March 1st 2022
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
September 10th 2021
September 22nd 2020
FDA approval given for new drug to treat obesitySeptember 15th 2014
FDA has approved a combination of the generic drugs naltrexone and bupropion (Contrave) for chronic weight management in obese adults (body mass index [BMI] >30 kg/m2). This combination agent has also been approved for use in those patients who are overweight (BMI >27 kg/m2) and have at least one weight-related comorbid condition such as diabetes, hypertension, or dyslipidemia.
Study: Hep C drugs could increase Medicare Part D spending in 2015August 12th 2014
The federal government’s cost for Medicare Part D will increase between $2.9 billion and $5.8 billion if we see 15% to 30% of hepatitis C (HCV)-infected beneficiaries receive treatment in 2015 and the cost of treatment averages $84,000, according to a new study by Milliman.
Age restriction on emergency contraception liftedApril 10th 2013
On April 5, a US District Court judge ruled that the emergency contraception (EC) pill Plan B One-Step must be made available over-the-counter to all girls and women, regardless of their age. This ruling, made by Judge Edward R. Korman, was in response to a 2011 move by Health and Human Services Secretary Kathleen Sebelius.
Judge orders FDA to make emergency contraceptive available without prescription for all agesApril 5th 2013
A New York federal judge has struck down the restrictions on levonorgestrel-based emergency contraceptives and ordered the FDA to make the drugs available without a prescription and without point-of-sale or age restrictions within 30 days, according to an April 4th memorandum and order
New Jersey compounding pharmacy recalls all products, fearing mold contaminationMarch 18th 2013
Med Prep Consulting, Inc., a compounding pharmacy in Tinton Falls, NJ, is voluntarily recalling all lots of compounded products from its facility for fear of mold contamination, according to an FDA press release.
Survey reveals healthcare provider trust in OTC medicationsMarch 7th 2013
Almost 98% of primary care physicians (PCPs), nurse practitioners, and pharmacists trust and recommend over-the-counter (OTC) medicines to their patients, according to a new survey released by the Consumer Healthcare Products Association (CHPA).
Med school gift restriction policies linked to subsequent prescribing behaviorFebruary 11th 2013
Physicians who attended a medical school with an active gift restriction policy were subsequently less like to prescribe newly marketed psychotropic medications over older, cheaper alternatives, according to a study published in the January 2013 issue of BMJ.
FDA warns company over flu inhalerJanuary 31st 2013
FDA and the Federal Trade Commission (FTC) issued a warning letter to Flu and Cold Defense LLC (Boca Raton, Fla.) for making misleading, unproven claims about its GermBullet inhaler, and said the company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.
FDA approves new seasonal flu vaccine made using novel technologyJanuary 17th 2013
FDA approved the first trivalent influenza vaccine (Flublok, Protein Sciences) made using an insect virus (baculovirus) expression system and recombinant DNA technology for the prevention of seasonal influenza disease in people aged 18 to 49 years.
Merck tells physicians to stop prescribing TredaptiveJanuary 15th 2013
Merck is halting sales of its cholesterol drug-extended-release niacin/laropiprant (Tredaptive)-after preliminary data from a study showed that it did not achieve its primary end point of reduction of major vascular events and also raised safety concerns.
Specialty tier falls out of favor because of access issuesJanuary 1st 2012
Spending growth for specialty drugs rose 19.6% between 2009 and 2010, while growth of traditional drugs decreased by 1.4%, according to Express Scripts' 2010 Drug Specialty Report. Payers are struggling to appropriately manage high-cost drugs while ensuring their members get the care they need. One strategy is introducing a specialty drug tier to the formulary, which raises a red flag on access issues.
Study: Prescription patterns and predictors of aldosterone antagonist use in heart failureJanuary 1st 2010
Heart failure (HF) guideline-recommended aldosterone antagonist therapy was received by less than one-third of eligible patients participating in a quality improvement registry who had been hospitalized for HF.
Diclofenac sodium topical solution (Pennsaid): Nonsteroidal anti-inflammatory topical solution approved for chronic management of knee osteoarthritisJanuary 1st 2010
New formulation: Diclofenac sodium topical solution (Pennsaid) was approved on November 5, 2009, to treat the signs and symptoms of osteoarthritis of the knee.
Exenatide drug label to include information on post-marketing surveillance of altered kidney functionJanuary 1st 2010
In early November 2009, FDA approved revisions to the drug label for exenatide (Byetta, Amylin Pharmaceuticals), an injectable glucagon-like peptide-1 agonist for the treatment of type 2 diabetes mellitus.
FDA Pipeline preview, January 2010 (Testosterone undecanoate injection, Telavancin, Ampligen, Doxepin, Everolimus, Aztreonam lysine, Erlotinib, TG4010, BSI-201, Midazolam, Aimspro, Motorgraft, BHR-100, Dextran sulfate)January 1st 2010
Recent FDA action (through January 2010) related to testosterone undecanoate injection, telavancin, Ampligen, doxepin, everolimus, aztreonam lysine, erlotinib, TG4010, BSI-201, midazolam, Aimspro, Motorgraft, BHR-100, dextran sulfate