There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
Management from 2016 Manny Award winners and finalists weigh in on various industry topics presented to them by Med Ad News.
The amount of new drug approvals in 2015 was the FDA’s highest total since 1950 due in part to revamped pipelines, but a tough future looms as the grumblings over pricing have risen to a roar.
AbbVie’s biologic therapy Humira for autoimmune diseases was the worldwide prescription-drug sales leader in 2015 for the fourth consecutive calendar term.
The outlook remains bright due to a favorable regulatory arena, support for biopharma-friendly legislation and development incentives, expanding scientific opportunities in key therapeutic areas such as immuno-oncology, and big pharma’s continued push to obtain innovation.
Long-established healthcare communications agencies in 2015 saw their businesses expand, and relative newcomers continued to find their stride.
The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.
Executives from the 2015 and 2014 Manny Award winners and finalists share their views on a variety of industry-related topics.
The top pharmaceutical companies are blurring the lines with biotech and have been engaging in many collaborations, acquisitions, and restructuring plans in the past year.
Humira during 2014 remained the world’s best-selling prescription medicine; Sovaldi vaulted into second place in its first full year on the market; Harvoni is challenging Humira for the 2015 sales crown.
The U.S. biotechnology arena is undergoing a record-breaking M&A cycle for the industry. After generating M&A activity valued at $235 billion during 2014, the U.S. biotech sector produced more than $100 billion in deals during first-quarter 2015.
As the pipelines of their pharmaceutical and biotech clients continue to yield new drugs for patients, agencies are also seeing their business grow.
Biologic medicines and immunotherapy are front and center amongst many of the R&D strategies and platforms for the industry’s leading developers.
The industry’s patent cliffs have become less steep, but the Affordable Care Act will give pharma new challenges.
Fluidity was the state of pharmaceutical advertising in 2013, as agencies shifted their operations, personnel, and tactics to meet the needs of their clients, driven by the pace of digital.
The worldwide drug-delivery arena is growing each year as the increasing aging population is in need of improved methods of administration for products and therapies.
From big pharma to smaller specialty entities, contract manufacturing serves as a strategy for various industry players.
The global market for consumer-care products generated slower growth in 2010 than during the previous year, partially because of a weaker flu season in North America and Europe.