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In January 2013, FDA told manufacturers to lower the dose of zolpidem, the insomnia treatment, for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).

The global pancreatic cancer treatment market value in the six major countries (U.S., France, Germany, Italy, Spain and the UK) will increase from $529 million in 2012 to $1.63 billion by 2017.

Peter Houston looks at the pharma marketing takeaways from last week’s Digital Innovation Summit.

The National Institute for Health and Care Excellence (NICE) has finally published the formal consultation on value-based assessment (VBA).

With the introduction of every new technology, tactic, or gimmick comes what I call a tactical scrum. It’s like watching young kids play their first game of T-ball or soccer.

Baxter International plans to create two separate, independent global healthcare companies, with one focused on biopharmaceuticals and the other on medical products.

Adrian van den Hoven, Director General of the European Generics Association (EGA), this week called for the removal of barriers to generic medicines across the European Union.

A few weeks back I wrote on this blog about the need for CEOs to get social. I’m realistic, I know that the majority of CEOs still don’t engage directly in social media. Mostly it’s “the team” that does it, the marketing team, or the social media team, or the whole team. Great. Have you told them what rules they’re playing by?

Any complacency that the world of healthcare might be feeling about advances in the ability to treat patients suffered a head-on assault in Dublin, Ireland, last week, at a conference organized under the auspices of the Irish Presidency of the European Union and featuring a galaxy of Irish and European stars from the worlds of politics, regulation, research, industry and patients.

Either the doctor’s best friend or nightmare, the e-patient movement (the ‘e’ could stand for engaged or empowered) is here to stay and growing, writes Marylyn Donahue.

Yesterday, the Supreme Court heard arguments on the matter of pay-for-delay settlements between patent holders and generic firms.

Allergy season’s dank fecundity might be welcomed in many parts of America this year. Anything that’s warmer. But the worst allergy sufferers might soon be headed back to the doctor’s office for another round of allergy shots. Or perhaps not.

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure.

An interactive training program designed “to help patient advocates better influence decisions related to access to new medicines” was launched today by Eli Lilly.

On December 8, 2012, the Supreme Court agreed to hear the Federal Trade Commission (FTC) v. Actavis, Inc. case.

So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation.

Dr. Greg Koski of the Alliance for Clinical Research Excellence and Safety (ACRES) talks to Moe Alsumidaie of Applied Clinical Trials about the urgent need for change in the clinical research industry.

The approval last year of Johnson & Johnson’s (J&J) treatment for tuberculosis (bedaquiline) - at the time the first TB drug approval in 40 years - “remains an exception to the generally gloomy outlook” for investment in TB R&D, writes Andrew Ward in this week’s Financial Times.

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests.

European physicians have insufficient knowledge of biosimilars, according to a survey carried out by the Alliance for Safe Biologic Medicines (ASBM).

Supply chains risks in China still include extremely high levels of corruption, environmental pollution issues and slow working conditions reforms, according to new analysis from Sedex.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Sylvant (siltuximab) for adult patients with multicentric Castleman’s disease.

We love being told secrets especially about something so few know anything about, like how to launch a drug successfully given two-thirds don’t meet expectations.

AstraZeneca’s decision to cut 5,050 jobs by 2016 and cease R&D operations at its Alderley Park, UK facility has many wondering where CEO Pascal Soriot plans to take the company.

sponsored by Cegedim

Innovation as a consideration of value-based pricing decisions will be conspicuous by its absence in future NICE decisions.

It’s no secret that the use of digital marketing in the life sciences industry has evolved considerably in recent years. The tools and strategies necessary for pharma brand teams to effectively engage with an increasingly more educated and informed consumer pool are seemingly advancing, or at least being modified, regularly.

The incremental cost effectiveness ratio (ICER) – or the threshold for determining whether the costs of a new medicine are worth it – has been controversial since it’s inception.

Despite its importance as a vital indicator of overall population health status, cancer suffers from an information deficit – particularly when considered from a global perspective.

The European pharmaceutical industry is changing its approach to R&D and is increasingly relying on outsourcing for drug discovery, writes Faiz Kermani.