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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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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Combination product approved for some hypertension patients

A combination product for hypertention was recently approved by the FDA. Tribenzor, the three-in-one product, uses other hypertention drugs olmesartan medoxomil, hydrochlorothiazide, and amlodipine to relax blood vessels and allows blood to flow more freely. This combination product hopes to help those with hypertension by simplifying pill regiments, reduce the number of pills a patient takes and lower co-pay for the pills. It is hoped that this combination product will allow more individuals to reach their goal for their best blood pressure. Modern Medicine has more on the new combination product.

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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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J&J receives FDA warning letter for unapproved med device products

CNN Money reports that the FDA has set Johnson and Johnson a warning letter for selling joint products have have yet to be approved. By selling these products, they are violating the Federal Food, Drug and Cosmetic Act. Upon receiving information from DePuy, the Johnson and Johnson subunit, it will then test products for market approval.

This blog is co-posted with The Drug Delivery Blog.

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Rare disease patients seek treatment

In a recent article at Time Magazine, they ponder whether or not it is time for Pharma companies to begin treatment for rare diseases. For the most part, many go unresearched due to the small numbers of people affected, which often leaves too few people to undergo clinical trials. An estimated 8% of the US population suffers from a rare disease.

Some professionals, including Dr. Christopher Forrest of the University of Pennsylvania and colleagues from the Office of Rare Diseases Research at the National Institutes of Health have issued a call for a rare disease directory that would serve all worldwide. This would allow international collaboration between patients and doctors to find treatments for the diseases.

Do you see this as a part of the future for the Pharma industry?

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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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Dr. Bill Maisel to direct Center of Devices and Radiological Health

According to MedCity News, Dr. Bill Maisel has been selected to function as the deputy director of science for the Center of Devices and Radiological Health (CDRH) and chair the Center Science Council (CSC). The latter will be responsible for issuing the recall of devices in addition to setting standards for their approval. This is stirring up some controversy in the medical device industry.

In a statement written for the House Energy and Commerce health subcommittee last year, Maisel wrote last year, he stated:“[I]t is critical that the safety and performance of medical devices be improved, that the frequency of medical device malfunctions and adverse events be reduced, and that patients and physicians be adequately informed about device clinical effectiveness and risks in a timely fashion. In short, FDA needs to improve its science-based device assessments and decision-making."

What effects do you think this will have on the medical device industry?

This blog is co-posted with the Drug Delivery Blog.

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Biosimilars: To develop as a generics or new products?

In a recent article written by Thomas Gryta at the Dow Jones Newswire, he looks at the current situations for large Pharma when developing biosimilars: treat them as generics or new products? While there is now a pathway to have biosimilars approved, the FDA is still yet to provide the guidance on how they are suppose to be developed. Many companies are making their own decisions before the FDA officially ways in. They're looking to secure the market that will come from biosimilars being marketed under individual names. Read Gryta's full article here.

Which path should companies developing biosimilars follow? The generic route or a new product route? How much of a factor is it that the generics are large molecules when it comes to this decision?

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Industry Alert: Official Call For Presenters 12th Annual Immunogenicity For Biotherapeutics

From: Anne Reel, Senior Conference Producer
Re: Call for Speakers & Presentations
Event Date: April 2010
Event Venue: Washington DC
SUBMIT YOUR PROPOSAL NOW!

The Institute for International Research (IIR) is currently seeking presenters for the 2011 12th Annual Immunogenicity for Biotherapeutics event. This 3-day event will take place April 2011 in Washington DC. We invite you to submit a proposal for a speaking opportunity directly to Anne Reel, by September 10, 2010. Please send to AReel@iirusa.com.

Submission Guidelines & Details

CUSTOMIZE YOUR CONFERENCE AGENDA!
We are currently recruiting biopharmaceutical scientists who can share NEW DATA through detailed case studies on what has worked (and what hasn't worked) for Immunogenicity related to development and validation of Immunoassays, outsourcing, technology, and more. This three day event will focus on current challenges the industry sees today and provide a forum for experts to come together and share knowledge and expertise.

