Key Highlights BIIB-037 Amyloid beta PET data show positive Abeta reduction; cognitive results are not interpretable with such small numbers. (BIIB) BIIB-037 Phase Ib result interpretation may be effected by the ApoE4 dropouts in the treatment arm. (BIIB) MK-8931 and BIIB-037 show sufficient target engagement, but there is no evidence to date that amyloid clearance […]
With the approval of the first CAR-T therapies – Novartis’ Kymriah and Gilead/Kite’s Yescarta – what had been the promise of cutting-edge science is now reality.
Patient centricity is the buzzword of this decade, and necessarily so: it either underpins, or is an inevitable result of, all the forces shaping today’s rapidly evolving healthcare landscape.
Pharmaceutical companies constantly re-assess their pipelines and portfolios to determine the best strategies for their business.
Over the nine-year period from 2006 to 2014, the Big Pharma, Mid Pharma, and Japan Pharma peer sets collectively spent an annual average of $94bn on R&D of pharmaceuticals, with spending growing at a compound annual growth rate (CAGR) of 6%.
Datamonitor Healthcare has carried out a comprehensive analysis of gene therapy products in commercial development worldwide based on information derived from Pharmaprojects.
Precision medicine is typically associated with the use of therapies that target particular disease-linked genetic mutations, identified via a diagnostic test.
We set out to examine the extent to which order of market entry influences the prospects of achieving a satisfactory return on investment for companies developing branded generic and generic inhaled products.
Biosimilars are expected to drive significant cost savings for healthcare systems, yet there are many considerations that will affect the success of biosimilars, ranging from clinical development, regulatory approval, and ongoing legal disputes around patents. In the US, this is still a seminal period, and for that reason the potential effects of biosimilars in terms of levels of competition are still too early to gauge. Still, European experience with biosimilars may give an indication as to how market dynamics will play out and the degree to which biosimilar sponsors may discount their biosimilars in the US.
Data plays a key role in healthcare systems’ shifts towards value-focused outcomes. Such data includes outcomes and cost data, adherence data, and increasingly, patient-reported data, behavioral and social media data.
Recent years have seen changes in the marketplace that have made successful new drug launches difficult to achieve. Many therapy areas are becoming hypercompetitive, with similar treatments jostling for position, and even those products with evidence of superior efficacy or better tolerability still have to overcome reimbursement hurdles.
Between 2012 and 2016, Big Pharma – a peer set of approximately 16 firms across the world with large R&D and sales organizations, and annual revenues in excess of $10bn – signed over 1,200 drug-focused deals, growing at a compound annual growth rate of 12%.
Biosimilar competition is providing payers with opportunities to contain costs in a category that accounts for a significant proportion of total drug expenditure. The launch of the biosimilar insulin Basaglar is a threat to the insulin-based product market, which includes long-time reference product Lantus as well as newer entrants Toujeo and Tresiba. More aggressive payers are excluding branded insulin products in favor of the less expensive biosimilar, forcing switches in existing patient populations. As such, manufacturers of branded insulin products will need to offer deeper discounts to remain on payers’ formularies and contracts.
Immuno-oncology is an emerging field in medicine that has the potential to radically change how cancer is treated.
The competitive landscape for regenerative medicine continues to evolve. As private sector investment in active players continues, efforts by governments in the US and EU are helping to advance the field, including the recent passage of the 21st Century Cures Act in the US, providing a special status pathway for regenerative medicine advanced therapies.
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