Novartis AG’s involvement–however tangential–in the Donald Trump/Michael Cohen/Stormy Daniels scandal is just the latest incident to tarnish the pharmaceutical industry’s public image. Explore how negative public perception could accelerate the move to price controls–and why it’s an industry-wide problem.
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.
As gene therapy becomes an increasingly prominent area of interest, players are formulating new strategies to enter the marketplace. In Vivo speaks with GE Healthcare’s General Manager of Cell and Gene Therapy for an inside look at the company’s plans to expand into this area.
Tap into the findings of the latest Regulatory Affairs Professionals Society Overall Compensation & Scope of Practice Survey, a comprehensive study of the salaries, hiring trends, and other noteworthy data for regulatory professionals in 64 countries around the globe.
Paul Peter Tak, formerly of GlaxoSmithKline, is “following the science.” He’s joined Flagship Pioneering as a venture partner and is already CEO of an “undisclosed biotech start-up operating in stealth mode.” Learn more about Flagship’s approach–creating think tanks to build companies from scratch around important unmet challenges–and why Tak finds that so appealing.
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.
What will be the biggest trends in biopharma during 2019? In Vivo brings you the predictions of various industry experts, who weigh in on their predictions for what 2019 may hold for R&D, market access, digital and AI, and the organizations and people who play a key role in the industry.
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.
Wearable technologies have the potential to transform medicine and the delivery of healthcare more significantly than any other component of the digital revolution – or indeed than many other scientific advances.
FDA draft guidance on combination products provides some insights, but its seven-page annex provides details on regulatory considerations for adding a drug coating to an existing device. For five common drug-coated-device scenarios, learn whether you can rely on a 510(k) submission. Discover what other related guidance is in the works.
What’s in store for chronic disease management in the future? Tap into this informal discussion with health entrepreneur Julia Hu, founder of Lark Health, for a look at her views of what’s to come, including the use of artificial intelligence nursing.
Verseon’s computational drug-discovery platform designs candidates that probably wouldn’t be found with conventional methods, according to CEO Adityo Prakash. Discover why he believes Verseon’s approach is paving the way for next-level drug discovery. Gain insights into his refusal to license Verseon’s technology and learn about the company’s blockchain-based subsidiary, BlockRules.
A recent letter to Vanda from the US FDA regarding the firm’s listing of indications without corresponding safety information on the company’s website left Vanda’s CEO confounded as to the reasoning behind this action, even as the firm moved to take corrective action.
Sanofi plans to continue distributing Zantac OTC heartburn remedy in the US while conducting its own tests to determine whether levels of N-nitrosodimethylamine (NDMA) in the active ingredient are above safe levels, Novartis AG, which licenses OTC Zantac, has said it stopped distribution worldwide.
The U.S. FDA’s reorganization of its Office of New Drugs (OND) faces leadership challenges, thanks to recent departures. How will the FDA staff these new divisions? Learn more about the departures, gain insights into the agency’s options, and explore the implications for the industry.
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.
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.
Find out the circumstances surrounding the unexpected positive results that the January 2019 US government shutdown (including the shutdown of US FDA) had on a breakthrough allergy immunotherapy in this thoughtful analysis from the industry experts at Pink Sheet.
The FDA’s early release of inspection findings of a testing lab’s possible involvement in data falsification in the testing (and subsequent FDA approval) of Zolgensma is unusual, signaling the likelihood that Novartis will face tough scrutiny of its actions – and perhaps stiff fines because of the fraud. Learn why one analyst is alluding to the possibility of a government investigation on the call Novartis held for the investment community, and why he’s calling for corporate officers to be held liable for statue violations, regardless of whether they knew of any wrongdoing.
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.
Commissioner Scott Gottlieb announced that exclusivity for certain existing protein products will not be extended further, in remarks made at the FDA/CMS Summit. The announcement affects existing products, including insulin and human growth hormone, that, under the Public Health Service Act, are “deemed to be licensed” in 2020.
As Democrats gained a majority in the House after the 2018 US midterm elections, many wonder who will be on their radar when they turn their attention to holding hearings on drug pricing. The answer? It’s not likely to be the FDA.
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 FDA plans to “harmonize domestic and international requirements, and modernize the regulation” through a new rule that will blend its Quality System Regulation (QSR) with ISO 13485. Will FDA will swap out the QSR with ISO 13485? Probably not. Find out what it will likely do instead–and when it will do it.
“Junk science” is being blamed for a lawsuit filed against Unilever for alleged “micro-tears” caused by their St. Ives Apricot Scrub. The suit, first filed in 2016, may be coming to the end of the road, as Unilever requests a summary judgement in the matter.
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.
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.
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.
Names have not been made public, but two frontrunners have been chosen as contenders for notified bodies under the European Union’s new Medical Device Regulation. Find out who the frontrunners could be, and how timing is playing a critical role in this crucial announcement.
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.
The Trump Administration’s “Blueprint to Lower Prices and Reduce Out-of-Pocket Costs” includes dramatic changes to protected classes, rebates and PBM reimbursement. Discover why the blueprint has industry leaders worried. Explore the implications for biopharmas and PBMs in particular and the healthcare industry in general.
Ongoing pressures on drug pricing and reimbursement mean that current research and development (R&D) economics are unsustainable. The process of discovering and developing a drug has not fundamentally changed for decades, and on average it still costs $2.6bn and takes over 10 years. Fortunately, tools are emerging to help improve R&D success rates. Most are built on better use of more kinds of data, including using artificial intelligence (AI) to process massive quantities of information that humans cannot manage. Some of these new tools promise cost and time savings of between 20–50%
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.
Find out which stories captured the attention of In Vivo readers last year, with In Vivo’s annual list of most-read articles. This top-ten list offers a glimpse into the issues, events, and trends that mattered most to In Vivo readers in 2018.
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.
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.
Learn about the voluntary U.S. FDA pilot program that uses Capability Maturity Model Integration (CMMI) from quality,compliance and regulatory officials at three major device firms. Walk through the CMMI process,and discover why it’s nothing like a typical regulatory audit.
In Vivo interviews Eva Marchese, VP at consulting group Charles River Associates, for insights into the challenges facing the PD-1/LD1 European market’s reimbursement and access schemes for IO products. Gain insights into the sustainability obstacles for immuno-oncology products in this vital interview.
As the pharmaceuticals industry gets its issues with data integrity under control, a new challenge has arisen, according to US FDA comments at a recent meeting of the International Society for Pharmaceutical Engineering. Find out how these out-of-specification investigation (OOS) issues are playing out, with expert reporting from Pink Sheet.
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.
The Intersection Between Tech and Pharma Special Report (Part 3. Intel, Samsung, IBM, and GE)
In January 2015, Fortune reported that at $2.9tn, the state of the US healthcare industry is very strong and continues to grow. Additionally, a Top Issues report revealed that 40% of Fortune 50 companies pursued new healthcare partnerships in 2014. Given the rapid change in the healthcare industry over the last few years, it is no surprise that we are starting to see more non-traditional healthcare partnerships, specifically with big tech companies.
In the wake of scathing investigative reports from over 250 journalists from the International Consortium of Investigative Journalists (ICIJ) regarding the safety and oversight of implanted medical devices, this article examines the situation from a uniquely EU perspective.
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.
Immuno-oncology: spurred by the approval of first-generation checkpoint inhibitors in 2014, this important market has continued to grow exponentially, as deals are made not only around checkpoint inhibitors themselves, but also for related molecules and technologies to be used in synergy with them. Examine the origins of this important and growing area in this essential In Vivo report.
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