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.
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.
This technology report provides an overview of the current landscape for digital health devices and software. This includes a summary of regulation and reimbursement policies and highlights of major product categories.
The 39th annual J.P. Morgan Healthcare Conference (JPM) was held virtually from January 11-14, 2021. A list of events and catalysts that were announced or updated at the conference are included in this report. Below are some key points from company presentations.
Rgenix, founded by three brothers who are prominent physician researchers, sees itself at the forefront of cancer treatment. They are finding drugs that shut off metastasis rather than the more common goal of using the immune system to destroy cancer receptors.
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.
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.
Three bills that would cover eye, dental and hearing examination for US Medicare beneficiaries were passed by the US House Ways and Means Committee on 22 October and there is a similar bill in the Senate. Medtech Insight looks at the next steps for these House bills and the related Senate bill.
To help companies respond and adapt the processes they may have in place as rapid EU regulatory activity continues, Medtech Insight summarizes the six documents that have recently appeared on the European Commission’s medtech website.
The delivery of drugs via medical devices being commonplace and introduction of new EU rules for these products via the MDR has the pharma industry dismayed at the uncertainty ahead and searching for notified body capacity. Medtech Insight look at the ongoing uncertainty and the state of Europe’s healthcare regulations.
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.
At the 2019 congress in Barcelona from 27 September to 1 October, the European Society for Medical Oncology (ESMO) proved once again it is a match for ASCO. Scrip shares the main points of the event including Seattle Genetics victory for mid-caps.
With the Singh brothers of Ranbaxy being arrested over allegations of financial fraud, Scrip looks at the history of issues at the company and how things appear headed even further downhill with Daiichi Sankyo also separately pursuing enforcement of damages against the brothers.
Hal Barron, Chief scientific officer at GSK recently spoke about winning the hearts and minds of 10,000 R&D employees and adopting practices from acquired company, Tesaro. Scrip covers the talk topics including how doubters are coming around amid recent successful approvals
Less than one month into his new job, Sanofi CEO Paul Hudson shared his perspective on how he plans to build on Sanofi’s strengths and deliver needed changes. Scrip shares details about Sanofi’s leadership history and Hudson’s early priorities at the helm.
Speaking with Scrip recently, Amarin CEO, John Thero talked about the upcoming US advisory committee meeting for Vascepa and commercial expansion plans and deflected questions about a big pharma buyout. What he did say was that, “We’re planning for success.
The Safe Cosmetics and Personal Care Products Act reintroduced to the US House of Representatives calls for greater duties and resource demands on companies and the FDA than the proposed Personal Care Act in the Senate and allows room for states to impose more stringent regulations.
Alcohol-related hangovers are genuine illnesses according to a recent ruling by a high-level German court. HBW looks at the case against a German wellness manufacturer for health claims made for its “anti-hangover” supplements and how deeming hangover’s a disease affects the outcome of the case.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee advises ibuprofen manufacturers to add warnings on patient information leaflets concerning acute generalized exanthematous pustulosis associated with use of the drug. HBW provides details about the skin reaction being noted and the informational changes required.
Skin-firming and anti-wrinkle claims on products marketed as cosmetics are being tested in California federal course. The results will have considerable implications on the health, beauty and wellness industry. HBW looks at similarities and differences of the two cases.
The US Food and Drug Administration says reports of high levels of N-nitrosodimethylamine in the histamine-2 blocker ranitidine resulted from a third-party laboratory’s use of the incorrect test for the drug treatment. HBW covers the recommended testing method.
Hal Barron, Chief scientific officer at GSK recently spoke about winning the hearts and minds of 10,000 R&D employees and adopting practices from acquired company, Tesaro. In Vivo covers the talk topics including how doubters are coming around amid recent successful approvals
According to a recent Bain & Company survey, while nearly 80% of health care executives said they needed to be more agile, more than half said they were not familiar with formal agile methodologies and tools and were not using them in their companies.
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.
MorphoSys, out of Munich, is one of a handful of mature European biotech companies appearing ready for greatness. In Vivo spoke with the CEO about the firm’s next generation antibody platform and why US expansion is crucial to its future.
Novartis is developing a new type of immunosuppressive agent, an anti-CD40 monoclonal antibody, which might allow organ transplants to last longer in recipients, reduce pressure on transplant waiting lists, and improve long-term outcomes. In Vivo interviewed Novartis’ Head of Immunology, Hepatology and Dermatology.
