Vertex Pharmaceuticals Inc said it received a subpoena from the U.S. Department of Justice in the third quarter related to its marketed medicines, seeking documents related primarily to its “good laboratory practices” in a bioanalytical lab. Good laboratory practices are rules that govern non-clinical safety studies, ensuring quality, integrity and reliability of data. Bioanalytical labs […]
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.
Regeneron Announces EU Approval of EYLEA (aflibercept) Injection for the Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization
TARRYTOWN, N.Y., Oct. 30, 2015 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Bayer HealthCare has received European approval for EYLEA® (aflibercept) Injection for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV). Myopic CNV is an eye disease associated with high degrees of myopia (near-sightedness) and frequently affects people […]
AbbVie Inc (ABBV.N) reported higher quarterly sales and net income on Friday and forecast double-digit growth of earnings per share through 2020, putting the drugmaker in line to beat Wall Street’s current expectations. AbbVie, which was spun out of Abbott Laboratories in 2013, expects revenue of $37 billion in 2020, which is $5 billion more […]
PARIS – After experimental multiple sclerosis drug vatelizumab failed to meet its primary endpoints in a mid-stage trial, Sanofi AG (SNY) said it has dropped plans to develop the drug with India-based Glenmark Pharmaceuticals. During a second-quarter results analysis with media members, Glenmark revealed that Sanofi was terminating the development agreement for vatelizumab, also […]
FDA approves new Novartis dual combination bronchodilator Utibron Neohaler for patients with chronic obstructive pulmonary disease
– Utibron Neohaler (indacaterol/glycopyrrolate) demonstrated superior and sustained improvements in lung function compared to either of its single bronchodilator components as well as placebo, and improved lung function compared to placebo at 5 minutes after the first dose and throughout the dosing interval.1 It does not replace the use of a rescue inhaler – Utibron […]
After months of speculation on who Pfizer Inc. (PFE) will attempt to buy are now officially over — sort of. It has been confirmed that Pfizer Inc. and Allergan Plc (AGN), according to the Wall Street Journal, are discussing a potential merger. The two companies have declined to comment. Analysts have been speculating on […]
The U.S. Food and Drug Administration expanded the use of Bristol-Myers Squibb Co’s skin cancer drug, Yervoy, as an additional therapy for patients with late-stage melanoma. This approval extends Yervoy’s use to patients with stage III melanoma, who have a high risk of recurrence after surgery, the agency said on Wednesday. Due to the potential […]
Gilead Sciences Inc on Tuesday said its quarterly profit rose 70 percent, but sales growth for its hepatitis C drugs flattened as health insurers limited access to the expensive treatments. Shares of the biotechnology company fell slightly. Gilead’s quarterly product sales rose 37 percent to $8.2 billion. Sales of hepatitis C drugs Sovaldi and Harvoni […]
– Strategic priorities include clinical-stage pipeline and core research function – SAN DIEGO, Oct. 27, 2015 /PRNewswire/ — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced plans to improve efficiencies and reduce costs as it focuses on the advancement of its research and development priorities. Arena intends to focus on its key strengths by concentrating […]
London-listed pharma firm Shire said its dry-eye disease drug lifitegrast significantly improved patient symptoms in a new study, supporting a re-submission of the potentially block-busting medicine to U.S. regulators early next year. Shares in Shire jumped more than 6 percent after it announced the positive results of the study on Tuesday. They were trading up […]