FDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated with 2 or more chemotherapies.
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FDA approved nusinersen (Spinraza, Biogen), the first drug to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.
A new combination drug for type 2 diabetes will available in the US in the coming months.
FDA issued two important drug warnings this week: one linking certain diabetes medications to bladder cancer and another about the use of general anesthetic and sedation drugs during pregnancy.
FDA recently approved bevacizumab (Avastin, Genentech) for patients with platinum-sensitive recurrent epithelial ovarian (psOC), fallopian tube or primary peritoneal cancer.
The US growth rate for spending on medicines is expected to fall in 2016 and beyond, according to new research.
FDA’s approval of a new indication for empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) could net the pharmaceutical manufacturers more than $1 billion.
Two new major studies on a biosimilar to trastuzumab (Herceptin, Genentech) to treat HER2-positive metastatic breast cancer and HER2-positive gastric cancer demonstrated equivalency.
Two new diabetes drugs, both long-acting injectable insulin products, were simultaneously approved by FDA.
A global phase 3 study of erenumab (Amgen and Novartis) showed that the drug was able to prevent migraines headaches.
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After a successful phase 3 study, a breakthrough therapy to treat multi-drug resistant (MDR) HIV-1 is expected to launch in the United States in 2017.
After Gilead received FDA approval for a new drug for chronic hepatitis B virus (HBV), it said low-cost, generic versions would also soon be available. That is good news for Gilead, which has been targeted by Congressional representatives for the high cost of Sovaldi and Harvoni hepatitis C treatments.
FDA granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.
U.S. congressmen last week asked the Department of Justice and the Federal Trade Commission to investigate three insulin makers for price collusion-the latest in concerns over insulin prices.
In a big move for patients who take blood pressure medication on a regular basis, FDA last week approved the first generic versions of 4 drugs that contain the blood pressure-lowering medication olmesartan medoxomil (Benicar, Daiichi Sankyo).
Wide variation exists in practice-level statin prescribing for patients with diabetes, according to a new study.
New data presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, this week shows that secukinumab (Cosentyx, Novartis) has long-lasting skin clearance in patients with moderate-to-severe plaque psoriasis.
Anthem Blue Cross recently launched a year-long diabetes prevention program to educate, treat and support its qualified California members who are at risk of developing type 2 diabetes.
As the healthcare profession continues to face challenges with antibiotic resistance, drugmakers are developing novel antibiotics that will be effective against some of the worst infections. One drugmaker submitted New Drug Applications (NDAs) for approval of IV and oral delafloxacin (Baxdela) to FDA.
Soon after FDA granted accelerated approval for atezolizumab (Tecentriq, Genentech) to treat bladder cancer, the agency okayed the drug to treat metastatic non-small cell lung cancer (NSCLC).
A majority of oncology drugs-particularly older cancer drugs-had price hikes in 2015, according to a study. Plus, Ariad Pharmaceuticals raised the price of its chronic myeloid leukemia (CML) drug ponatinib (Iclusig) for the fourth time this year to around $199,000 a year, according to The Street.
FDA tentatively approved the abbreviated new drug application (ANDA) for generic quetiapine fumarate extended-release tablets (brand Seroquel XR, AstraZeneca) to treat schizophrenia and manic/mixed episodes associated with bipolar disorder.
The US Drug Enforcement Administration (DEA) has reduced the amount of almost every Schedule II opiate and opioid medication that may be manufactured in the US by 25% or more.
As Mylan continues to face criticism over price hikes on its EpiPen epinephrine injection, the company agreed to a $465 million settlement with the U.S. Department of Justice and other agencies for overcharging on the EpiPen.
FDA recently expanded the use of lumacaftor/ivacaftor (Orkambi, Vertex Pharmaceuticals) to treat cystic fibrosis in children aged 6 to 11 years who have two copies of the F508del mutation.
FDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases. Here are the top 3 new approvals.
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