Showing posts with label Future of biopharma. Show all posts
Showing posts with label Future of biopharma. Show all posts

Thursday, July 10, 2014

Researchers Regenerate Cornea, Successfully Grow Tissue from Stem Cells

A team of Boston researchers has identified a way to leverage limbal stem cells in order to regenerate human corneal tissue—One of the first examples of developing tissue from an adult-derived human stem cell.  The research, a collaboration between Massachusetts Eye and Ear, Boston Children’s Hospital, the VA Boston Healthcare System and Brigham Women’s Hospital, provides hope for those with eye-damaging injuries or diseases. 

The loss of limbal stem cells, which help maintain and restore corneal tissue, is one of the leading causes of blindness. 

It’s long been known that limbal stem cells have powerful regenerative potential, but the issue has been locating these stem cells.  The breakthrough came when Markus Frank, M.D. and Natasha Frank, M.D., co-senior investigators on the study, discovered the existence of ABCB5 molecules in limbal stem cells as well as their role in the maintenance and survival of the cell.  Scientists were then able to leverage the ABCB5 molecule as a marker for these cells and more easily identify them.  

Stem Cell Therapy Research Tissue Grow
The Frank team then put this theory to the test on two groups of mice--A group with fully functioning limbal cells and those without.  Using the presence of the ABCB5 molecule, researchers were able to locate and then extract these cells from donor tissue and transplant them into the corneal tissue of one of the groups.  They found that this group of mice was able to re-generate fully functioning corneas.  

The control group was divided in two with half the mice being given limbal cells that were ABCB5 negative and half receiving no limbal cells.  Both of these groups failed to repair the damaged tissue.  This helped to confirm ABCB5 molecule status as being responsible for the regenerative properties of these stem cells.  

“ABCB5 allows limbal cells to survive, protecting them from apoptosis [programmed cell death],” said Markus Frank.  “The mouse model allowed us for the first time to understand the role of ABCB5 in normal development, and should be very important to the field in general,” added Natash Frank. 

What’s next for the team?  Said Frank in a Fox News interview, “For the first step, we’re really working towards an autologous graft in patients who are blind in one eye.  And then the second step, we’d really work towards using donor derived cells to transplant in a similar manner that may require immune suppression – but it may not.” 

What else is new in the field of cell therapy?  Join us for the Cell Therapy Bioprocessing conference, September 15-16, Boston, MA.  Download the agenda to see what’s on tap.

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Thursday, October 20, 2011

Should the exclusivity period for biosimilars shorten?

This week, 51 of the members of the House of Representatives asked President Obama not to shorten the exclusivity period of biosimilars from 12 years to seven as a part of the Affordable Care Act.  His latest plan for economic growth and debt reduction, branded biosimilars producers would face the shortened exclusivity time.  The House of Representatives believes that biosimilars can be a great asset to the market and patients who face the high prices of biologic drugs.  Patient Docs believes that the ultimate losers in this potential situation are the patients. Many companies would look to move abroad where they were in an atmosphere that supported and acknowledged the importance of innovation, leaving America because of no incentive to develop these cheaper drugs.

What do you think about the exclusivity period?  Should it be seven or twelve years, and how does each scenario affect the American people?


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Monday, August 29, 2011

Announcing Exclusive Updates to the Biorepositories Event

We're excited to share with you exclusive updates to the 4th Annual Biorepositories conference featuring these updates:

New Sessions including:
Regulatory Keynote - Setting New Biorepository Performance Standards
Dr. Helen Moore, Biospecimen Research Program Coordinator, NIH’s Office of Biorepositories and Biospecimen Research

Strategies to Create Quality Attributes and Streamline Searches of Biorepository Specimens
Renu Vora, Senior Associate Scientist, Centocor

Case Study Spotlights on Incorporating Next-Generation Technology into your Biospecimen Management:  


Innovative Systems Pathology for Functional Interrogation of Biospecimens
Michael Roehrl, PhD, Assistant Professor of Pathology and Laboratory Medicine, BOSTON UNIVERSITY

High-Throughput Techniques for Diagnostic Testing and Blood-Banking, and Use of Excess and Discarded Materials in a CLIA Lab 
Lynn Bry, MD, PhD, Associate Director, PARTNERS HEALTHCARE

