Friday, July 31, 2009

United Therapeutics lung drug gets FDA nod, shares rise

According to Esha Day of Reuters, United Therapeutics Corp (UTHR.O) said U.S. health regulators approved its inhaled drug to treat pulmonary hypertension, sending its shares up as much as 13 percent.

The Food and Drug Administration approved Tyvaso inhalation solution for the treatment of pulmonary arterial hypertension (PAH) using the Tyvaso inhalation system, the company said.

Even though the drug, Tyvaso, had faced a couple of delays on its way to approval, analysts were expecting a regulatory nod by Thursday's action date as it was mostly the drug's delivery device that had faced a close scrutiny than the drug itself.

Another win for biopharma? We'd like to hear your thoughts.


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Thursday, July 30, 2009

Biotech Drugs: More or Less Exclusivity?

This article in telegram.com brings up the much talked about debate in biologics in exactly how many years should makers of drugs by exempt from generic competition. Many pills are hard to re-produce but there are many drugs that are made of simple chemicals and are easy to replicate. Congress is trying to approve legislation now that would allow the FDA to approve generic versions of biologic drugs, and this could save consumers a lot of money in the long-run.

The Health Committee has approved for 12 years of exclusivity for the biotechnology industry, but the Obama administration seems to think that 7 years is a fair compromise? Do you agree with the Obama administration?

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.


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Wednesday, July 29, 2009

All Your Sample Storage Answers, All in One Location

Biorepositories 2009 facilitates interaction and networking with the industry’s top thought leaders. Bring your most pressing concerns, challenges, and questions to share during the interactive panel discussions including:

NCI and FDA representatives address biorepository standardization issues and regulatory challenges.

How to effectively collaborate with academics, hospitals, and non-profit organizations to increase your sample collection and expand your access to patient populations.

Millennium and Amylin focus on outsourcing strategies including best practices for evaluating service providers and building effective vendor relationships.

Go green in your biorepository – bring home solutions to reduce your footprint and maximize energy efficiency while still maintaining sample integrity.

Celgene and Axogen tackle transportation challenges to ensure sample safety and quality are top priorities when moving your fragile specimen samples.

Take advantage of this fantastic networking opportunity and be ready to bring home fresh ideas to implement in your organization. Register before August 7th and save $300!See you in September!

If you're interested in networking with other professionals in the biorepository field, join us here at the Biorepositories LinkedIn Group!


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Countries creating laws to lower drug prices

The Wall Street Journal has an interesting look at how some countries are creating laws to combat the high prices of life saving medications. President Gloria Macapagal Arroyo of the Philippines reduced the drugs prices when the manufactures of several drugs failed to lower their prices to comply with a new law. The article states that drug companies have looked to emerging markets as a place to make up for the falling revenue in places such as the US, Europe and Japan. The Philippines new actions could cost large Pharma companies between $146 million and $208 million. Read the full article here.


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Monday, July 27, 2009

Do you have a 2010 action plan for your PAP program?

As the nation’s policymakers debate healthcare reform amid rising unemployment rates, more Americans are losing their healthcare insurance and access to essential medications. Now more than ever before, there is a tremendous opportunity for pharmaceutical patient assistance program administrators to leverage, improve, and optimize these programs by increasing access and enrollment.

IIR’s Patient Assistance Programs event is back this October, and the 2009 agenda provides the essential content to guide you through the continued economic and political restructuring. Join us this year as leading industry experts offer fresh insights and approaches for your PAP:
• Receive updates and direction on future industry guidelines and regulations
• Dive into current trends and the shifting landscape
• Implement new technologies and procedures to be more time and cost efficient in this economy
• Gain practical solutions to increase program awareness and infuse new energy into your PAP
• Discover how to build effective partnerships with government and patient groups
• Establish a 2010 action plan for your PAP program

Click here to view the finalized agenda!

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Samsung to invest US $389 Million in Biosimilars

According to this article in Reuters Samsung Electronics plans to invest $500 billion won, approximately US $389 million, in the biosimilar business says Lee Youn-ho, Korea's economy minister.

