At the 2019 J.P. Morgan Healthcare Conference, bluebird bio Inc. became the first company to propose a 5-year annual installment payment plan for its gene therapy Lentiglobin, the first such payment plan proposal of its kind. Hear more about the reaction to the proposal from other pharma players and from insurers in this informative Scrip article.
The US Centers for Medicare and Medicaid Services (CMS) say they are seeking to improve medical devices reimbursement procedures as the device industry looks for a policy to help breakthrough devices receive temporary and automatic Medicare and Medicaid coverage. Read more here.
Leading UK and EU notified body BSI expects the UK to remain a full member of the EU regulatory regime post-Brexit, but it has a contingency plan. Learn what this contingency plan means for device manufacturers. Gain insights into the implications of a non-negotiated Brexit, and find out if the other notified bodies have contingency plans.
“Almost everyone at Deciem has been involved in a major criminal activity.” So claimed Deciem Inc. founder Brandon Truaxe on an October 8 Instagram post in which he also announced the controversial Estee Lauder Companies-backed startup would be ceasing operations “until further notice.” Find out more here.
Find out more about the proposed The Safe Cosmetics and Personal Care Products Act 2018. This bill would institute a number of reforms for the industry and establish a new set of guidelines for safety, and is very similar to previous proposals for cosmetics reform submitted by Rep. Jan Schakowsky, D-Ill.
Tap into the state of Takeda’s R&D strategy and how it might change in the wake of their Shire acquisition, due to take place in 2019 to the tune of $62.4b. Find out more about Takeda’s new rare diseases therapeutic areas unit, their partnering efforts to build out the pipeline, near term highlights, progress in penetrating Chinese markets, and more.
The Global Medical Device Nomenclature is emblematic of the global trend toward building high-quality data sets in the public arena to derive better information about how medical devices perform. Medtech Insight covers that the new chair of the agency saying how the GMDN usage is poised to explode.
Over the counter products are among the first to be recalled in Europe following the discovery of a human carcinogen in ranitidine-based drugs. HBW covers how investigations are underway worldwide while regulators across Europe are divided between “take immediate action” and “wait and see”.
Pharma companies faced a “patent cliff” a decade ago with generic competition threatening to slash sales of certain blockbusters. The new threat is biosimilars. Scrip shows how some mature cancer and autoimmune biologics are still the major drivers of revenues, and how biosimilars are gaining on them.
NGO Women’s Voices for the Earth recently called for a ban of five ingredients used in fragrances for personal-care products. These ingredients were recently removed from the safe food additives list by the FDA, despite the FDA’s claims that they pose no risk to public health. Go deeper into this clash between hazard and risk ideologies in this informative article.
Abbott’s Merlin patient care network works with the CardioMEMS HF sensor system. The Merlin 10.0 update to the network allows physicians to share custom messages directly with their patients. Medtech Insight looks closer at the software and its intended benefits.
Changes are coming to the structure of the FDA’s Center for Drug Evaluation and Research division the Office of New Drugs. This long-planned reorganization is still in the nascent stages, but expected to bring a more modern approach that, along with IT improvements and other streamlined processes, will make drug reviews more efficient.
Although original estimates put staff losses at the European Medicines Agency at about 19% due to the EMA’s relocation from London to Amsterdam, the EMA reports that these losses may actually be much higher, forcing the agency to take a hard look at its most pressing priorities moving forward.
The ICD market alone lost nearly $1bn from $8.3bn in 2019 to $7.4bn in 2020 due to a combination of lockdowns, supply chain disruptions, and logistical strain in the healthcare space. The global market for ICD devices, along with many other medical devices, is currently recovering from a major economic downturn. Therefore, to provide context as to the nature of this market recovery and what exactly it is recovering from, data from 2019 are included. Types of cardiac defibrillators covered by the scope of this report include ICDs, subcutaneous ICDs (S-ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The regions covered by this report are the US, the 5 major European economies (UK, France, Spain, Italy, Germany), Japan, and the rest of the world. The forecast range is 2020-2025.
