LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA–(Marketwired – Apr 30, 2015) – GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO® ELLIPTA® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is […]
Artificial intelligence generated plenty of chatter amongst the pharma marketing intelligentsia in 2018. Will 2019 be the year when the industry fully embraces it as more than just a tactic?
Leadership representing the 2018 Manny Award agency and network winners and finalists share their views on various healthcare industry trends and developments.
The top pharmaceutical companies are trying to proactively tackle, through shifts in R&D strategy and other tactics, the healthcare demands of the future.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
Current health systems built to evaluate and pay for traditional drugs are going to struggle with gene and other unusual therapies – but manufacturers can take steps before launch to define how manufacturers assess and value these new products.
This yearly review analyzes recent developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers and biobanks.
A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.
As more innovative – yet even more expensive – therapies enter the U.S. market, brand marketers will have to find equally new and innovative ways to prove the value of their medicines to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.
On Oct. 28, 2016, my mother, Joan Biamonte, died of complications from metastatic carcinoma of the lung. Despite having her original tumor characterized and going through a regimen of chemotherapy allegedly tailored to her tumor type, her cancer proliferated and spread into her liver and brain.
(Reuters) – The U.S. Food and Drug Administration on Thursday approved the sale of Breo Ellipta as a once-daily treatment for asthma in patients aged 18 and older, GlaxoSmithKline and Theravance Inc said. The FDA declined to approve Breo for younger asthma sufferers. The agency, in a so-called complete response letter, told the companies […]
(Reuters) – The U.S. Food and Drug Administration on Thursday approved The Medicines Co’s dry powder blood-clotting agent for use in hospital settings, a month after the treatment received approval in Europe. The treatment, Raplixa, is a combination of two human plasma-derived blood-clotting proteins – fibrinogen and thrombin. (1.usa.gov/1HVGQSd) Raplixa is used to control bleeding […]
LONDON and SAN FRANCISCO, April 30, 2015 /PRNewswire/ — GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO® ELLIPTA® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the […]
WOODCLIFF LAKE, N.J., April 30, 2015 /PRNewswire/ — Eisai Inc. and Eisai Co., Ltd. have entered into a settlement agreement with Glenmark Pharmaceuticals, Ltd., Glenmark Generics Ltd., and Glenmark Generics, Inc., USA (“Glenmark”), to resolve their patent litigation relating to Eisai’s BANZEL® (rufinamide) in the United States. As a result of the settlement, Glenmark will be […]
(Reuters) – Celgene Corp’s dependence on its big-selling multiple myeloma drug Revlimid raised investor concerns on Thursday as sales of its other medicines fell short of expectations. Celgene shares fell 5 percent after the company reported quarterly results in which Revlimid shored up profits. Industry analysts see room for Revlimid to grow much further, with […]
(Reuters) – Four brand-name medications accounted for almost one-tenth of the $103 billion in prescriptions filled by older or disabled Americans under Medicare’s drug program in 2013, U.S. officials reported on Thursday. The Centers for Medicare and Medicaid Services (CMS) said AstraZeneca Plc’s Nexium “purple pill” for acid reflux topped the list with prescriptions totaling […]
IMS Health Finds Wide Disparity Between Essential Medicines List of WHO and Several Pharmerging Countries
DANBURY, Conn.–(BUSINESS WIRE)–The high level of disparity between the World Health Organization’s Model Essential Medicines List (EML) and the EMLs of nine pharmerging countries was highlighted in remarks by Murray Aitken, executive director of the IMS Institute for Healthcare Informatics, at the WHO’s Expert Committee session on April 20. At the Geneva meeting, Aitken presented […]
U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Previously Untreated Advanced Melanoma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA […]
BOCA RATON, Fla., April 29, 2015 /PRNewswire/ — Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Repaglinide Tablets USP, which is being manufactured and supplied by Standard Chem. & Pharm. Co., Ltd. Taiwan, and will be available in 0.5mg, 1mg, and 2mg strengths. […]