Coupling Biorepositories with Informatics and Mining of EMR Data for Future Use
Wendy Wolf, PhD, Executive Director – Biorepositories, CHILDREN’S HOSPITAL BOSTON

Technical Advances in Frozen Sample Aliquotting to Boost Sample Homogeneity and Renewability
Dale Larson, Director, Biomedical Systems Group, DRAPER LABORATORY

Testing the Effects of Anhydrobiosis and Ambient Storage on RNA Sequencing
Kristin Ardlie, PhD, Director, Biological Samples Platform, BROAD INSTITUTE

For more information on these updates and the complete agenda, download the brochure here.  Biorepositories 2011 is taking place September 19-21, 2011 in Boston, MA as a part of the Clinical Business Expo.


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Friday, December 24, 2010

Happy Holidays from Future of Biopharma

We're taking some time off from our coverage of biopharma to celebrate the season with our loved ones. We want to sincerely thank you for your readership, your comments and your participation. We look forward to returning to the world of Pharma in 2011!

Here are our top posts from 2010:
FDA approves first biosimilar
2010 DDP Awards: Technology Innovation Nominee: Topi-Click
How will healthcare reform affect Pharma?

We wish you Happy Holidays!


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Tuesday, November 23, 2010

Brain cancer vaccine in mid-stage trail

Biotech company Celldex Therapeutics announced that their experimental vaccine to extend the lives of brain cancer patients is in midstage trial.

According to Reuters:
The trial, named ACT III, showed 66 percent of patients had no disease progression at 5.5 months from the start of vaccination, a statistically significant increase over a predetermined progression-free rate estimate of 53 percent, with standard of care.

Celldex has the only other FDA approved cancer vaccine on the market, a vaccine for advanced prostate cancer.



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Wednesday, November 17, 2010

Biosimilars forcing Big Pharma to go generic

In a recent article at The Economist, they look at the ironic turn drug companies have taken. In an effort to join the trend of double digit growth, many major Pharma companies are extending their assets and partnering with companies in order to ride the wave of successful biosimilar sales.

Although biotech-based drugs account for only a fifth or so of global drugs sales they are projected to grow at double-digit rates as sales of many conventional drugs decline, especially with a large number of patent expirations coming. Add the fact that many biotech drugs produce enormous profits—some treatments cost $100,000 or more per year—and it is easy to see why the sector looks like a juicy target for generic assault.

Do you expect to see an increasing number of partnerships come about like Pfizer and Biocon? What will their importance be for the industry?


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Wednesday, October 13, 2010

Pfizer buying King Pharmaceuticals

Pfizer recently announced it's purchase of King Pharmaceuticals for #3.6 billion. Big pharma continues to buy small Pharma firms looking to acquire new products to their pipelines.

King's main products include, pain drugs, including painkillers designed to be resistant to abuse, and EpiPen, a pre-filled injection to treat allergic reactions. Pfizer has stated that they will cut $200 million in costs. News Observer has the full story.


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Wednesday, September 29, 2010

Lipid bubble vaccine delivery method patented

A new vaccine delivery method, which delivers vaccinations by small lipid bubbles has been patented. Vaccine News Daily reports that the vaccines is delivered in a lypozome, which inside contains a double layer of lipids.

This DNA molecule, Dow told PhysOrg.com, is fused to an immunogen, which is a protein fragment that the immune system mounts a specific attack against. The researchers said that the protein fragment could be part of an infectious organism or some other type of health hazard, like a cancer tumor.



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Wednesday, September 15, 2010

Who can you meet next week at Business of Biosimilars?

The Business of Biosimilars event is taking place next week! It's not too late to register and join these industry leaders:

