The US Department of Health and Human Services is hoping for stability in its ranks in order to move its drug pricing reform policy forward, according to HHS Deputy Secretary Eric Hargan. Find out more about anticipated personnel adjustments to the HHS in this Pink Sheet article.
Lifesaving chimeric antigen receptor T-cell (CAR-T) therapies could soon move to outpatient settings, easing the financial burden currently felt by providers, according to US FDA Commissioner Scott Gottlieb, who said a label change to allow for outpatient treatment under Medicare Part B is in the works.
Both direct reports and external stakeholders weighed in on their thoughts about the leadership of Scott Gottlieb, Commissioner of the US FDA. All signs point to a desire for continuity at the agency following the US mid-term elections in the fall of 2018.
How does the 2018 pipeline compare to 2017’s? In Vivo’s 2018 pipeline infographic examines pipelines by therapeutic area, company and phase. Find out which therapeutic areas are growing, which are shrinking, and which pharma companies have the most robust portfolios.
Although the ranking of Scrip’s top 100 pharma companies remained largely the same as the previous year, there were some surprising moves up – and down – in rank for major players within pharma. Find out who in the top 20 moved, and in what direction, in this essential resource from In Vivo.
Traditionally, the subject of logistics has not been considered until late in the development process for cell and gene therapy. Industry experts at the October 2018 Cell and Gene Meeting on the Mesa in San Diego suggest that considering logistics early in the planning stages for cell and gene therapy is a critically important move.
Swissmedic, Switzerland’s medicines authority, recently completed a full review of Switzerland’s classification system for medicines, deeming 500 OTCs previously available only in pharmacies now suitable for marketing in drugstores, as well. Read more about this sweeping change and how it is affecting hundreds of OTC medicines in Switzerland.
A working group appointed by US FDA Commissioner Scott Gottlieb convened to study the FDA’s capacity to handle the supplement sector and the potential need for Congress to legislate improvements to the agency’s oversight powers in the supplement space.
Probiotic labeling came under fire in a recent opinion piece published in JAMA Internal Medicine, which called for more detailed and extensive labeling for probiotic supplements, as well as improved good manufacturing practices (GMP) as they pertain to the production of products containing live microorganisms.
A leadership shakeup at Roche Pharmaceuticals resembles a game of musical chairs, as Roche’s CEO steps down to join Gilead as chairman and CEO, while the lead at Roche-owned Genentech moves over to fill the top position at Roche.
The recent shakeup at Bayer AG took some observers by surprise, but was heralded by most as a much-needed measure to maintain the German giant’s viability. Find out how this restructuring will play out, and what top analysts make of the move to streamline the organization.
Hawaii’s ban on the sale of sunscreens containing octinoxate and oxybenzone is expected to go into effect in 2021. It’s intended to protect marine ecosystems–in particular, coral. Opponents of the law included the Consumer Healthcare Product Association and the Hawaii Medical Association. Find out how manufacturers will adjust, and gain insights into the U.S. FDA’s perspective on regulating certain sunscreen ingredients.
Estée Lauder’s CEO revealed that “a small group of employees” was responsible for intentionally altering test results behind product claims. The shocking disclosure was mitigated by the fact that the problem was discovered internally. Nevertheless, stock tumbled following the announcement–but has largely recovered. Find out how the disclosure may affect Lauder moving forward, and learn how analysts reacted
Sanofi and Regeneron made an offer: They would drop the cost of their PCSK9 inhibitor Praluent (alirocumab) for improved access. Express Scripts took them up on it. Learn whether this deal will affect the high rejection rate for PCSK9 drugs. Find out whether this deal is a one-off or the start of a trend.
In this interview, John Baldoni describes GlaxoSmithKline’s artificial intelligence efforts. Baldoni, who leads GSK’s AI initiative, discusses the company’s machine-driven discovery and development methods and how they can cut time and costs. Gain insights into the AI team’s timeline and what it has accomplished already. Discover who GSK’s AI partners are–and why such deals are “tricky.”
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