As ROI across R&D investments in big phama declines, companies look for new and innovative ways to access and nurture innovation via partnerships and through the use of new data types. In the process, the business models, products, and role of big pharma in healthcare is changing.
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.
In considering pricing models for the increasingly important area of gene therapy, what are the options facing biopharma? This article from In Vivo explores the question of how to pay for gene therapy in a way that’s sustainable to developers of these potentially curative therapies, while ensuring patient access.
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.
The assessment of cosmetic preservative safety continues to be complex and fraught with controversy, as some in the industry look to the Cosmetic Ingredient Review (CIR) program to set the record straight about the use of certain cosmetic preservative ingredients.
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.
What’s the meaning of “hypoallergenic”? Judges in the federal court Northern District have disagreed, with a judge recently siding with Johnson & Johnson’s definition of the term as part of an ongoing lawsuit. Find out more about the suit and its implications for your business in this article from Rose Sheet.
It’s payback time for Unilever, as the maker of Schmidt’s deodorants must re-label its products, removing reference to certain wetness-absorption claims. In 2016, Unilever was responsible for making close competitor Colgate’s Tom’s of Maine remove similar claims to their deodorant products at a self-regulatory forum.
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.
A no-deal Brexit would dramatically affect regulatory alignment and trade, but it’s far from the only regulatory concern in the medtech industry. Learn about the various challenges, including GDPR and the uncertainty around the new Medical Device and IVD Regulations.
The EU’s piecemeal approach to transparency makes compliance harder, but this expert advice can smooth the path forward. Learn about implications of these”sunshine”rules in the EU and U.S., how they differ,and what the EU can learn from the U.S.
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.
How do you compete with rheumatoid arthritis giants Humira and Xeljanz? Eli Lily & Co. is betting that pricing their janus kinase (JAK) inhibitor, Olumiant at 50% and 60% less, respectively, may just do the trick. Find out more about Lily’s gambit, even as Olumiant failed to gain FDA approval for a 4mg dose.
Novartis Oncology CEO and newcomer to the company, Liz Bennett, sat down with Scrip ad talked about her plans for an organization currently in transition, and her strategy for moving new blockbusters forward. Access her insights into the future of Novartis Oncology in this illuminating interview.
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.
Although their patent protection has expired, big-name blockbusters continue to produce huge revenues for the pharmaceutical companies that produce them. Take a look at how some well-known drugs may no longer be making headlines, but continue to be big earners.
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.
The 2018 Nobel Prize for Chemistry was recently jointly awarded to George Winter and two other scientists for their pioneering work in the directed evolution of antibodies, research which led to the development of Humira, the world’s most successful drug.
Capture the key takeaways from Novartis’ third quarter call in this illuminating article from Scrip. Eight Things To Know From Novartis’ Third Quarter Call brings you the most important developments from the third quarter earnings call that occurred on October 18. Gain insight into the progress on new launches, regulatory developments, and more.
Despite a recent decision not to commercialize their version of Sanofi’s Lantus (insulin glargine), Merk & Co. Inc. says they remain committed to oncology and immunology biosimilars. The decision to withhold their insulin glargine biosimilar (known as Lusduna) from the US market comes even as the copy already received tentative approval by the US FDA in 2017.
At the annual Alliance for Regenerative Medicine’s Cell and Gene Meeting on the Mesa in San Diego, the struggles of setting pricing and reimbursement for these new, one-time treatments, and the opportunities to influence how these new treatments are paid, were a recurring theme.
Tap into the state of Takeda’s R&D strategy and how it might change in the wake of their Shire acquisition, due to take place in 2019 to the tune of $62.4b. Find out more about Takeda’s new rare diseases therapeutic areas unit, their partnering efforts to build out the pipeline, near term highlights, progress in penetrating Chinese markets, and more.
The European Commission has finally released some long-awaited and eagerly anticipated deadlines for Medical Device Regulations and In Vitro Device Regulations implementation measures. The deadlines shed light on progress made by the EU Commission in this area, as application dates for regulations are quickly approaching.
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.
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 Centers for Medicare and Medicaid Services (CMS) say they are seeking to improve medical devices reimbursement procedures as the device industry looks for a policy to help breakthrough devices receive temporary and automatic Medicare and Medicaid coverage. Read more here.
Medtech Insight’s Compliance Corner is back for the final installment of the three-part series on Investigator Horror Stories. Tap into the recollections of top industry insiders for a jaw-dropping look at some of the more outrageous tales from the world of compliance.
Explore the findings of an October 2018 panel discussion of market analysts and market access specialists as they discuss the question: As new cures and treatments for patients develop, how does the conversation shift from delivering market access to products to focusing on patient access to progress?
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.
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.
Sign up to the Pharma Intelligence Report Store Newsletter to get the latest blogs, news, reports and discounts!