Samsung did not confirm the amount of the investment but has mentioned that biosimilars have produced a great growth opportunity for the company.

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.


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Friday, July 24, 2009

The effect of healthcare reform on innovation

At Investors.com, Sally Pipes recently voiced her opinion on how health care reform could damage successful innovation in the biotech industry for years to come. Health care reform is important but will have to rely on a variety of places to be successful: hospitals, doctors, insurers and drug companies.

The current favorite place that law markers are looking to reduce costs is the drug makers. While they are the ones with cash, one must remember it takes years and over $1.3 million to make a new medicine. Taking money from the drug makers could have long term effects such as finding cures in the future and experiencing long-term health problems. There are also millions employed in the industry. The number of researchers would have to dwindle, putting stress on already stressed conditions with too few researchers.

What do you think? What are going to be other affects on the biotech industry from healthcare reform?


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Thursday, July 23, 2009

2nd Annual Bioanalytical Method Development

What’s new in 2009 for Bioanalytical Method Development?
• Tackle biomarker assay issues with Biomarin, Human Genome Sciences, and Genentech – bring back to your lab new approaches for including biomarkers in your PK/tox program, using biomarker assays as a trigger for treatment, and strategies to resolve heterophilic interference
• Half-day dedicated to all new Fc Functionality data
• Improve your developmental strategies for free and/or total antibody drug at the half-day workshop dedicated to case studies and open dialogue on the challenges, pros, and cons of developing free and total assays with Eli Lilly and Amgen
• Industry experts share strategies to generate meaningful data on molecular interactions to support biotherapeutic development
• Pfizer presents data on interference generated in different assay formats, using modeling as a predictive tool, and how to generate significant savings by reducing the number of assays requiring GLP validation.

Why IIR’s BAMD?
• Shorten development timelines to improve speed to market
• Network with colleagues to solve your biggest challenges
• Reduce costs by improving efficiencies in your lab

This is a unique opportunity to mingle with such an esteemed group of scientists all focusing on the advancement of bioanalytical method development! Register now and save $400 when mentioning code FVFVSBF.


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Australian Firms Begin First Tests of Swine Flu Vaccine

Todd Neale of ABC News reports that Adelaide-based Vaxine Pty Ltd and Melbourne-based CSL Biotherapies injected the first adult volunteers this week in separate trials starting days apart.

Now in its winter flu season, Australia has reported about 15,000 confirmed cases of the new H1N1 virus and 41 deaths. That has made Australian health officials and drug manufacturers anxious to get a vaccination program under way as soon as possible.

Australian Firms Begin First Tests of Swine Flu Vaccine


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Wednesday, July 22, 2009

Cell Based Assays 2009

In its fifth year, IIR’s Cell Based Assays is the principal event for industry leaders and colleagues to discuss how to overcome the challenges of cell based assay development and validation.

For 2009, we have added more networking time for you and your peers, including the return of moderated round table sessions that will allow you to address all your current questions surrounding: regulatory considerations, assay development and validation efficiencies, potency assays, neutralization antibodies assays, technological advancements, statistical analysis, and more.

Additionally, we have organized a Dine-Around which will provide the ultimate Berkeley experience. This dinner is a venue for conference participants to meet others with similar interests, for Berkeley is an epicenter of food culture that offers an eclectic range of restaurants.

Don’t forget - make sure you register by this Friday, July 24th, to save $400 off the standard rate!

We also invite you to join our LinkedIn group to start networking with other professionals in the Cell Based Assays field to discuss such things as biopharmaceutical labs have many obstacles to overcome in developing, validating, maintaining, and transferring complex cell based assays in a quality control environment.


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Tuesday, July 21, 2009

Live from MDRx: How to Transform Physician Interactions with Medical Information





Peter Frishauf, Chairman, Crossix
Founder, Medscape




Stephen E. Smith, Chief Strategist, SO-NET m3 USA CORP.,
Co-Founder, Medscape





George D. Lundberg, MD, Former Editor in Chief,
Medscape

At IIR's Physician Relationship Management event today in Philadelphia, the founders of Medscape, George Lundberg, MD, Peter Frishauf, and Stephen Smith are discussing "How to Transform Physician Interactions with Medical Information."

