Formulary Watch |

New drug approved for chemotherapy nausea

FDA recently approved granisetron (Sustol, Heron Therapeutics) extended-release injection to prevent nausea and vomiting associated with repeat courses of chemotherapy.

AbbVie hep C drug combo enters market

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 value rises after new Keytruda approval

Merck’s Wall Street value is climbing after its cancer drug pembrolizumab (Keytruda) received yet another approval from FDA.

PBM giants pare down drug expenses

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.

Medicare drug pricing debate heats up

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: Antibiotics class must carry warning

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.

New diabetes drug up against leading brands

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).

Overtreating glucose levels can take a toll on diabetes patients

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.

Wide geographic differences exist in treating diabetes

New weight management pill available soon

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 approves drug for pregnant women with HIV

FDA recently approved an expansion to the prescribing information for darunavir (Prezista, Janssen Therapeutics), to treat pregnant women with HIV.

Diabetes complications fuel rising costs

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 approves first once-monthly injection to lower cholesterol

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.

Top 4 ways US is combating opioid epidemic

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.

FDA approves cannabis-derived drug

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").

Cheaper hep C drug enters competitive market

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).

Patient navigators can benefit diabetes outcomes

Empowered patients more likely to stick to diabetes treatments

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.

Zika vaccine on the horizon

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 approves rare liver disease drug

FDA recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.

FDA approves first treatment for acute GVHD

FDA just granted Breakthrough Therapy Designation for the first treatment for acute graft-versus-host disease (GVHD): ruxolitinib (Jakafi, Incyte Corp.).

FDA approves novel kidney disease drug

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.

New kidney warning on popular diabetes drugs

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 halts migraine patch sales over burns

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.

First US cholera vaccine available

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.

FDA warns about OTC antacids, antidiarrheal med

FDA is warning consumers about the risk of serious bleeding when using over-the-counter aspirin-containing antacid products to treat heartburn. The agency also issued a separate warning about loperamide (Imodium, Johnson & Johnson), saying that abuse or misuse of the product can cause serious heart problems that can lead to death.

New hypertension drug gets FDA approval

The first and only fixed-dose combination of a beta blocker beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the US in the second half of the year. FDA approved nebivolol and valsartan (Byvalson, Allergan) 5 mg/80 mg tablets in early June.

FDA approves Zinbryta to treat multiple sclerosis

FDA recently approved daclizumab (Zinbryta, Biogen and AbbVie), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS).

Top 5 facts about cancer drug costs

The global oncology market was worth $107 billion in 2015, and global annual cancer drug costs surged by 11.5% from 2011 to 2015, according to a new report.

First 4-strain flu vaccine available

FDA recently approved the first 4-strain, cell culture-derived, inactivated seasonal flu vaccine available in the United States. Flucelvax Quadrivalent influenza vaccine (Seqirus) helps protect against the 2 influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.