The year's new drugs and biologics 2018: Part II - News that shaped the industry in 2018.

This eagle's-eye overview of the drug industry in 2018 provides insight into some of last year's top stories, including a large and still growing outbreak of Ebola in the Democratic Republic of the Congo, as well as the potential uses (and abuses) of CRISPR technology. As in previous years, we also review orphan drug development, new regulatory agency-supported programs such as Priority Medicines Scheme (PRIME) and Sakigake, pipeline attrition, and pharma/biotech mergers and acquisitions of note. Finally, we take a glimpse into the crystal ball to anticipate the new drugs that will be approved in 2019.

The year's new drugs & biologics, 2017, part II - News that shaped the industry in 2017.

This eagle's-eye overview of the drug industry in 2017 provides insight into some of last year's top stories, including the growing opioid crisis affecting the U.S. and other developed countries and the 2017-2018 influenza epidemic, with a spotlight on the need for a universal flu vaccine. As in previous years, we also review orphan drug development, new agency-supported programs such as PRIME and RMAT, pipeline attrition and drug pricing, as well as pharma/biotech mergers and acquisitions of note. Finally, we take a glimpse into the crystal ball to anticipate the new drugs that will be approved in 2018.

American Academy of Neurology - 69th Annual Meeting (April 22-28, 2017 - Boston, Massachusetts, USA).

The Annual Meeting of the American Academy of Neurology (AAN) is the largest conference convening neurology professionals from all over the world to share and discuss the latest breakthroughs in neurology treatment. The conference covers basic scientific research to clinical application through a wide range and interesting programs. This report covers some of the therapeutic highlights presented during the conference.

The year's new drugs & biologics 2016: Part II - Trends and highlights of an unforgettable year.

This eagle's-eye overview of the drug industry in 2016 provides insight into some of last year's top stories, including disease outbreaks that drove R&D, orphan drug development, pipeline attrition, drug pricing, and the ongoing movement in M&A. We also consider recent political events in the U.S. and U.K. and their potential impact on the industry in the years to come, and take a glimpse into the crystal ball to anticipate the new drugs that may be approved in 2017.

European Association of Urology--31st Annual Congress (March 11-15, 2016--Munich, Germany).

The 31st Annual European Association of Urology (EAU) Congress held in Munich, Germany, was a platform for expert urological specialists from all over the world to find a unique space to share their evidence-based knowledge during state-of-the art lectures, presentations and courses. This report covers selected presentations covering cancer-related presentations.

The year's new drugs & biologics 2015 - part II:Trends and highlights that marked a complicated year.

This eagle's-eye overview of the drug industry in 2015 provides insight into some of last year's top stories, including drug pricing, orphan drug development, the FDA's priority review voucher system, pipeline attrition, and the ongoing movement in M&A. We also take a look into the crystal ball and anticipate the new drugs that may reach the market in 2016.

The year's new drugs & biologics 2014 - Part II: trends & challenges.

2014 was a year of continued high activity in the pharma and biotech industry, as evidenced in part I of this annual two-part review article published last month in this journal (1). As of December 23, 2014, a total of 55 new chemical and biological entities had reached their first markets worldwide, together with another 29 important new line extensions. Another 19 products were approved for the first time during the year but not yet launched by December 23. Furthermore, during the now-traditional year-end sprint, several regulatory agencies issued last-minute approvals for other compounds that missed the deadline for inclusion in that article, bringing the total of new approvals for the year to a somewhat higher number. In addition to the successful development, registration and launch of new drugs and biologics, there are various other trends and tendencies that serve as indicators of the overall health and status of the industry. These include the pursuit of novel programs designed by regulators to stimulate the development of drugs for diseases that are currently under-treated; the regular and pragmatic culling by companies of their R&D pipelines; and the decision to unify pipelines, portfolios and sales forces through mergers and acquisitions.

A report from the European Society of Cardiology Congress 2014 (August 30-September 3 - Barcelona, Spain).

The European Society of Cardiology (ESC) Annual Congress is the largest cardiology conference in the world and this year ran in Barcelona from August 30 to September 3. During the meeting, more than 30,000 cardiologists from over 100 countries met to share their knowledge in all cardiovascular fields, from basic science to management and prevention of cardiovascular diseases. Apart from more than 4,500 interesting abstracts presented in posters and oral sessions, five new ESC Clinical Practice Guidelines were presented among the latest clinical trial results, updates and registries.

