Senior medical affairs officials sat down at a roundtable discussion facilitated by the Boston Consulting Group to discuss the role of medical affairs along the pharma value chain. Take a look at the outcome of this discussion and explore the role and challenges of medical affairs in pharma.
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.
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.
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.
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.
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.
The use of modern-day gene therapies has moved from concept into reality, with the expansion of the pipeline and the launch of CAR-T therapies, and others, to market. Find out how the industry is responding to these changes and examine the strategies some companies have adopted to deal with related manufacturing issues.
Major deal news, exciting new scientific developments, and an atmosphere of bold enthusiasm masked concerns over US drug pricing and political worries at the 2019 J.P. Morgan Healthcare Conference in San Francisco. Scrip was there to report on what was discussed – and what wasn’t – at the largest pharma-industry business meeting of the year.
A working group appointed by US FDA Commissioner Scott Gottlieb convened to study the FDA’s capacity to handle the supplement sector and the potential need for Congress to legislate improvements to the agency’s oversight powers in the supplement space.
In this interview, John Baldoni describes GlaxoSmithKline’s artificial intelligence efforts. Baldoni, who leads GSK’s AI initiative, discusses the company’s machine-driven discovery and development methods and how they can cut time and costs. Gain insights into the AI team’s timeline and what it has accomplished already. Discover who GSK’s AI partners are–and why such deals are “tricky.”
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.
Reckitt Benckiser has invested in ‘doctor in your pocket’ app Your.MD in response to consumers’ increasing demand for “personal, always-on mobile and data-driven” digital healthcare – that according to Aditya Sehgal, RB Health’s chief operating officer. The app’s AI-powered symptom checker claims to diagnose with high accuracy a range of medical conditions. For its part, Your.MD believes the tie-up with RB will be a game-changer for the firm. Will the new infusion of capital fulfill the goal of Your.MD to put a doctor in the pocket of every citizen in the world?
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.
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.
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
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.
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.
The cardiovascular risks associated with a higher-than-approved dose of Pfizer’s JAK inhibitor Xeljanz in a long-term rheumatoid arthritis study have raised questions about its other indications. Will the risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis trigger a label change in the drug’s other indications? Is the JAK-inhibitor class of therapies in jeopardy? Learn what the analysts are saying.
There is new leadership at UroGen Pharma, Ltd., as Novartis AG Oncology’s former Oncology CEO takes the helm. Scrip sat down to talk to Liz Barrett about her plans as CEO of UroGen, including assuming the tasks of ushering the company’s lead asset through the FDA approval and launch processes.
Preventing cyberattacks on medical technology occupies the waking thoughts of device software manufacturers, but the global ransomware episode in mid-May shows that companies must also be alive to threat posed to their provider customers.
“Almost everyone at Deciem has been involved in a major criminal activity.” So claimed Deciem Inc. founder Brandon Truaxe on an October 8 Instagram post in which he also announced the controversial Estee Lauder Companies-backed startup would be ceasing operations “until further notice.” Find out more here.
EU notified bodies associations are sounding the alarm that delays in designation could result in a host of problems in making medical devices available. They warn that designation delays represent the largest hurdle in keeping products on the market after the Medicines Device Regulation (MDR)’s May 2020 deadline.
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.
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.
What’s the ultimate task of an R&D organization? Industry veteran Tadataka Yamada shares his insights, offering a big-picture take on the state of the pharma R&D enterprise. Discover which areas most excite–and concern–him, and learn why “de-risking” the pipeline is harder than ever.
Swissmedic, Switzerland’s medicines authority, recently completed a full review of Switzerland’s classification system for medicines, deeming 500 OTCs previously available only in pharmacies now suitable for marketing in drugstores, as well. Read more about this sweeping change and how it is affecting hundreds of OTC medicines in Switzerland.
ZS’ Brian Chapman’s five predictions for medtech in 2019 sound generally positive. Find out about what makes him optimistic–such as the use of real-world evidence to drive reimbursement discussions. Gain insights into why he’s concerned about the impact of geopolitical uncertainty.
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.
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.
The US FDA Office of New Drugs is adopting a new, flatter structure under the leadership of Peter Stein, who issued remarks on the matter at Biopharma Conference IV. He used the platform to explain some of the changes to come, and offered advice for cutting down on inconsistencies in information issued from the agency to reviewers.
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