Pfizer Inc. announced that the U.S. FDA approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product.
While many of us from blue states and urban bubbles fret over some of the actions of President Donald Trump, it’s good to take a clear-eyed view of whether or not Trump and this administration has been good for the medical marketing industries. Moreover, it’s useful to consider how a “blue wave” in the midterm elections might change the dynamic.
Deal activity is rampant as Big Pharma gobbles up next-generation medicines and technologies to help overcome maturing pipelines and biosimilar threats.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
The U.S. FDA approved Agios Pharmaceuticals’ oral leukemia treatment Tibsovo (ivosidenib).
Drug regulators across Europe are hiring extra staff and increasing their workload as the role of British experts in the EU-wide system of medicines supervision winds down ahead of Brexit.
The U.S. Food and Drug Administration granted Roche an accelerated review for the Swiss drugmaker’s Elecsys product used to diagnose Alzheimer’s disease.
The U.S. Food and Drug Administration released the regulatory agency’s Biosimilars Action Plan.
The U.S. FDA approved Symtuza, the first complete darunavir-based single-tablet regimen for the treatment of human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults.
The U.S. FDA approved TPOXX (tecovirimat), the first drug with an indication for the treatment of smallpox.
U.S. FDA Approves Xtandi for Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer
Astellas Pharma Inc. and Pfizer Inc. announced the U.S. FDA approved a supplemental New Drug Application for Xtandi (enzalutamide), following FDA Priority Review designation.
The U.S. Food and Drug Administration said recalled Kellogg Co. Honey Smacks cereal was still being sold at retail outlets and warned consumers not to purchase the product.
Akcea and Ionis’ Tegsedi (inotersen) received marketing authorization approval from the European Commission for treating stage 1 or stage 2 polyneuropathy in adults with hATTR.
Bausch + Lomb announced the U.S. FDA accepted the New Drug Application for the company’s sub-micron loteprednol etabonate ophthalmic gel 0.38% with a PDUFA date of Feb. 25, 2019.
The FDA approved Merz Neurosciences’ supplemental Biologics License Application for Xeomin (incobotulinumtoxinA), a treatment for chronic drooling in adults with neurodegenerative diseases.
The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada approved Erleada (apalutamide tablets), an oral treatment for patients with non-metastatic castration-resistant prostate cancer.
The U.S. Food and Drug Administration withdrew the regulatory agency’s draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.
The U.S. FDA approved Alkermes plc’s Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.
AstraZeneca won rapid regulatory approval for new uses of two of the company’s important cancer drugs in Japan.
The U.S. Food and Drug Administration approved Dermira Inc.’s topical cloth for excessive armpit sweating, providing patients with an easy-to-use option for an often embarrassing condition.
The European Commission approved Pfizer’s Xeljanz in combination with methotrexate for treating active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
The U.S. Food and Drug Administration approved Array BioPharma Inc.’s oral combination treatment for use in patients with the deadliest form of skin cancer.