Actavis has received final approval from FDA on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (buprenorphine 2 mg and 8 mg sublingual tablets) indicated for treatment of opioid dependence.
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FDA approved Farydak (panobinostat) for the treatment of patients with multiple myeloma, which is attributed to 10,710 deaths in the U.S. annually.
FDA has authorized marketing of Bloom Syndrome carrier test, a direct-to-consumer genetic test from 23andMe.The test is designed to identify healthy individuals who carry a gene that could cause Bloom Syndrome in their offspring.
The introduction of high-cost, high-use PCSK9 inhibitors (proprotein convertase subtilisin/kexin 9) enzyme inhibitors to treat high cholesterol, takes the industry step closer to a future where “healthcare costs break the bank,” according to industry insiders.
FDA expanded approval of lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma. Revlimid acts as an immunomodulating agent and inhibits the growth of myeloma cells by inducing cell cycle arrest and cell death.
A study of more than 1,500 cigarette smokers who were not ready to quit smoking but were willing to cut back on cigarette consumption and combine their approach with varenicline (Chantix, Pfizer) increased their long-term success of quitting smoking.
President Obama’s recent proposal to nearly double funding for antibiotic resistance programs to $1.2 billion in the 2016 federal budget confirms that the battle against “superbugs” is indeed moving up the government agenda.
FDA has approved rufinamide (Banzel, Eisai) for the treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients.
FDA has approved lenvatinib (Lenvima, Eisai) for the treatment of progressive, differentiated thyroid cancer.
FDA has granted priority review for LCZ696 (Novartis), an investigational drug for the treatment of heart failure with reduced ejection fraction (HFrEF).
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Currently, the IBS treatment market is naïve and underpenetrated, with only 4 products indicated for IBS in the 7MM.
In a move widely seen as a way to better compete with the other major chain drugstores, Rite Aid Corp. has announced an agreement on Feb. 11 to buy the pharmacy benefits manager (PBM) EnvisionRx for about $2 billion.
A pivotal phase 3 trial evaluating the safety and efficacy of investigational ixazomib (Takeda), the first oral proteasome inhibitor (PI), conducted in patients with relapsed or refractory multiple myeloma achieved its primary end point of improving progression-free survival (PFS) at the first pre-specified interim analysis.
Imprivata Confirm ID is the first comprehensive product that simplifies the adoption of DEA requirements for the electronic prescribing of controlled substances.
Center for Drug Evaluation and Research (CDER) Trade Press Scientists are working to develop breakthrough therapies for pancreatic cancer, one of the deadliest cancers affecting men and women.
Amgen has announced positive results from a clinical study evaluating the safety and efficacy of biosimilar candidate, ABP 501, compared with Humira (adalimumab) in patients with moderate-to-severe rheumatoid arthritis.
The American Lung Association has called for a halt to the sale of all tobacco products at all retailers with pharmacies.
Because there was no approved medication treatment for idiopathic pulmonary fibrosis (IPF) until mid-October, 2014, physicians primarily focused on non-pharmacological treatments to help patients improve. Even with FDA’s approval of nintedanib (Ofev) and pirfenidone (Esbriet), physicians will continue to recommend certain therapies that generally ease symptoms and improve patients’ quality of life.
While physicians laud FDA’s approval of nintedanib (Ofev) and pirfenidone (Esbriet) for treating idiopathic pulmonary fibrosis (IPF)-the first approved medications to treat the disease in the United Sates-they don’t know how to use them.
Antiviral drug oseltamavir (Tamiflu, Roche) shortens the length of flu symptoms by about 1 day, and reduces respiratory infections that sometimes develop by 44%, according to a study published in The Lancet.
The Patient-Centered Outcomes Research Institute (PCORI) has issued 6 new funding announcements offering up to $138 million in support for studies comparing how well different approaches to care work for patients given their particular circumstances and concerns.
FDA has expanded the approved use of ranibizumab (Lucentis, Genentech) to treat diabetic retinopathy in patients with diabetic macular edema (DME).
It is possible to get treatments to stroke patients even before they arrive at a hospital, according to a study published in the New England Journal of Medicine.
Managed care and hospital decision-makers are in a key position to “move the needle” at the system level on improving adult immunization coverage rates in the United States.
After six years on the job, FDA commissioner Margaret Hamburg, MD, is resigning from her position. Her tenure has ushered in personalized medicine and faster approval of several drug classes.
Non-medication strategies were effective in hospital patients with delirium, according a new study published in the February 2 edition of the JAMA Internal Medicine.
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