allowed the two companies to go forward with their blockbuster merger, according to a recent federal court filing. The states are… Read More »

CMS Ignores Federal Judge Ruling To Approve Medicaid Work Rules in Utah

Use Our Content This story can be republished for free (details). Less than 48 hours after a federal judge struck down Medicaid work requirements, the Centers for Medicare & Medicaid Services on Friday gave Utah permission to use those mandates. CMS Administrator Seema Verma said in her approval letter that requiring Medicaid enrollees to work… Read More »

FDA is Expected to Approve Brexanolone for the Treatment of Postpartum Depression

In 2015, we first reported on SAGE-547 (SAGE Therapeutics), a new medication for the treatment of postpartum depression (PPD).  SAGE-547, now called brexanolone, is an allosteric modulator of GABAA receptors.  Since that time, Sage Therapeutics has conducted three randomized controlled trials, enrolling a total of 247 women diagnosed with moderate to severe postpartum depression. It… Read More »

FDA declines to approve Mallinckrodt's abuse-deterrent opioid painkiller

(Reuters) – The U.S. Food and Drug Administration has declined to approve an abuse-deterrent version of Mallinckrodt Plc’s opioid painkiller Roxicodone, saying some parts of the company’s application need further evaluation. The treatment is a reformulated version of the company’s commonly abused painkiller Roxicodone, intended to make the drug less desirable and more difficult to… Read More »