AARP * Abbott Laboratories * Alston & Bird * American Enterprise Institute * Amgen Inc * BD Medical Pharmaceutical Systems * BioProcess Technology Consultants * BNA * Boston Healthcare Associates Incorporated * Camargo Pharmaceutical Services * Celltrion Inc * Center for Medicine in the Public Interest * Charles River Laboratories * Covance Laboratories * Cureline * Dr Reddys Laboratories Inc * Ellen Bowe * EMEA * Engel & Novitt * ENTRA Pharmaceuticals Inc * Federal Trade Commission * Gedeon Richter USA Inc * Global Health Consulting * Goodwin Procter LLP * Greenstone Ltd * HartmannWillner LLC * Health Canada * Hospira Australia * Hospira Inc * Industry Standard Research * Ion Pharmaceuticals * IRS * Johnson & Johnson * LifeCell International Private Limited * Makovsky & Co Inc * Massachesetts Life Sciences Center * McDonnell Boehnen Hulbert Berghoff * Merck & Company Inc * Mergermarket Financial Times Group Pearson PLC * Montclair Bioequivalence Services LLC * North American Thrombosis Forum * Novartis * Organon NV * PAREXEL International LLC * Pfizer * Phillip Morris Intl R&D * Potomac Group * PPD Inc * Quintiles * Sandoz International GmbH * Sanford Bernstein * Sanofi Aventis * Smithers Group * STC Biologics Inc * Synthon Pharmaceuticals Inc * Takeda * The Center for Evaluation of Value and Risk in Health (CEVR) * The Dunn Group Inc * Trident Group LLC * Werthenstein BioPharma GmbH * Wolters Kluwer

To view all the presentations and speakers at our event, visit the Business of Biosimilars Agenda.



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Monday, September 13, 2010

Call for global approach to developing biosimilars

The European Generics Industry is calling for a world wide standard to develop biosimilars. Leaders believe standards need to be set for the industry world wide in order to create a consistent, scientific global approach in order to fully reach the potential that biosimilars can have world wide.

Greg Perry, director general of the European Generic Medicines Association (EGA), stated, "If healthcare systems are to continue to function long-term, we must address the importance of biosimilar monoclonal antibodies (MAbs) next. Science for MAbs is already here today and our industry is expecting a workable guideline."

Do you think a global, united front on biosimilars will aid the development of them? What could be the benefits of the scientists of the world having the same standards for developing biosimilars?



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Wednesday, September 1, 2010

Biorepositories: An Interview with Tracie DeHart, Dow Agrosciences

Tracie DeHart, Dow Agrosciences, a speaker at this year's 2010 Biorepositories Conference, recently sat down with Courtney Leonard, the Biorepositories Conference Director to discuss some of the current trends in the biosciences industry..

They discussed:
-Tracie’s background in sample management
-Operating a biorepository in the biopharma industry versus the agrobio industry
-Setting up an in house biorepository
-And more!

Click here to download the transcript, and visit the Biorepositories 2010 webpage to download the podcast.



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Tuesday, August 31, 2010

Biologics lead to tricky regulation ground

The Lawyers Weekly looks at the legal problems that will arise as a result of the pathway that is now built from biosimilars. There is anticipated legal battles that legal battles will rage due to lack of regulation in the industry. Currently, biosimilars aren't required to have clinical trials, but they are not exact molecular duplicates like generic drugs. There are currently many discussions happening over whether or not biosimilars should have to undergo clinical trials. Our LinkedIn Group is currently debating this topic. Join the Business of Biosimilars LinkedIn group and find out what our members have to say about whether or not biosimilars should be required to go through clinical trials.



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Monday, August 30, 2010

Sanofi Aventis receives no from Genzyme for first offer

Forbes shares that the first attempt for Sanofi Aventis, a bid of $18.5 billion, was rejected by Genzyme. Genzyme believes that the company should be valued at a much higher price. The bid from Sanofi Aventis has been expected. Genzyme is facing a few manufacturing issues when inspectors found particles of trash and other particles in the medication manufactured at several plants. Stock prices of Genzyme, however, continue to rise today, showing that investors believe that Sanofi Aventis will come back with a higher bid.


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Thursday, August 26, 2010

Vaccines could extend cancer patients lives

Therapeutic vaccines are one way to extent cancer patients lives. The Seattle Times recently looked at the vaccines that are in development to the patients own immune systems to fight the cancer within the body. The vaccines train white blood cells to identify cancer cells and fight against them. After researching for years, doctors are now starting to see some of these vaccines work. Provenge is one of these vaccines, and it was approved by the FDA in April. In addition to prostate cancer, researchers are working on treatments for melanoma, breast cancer and cancers of the lung, colon and pancreas. The approved vaccines work in men who have advanced prostate cancer to prologue their lives. Many patients see it as a valuable alternative to chemotherapy and radiation treatment.



