Roche’s Tecentriq will get a speedy review by U.S. regulators in a tough-to-treat form of breast cancer, seeking to be the first company to have an immunotherapy win approval in this indication.
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.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
This yearly review analyzes recent developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers and biobanks.
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.
Clinical data for a fish-oil-based drug from Amarin Corporation confirmed the drug’s ability to reduce the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death.
Theravance Biopharma Inc. and partner Mylan NV won U.S. regulatory approval for their treatment Yupelri for a chronic lung condition that causes breathing-related problems.
The FDA will issue a sales ban on fruit and candy flavored electronic cigarettes in convenience stores and gas stations in a move to counter a surge in teenage use of e-cigarettes.
Bristol-Myers Squibb snagged regulatory approval from the U.S. FDA for Empliciti (elotuzumab) for adults with multiple myeloma who have received at least two prior therapies.
The U.S. Food and Drug Administration accepted for priority review the license application for the use of Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis
An FDA advisory panel voted against approving Alkermes Plc’s depression treatment ALKS 5461 in patients with an inadequate response to standard antidepressant therapies.
Merck’s blockbuster anti-PD-1 therapy Keytruda won FDA approval in combination with chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
The U.S. Food and Drug Administration approved Novartis AG’s copy of Humira, the world’s bestselling prescription medicine developed by U.S.-based AbbVie Inc.
The U.S. Food and Drug Administration approved TherapeuticsMD’s oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats.
The U.S. FDA declined to approve a pre-filled syringe version of Regeneron Pharmaceuticals Inc.’s blockbuster eye drug Eylea.
Japan’s Shionogi and Swiss drugmaker Roche won U.S. FDA approval for Xofluza, the first new flu drug approved by the regulatory agency in nearly 20 years.
Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.
An EMA panel recommended approving a potential blockbuster drug from Shire Plc to treat a rare hereditary disease.
The European Medicines Agency’s CHMP adopted a positive opinion for the marketing authorization of Sanofi’s dengue vaccine.
U.S. Food and Drug Administration Commissioner Scott Gottlieb announced that the regulatory agency is relaunching the Drug Competition Action Plan in 2019 with some additional initiatives.
The U.S. Food and Drug Administration rejected Novartis’ bid to repurpose canakinumab, a drug already approved for rare inflammatory diseases, for use in a group of heart attack survivors.
The U.S. Food and Drug Administration approved Pfizer Inc.’s Talzenna (talazoparib) for an advanced form of breast cancer.
The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend AcelRx Pharmaceuticals’ Dsuvia to manage moderate-to-severe pain.
The U.S. Food and Drug Administration lifted a clinical hold and accepted an Investigational New Drug Application (IND) for an experimental sickle cell disease treatment being jointly developed by Vertex Pharmaceuticals and CRISPR Therapeutics.