Pharmaceutical companies constantly re-assess their pipelines and portfolios to determine the best strategies for their business.
It is no secret that Americans spend heavily on healthcare – in 2013, US healthcare expenditure totaled nearly $3bn ($9,255 per person) and accounted for 17.4% of gross domestic product.
Patient centricity is the buzzword of this decade, and necessarily so: it either underpins, or is an inevitable result of, all the forces shaping today’s rapidly evolving healthcare landscape.
Brazil, Russia, India, China, Mexico, Indonesia, South Korea, and Turkey – known collectively as the BRIC/MIST countries – have been a source of welcome growth for a pharmaceutical industry struggling to generate significant gains in its traditional core markets.
Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market.
Long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination inhalers have been gaining traction due to an expanding evidence base for their wider use, and competitive pricing.
The prostate cancer market has become saturated in the metastatic castration-resistant prostate cancer (CRPC) setting; the approval of second-generation antiandrogens, radiotherapies, and chemotherapies has resulted in a great deal of development targeting earlier stages of the disease.
Highlights: The budget impact of multiple myeloma is set to increase While multiple myeloma represents a relatively small patient population in comparison to other cancers, payers are concerned about the rising spend on the indication. New biologic therapies are increasingly gaining label expansions in earlier treatment lines, and with life expectancies improving, patients are requiring […]
The next wave of key therapies in asthma includes biologics, with interleukin (IL)-5 inhibitors first to reach the market.
Continued growth in healthcare expenditure and the high number of individuals without health insurance coverage were the key drivers of the passage of the healthcare reform law.
Recently there have been several new regulatory changes in the UK aimed at reducing the regulatory burden and allowing earlier access to medicines which are seen as a positive development for the pharmaceutical industry.
Historically Japan has been plagued with delays, with new drug approvals sometimes taking three or four years longer than in the US and EU.
Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.
Total sales from the mid pharma peer set amounted to $69.4bn in 2011; by the end of 2012, this figure rose by 1.6% to $71.0bn. During 2012 the peer set constituents exhibited varying degrees of sales growth.
With the passage of the FDA Safety and Innovation Act of 2012 (FDASIA), the Breakthrough Therapy Designation (BTD) was introduced as the newest mechanism to facilitate expedited development and review. Here we provide an overview of the BTD pathway and its evolution over the past three years.
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