Enanta Pharmaceuticals Inc.'s New Drug Application (NDA) for its pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), developed in conjunction with AbbVie, has been accepted by the U.S Food and Drug Administration. Read More »
The American Pharmacists Association (APA) recently announced that new research shows adding 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy led to an increase in survival rates and for patients with recurrent prostate cancer. Read More »
Daiichi Sankyo Inc. will take the helm on handling U.S. commercialization of the FDA-approved RoxyBond (oxycodone hydrochloride) oral-use medication manufactured by Inspirion Delivery Sciences LLC, the companies announced recently from their respective New Jersey hubs. Read More »
The Health Affairs Blog, a vehicle for commentary on health policy and issues, recently wrote about how the Cures Act and FDA Draft Guidance suggest flexibility on communication of real-world drug impacts. Read More »
Amgen's Fourier trial for Repatha met its primary composite endpoint and the key secondary composite endpoint. Read More »
CVS Health has released an article about making it easier for patients to prevent and manage chronic disease. Read More »
Spinraza (nusinersen) recently won European Commission authorization to treat 5q SMA — the most common form of spinal muscular atrophy — becoming the first such drug to achieve European approval, manufacturer Biogen announced from Cambridge, Massachusetts. Read More »
Express Scripts has released its 2016 Drug Trend Report for the commercial market. Read More »
Trumenba, Pfizer’s branded vaccine against certain forms of meningococcal disease, officially won approval from the European Commission for patients aged 10 years and up, representing progress for protection in the young adult demographic. Read More »
Government-mandated disclosure bills could have a negative impact on competition if pharmacy benefit managers are forced to publicly disclose too much information on their negotiations with drug companies, according to Emory School of Law professor Joanna Shepherd. Read More »
The U.S. Supreme Court issued a 9-0 ruling today that will have the effect of speeding the process for biosimilars going to market. Read More »
As a Senate committee prepares to evaluate U.S. drug distribution at a hearing tomorrow, the Pharmaceutical Care Management Association readily demonstrates that manufacturers’ pricing does not correlate with agreed-upon rebates and discounts with pharmacy benefit managers. Read More »
The Texas Pharmacy Association (TPA) has received a grant from the Community Pharmacy Foundation and Texas Department of State Health Services that will allow the association to create community-based health care provider digital linkages with pharmacists. Read More »
The Centers for Medicare and Medicaid Services recently authorized Texas-based McKesson Specialty Health as a Qualified Clinical Data Registry, rendering it eligible to participate in the Merit-Based Incentive Payment System for 2017. Read More »
Fortified with time-release traits, Egalet Corp.’s Guardian tablet has received a U.S. patent, enabling the Pennsylvania-based firm to adapt the medication for potential future products. Read More »
Mutual recommitment to a partnership between Pfizer and two U.S. foundations has successfully ensured continued access to Pfizer’s Sayana Press contraceptive for women in the world’s poorest nations. Read More »
A pioneering prototype blending a mood stabilizer with technology is on the radar for two companies determined to develop a combination drug/device that, if approved by the FDA, could potentially address serious mental health challenges. Read More »
With kidney disease ranking in the nation’s top 10 causes of death, Sanofi recently announced a breakthrough with FDA approval of its branded Thymoglobulin for boosting immunosuppression for patients to prevent rejection following kidney transplants. Read More »
Pfizer Inc. and Celltrion Healthcare presented data at the 12th Congress of the European Chron’s and Colitis Organisation showing Inflectra (infliximab CT-P13) delivers similar efficacy and safety as Remicade (infliximab) for treating Chron’s Disease. Read More »
AstraZeneca and TerSera Therapeutics LLC (TerSera) have entered a agreement that gives TerSera the commercial rights to Zoladex in the United States and Canada. Read More »
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