Amarin’s John Thero says the firm expects a jump in sales for Vascepa from potential label expansion allowing a larger patient groups with lower triglycerides than current label indications. At the same time, he notes competitors fail to show broader cardiovascular risk reduction.
Tap into Pink Sheet’s look back on Scott Gottlieb’s nearly two year tenure as Commissioner of the US FDA. Examine the legacy of his short-lived, yet productive stint, and look back on his list of accomplishments as leader of the agency.
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.
Citing the negative impact on both coral reefs and human health, the citizen-led Center for Biological Diversity has officially petitioned the US FDA to ban the use of oxybenzone and octinoxate, reportedly present in over 3,500 sunscreens on the market today.
UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit, according to guidance issued in February. BBC said the guidance represented a plan “to replace the CE safety symbol on products in the event of a no-deal Brexit.” Is this actually the case? Find out what the UK Association of British HealthTech Industries (ABHI) had to say.
Robert Temple, the FDA’s voice of institutional memory, believes drug regulation has quietly entered a third era: the “Age of Individualization.” Unlike the prior eras of safety and efficacy, there is no milestone legislation to set the ground rules. But, Temple stressed, there have been significant changes in areas like the assessment of drug-drug interactions, metabolic response to therapeutics, and in the FDA’s willingness for sub-population analyses. Is there a change in the air that will result in further change in drug development as it relates to the Age of the Individual?
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.
ECHA’s plan to ban the use of intentionally added microplastics in cosmetics is based on “a whole clutch of errors and misunderstandings,” according to Cosmetics Europe’s Director-General John Chave. Find out why the industry is worried about this ban–and why they consider it unfair. Gain insights into which solutions would satisfy the industry, and learn why biodegradable plastics–which represent a potential win-win for industry and environmental advocates–may not be viable.
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.
The BCMA CAR-T therapies gap between industry leaders Celgene and bluebird bio and their competition in the space is closing, according to data released at the December 2018 American Society of Hematology (ASH) meeting in San Diego.
GlaxoSmithKline PLC and Pfizer Inc. have closed their consumer health joint venture to create the “global leader in OTC products.” Operating under the GSK Consumer Healthcare name, the joint venture – announced in December last year – has around a 7.3% share of the global consumer health market, well ahead of the next competitor, Johnson & Johnson, at 4.1%. Under the leadership of Brian McNamara, the new company has begun to assemble a management team that combines talent from both GSK and Pfizer. Who’s on the dream team, and what’s on the horizon for this new superpower?
As pharma companies increasingly include access to unlicensed medicines as part of their commercialization game plans, new challenges – and opportunities – are born. In this informative article, In Vivo examines both the potential pitfalls and probable triumphs of incorporating unlicensed medicines into commercial strategies.
The second day of the 2019 JP Morgan Healthcare Conference has concluded, and Pink Sheet was there to bring you all of the breaking news, major announcements, and insights from the largest investment healthcare symposium in the world.
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.
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.
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.
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.
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.
The continuous glucose monitoring (CGM) segment of the diabetes management market is exploding, while big names in the blood glucose monitoring (BGM) sector are facing increased competition from lower-cost developers and related innovative diabetes-monitoring products. Examine the competitive landscape for CGM and BGM in this informative Medtech Insight article.
Shortly after US FDA approval of its blood-disorder drug Cablivi, Sanofi announced “a rigorous pipeline prioritization review.” It’s fast-tracking 17 programs and discontinuing 13 development and 25 research projects. What’s left? Will Sanofi divest its animal health and/or consumer healthcare units? Find out what experts are saying.
Device makers often fail to consider what happens once their product is in a patient’s hands, says a seasoned U.S. FDA investigator. She identifies seven common human-factor–usability–problems. Learn what they are so you can enhance compliance and patient safety.
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.
Is a suffix that distinguishes biosimilars and other biologic products necessary in adverse event reporting? The US FDA says yes, although to date, nearly every adverse event report received by the FDA have identified biosimilars simply by their brand names.
At December’s FDA/CMS Summit in Washington, Health and Human Services Secretary Eric Hargan used Pfizer’s recent price hike of 41 of its products as evidence that higher drug costs are a direct result of the rebate system, a viewpoint touted by the Trump administration in their quest to lower drug prices.
In an announcement that came as a surprise to industry experts, Scott Gottlieb announced his resignation as head of the US FDA after only a 22-month tenure. See what his legacy will be, and what his departure means for pilot projects currently in the works.
AHPA called on FDA to regulate kratom as an NDI to avoid a patchwork of state regulations. Kratom, used to manage opioid withdrawal, garnered unwelcome scrutiny after being linked to a salmonella outbreak. Will the FDA treat it like any other dietary ingredient? Find out what may lie ahead for this herbal extract.
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.
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.
AbbeVie is banking on the success of a possible simultaneous European/US launch of Skyrizi, its psoriasis drug, to bolster the company’s declining revenues in Europe. Read about how the company plans to use Skyrizi to bounce back from the genericization of its blockbuster Humira in this informative article.
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.
Will Novartis’ Zolgensma or Biogen’s Spinraza be the standard of care for spinal muscular atrophy? Novartis shared its perspective with Scrip. Find out what Biogen had to say about the competition during an earnings call–and read how Novartis’ Paul Hudson responded. Learn how Novartis plans to handle payments for the expensive therapy. Is it considering outcomes-based payments? Gain insights into the clinical benefits of both medications and learn what’s next.
What’s the secret to successfully transforming research and development innovation into drug launches? Taking risks, but doing so in a focused, smarter way, say the heads of Britain’s two largest pharma companies. Read more about the secrets to their success here.
At Roche’s on-site investors briefing at ASCO in 2018, company execs unveiled the oncology leader’s strategy for staying ahead in the market: heavy investment in digital and personalized healthcare. Read more about the company’s plans in this illuminating article from Scrip.
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.
> Reckitt Reaps ROI Reward In Geo-Targeted Symptoms App Promoting Mucinex, Delsym > Biogen CMO Notes iPhone’s Potential For Early Detection of Alzheimer’s > Interview: Philips Plugs Into Patient Connectivity
GlaxoSmithKline PLC and Pfizer Inc. agreed to an all-equity deal that sees the two pharma giants teaming up for a consumer healthcare product joint venture. Explore the ins and outs of the deal, and how it positions both GSK and Pfizer, as each are looking to raise investor confidence.
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.
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 wheels are turning for Takeda’s huge acquisition of Shire, assuming the European Commission’s approval on antitrust concerns, and the approval of the respective companies’ stakeholders. The $62.4b deal is the biggest overseas M&A deal in Japanese history, and brings with it speculation of future divestments by Takeda.
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.
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.
The FDA recently approved its first-ever approval of a drug that contains a marijuana derivative, but the agency says that it will only focus its enforcement policy of similar dietary ingredients on products marketed with drug or disease claims. Find out more about this complex issue here.
Find out how the International Organization for Standarization (ISO) has changed its benefit-risk language in the wake of shifting attitudes towards flawed devices which nonetheless do deliver health benefits. Medtech Insight spoke with Jos Van Vroonhoven, who convened the joint working group that revised the standard, for an inside look at what has changed.
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.
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.
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