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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.

While biopharmaceutical companies are using websites and third-party postings to provide information on medical products - despite a host of regulatory issues - social media use is in its infancy related to the design and conduct of clinical trials.

Amid the looming March 31 deadline for remaining uninsured and underinsured Americans to purchase health insurance mandated by the Affordable Care Act (6 million newly Medicaid-eligible individuals are expected to enroll), pharmaceutical manufacturers and other key players in this space are emphasizing the importance of enhancing access to medications for the now rapidly expanding patient base.

As the U.S. heads towards a public market place in which Medicare, Medicaid, CHIPs, VA, and now Obamacare will shortly comprise almost 70% of the American healthcare market, American Rx marketers recently endured a “close call” with the U.S. Department of Health and Human Services over the arbitrary deletion of dozens of key drugs from a major American public Rx platform – Medicare Part D.

Japan’s schizophrenia treatment market value will see revenues doubling from $0.7 billion in 2012 to $1.4 billion by 2022 (a Compound Annual Growth Rate [CAGR] of 7.74%), says a new report from GlobalData.

Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, outlined the importance of the Department of Health and Human Services (HHS) National Vaccine Plan, in a FDA blog on March 11, 2014.

In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year.

The plan to accelerate generic pricing and reimbursement has become another tragic European casualty, writes Brussels correspondent Reflector.

Despite a slight boost in funding for the Food and Drug Administration and stronger tax incentives for investment in R&D, significant changes in Medicare drug reimbursement and coverage policies have biopharmaceutical companies up in arms.

The Asia-Pacific (APAC) region is experiencing a significant boom in the volume of private equity and venture capital investments in biotechnology.

Historically, pharmaceutical companies have leveraged remote patient monitoring (RPM) in a very limited way to improve data collection in clinical trials.

Interaction between pharma representatives and doctors has traditionally been a paper-based and static experience in which the representative enters with one-quarter of a campaign in hand and then tries to deliver the remaining pieces three more times through the year.