The FDA is investigating data manipulation issues associated with Novartis’s filing for their type 1 spinal muscular atrophy drug, Zolgensma. This Scrip story looks at the claims, background on the issue, and the Swiss manufacturer’s recent response.
Novartis’s Zolgensma losing EU accelerated assessment serves as a warning to other companies. This Scrip story covers a half dozen other examples of companies and drugs who are now forced to slow their development pace—opening room for competitive threats.
Pharma companies faced a “patent cliff” a decade ago with generic competition threatening to slash sales of certain blockbusters. The new threat is biosimilars. Scrip shows how some mature cancer and autoimmune biologics are still the major drivers of revenues, and how biosimilars are gaining on them.
A relatively small number of costly drugs account for a sizable portion of pharma industry revenues. This informative and easily scannable Scrip infographic shows which drugs are the golden eggs, which companies are behind them, and how the landscape has changed in the past decade.
Rgenix, founded by three brothers who are prominent physician researchers, sees itself at the forefront of cancer treatment. They are finding drugs that shut off metastasis rather than the more common goal of using the immune system to destroy cancer receptors.
While the drug industry and patient advocacy groups have worried about price controls or reimbursement restrictions for drugs that treat orphan diseases, a review of formulary data shows that patient access to high-priced drugs has not been severely hampered despite some payer pushback.
IXICO is a neuroscience data specialist that wants to partner with large and small pharmas to help them develop better-targeted clinical trials using imaging and digital biomarkers data. In Vivo looks at the CEO’s activity planning review and subsequent leadership restructuring.
China has the potential to be the world’s largest market for rare disease treatments but may need to develop their own gene therapies as imported products will be too costly. Read about a father’s journey to find a gene therapy to treat his young son’s rare condition.
In Vivo looks at how gene therapies have gone from being just implausible science fiction premises, to becoming clinical realities taking an ever-larger portion of pharma R&D attention. This article covers how gene therapies work, where the field has been and where it’s going.
Founder-CEOs do not typically remain at the helm as biotechs mature, as the majority of scientist-founders lack the skills to lead a company beyond discovery and early development. Exceptions to that rule are multiplying, though, especially in Europe as companies aim directly for Nasdaq. In this fascinating read, In Vivo reviews the many, varied paths toward biotech CEO, and what it takes to lead a company to IPO and beyond.
Oncolytic virus company Theolytics has emerged ready to raise a series A round and get its preclinical assets into human trials by 2021. CEO Charlotte Casebourne talks to In Vivo about the challenge of standing out from the crowd in oncology, how viruses have evolved as a treatment approach in cancer, and how oncolytic viruses might be the answer to the cancer drug pricing conundrum. Learn what this young CEO (at age 26) has to say about the skills required to be a biotech CEO today, the concerning issue of access to novel personalized cancer treatments, and the biggest challenges she sees in cancer drug development today.
Acquisitions and licensing are core to pharma and big biotech growth as pipelines thin and assets lose patent protection. Looking back at significantly sized acquisitions over just five years reveals that half of 2014’s acquisitions can already be judged as outright failures or, at best, questionable. But some lessons can be learned from dud deals. This article from In Vivo Examines deal failures, from the most surprising to the most expected, given the level of risk at stake. If past Is prologue, dealmakers would be wise to look back and consider these lessons of the past.
Trialtrove’s 2018 Completed Trials: State of Industry-Sponsored Clinical Development report takes a detailed look at the record of completed trials over the calendar year, highlighting key trends by therapeutic area; the company sponsorship landscape; and trial phase, including progress of designated pivotal trials and success in meeting endpoints. This insightful annual review of clinical trials initiated by industry sponsors is a useful gauge of the diversity and innovative potential of biopharma’s investments in R&D. This year’s report reveals that, for all the consistencies in many aspects of the clinical trial landscape, changes are in the wind – particularly as companies outside the “Pharma Top 20” now contribute more completed trials than any other type of sponsor.
With a population of 1.3 billion and a large patient pool with rare genetic conditions, China has the potential to be the world’s largest market for rare disease treatments. It is believed, however, that China will need to develop its own gene therapies, given that such imported products will be simply too costly for what is a largely self-pay market. Read about one very determined Chinese father’s journey on two continents to find a research provider with the particular expertise to find a new gene therapy to treat his young son’s very rare condition.
The owner of AMA Labs, which provides testing for cosmetic, drug, medical device and other products, was arrested on charges of wire fraud and conspiracy following an indictment in New York federal court. The firm that bills itself as “the premier sunscreen testing laboratory” falsified results for 30 years by testing products on fewer subjects than it reported, federal prosecutors allege. Letzia pleaded not guilty but four AMA Labs employees pleaded guilty to similar charges in May. Get the whole story, and what this could mean for the approval or compliance status of products tested by AMA that are currently available.
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