FDA Commissioner Marty Makary said publishing complete response letters recognizes public interest in the transparency and credibility of agency decision-making about drugs. He also said the move complies with an executive order that covers the communication of scientific data. The post Embracing Transparency, FDA Will Make All Future Drug Rejection Letters Public appeared first on MedCity News.| MedCity News
Eschewing the traditional model of financing biotech startups milestone to milestone to support a lead asset, Treeline Biosciences’ well-funded pipeline is comprised of multiple complementary programs. Select investors have supported the approach of Treeline, which said it has raised more than $1.1 billion to date. The post Startup Treeline Bio Emerges From the Shadows With $1B+ Raised and 3 Cancer Drugs in the Clinic appeared first on MedCity News.| MedCity News
Novartis, which already has experience with RNA interference therapies, is now turning to this modality as a potential way to treat Parkinson’s disease. The pharmaceutical giant is licensing rights to an Arrowhead Pharmaceuticals RNAi therapy designed to inhibit production of alpha synuclein, a protein associated with Parkinson’s progression. The post Novartis Tries Again in Parkinson’s, Putting Up $200M for Arrowhead’s RNAi Therapy appeared first on MedCity News.| MedCity News
Injectable Leqembi permits weekly maintenance dosing of the Eisai and Biogen Alzheimer’s disease drug that may be done at a patient’s home. Other recent notable regulatory news includes several rare disease drug approvals and narrower FDA nods for Covid-19 vaccines. The post Alzheimer’s Therapy Is Coming to the Home With FDA Approval of Injectable Eisai, Biogen Drug appeared first on MedCity News.| MedCity News
Each week we highlight five things affecting the life sciences industry. Here’s the latest. ... READ MORE >| The Real Economy Blog
Heart devices lead medtech’s summer financing surge. This and more in this week’s life sciences update.| The Real Economy Blog
In biopharmaceutical research and development, the path from discovery to approved therapy can be long and complex, requiring innovation at every step. Success depends on understanding biology at its... This content originally appeared on pacb.com| PacBio
Novo Nordisk’s GLP-1 drug Wegovy expanded its label to include the metabolic disorder known as MASH. Analysts say there’s room for many MASH drugs with the treatment landscape expected to shape up to include combinations of therapies bringing different approaches to this fatty liver disease.| MedCity News
Each week we highlight five things affecting the life sciences industry. Here’s the latest.| The Real Economy Blog
We explore four hypothesized value drivers of platform-based companies and evaluate the actual value achieved 10-15 years out from initial capital raise. We found that discovery platforms showed the highest lead asset success rates, significantly more out-licensing activity than non-platforms, and accounted for nearly all multi-asset approvals within our cohort. All platform types showed increased survivability and more licensing opportunities. The post Realized value of platform-based biote...| Recon Strategy
Merck's acquisition of Verona is the latest in a long line of "revenue acquisitions". How have prior mid-size biopharma revenue acquisitions fared?| Recon Strategy
Introduction It has become a truism in the pharmaceutical industry that new product performance is more often divergent from pre-launch forecasts than on target. In fact, less than 24% of major products (>$250M annual US sales expected or achieved by year 5 post-launch) launched in the 2014 – 2019 timeframe was within 30% of pre-launch […]| Recon Strategy
It is strategic planning season at many pharma companies. Even more than most years, planning strategies against a robust set of macro-scenarios will be crucial to mid- and long-term success. While historically these scenarios have revolved around targeted issues like assessing the promise of a new modality, the potential of serving an unmet need, or […]| Recon Strategy
Download a PDF of this paper here. M&A deals in biopharma often capture headlines for their large valuations, yet these figures rarely reflect the true financial return realized over time, as most fail during development. Typical deal-structures involve a modest upfront payment with more significant sums tied to development milestones – which allows buyers […]| Recon Strategy
As part of my pre-work for the No Patient Left Behind program, I’ve obtained a new certification entitled Biotech Unveiled: Understanding the U.S. Biomedical Innovation Marketplace and its Global Role from RA Capital Management. I highly recommend this *free* course, which articulates a Biotech Social Contract that – if consistently implemented by biopharma, payers, investors, […]| Natalie Hanson
For years, digital biomarkers have seemed like a promising way to transform drug clinical trials, yet their adoption journey has been uneven. We’ve watched as the excitement for Proteus’s ingestible sensors dissolved when the company filed for bankruptcy. We’ve seen major investments to build large and sophisticated digital health teams by biopharma companies (e.g., Biogen) […] The post Keys to harnessing the value of digital biomarkers in clinical trials appeared first on Recon Str...| Recon Strategy
Introduction In 2017, the FDA approved Luxturna for the treatment of Leber’s congenital amaurosis (LCA), marking the first gene therapy used for an inherited disease in the U.S. The curative potential of gene therapy garnered significant pharma industry interest over the next few years, with notable multi-billion dollar acquisitions from Novartis and Roche. Since that […] The post Commercial performance of AAV gene therapies: Market review and future implications appeared first on Recon S...| Recon Strategy
To address the complicated healthcare landscape in the U.S., Pfizer launched a new direct-to-consumer virtual service called PfizerForAll. It follows Eli Lilly, which launched a similar product in January.| MedCity News
We can’t wait for others to find a solution to high drug prices. It’s clear what should happen in a functioning drug pricing market federally and in California, but it is not happening today.| MedCity News
NOWDiagnostics’ First To Know has FDA De Novo marketing authorization as a new test for syphilis. The at-home product needs only a single drop of blood to test for this sexually transmitted infection.| MedCity News