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

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.

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.

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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.

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.

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.

Just think what Frankenstein could do with this product. It looks like skin, feels like skin, but it’s not skin. It’s LabSkin, a facsimile, being manufactured by a clinical research group Venn Life Sciences.

A milestone of sorts took place on Monday March 3 when MarijuanaDoctors.com began airing a television commercial that looks to be the first ever marijuana commercial on a major TV network.

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight.

The Myelin Repair Foundation is more than just a policy precedent - it’s also emerging as the stimulus behind a future cure for MS.

When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process for generic drugs, and combat the agency’s backlog of drug applications.