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Friday, August 20, 2010

Thermo Fisher Scientific Inc. expands biorepository in Maryland

According to Boston.com, Thermo Fisher Scientific Inc. will be expanding their facility in Frederick, Maryland by 22,000 square feet. The extra space will be used to host cancer specimens. The majority of samples hosted at the facility are from clinical trials conducted by the National Cancer Institute.



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Thursday, August 12, 2010

Podcast: Mark McCamish, Sandoz, on the approval of a generic version of Lovenox

Recently, the U.S. Food and Drug Administration granted marketing approval of the Abbreviated New Drug Application (ANDA) for enoxaparin sodium for injection, a product that has been designated therapeutically equivalent to Lovenox®. While it is not protein-based, it is an extremely complicated molecule to make and refine - similar to attempting to reproduce a biologic.

We interviewed Mark McCamish, Head of Global Biopharmaceutical Development at Sandoz and Keynote Speaker at the 2nd Annual Business of Biosimilars event to get his expert industry perspective on the recent development.

Read the podcast transcript here:
http://bit.ly/9HKVmu

Visit our webpage to download
http://bit.ly/dcqkmU

Visit the Business of Biosimilars Webpage:
http://bit.ly/dlO5j8



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Thursday, July 29, 2010

FDA approves first biosimilar

On Friday, the FDA announced its approval for the generic blood thinner Sanofi Aventis blood thinner Lovenox. This highly complex drug is the first and now sets a pathway for other generic copies of proteins to be approved. Due to the complexity of these molecules and how they are copied, there is still debate about how many safety trials should be conducted. (Source: The Great Beyond)

On Monday, Sanofi Aventis asked the US Court to withdraw it's approval on the drug, believing that they may have not tested for the same active ingredient in Levenox. They also stated in the papers they took to court:

"If not remedied, FDA's decision will cause Sanofi-Aventis irreparable harm and may result in entry into the market of a generic product that is not clinically equivalent to Lovenox with respect to safety or efficacy," Sanofi said in court papers.

Read more about Sanofi's request at Reuters.



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Monday, July 26, 2010

Sanofi Aventis eyeing Genzyme

Reports Friday surfaced that Sanofi Aventis is looking to acquire Genzyme as it faces stiff competition from generic drugs. By acquiring Genzyme, it would be their first step into the generics and biosimilars market.

According to the article:
[Genzyme's] research pipeline includes candidates for genetic diseases like Duchenne and Becker muscular dystrophy, Niemann-Pick type B, and Parkinson disease. It also has drugs in development for cardiometabolic, renal, transplant, and immune diseases, as well as hematologic oncology.

Source: Genetic Engineering & Biotechnology News




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Thursday, July 22, 2010

Limited time offer to attend the 2nd Annual Business of Biosimilars

As a reader of Future of Biopharma, we'd like to extend to you a special offer. For five days only you will have the opportunity to save $700 off the standard registration rate at the 2nd Annual Business of Biosimilars Conference. This WEB ONLY offer is valid THROUGH MONDAY, JULY 26th. Please use code XP1586WEB to receive this discount. That's a Savings of $700 for a 3 day pass!

We know that this has been a tough year to get approval to attend events, but there's only ONE event your industry, key partners AND competitors will be at this year...Business of Biosimilars in September in Boston. In addition to saving $700 when you register through this offer, you will get access to a full day seminar on Strategies to Expedite Approval of Your Follow-On Biologic: From Drug Discovery to Post Approval, a dinner workshop on IP Protection and Patent Litigation, and over 30 expert faculty members including representatives from Sandoz, Biogen IDEC Inc., Hospira, Sanofi-Aventis, the FTC and much more.

Visit the webpage here to find out more information on the speakers and topics of this event:
http://bit.ly/cA9IaI



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Wednesday, July 21, 2010

Biorepositories Global Sample Management Survey

If you are in the Biorepositories field, we invite you to take our brief survey. Your feedback is extremely valuable to us as we plan for 2011. As a token of our appreciation IIR will offer you $300 off the current early bird registration price for Biorepositories 2010 if you register for the event and complete the survey before this Friday, July 23rd. Mention Priority Code XP1598LINKJULY.

Take the survey here:
http://www.surveymonkey.com/s/9FPV9DB




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