PCSK9 inhibitors such as alirocumab (Praluent, Sanofi) and evolocumab (Repatha, Amgen) are priced too high to benefit the US healthcare system, according to a new study.
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FDA recently approved granisetron (Sustol, Heron Therapeutics) extended-release injection to prevent nausea and vomiting associated with repeat courses of chemotherapy.
In an era when legislators, pharmacy benefit managers and others continue to protest the high cost of hepatitis C drugs, new drugs to treat the disease are welcomed. FDA recently approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira XR, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, including those with cirrhosis. AbbVie already markets Viekira Pak, which competes with Harvoni and Sovaldi (Gilead Sciences).
Merck’s Wall Street value is climbing after its cancer drug pembrolizumab (Keytruda) received yet another approval from FDA.
When Express Scripts and CVS Health announced their 2017 formularies on August 1, a common theme emerged among the healthcare giants: several blockbuster drugs will be removed from both companies’ formularies and lower-cost options such as biosimilars are being embraced.
A senator is investigating whether Medicare's prescription drug benefit is vulnerable to manipulation by pharmaceutical companies after an exclusive Associated Press report showed that Medicare’s spending on certain drugs soared by 85 percent.
FDA added new safety labeling changes for a class of antibiotics, fluoroquinolones (Levaquin, Cipro and other branded drugs), to enhance warnings about their association with disabling and potentially permanent side effects. Plus, the new labeling says that the drugs’ use should be limited in patients with less serious bacterial infections.
FDA approved lixisenatide (Adlyxin, Sanofi-Aventis), a once-daily mealtime GLP-1 receptor agonist injection for type 2 diabetes, which will compete against the once-weekly pen dulaglutide (Trulicity, Eli Lilly) and the injectable liraglutide (Victoza, Novo Nordisk).
Mayo Clinic researchers found that beyond overtesting, focus on HbA1C levels can lead to serious harms for patients, especially as more diabetes drugs are needed to keep HbA1C within desired targets.
A large-scale observational study led by Columbia University researchers may offer new approach to studying diverse patient groups.
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FDA recently approved the New Drug Application (NDA) for (lorcaserin HCl) CIV extended-release 20 mg tablets (Belviq XR, Eisai Inc. and Arena Pharmaceuticals), a once-a day dosing option for chronic weight management.
FDA recently approved an expansion to the prescribing information for darunavir (Prezista, Janssen Therapeutics), to treat pregnant women with HIV.
Medication nonadherence and complications from type 2 diabetes is resulting in signficant economic and societal burdens in the U.S. and other countries, according to a new report.
FDA approved evolocumab (Repatha, Amgen) Pushtronex system, the first monthly single-dose injection of a PCSK9 inhibitor. Repatha was already approved by FDA as the only PCSK9 inhibitor with a monthly dose last August.
Expanding access to buprenorphine, a medication to treat opioid use disorder, is one of several new actions announced by Health and Human Services (HHS) to combat the opioid epidemic. Here are the top 4 new provisions from HHS.
For the first time, FDA approved dronabinol oral solution (Syndros, Insys Therapeutics), a liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC").
A new drug approved by FDA to treat chronic hepatitis C virus (HCV) infection this week enters a competitive, lucrative market headed up by Gilead Science’s Sovaldi and Harvoni, as well as AbbVie’s Viekira Pak. FDA granted priority review and breakthrough therapy designation to Gilead’s combination product, Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg).
Study seeks to determine whether significant improvement in glycemic control can be achieved when regular coaching is part of the process.
Empowerment is an important factor to address everyday aspects of dealing with a chronic disease, including diabetes, according to a study that evaluated the effect of diabetes empowerment on medication adherence and self-care behaviors in adults with type 2 diabetes.
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) plans to help bring a vaccine for the Zika virus to market immediately via Emergent BioSolutions Inc., which also developed the anthrax vaccine.
FDA recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.
FDA just granted Breakthrough Therapy Designation for the first treatment for acute graft-versus-host disease (GVHD): ruxolitinib (Jakafi, Incyte Corp.).
After initially rejecting calcifediol (Rayaldee, Opko Health) for chronic kidney disease earlier this year because of manufacturing concerns, FDA approved the drug four months ahead of its new timeline.Rayaldee extended release capsules is the first drug to receive FDA approval for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.
Soon after FDA warned about a potential increased risk of foot and leg amputations with the use of the type 2 diabetes medication canagliflozin (Invokana and Invokamet, Janssen Biotech), the agency strengthened the existing warning about the risk of acute kidney injury with Invokana and Invokamet, as well as dapagliflozin (Farxiga and Xigduo XR, AstraZeneca).
Teva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of serious burns with the use of the patch.
FDA approved the first US vaccine for cholera, Vaxchora, made by PaxVax Bermuda Ltd. in Hamilton, Bermuda. Vaxchora is the only single-dose vaccine for cholera currently licensed anywhere in the world.
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