The year's new drugs & biologics, 2013: Part II.

The demise of the pharmaceutical industry, so pessimistically predicted by many in recent years, has not come to pass and in fact the patient is alive and well. New programs enacted by drug regulators have been enthusiastically taken up by the industry, including the FDA's breakthrough therapy and qualified infectious disease product (QIDP) designations, as well as the now-consolidated orphan drug programs in many countries. Pharma companies pragmatically wean nonperformers from the pipeline in an efficient manner, resulting in somewhat leaner but higher-quality pipelines. Mergers and acquisitions also continue to drive consolidation and efficiency in the industry, a trend that continued during 2013. This article provides an updated review of these and other trends in the pharmaceutical industry in the year just passed.

A report from the 65th Annual Meeting of the American Academy of Neurology (March 16-23, 2013, San Diego, California, USA).

The Annual Meeting of the American Academy of Neurology (AAN) is one of the largest international conferences for neurologists and neuroscience professionals, and is dedicated to basic, clinical, epidemiologic, translational and educational research. More than 10,000 attendees from all over the world converged on this international forum for the exchange of cutting-edge findings through comprehensive educational programs and more than 2,300 interesting presentations.

2012 in review - part II: overcoming the obstacles in the pharma/biotech industry.

As highlighted in the first part of this review published last month, the year 2012 saw the approval of a remarkable number of new drugs, and among the new drugs reaching the market, a significant proportion were orphan drugs developed for treating less prevalent diseases. These drugs are certainly not expected to become blockbusters, but are of high interest because of their efficacy in a narrow spectrum of patients. This trend aligns with the general tendency of staying away from fit-for-all blockbusters into personalized medicine as one of the strategies for overcoming the patent cliff that resulted in a long list of drugs going off patent and being approved as generics also during last year. The emerging scenario resulting from new developments in the form of new drugs and biosimilars and newly available generic medications paralleled by strategic movements within the pharmaceutical industry to reinforce their position in the market, as reflected by merger and acquisition deals accompanied by significant efforts into prioritization resulting in spin-off and split transactions, is reviewed in this second part. This paper includes a significant amount of data in tables for quick review and to profile the new strategic movements in drug pipelines. Further information, including details on mechanisms of action, current status, itemized pharmacology, pharmacokinetic and clinical trial research findings and updated information can be found in the proprietary databases Thomson Reuters Integrity(SM) and Thomson Reuters Cortellis™.

The year's new drugs & biologics, 2011.

2011 was a good year in many respects for the pharmaceutical industry, especially regarding the approval and launch of several important new products. The FDA reported a record high rate of approvals during FY2011 (October 1, 2010-September 30, 2011), reflecting the agency's commitment to maintaining "a state-of-the-art drug approval process that brings important drugs to market quickly and efficiently" (1). While not all of the new drugs and biologics listed in FDA's fiscal year summary meet the criteria for inclusion in this article, most of them do, and hence are reviewed in the following pages. Also covered in this year's expanded article are new approvals and new launches in other global markets, line extensions and other developments of interest to the industry: generic drug approvals, product withdrawals and discontinuations, new developments in the area of orphan drugs and diseases, and more.

A report from the 2011 Alzheimer's Association International Conference (July 16-21 - Paris, France).

Alzheimer's disease (AD) is indeed a source of sadness weighing on all those who after sharing a full life now depend on each other for the most basic functions. Nevertheless, besides the dramatic impact it imposes on the life of sufferers and their caregivers, AD, as well as other forms of dementia that affect the elderly, but also younger patients, also incurs in substantial healthcare costs for patients, their families and others, including society at large. The progressive aging of the population largely depending on improved preventive and curative healthcare is progressively worsening the situation because of the increasing number of elderly people and the consequent increase in dementia sufferers. Effective and cost-effective treatments are thus required for reversing, improving or preventing these cognitive impairments. Fortunately, research has resulted in therapeutic opportunities that were reviewed during the 2011 Alzheimer's Association International Conference (AAIC) in Paris, and will be briefly reviewed in the following report.