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.
In the wake of new CEO Vas Narasimhan, and like several of its peers in the industry, Novartis AG recently announced it was paring back their pipeline, from 430 products to 340. Find out which products got the axe and what the focus of the company will be in the months and years to come in this illuminating article from Scrip.
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.
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.
Examine the 30-year friendship that built Regeneron in In Vivo’s interview with company leaders Len Schleifer and George Yancopoulos. The two reflect back on the company’s beginnings and take a look at what’s in store for the future in this insightful – and often funny – interview.
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.
Higher than expected staff losses at the European Medicines Agency due to the relocations to Amsterdam are posing challenges to implement new EU legislation. While the planned move to a permanent HQ in the Dutch capital has led to a decrease in staff, the agency is having to further prioritize its business activities.
Other big names may be withdrawing from neuroscience R&D, but Biogen has seen opportunity in the area, choosing to go in big, filling the space left by the recent GlaxoSmithKline PLC, Pfizer Inc., AstraZeneca PLC, Novartis AG, and Sanofi neuroscience exodus.
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.
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.
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.
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
Less than one month into his new job, Sanofi CEO Paul Hudson shared his perspective on how he plans to build on Sanofi’s strengths and deliver needed changes. Scrip shares details about Sanofi’s leadership history and Hudson’s early priorities at the helm.
In January 2015, Fortune reported that at $2.9tn, the state of the US healthcare industry is very strong and continues to grow.
Bristol-Myers Squibb’s acquisition of Celgene wasn’t the only big news in January. Read this brief for a comprehensive review of announcements from diagnostic, device and biopharma companies. Gain insights into both business and clinical developments, and get a peek into the in vitro diagnostics, medical devices and pharmaceuticals pipelines.
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