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.
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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.
NIH-funded study shows less diabetic retinopathy progression among those who underwent intensive glycemic control.
IMS Health study: Up to 15% of healthcare system costs avoidable and effective patient activation by multiple stakeholders is key to driving improvement.
FDA’s pace of biosimilar approvals is picking up, as it approved two major drugs for rheumatoid arthritis and other inflammatory diseases in the past month.
FDA recently approved an expanded use for Invokamet (Janssen): Invokamet XR, an extended-release combination drug to treat type 2 diabetes. The original Invokamet was approved by FDA in 2014.
FDA approved once-daily Yosprala (Aralez), a fixed-dose combination of aspirin, an anti-platelet agent and omeprazole, a proton pump inhibitor (PPI), for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.Here are the top 5 facts to know about Yosprala.
Even though an FDA panel recommended against approving a new drug to treat Duchenne muscular dystrophy in April, the agency granted accelerated approval to eteplirsen injection (Exondys 51, Sarepta Therapeutics) in mid-September.
FDA’s approval of a new biosimilar-the third FDA-approved biosimilar-stands to save the US healthcare system millions of dollars.
Despite offering a generic version of its EpiPen, Mylan has been unable to curb the backlash that began in late August over the cost of its epinephrine injection.
FDA recently approved the only oxycodone with oral abuse-deterrent features.
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