2016: A Biopharma Market in Flux
04 March 2016
M&A activity will continue to dominate in 2016 as biopharma companies respond to a similar wave of restructuring on the insurance and provider side of health care. Even though the track record for ever-larger combinations is mixed, scaling up remains a compelling proposition for biopharma in an era of growing payer power and the high-cost complexities of drug development.
Syndax Cuts Price But Bags $53M in Second IPO Try
03 March 2016
Over the past year, Syndax Pharmaceuticals has altered its strategic course and hired new management to implement it. And it looks like that change was big enough to propel Waltham, MA-based Syndax through the IPO queue on its second attempt since late 2014—albeit not on the terms the company had hoped for.
Can Better Modeling Reduce Pharmaceutical Development and Manufacturing Costs?
03 March 2016
In the UK, a new four-year initiative has been launched to streamline drug development and manufacturing by leveraging better computer-based process modeling and simulation. Dubbed Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT), the $29-million program, part of the UK's Advanced Manufacturing Supply Chain Initiative, aims to develop the tools required for an “efficient, knowledge-based, quality by design-oriented [pharmaceutical] supply chain.”
New Strategies Needed to Clarify Off-Label Marketing
03 March 2016
Litigation, high court decisions and the internet have altered the landscape for exchange of information on drugs and medical products, but the FDA has not kept pace in updating its rules governing what marketers can say about their therapies. Despite considerable pressure to address these issues, FDA has yet to issue new guidance or to hold a public meeting on the subject, something that top officials said they would do more than a year ago. The result is inconsistent policies that lead manufacturers to seek clarification in the courts.
Scientists create digital 'magic wand' to improve at-home device cybersecurity
02 March 2016
Medical device security is at the top of most people's minds lately, especially as products move into the home setting and monitoring becomes more challenging. Now, researchers are tackling the issue by creating a digital "magic wand" that could increase device cybersecurity at home.
Why neglected tropical disease and rare disease researchers need each other
02 March 2016
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. Views represented here may not be those of PhRMA, though they are no less key to a healthy dialogue on issues in health care today.
South Korea approved more clinical trials in 2015
02 March 2016
South Korea's Ministry of Food and Drug Safety announced this week that a "significant number" of South Korean drugs were approved for Phase III trials in 2015.
New report celebrates a decade of progress in chronic diseases
01 March 2016
In the last 10 years, incredible progress has been made by the biopharmaceutical industry in the treatment of chronic diseases. With about half of all Americans, or 117 million people, living with one or more chronic health conditions, this innovation is more critical than ever. Patients with chronic diseases are frequent users of medical care, accounting for 81 percent of hospital admissions and 76 percent of physician visits.
Advancing the science for patients with rare diseases
01 March 2016
When you have a loved one with a rare disease, the importance of persevering to find new, innovative treatments takes on new meaning. This year on Rare Disease Day, I am excited to celebrate the advances we saw in treatments last year and the hope we have for continued progress in the years ahead.
FDA challenges industry to improve reproducibility and accuracy of informatics pipelines
01 March 2016
The FDA has set up the first challenge to use its cloud-based NGS data platform, precisionFDA. Officials at FDA have tasked participants with applying their informatics mapping and variant calling pipelines to well-characterized whole-genome sequencing read data sets, with a view to assessing performance in terms of accuracy and reproducibility.
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NovaMedica team wishes you a Merry Christmas and a Happy New Year!
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