Outlook 2019

Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.

Looking look back on US wellness market developments and events in 2019, HBW Insight finds a firm that doesn’t compete in the dietary supplement sector, Amarin, made a good bit of news that affected the industry during the year. We track news across the wellness space from the past year.

As HBW Insight looks back on notable US wellness market developments and events for the previous 12 months, we find that news in the CBD space from the FDA and the industry dominated the sector throughout 2019.

Scrip highlights the key transactions involving Indian firms in 2019. Divestments and licensing were among the prominent themes that dotted the deal landscape in the year gone by.

Net price growth of 0.3% for branded drugs in 2018 was 1.6% below Consumer Price Index inflation, while invoice prices grew an average of 5.5%.

As the pipeline and market for novel cell and gene therapies expands, it is time for drug developers to address other critical aspects in the logistical chain – and for these complex therapies a lot of those issues relate to manufacturing. Looking at specific cases, In Vivo has underlined the main manufacturing challenges facing cell and gene therapy developers, and highlighted methods and approaches being used to generate solutions. 

2019 could be a monumental year for the South Korean pharma industry, as several new drug assets await the green light from the US FDA.

2019 promises to be action-packed for Indian firms as they stay hungry for M&A and on course to transition to a more innovation-led play. But election year surprises in India, rising patient awareness, and the entry of non-traditional players like Amazon could well up the variable quotient for pharma, industry pundits tell Scrip.

After much turmoil in 2018, the biopharma sector in China is embracing multiple uncertainties in the year of the boar.

A New Year and a new look. For 2019 we have merged the Scrip 100 with In Vivo’s annual preview magazine, creating a new beast known as Outlook. This encompasses all the best aspects of both issues and covers more topic areas than ever before.