Nando has registered two new EU notified bodies as of August 2019, though the European Commission has said four notified bodies have been designated. Nando’s tardiness in updating their databases is affecting companies that need their medical products tested, especially given the huge volume of products compared to the number of notified bodies available.
Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, recently told Scrip, “an ongoing and wide-ranging discussion is needed about assessment, payment and reimbursement of innovative products, as well as the evidence that supports them.”
AstraZeneca’s Farxiga (dapagliflozin) appears set to become new standard or care in the treatment of hear failure based on results of the DAPA-HF Phase III trial present at the European Society of Cardiology Congress on 1 September. Scrip looks at Farxiga and its nearest competitors.
While a 30-day supply of the first oral GLP-1 agonist will cost $772.43, similar to the injectable version, this is still steeper than oral diabetes medicines and Scrip looks at how deep discounts may be needed to secure market access.
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? Scrip talks to one CEO who knows.
A US Food and Drug Administration initiative to standardize safety assessments of new drug and biologic applications could mean changes in how sponsors classify clinical trial adverse events and the types of information companies routinely submit to the agency.
The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program. Pink Sheet covers how the FDA will focus on applicants that are expected to have a major impact on the standard of care.
At a meeting of mitochondrial disease drug development, officials of US Food and Drug Administration said that just because a measure is relevant to the patient community does not mean it can capture meaningful change in a clinical trial. Pink Sheet looks at the implications to sponsors.
After more than two years of work, the US Food and Drug Administration is ready to formally begin its reorganization of the Office of New Drugs. Pink Sheet covers how this could cause signatory authority and other changes for sponsors with pending applications.
Consultant Sarah Sorrell offers insights on the EU’s new medtech regulations that have introduced much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. Medtech interviewed her about what the requirements entail and problems with understanding them.
A new Technical Information Report from the Association for the Advancement of Medical Instrumentation aims to help befuddled US device makers that operate under the FDA’s QSR ensure they are compliant with standard from the ISO.
Two medical device manufacturers have been granted the first certificates under the EU’s new regulations that are coming into force next year. Medtech looks at whether this is a sign that the whole sector is going to be able to meet regulations.
The European Commission seems like it will widen the grace period for MDD-approved products to comply with the new Medical Device Regulation (MDR), including Class I medical devices that have never before been reviewed by notified bodies. This extension will allow notified bodies to focus on higher-risk products.
The post-market clinical follow-up requirements for device and diagnostics companies based on the new medtech regulations are complex. They contain vague terms that need clarification for companies to understand how to comply. Expert and consultant Sarah Sorrel provides her interpretation in this interview with Medtech Insight.
With higher standards and new, demanding regulations for EU notified bodies, six notified bodies have been called into question by the European Commission. All are listed with warnings on the Commission’s Nando database. Some of those six offer testing in other medtech directives, and in those other directives, they remain competent.
Acquisitions and licensing are core to pharma and big biotech growth as pipelines thin and assets lose patent protection. Looking back at significantly sized acquisitions over just five years reveals that half of 2014’s acquisitions can already be judged as outright failures or, at best, questionable. But some lessons can be learned from dud deals. This article from In Vivo Examines deal failures, from the most surprising to the most expected, given the level of risk at stake. If past Is prologue, dealmakers would be wise to look back and consider these lessons of the past.
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.
Founder-CEOs do not typically remain at the helm as biotechs mature, as the majority of scientist-founders lack the skills to lead a company beyond discovery and early development. Exceptions to that rule are multiplying, though, especially in Europe as companies aim directly for Nasdaq. In this fascinating read, In Vivo reviews the many, varied paths toward biotech CEO, and what it takes to lead a company to IPO and beyond.
Leading pharmaceutical executives called to testify before a Senate Finance Committee hearing on drug prices were likely the first of many to be summoned. It’s a no-win situation, but preparation can help. Find out why changing the subject can be a smart tactic. Discover how some senators may try to lure execs into inadvertently lying–and learn how to avoid it.
The US FDA intends to make changes to its 501(k) process, and is currently considering a proposal to impose an age limitation on predicate devices as a means of encouraging the use of more modern predicates. Opponents of the plan argue that such a step would do little to achieve the FDAs goals in this area.
Explore the repercussions of two medical device sterilization plant closings in this informative Medtech Insight article. Closed due to environmental and health concerns, the plants’ cessation of operations could mean medical device shortages, while opening the door to new sterilization innovations.
In response to the recent controversial European Commission decision to classify products containing cannabidiol (CBD) as “novel foods”, the Cannabis Trades Association UK has begun legal action to challenge the classification. Read more about the controversy and legal proceedings here.
In Vivo takes a look at the hot-button topic of drug value in this thought-provoking article, which examines the role of ICER (Institute for Clinical and Economic Review) and wonders if a more sophisticated method of assigning value in the US market is necessary.
2019 should be a big year for the generics and biosimilars industries, as a sizable number of blockbuster drugs are losing their market exclusivity. Find out which drugs will see their first generic and biosimilar versions this year and what the repercussions will likely be.
During the first hearing of the Subcommittee on Economic and Consumer Policy, part of the House Committee on Oversight and Reform, US lawmakers focused on the issue of the safety of talc and asbestos in personal care items.
Merck KGaA’s head of global research and development, Luciano Rossetti, sat down with In Vivo to discuss the track the German company is taking toward becoming a major player in global immuno-oncology. Tap in to his insights and opinions in this essential interview.
Several drugs recently lost their Breakthrough Therapy Designations (BTDs), and Pink Sheet has identified others in the pipeline that might suffer the same fate soon. Take a look at the therapies possibly on the chopping block and the reasons behind it in this informative article.
Go behind the scenes with Scrip, as expert analysts examine the machinations of Roche’s acquisition of Spark Therapeutics, Inc. Find out in this informative article how Roche secured the deal in the face of strong competition from three other rival companies.
Scrip sat down with the heads of McKinsey & Company for an informative Q&A about pharma’s efforts to expand and update in the areas of advanced analytics and digitization. Tap into their insights about where the industry is now, and where it may soon be heading.
Find out who the big winners were at the 24th annual OTC Marketing Awards. This article contains highlights from the gala awards evening, as well as a full list of all winners announced at the event, which celebrates the best in the British OTC industry.
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