Three Drivers for the Medscape's Founding Fathers

1. We came from a corporate culture that allowed for creativity and primed us to question everything.

2. Technology was in place about three years too early for industry, but not three years too early for our audience.

3. Physicians were getting killed by information overload and they were burning out.

In discussing Medscape's history and growth, Dr. George Lundberg shared with the audience that word about Medscape spread virally with very little marketing on their part. It was at the time when the rate of individual internet adoption was increasing very quickly. It was pre-pharma web marketing. They also had some key relationships including one with the founder of Yahoo, Jerry Yang, who introduced his followers to Medscape.

In addition, Medscape made a controversial decision to make access free . Coming from a controlled journal background, Dr. Lundberg wanted to provide broader access with the caveat that the content was behind registration so Medscape would know know what each member was interested in and their specialty and customized the site accordingly. They learned from friends who started Wired Magazine and created an email newsletter "Med Pulse" which was and is a big driver of traffic to the website. At the time, Medscape had the advantage that there weren't a lot of web resources, so they took advantage of that.

Peter stated that as an observer of social orders, another form of anarchy is the four way stop sign...whoever gets to the intersection first, goes first. But there has to be rules. If someone runs a stop sign they get a ticket. And Peter believes that when it comes to trust, the online communities are creating reputation systems "trust marks" so there is more credibility, but traditional peer review still an important way to establish credentials.

To conclude the presentation, the presenters looked at three factors that lead to the success of Medscape:

1. We believed that content was king, because it empowers people. Knowledge is the only thing left that they value. It wasn't that it was new, it wasn't the technology, technology was just the tool to deliver the content.

2. Right balance of broad and deep content to attract a large number of physicians, but deep enough that they were relvant and searchable. Strategic content partners made this possible.

3. With everything we did, we asked, Is this going to be of value to the physician...and we had the culture that allowed us to do that.

If you're interested in networking with other professionals who market to physicians, join us in these groups:
Join MDRX on LinkedIn: http://www.linkedin.com/groups?gid=1811679
Follow MDRX on Twitter: http://twitter.com/mktg2docs


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Monday, July 20, 2009

Follow-on Biologics Hearing Testimony

This article in Patent Docs discusses how the House Subcommittee on the Courts and Competition Policy heard testimony from seven witnesses, including Momenta Pharmaceuticals General Counsel Bruce Leicher who will be speaking at Business of Biosimilars in September.

Economist Alex Brill mentioned in his testimony that "a properly designed pathway for biogeneric entry will, over time, lead to additional market entrants, lower prices, increased access to drugs and a few billion dollars a year in reduced spending."

Take a look at the full post at Patent Docs to see the rest of Mr. Brill's testimony.

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.


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Friday, July 17, 2009

14th Annual Summit on the Medicaid Drug Rebate Program

For fourteen years, IIR’s MDRP event has been at the forefront of policy changes and operational compliance. This year, President Obama’s budget proposals contain provisions that will directly impact Medicaid Rebate processes.

Can you afford to wait and see how sweeping reform will impact your business?

The MDRP summit provides a strategic action plan that will position your organization to weather increased oversight of the OIG and respond to sweeping regulatory reform, as well as the other pricing related legislative proposals that have the potential to impact your job.

Change has come to Washington and there is no doubt there will be changes to both Medicaid and Medicare which will directly impact Medicaid Drug Rebates. Join us in September, for a keynote presentation from a key architect in the congressional reform proposals, Senator Tom Daschle, as he shares his of how the proposed changes on Capitol Hill will impact the pharmaceutical industry and Medicaid Drug Rebates.

Visit our website www.medicaiddrugrebates.com for what else is new at the 2009 MDRP.

We look forward to greeting you again in Chicago this September!