In Vivo looks at how gene therapies have gone from being just implausible science fiction premises, to becoming clinical realities taking an ever-larger portion of pharma R&D attention. This article covers how gene therapies work, where the field has been and where it’s going.
It’s payback time for Unilever, as the maker of Schmidt’s deodorants must re-label its products, removing reference to certain wetness-absorption claims. In 2016, Unilever was responsible for making close competitor Colgate’s Tom’s of Maine remove similar claims to their deodorant products at a self-regulatory forum.
As a European wave of Humira biosimilars challenges the best-selling drug in the world, the question of how biosimilars will affect the market, from payers, to practitioners, to patients, comes to the forefront. Examine how biosimilars are poised to change the landscape as focus shifts from whether to adopt their use to how to actually use them effectively.
An informal round table discussion among more than 20 key market access leaders in biopharma convened by the Boston Consulting Group (BCG) yielded some interesting insights into the innovations that are forcing changes to the way the industry runs.
Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? In Vivo talks to one CEO who knows.
Novartis Oncology CEO and newcomer to the company, Liz Bennett, sat down with Scrip ad talked about her plans for an organization currently in transition, and her strategy for moving new blockbusters forward. Access her insights into the future of Novartis Oncology in this illuminating interview.
Trialtrove’s 2018 Completed Trials: State of Industry-Sponsored Clinical Development report takes a detailed look at the record of completed trials over the calendar year, highlighting key trends by therapeutic area; the company sponsorship landscape; and trial phase, including progress of designated pivotal trials and success in meeting endpoints. This insightful annual review of clinical trials initiated by industry sponsors is a useful gauge of the diversity and innovative potential of biopharma’s investments in R&D. This year’s report reveals that, for all the consistencies in many aspects of the clinical trial landscape, changes are in the wind – particularly as companies outside the “Pharma Top 20” now contribute more completed trials than any other type of sponsor.
Novartis’s Zolgensma losing EU accelerated assessment serves as a warning to other companies. This Scrip story covers a half dozen other examples of companies and drugs who are now forced to slow their development pace—opening room for competitive threats.
With Democrats taking control of the US House of Representatives in the fall of 2018, the future of proposed legislation to update cosmetics industry regulations is hazy, but likely to result in stricter regulations for products sold in the United States.
How did biopharma shape up for 2018 in terms of mergers, acquisitions, and other business deals? Explore what transpired during last year for M&A in biopharma, when tax cuts were expected to spur major activity. In Vivo brings you a vital look back at the events of 2018.
This medical market and technology report provides a comprehensive discussion of the global market for neurointerventional cerebral aneurysm and AVM embolization systems. This market comprises the following product segments: endovascular coils, liquid embolics, stents for stent-assisted coiling, flow diversion and flow disruption systems, and other novel/emerging embolization devices. Markets covered by this analysis comprise the US, Japan, the five major European markets (France, Germany, Italy, Spain, and the UK), and the rest of world (RoW) markets. The forecast range for this report is 2020–25.
The US Food and Drug Administration is considering how to respond after a contaminant was found in drugs containing, ranitidine, the active ingredient in Sanofi’s Zantac OTC heartburn remedy and multiple generic equivalents. HBW also looks at similar investigations in Europe
Burt’s Bees is making another foray into the toothpaste category with a line for adults and children and a strategic licensing partnership with Procter & Gamble, makers of Crest. Discover the details of this third attempt to successfully enter the oral care space by the Clorox-owned Burt’s Bees.
At the October FDA panel discussion at the Biopharma Congress, CDER deputy director for clinical science reiterated his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims. Pink Sheet looks deeper at his words.
ZS’ Brian Chapman’s five predictions for medtech in 2019 sound generally positive. Find out about what makes him optimistic–such as the use of real-world evidence to drive reimbursement discussions. Gain insights into why he’s concerned about the impact of geopolitical uncertainty.
While the drug industry and patient advocacy groups have worried about price controls or reimbursement restrictions for drugs that treat orphan diseases, a review of formulary data shows that patient access to high-priced drugs has not been severely hampered despite some payer pushback.
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