A Shanghai testing laboratory has been handed an FDA warning letter for refusing a GMP inspection but told the agency it rightfully did so. Pink Sheet shares the exact working of the FDA letter as well as the highly unusual response from the laboratory.
The detection of cancer-causing impurities in drugs with well-established safety profiles may call for regulators across the globe to revise their approach for evaluating quality. Pink Sheet looks at whether or not companies seem to know their own products.
A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be deemed BLAs in six months as the FDA is addressing the transition of authorized generic insulins to regulation under the PHS act.
Higher than expected staff losses at the European Medicines Agency due to the relocations to Amsterdam are posing challenges to implement new EU legislation. While the planned move to a permanent HQ in the Dutch capital has led to a decrease in staff, the agency is having to further prioritize its business activities.
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.
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.
AveXis co-founder and CSO Brian Kaspar and his brother are no longer with Novartis, the Swiss manufacturer who acquired AveXis and its Zolgensma drug in 2018. After disclosing data manipulation to the FDA earlier this year about Zolgensma filings, Novartis announced two employees would exit the company.
Oncolytic virus company Theolytics has emerged ready to raise a series A round and get its preclinical assets into human trials by 2021. CEO Charlotte Casebourne talks to In Vivo about the challenge of standing out from the crowd in oncology, how viruses have evolved as a treatment approach in cancer, and how oncolytic viruses might be the answer to the cancer drug pricing conundrum. Learn what this young CEO (at age 26) has to say about the skills required to be a biotech CEO today, the concerning issue of access to novel personalized cancer treatments, and the biggest challenges she sees in cancer drug development today.
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.
The FDA is investigating data manipulation issues associated with Novartis’s filing for their type 1 spinal muscular atrophy drug, Zolgensma. This Scrip story looks at the claims, background on the issue, and the Swiss manufacturer’s recent response.
A relatively small number of costly drugs account for a sizable portion of pharma industry revenues. This informative and easily scannable Scrip infographic shows which drugs are the golden eggs, which companies are behind them, and how the landscape has changed in the past decade.
China has the potential to be the world’s largest market for rare disease treatments but may need to develop their own gene therapies as imported products will be too costly. Read about a father’s journey to find a gene therapy to treat his young son’s rare condition.
With a population of 1.3 billion and a large patient pool with rare genetic conditions, China has the potential to be the world’s largest market for rare disease treatments. It is believed, however, that China will need to develop its own gene therapies, given that such imported products will be simply too costly for what is a largely self-pay market. Read about one very determined Chinese father’s journey on two continents to find a research provider with the particular expertise to find a new gene therapy to treat his young son’s very rare condition.
The gene therapy Zolgensma will remain on the market, but Novartis and subsidiary AveXis Inc. may face civil or criminal action after revelations by the FDA that data used for approval had been manipulated. In fact, the drug giant knew about the problem months before Zolgensma was approved and said nothing. Learn what happened, why the FDA still asserts confidence in its approval of Zolgensma, and what these events could mean to Novartis and the gene therapy industry moving forward.
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”.
With Europe’s biggest cancer congress ESMO attracting large and small companies to present the latest data readouts across a broad range of tumor types, Scrip looked at the key players and the five key battlegrounds at stake.
Pink Sheet spoke with Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, who says, “an ongoing and wide-ranging discussion is needed about assessment, payment and reimbursement of innovative products, as well as the evidence that supports them.”
After much speculation and urges of caution related to whether the European Commission would support a proposal to expand the range of products covered by the Medical Device Regulation’s four-year grace period, the European Commission has now said it will support it.
Novartis AG tried to squash any murmurings that it had a disreputable intent in not disclosing the data fraud it knew about before approval of its gene therapy Zolgensma, saying the company wanted a full understanding of the issue first before bringing it to the attention of regulators. In a recent conference call with analysts, Novartis execs were bombarded with questions about their “prescribed process” of internal investigation, and when exactly they knew about the fraud. Find out how the pharma giant is handling such close scrutiny, how they are dealing with the AveXis scientists involved in the “data inaccuracies,” and the recent EMA decision to downgrade Zolgensma’s accelerated assessment.
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