FDA declined to approve Merck’s claim that its cholesterol-lowering drugs Zetia and Vytorin reduce the risk of heart attacks and strokes in patients with coronary heart disease.
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A treatment for community-acquired bacterial pneumonia (CABP) garnered comparable results to moxifloxacin in a newly published late-phase study.
A new report found that the majority of state Medicaid programs cannot afford hepatitis C medications, such as Harvoni and Sovaldi (Gilead Sciences), which can cost nearly $100,000 for a single course of treatment.
In another win for biosimilar drugs, FDA staff recently decided that Celltrion and Pfizer’s biosimilar (Remsima) to Johnson & Johnson’s Remicade for rheumatoid arthritis was “highly similar” to the branded drug.
FDA has approved expanded use of daclatasvir (Daklinza, Bristol-Myers Squibb) in combination with Gilead Sciences' Sovaldi (sofosbuvir), for the treatment of patients with chronic hepatitis C (HCV) genotype 1 or 3.
In one of the few arrangements of its kind, Cigna Corp and Aetna Inc. struck a deal with Novartis for a performance-based price for its heart failure drug, Entresto.
The Zika virus, a mosquito-borne epidemic in Brazil that is causing birth defects, was recently reported in the U.S. Here are the top 5 things to know about the disease:
After receiving pressure from Congress, FDA announced several measures aimed at curbing opioid abuse. The new plan calls for increasing abuse-deterrent formulations of opioid medications and upping access to naloxone and alternative pain treatments.
Much of the drug pricing debate in the United States in recent months has centered around the soaring prices of hepatitis C medications such as Harvoni and Sovaldi (Gilead Sciences), along with Technivie and Viekira Pak (AbbVie). However, the newly approved hepatitis C drug, Zepatier (elbasvir and grazoprevir, Merck) ups the pricing competition.
FDA has approved amphetamine extended-release orally disintegrating tablet (Adzenys XR-ODT, Neos Therapeutics, Inc.) for the treatment of ADHD in patients 6 years and older.
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FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma.
Johnson & Johnson faces $800 million racketeering lawsuit over its antibiotic, Levaquin.
Tresiba, the long-acting insulin that just came on the market in January, stands to net Novo Nordisk billions of dollars.
FDA recently approved (Halaven, Eisai), the first chemotherapy drug to demonstrate survival benefit for liposarcoma that cannot be removed by surgery or is advanced.
When the House Committee on Oversight and Government Reform met on January 26, legislators took a closer look at price hikes from companies such as Valeant Pharmaceuticals and Turing Pharmaceuticals.
Eli Lilly & Company finally releases a high-dose insulin pen, which will help cut down on medication errors associated with the U-100 Humulin insulin pens.
FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of adult patients with active ankylosing spondylitis and active psoriatic arthritis.
It is young white males who are dying from drug overdoses in the U.S., according to a New York Times analysis of death certificates.
Abbott's Compounding Pharmacy in Berkeley, Calif., is voluntarily recalling all unexpired lots of sterile compounded products because of lack of sterility assurance.
FDA has approved an expanded age indication for Hib vaccine (Hiberix, GlaxoSmithKine).
There is some good news for heart failure patients’ life expectancy, in a recent study published in the New England Journal of Medicine.
FDA advisers recommended approval of the first long-acting, subdermal buprenorphine implant (Probuphine, Titan Pharmaceuticals, Inc. and Braeburn Pharmaceuticals) for the maintenance treatment of opioid addiction.
Pharmaceutical companies are battling state legislation that would require state programs such as Medicaid to pay no more than other Federal government programs for drugs.
After a death and a hospitalized patient, FDA is cautioning that differences in dosing regimens between the 2 oral formulations of Merck’s antifungal drug Noxafil (posaconazole) have resulted in dosing errors.
Gilead Sciences, which already makes the leading hepatitis C drugs Harvoni and Sovaldi, recently received priority review from FDA for a new Hepatitis C combination drug.
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