Who will attend the leading industry conference on Immunogenicity? Attendees will be both new and experienced biopharmaceutical scientists working in Immunogenicity such as neutralizing assay development and validation, technology, regulatory issues, and more. We expect that the conference will attract between 150-200 attendees. We are looking for novel approaches to handling nonclinical and clinical issues including:

• Regulatory considerations
• Cell-based and ligand-binding neutralizing antibody assays
• Methods to overcome drug interference
• Development and validation of Immuno and bioassays
• Demonstration of applying PK/PD/ADA/AE to interpretation of nonclinical safety studies
• Presence of ADA in nonclinical species with no PD marker available
• Cell line changes and comparability issues - animal models?
• Patient populations with high pre-existing antibody "interference"
• Interference due to increased drug target with treatment
• Standardization of statistical analysis - confirmation cut-point
• Oligonucleotides, small peptides
• Drug conjugates
• Comparison of technologies

MAKE SURE YOUR BIGGEST ISSUES ARE ADDRESSED!
Are your biggest concerns not addressed here?
Contact Anne Reel to ensure that your pressing issue gets the attention it deserves! AReel@iirusa.com or 919-676-0306.


Do you want to reach this audience?
We have a limited number of slots available for solution providers/consultants.
People who wish to become part of the program should contact, Dave Borrok, Sponsorship Manager, at 646.895.7485 or e-mail dborrok@iirusa.com.
Sessions will be 30-45 minutes including Q & A.

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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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Biorepositories: An Interview with Lisa Miranda, President of Biobusiness Consulting

Lisa Miranda, President of Biobusiness Consulting, a speaker at this year's 2010 Biorepositories Conference, recently sat down with Courtney Leonard, the Biorepositories Conference Director and recorded a podcast.

They discussed:
-Lisa's involvement with the industry guidances on current best practices for biospecimen resource management, operations and cost recovery.
-Her insights into what you see as the toughest challenges with regards to guidances and standardization facing the industry right now?
-What role going forward will policy and governance plan in ensuring sustainable development, resource equity, and ROI?

And other items. Click here to read a transcript of the podcast, or visit the Biorepositories webpage to download the full audio file.

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Do you have concerns with how to balance in-house capabilities with outsourcing needs?

One of the workshops at this year's Biorepositories Event is The 2010 Build A Biorepository from the Ground Up: Lessons Learned from Industry Experts. It delivers a full day to help you evaluate your organization’s sample management needs and how to build a high utility, sustainable biorepository to meet those needs. Industry experts from Millennium, Gilead Sciences, GSK, and others, provide you the tools to:

→ Identify planning, management and requirements to develop and operate a biospecimen resource core facility.
→ Take frozen samples and turn them into a usable biorepository
→ Decide whether to archive or bank and understand the difference and why it affects how you establish and utilize your biobank

And much more… Click here for the full program agenda: http://bit.ly/dlzTrk

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More complex generics will be approved in more often in the future

At Forbes, they recently talked with Jeffrey George, global head of Novartis's Sandoz generic drug unit. Upon the approval of the generic for Lovenex, George believes that it has opened the pathway for other complex generics to be approved in the future. While the drug is not a generic, it has a complex sugar structure that is hard to copy.

George commented, "It underscores that the FDA really does have the institutional courage to approve affordable high quality alternatives to some of the more difficult to make products that are out there. There were a lot of interests lined up against this approval. It bodes well for the approval of more complex generic products in the future."

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Amgen to test safety and efficacy of biosimilar

Epogen will soon have competition. Amgen is testing it's biosimilar version of the drug. Contrary to other biosimilar tests, the study of the safety and the efficacy of the drug will be tested first. Then, Amgen will turn it into a Phase III trial next year.

Sumant Ramachandra, a senior vice president at Hospira, commented:
"This trial marks a key milestone for Hospira's biosimilars program. Congressional approval of a regulatory pathway for biosimilar drugs in the U.S. set the stage for our development of a U.S. biosimilar EPO. We hope to leverage our leadership in generics and our biosimilars experience in Europe to make affordable, safe and effective biosimilars available to U.S. patients and their healthcare providers once patents expire over the next several years."

Fierce Biopharma has more on the biosimilar from Amgen.

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