Time to change sunscreen? Only two of 16 current sunscreen ingredients have been “generally recognized as safe and effective” (GRASE) in the FDA’s proposed final sunscreen monograph–zinc oxide and titanium dioxide. Learn which popular form of sunscreen has been singled out for additional testing and whether sunscreen powders are viable. Read what industry leaders and environmental groups have to say about the FDA’s approach.
The International Consortium of Investigative Journalists (ICIJ) unveiled their International Medical Devices Database (IMDD) with the aim of alerting consumers to possibly dangerous and under-regulated medical devices, but some argue that the database could confuse laypeople who attempt to use it.
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.
Don’t dismiss cosmetics reform efforts underway in Washington, former FDA official John Bailey warned an Independent Cosmetic Manufacturers and Distributors workshop. At the same gathering, Linda Katz, director of FDA’s Office of Cosmetics and Colors, hinted broadly at what’s ahead. Find out what she had to say and gain insights into what’s expected to be the first major regulatory/legislative overhaul in decades
UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit, according to guidance issued in February.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.
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.
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.
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.
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.
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.
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.
Will drug rebates become illegal? U.S. FDA Commissioner Scott Gottlieb has suggested as much, and PBMs, among others, are paying close attention. Explore the implications–especially for PBMs–and find out why this is historically such a hot-button policy issue.
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.
AbbieVie’s Q3 earnings call was a chance for analysts and investors to ask tough questions about the worse-than-projected impact of the first adalimumab (Humira) biosimilars to hit the European markets. Executives remained optimistic for the future of the blockbuster drug and the financial well-being of the company.
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.
In Vivo examines efforts by Accenture Life Sciences to survey medtech CEOs on their digital preparedness as leaders look to build new revenue streams from innovative business models by effectively managing data. Discover what trends they uncovered in this illuminating article from In Vivo.
On September 28, 2018, the US FDA issued new draft guidelines for adaptive clinical trial designs, as well as additional guidance updates. Tap into these important updates, which replace draft guidance issued by the agency in 2010.
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.
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.
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.
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.
The recent shakeup at Bayer AG took some observers by surprise, but was heralded by most as a much-needed measure to maintain the German giant’s viability. Find out how this restructuring will play out, and what top analysts make of the move to streamline the organization.
Commercial payers in Massachusetts and AveXis may soon pilot an annuity payment model for Zolgensma. This would spread out insurance payments for the high-cost treatment over years to reduce the burden on payers. The pilot will likely involve a performance component. Learn who the players are and what they stand to gain–and what they risk. Find out how the annuity model would work in practice.
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.
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.
The tone of the 2018 ASCO annual meeting was one of regrouping, resolve, and refinement that may have left investors apathetic, but signaled a commitment to getting it right going forward to those in pharma. Examine the key takeaways from ASCO 2018.
Bayer AG is seeking to turn around its troubled Consumer Health division through implementing key portfolio changes and embracing growth-focused innovation, according to Heiko Schipper, President of Consumer Health. Find out what’s in store for Bayer AG’s Consumer Health group, straight from its top leadership.
Tap into Bayer AG’s plans to establish itself as a global innovator, particularly with their oncology, cardiovascular, and women’s health franchises. In this exclusive interview, In Vivo talks strategy with Dr. Carsten Brunn, Bayer’s Head of Pharmaceuticals, Americas Region.
The digitalization of health care has been much talked about over the last decade or so. But activity among the medical device manufacturers and service providers has only just recently accelerated as they start overcoming barriers and resistance to this new way of delivering health care.
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.
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.
Biogen’s chief medical officer says iPhone technology should in future be used for early warning diagnosis of Alzheimer’s Disease. Biogen CMO Alfred Sandrock has told a London neuroscience forum that constraints impeding CNS drug development include the fact diagnosis needs to be done earlier but that barrier could be mitigated in future by digital health solutions such iPhones used as “early warning” diagnostics, notably in Alzheimer’s Disease.
Expect more industry consolidation, counsels Morningstar’s Healthcare Observer report. Among the potential deals: BioMarin is a logical acquisition target. But for whom? Find out what Morningstar’s Damien Conover predicts. Discover which companies could be targets for Pfizer, and learn what Conover thinks of Pfizer CEO Albert Bourla’s insistence that it plans to grow organically.
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.
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.
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.
As Brexit looms and a no-deal scenario becomes increasingly a possibility, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated their guidance on how to respond should no deal with Europe be reached. What does it mean for Medtech? Find out here.
Pink Sheet brings you a look at the effects of the Bristol-Celgene merger on the public and political perceptions of the companies, with an examination of how pricing for Revlimid has affected Celgene’s public image and stock pricing.
With the details of Brexit as yet unresolved, UK standards and certification body BSI has successfully achieved a notified body designation in the Netherlands, securing a more stable future by allowing certificate holders to migrate UK conformity assessment certificates from the UK to the Netherlands if they wish.
UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit in March. Learn what this move would have meant to UK start-ups. Read the MHRA response to a Medtech Insight inquiry about the role of UK notified bodies after Brexit.
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.
Global regulators are looking to converge–or at least align–various requirements, and the US FDA is no exception. Officials have strongly suggested that the agency will replace its Quality System Regulation with ISO 13485. It won’t be simple. Discover the implications for device makers, and find out what’s involved in making this dramatic change.
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.
Go behind the scenes for the details on Genetech’s proposed “Combination Pricing Pilot” plan, which offers a discount for Avastin and Tecentriq when the two drugs are used in conjunction to treat patients with lung cancer. Pink Sheet brings you the details about the proposal, which ties into the company’s Medicare Part B interests.
As the number of cancer survivors increases, they are reshaping cancer research and clinical practice. Find out how–and discover the impact it will have on the allocation of research dollars. Learn how the looming physician shortage has implications for the emergence and increasing use of complex immunotherapy drugs.
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