Europe Establishes First Facility for Cell-Based Therapeutics

Oct 24, 2012 By: Adeline Siew

On Oct. 22, 2012, a consortium in France announced the establishment of Europe’s first ever industrial manufacturing facility dedicated to the large-scale production of novel, advanced cell-based therapy medicinal products. The plant, located in Les Ulis, near Paris, at the site of the French biopharmaceutical company LFB Biotechnologies, has the capacity to produce 3000 to 5000 therapeutic batches per year. The facility will be used for innovative R&D projects on autologous and allogeneic cell therapies that are progressing from early clinical research stage up to industrial production.

http://www.pharmtech.com/pharmtech/News/Europe-Establishes-First-Facility-for-Cell-Based-T/ArticleStandard/Article/detail/793994?contextCategoryId=35097&ref=25

FDA’s draft guidance documents on Biosimilars - from PharmTech Talk

From PharmTech Talk

Published by Amy Ritter on April 25, 2012 02:00 pm under Regulation

Apr. 16, 2012 marked the closing date for submitting comments on FDA’s draft guidance documents clarifying the approval process for biosimilars. More than 35 pharmaceutical companies, trade associations, and patient advocacy groups submitted public comments on the guidance documents, which are available here.

A careful slog through the comments, revealed a few common issues, but also some topics that reflected the commentator’s industry outlook. Both BIO and PhRMA, industry trade groups, commented on the importance of protecting the innovator’s data until the period of exclusivity had expired, and also requested that the criteria for granting exclusivity be further clarified.

More than a few of the commentators asked for clarification around interchangeability. The guidance document has little detail on the topic, other than defining it as an approval designation permitting free substitution with the innovator product. Companies including Elan, Bayer, and Novo Nordisk asked that the agency provide more detail around the requirements for interchangeability, both in terms of product characterization and the sequence of steps to follow to obtain that designation.

for more of Amy's analysis, see http://blog.pharmtech.com/2012/04/25/a-few-comments-on-the-comments/

Obamacare’s Effect on Drug Spending

Published by Angie Drakulich on April 6, 2012 08:10 am under Trends

This blog post was written by Ben Comer.

Provisions in the Affordable Care Act (ACA) drove out-of-pocket costs down, while increasing drug spending among 19 to 25-year-olds in 2011, according to research published on Wednesday. The decline observed in overall out-of-pocket spending last year was the “first on record,” and was “largely related to the introduction of the ‘donut-hole’ subsidy for Medicare Part D beneficiaries,” a highly-touted element of the ACA, according to the IMS Institute for Healthcare Informatics. While copays for commercial providers and Medicaid were flat (average commercial plan copays increased by $1.14, to $26.10 in 2011), seniors covered by Medicare Part D got the largest break, with average copays decreasing by $2.66 – from $25.97 in 2010, to $23.31 in 2011 – according to the report.

The dip in copay costs for seniors didn’t translate into an increase in volume for chronic or acute medications, however; in fact, patients 65-years and older reduced their drug usage by 3.1%. Prescription use among the same group declined in 2010 as well, by 2.7%, but the last two years represent an inflection from prior years, when “seniors’ usage of medicines grew on average at 4%,” the report found. College-aged patients (19-24 years old), on the other hand, were the only age group to increase their drug usage, by a modest 2%. That increase “coincides with the first full year of implementation of the provision of the ACA allowing under-26-year-olds to stay on their parents’ health insurance,” according to the report.

Michael Kleinrock, director of research development at the institute, said on a call with reporters that patients over 65 years old are foregoing the medications they use the most. Drug usage for hypertension, the most common disease among this population, decreased more than any other class of drugs. “This correlates strongly with the economy…seniors are on a fixed income, and costs [of living] are rising,” said Kleinrock on the call. Kleinrock called the development a “tipping point,” adding that seniors are resetting their expectations around how often, and under what circumstances, they will visit a doctor.

Per capita figures adjusted for currency changes showed a 0.5% growth in total drug spending in 2011 – to $320 billion. Other fun facts from the report include:

more...
http://blog.pharmtech.com/2012/04/06/obamacares-effect-on-drug-spending/

Pooling Resources to Strengthen Supply-Chain Security

With around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight, ensuring the quality and safety of the US’s drug supply is a herculean task. FDA has already taken steps to increase the number of overseas inspections, but it is impractical to assume that one agency is capable of inspecting the world’s manufacturing operations on its own. The Institute of Medicine released a report on Apr. 4, 2012 outlining several practical steps that FDA could take to strengthen supply-chain security.


One recommendation that stands out is that regulatory bodies in developed nations should work together to plan inspections and pool data, and should develop a harmonized set of inspection requirements so that inspections made by one country do not have to be repeated by other countries. According to the accompanying press release, “The report urges FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand to plan a system for mutual recognition of one another’s inspections, which would eliminate the wasteful duplication of effort. There is no need for American and European inspectors to examine the same facilities, especially when a vast number of facilities go uninspected.”

http://blog.pharmtech.com/2012/04/05/pooling-resources-to-strengthen-supply-chain-security/

ACA, JOBS Act, National health info, Crowdfunding and the Healthcare Market

HealthWorks Collective - The world's best thinkers on healthcare

Affordable Care Act Hits Two-Year Mark

Last week marked the two-year anniversary of the passage of the Affordable Care Act (ACA). With heightened focus on the ACA continuing this week, especially on the individual mandate, it’s important to take a step back and understand the strides that ...

PharmTech Talk

JOBS Act Passage—A Boost for Biopharma?

Amid one of the most divisive eras in our nation’s political history, one thing we can all pretty much agree on is the fact that our stalled economic engine needs a jumpstart. According to recent *data* from the US Bureau of Labor Statistics, the ...

American Medical News

National health information network soon will stand on its own

Health care organizations and federal agencies that piloted a data exchange say it’s ready to separate from the government.

How Crowdfunding Affects the Healthcare Market, and Your Walletfrom HealthWorks Collective - The world's best thinkers on healthcare by HerinaAyot

Crowdfunding may have an interesting effect on the healthcare space. Unlike technology, entertainment, retail and other sectors, novel medical technologies and therapeutics take years of pre-development, and require institutional manpower to further growth. Thus, most biotech and pharma companies do not consider their early-stage investors to be the general public, and only in certain cases are they in a position to raise ‘quick capital’ at this juncture.