Formulary Watch |

Pfizer makes huge multimillion-dollar Medicaid settlement

In one of the biggest drug pricing settlements in history, Pfizer is paying $784.6 million to settle claims alleging that the practices of its Wyeth subsidiary relating to the calculation of Medicaid rebates for Protonix (pantoprazole sodium) violated the Federal Civil False Claims Act and other laws.

AstraZeneca drug a breakthrough therapy for bladder cancer

FDA has granted breakthrough therapy designation for durvalumab (MEDI4736, AstraZeneca) for the treatment of urothelial bladder cancer.

FDA clears new treatment for epileptic seizures

FDA has approved brivaracetam (Briviact, UCB, Inc.) as an add-on therapy for the treatment of partial onset-seizures in patients with epilepsy.

Top 5 things to know about FDA’s Zika blood guidelines

FDA issued a new guidance recommending that individuals who have been to areas with active Zika virus transmission, who have potentially have been exposed to the virus, or have had a confirmed Zika virus infection should not donate blood. Here are the other top 5 things to know about FDA's new guidelines on Zika blood transmissions.

FDA denies claims for Zetia, Vytorin

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.

Pneumonia drug garners favorable results in study

A treatment for community-acquired bacterial pneumonia (CABP) garnered comparable results to moxifloxacin in a newly published late-phase study.

More bad news for hep C drug pricing

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.

Another win for biosimilar arthritis drugs

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 expands use of hep C 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.

Insurers set performance-based price for heart drug

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.

Top 5 things to know about Zika virus

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:

FDA makes sweeping changes for opioids

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.

Hepatitis C pricing heats up with new drug

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 clears long-acting ADHD drug

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.

FDA expands Opdivo use for metastatic melanoma

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma.

J&J’s antibiotic faces $800M lawsuit

Johnson & Johnson faces $800 million racketeering lawsuit over its antibiotic, Levaquin.

Diabetes drug Tresiba to make billions

Tresiba, the long-acting insulin that just came on the market in January, stands to net Novo Nordisk billions of dollars.

First chemo drug to show survival benefit for liposarcoma passes

FDA recently approved (Halaven, Eisai), the first chemotherapy drug to demonstrate survival benefit for liposarcoma that cannot be removed by surgery or is advanced.

Hearing ups pressure on drugmakers’ prices

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.

High-dose insulin pen hits market

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.

Cosentyx gets thumbs up for 2 new indications

FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of adult patients with active ankylosing spondylitis and active psoriatic arthritis.

More young white males dying from drug overdoses

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.

Compounding pharmacy recalls medications

Abbott's Compounding Pharmacy in Berkeley, Calif., is voluntarily recalling all unexpired lots of sterile compounded products because of lack of sterility assurance.

FDA approves new indication for Hib vaccine

FDA has approved an expanded age indication for Hib vaccine (Hiberix, GlaxoSmithKine).

Heart drug improves life expectancy

There is some good news for heart failure patients’ life expectancy, in a recent study published in the New England Journal of Medicine.

FDA panel greenlights Probuphine for opioid addiction

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.

Huge coalition to advance cancer treatments

Drugmakers debate pricing, legislation

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.

FDA warns about dosing errors with antifungal

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.

5 things to know about Gilead’s new hep C drug

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.