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Thursday, July 16, 2009

Global Congress on Comparator Studies

This is a reminder that the Global Congress on Comparator Studies conference kicks off on Monday in Philadelphia. There is still time to register if you’re interested in integrating a comprehensive blueprint for your comparator studies. Get your comparator studies up to standards before the new administration mandates it.

A selection of confirmed attendees:
Allergan Inc * Almac Clinical Services * Bernstein CMC Regulatory Consulting * Celgene * Cerexa Inc * Eli Lilly & Co * Facet Biotech Corporation * Farma Mondo SA * GlaxoSmithKline * Hospira Inc * Human Genome Sciences Inc * Merck & Company Inc * Multipharma Inc * Mylan Pharmaceuticals Inc * Myoderm Medical * Pfizer * Schering Plough Corporation * Takeda Pharmaceuticals North America Inc * Wyeth Pharmaceuticals

Global Congress on Comparator Studies 2009 is offering a terrific three day conference to amalgamate with industry thought leaders, network with colleagues and develop relationships with industry professionals. Join us to hear insight into how industry leaders are minimizing operational, regulatory and financial risks.


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Views on the exclusivity period of biogenerics

Bio and GPhA have released statements about the twelve year exclusivity period that was amended by the Senate Committee on Health, Education, Labor, and Pensions (HELP) for biologics last week.

Bio stated “the HELP Committee has embraced our long held belief that a minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of expanded competition.”

GPhA President and CEO Kathleen Jaeger claimed that her company would “continue to fight in the House to ensure a true balance is achieved between innovation and competition.”

For a more in-depth look at the reactions, read here.

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.


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Wednesday, July 15, 2009

Business of Biosimilars Event

The biosimilars debate is intensifying with Ted Kennedy’s new proposed legislation for 13.5 years of data exclusivity for biologics – almost double the time period proposed by the Obama administration. With the cost of US biologics already topping $60 billion and rapidly growing, there is increased pressure to approve a regulatory pathway for biosimilars.

Are you prepared to compete in this complex and controversial environment? The Business of Biosimilars Event will help answer your key questions and address the risks and rewards of entering into this dynamic market.

*Understand current legislation & regulatory developments

*Evaluate exclusivity periods and their impact on competition

*Prepare to overcome regulatory challenges with insights and updates from a former FDA representative

*Examine the current regulatory pathway in Europe with case examples of approved biosimilars and developments from the EGA

To view the full agenda click here!

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MDRx Physician Relationship Management next week!

In a little less than ONE WEEK, an all-new physician marketing and sales conference will be right in your backyard - Have you signed up? The Physician Relationship Management Event, July 20-21 in Philadelphia, is designed to help you better understand today’s healthcare professional by leveraging multi-channel strategies to earn access and achieve measurable impact.

This unique and comprehensive program is packed with interactive think tanks, dynamic panel discussions, and thought-provoking case studies. Don’t miss your opportunity to:

• Gain insight into how physicians are trained, work and think to improve sales team interactions
• Work in executive-led work groups to develop key physician relationship strategies
• Improve satisfaction with your brand by optimizing your physician channel mix
• Better understand and responsibly adapt to the changing regulatory landscape
• Create customized education initiatives tailored to today’s physician
• Engage effectively and compliantly in social media initiatives

And that is just the beginning. Visit the website for the complete speaking roster and session descriptions.

In this economy, idea exchange and innovation is vital to compete. Brainstorm new possibilities and walk away with clear strategies to optimize your online and offline initiatives to extend physician reach Secure your spot today by registering with code Twitter20 and save 20%.


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Monday, July 13, 2009

Countdown to Green Pharma

The latest LinkedIn Update for the Green Pharma Summit LinkedIn group went out this morning! As we're gearing up for the event next week, we thought you'd like to know what will be happening at the event! If you'll be at the event, use #greenpharma when you Twitter so we can follow along with you at the event!

Read the newsletter here:
http://www.iirusa.com/upload/wysiwyg/New%20Media/LINewsletter071009.htm


The Green Pharma Summit is about how Pharma is going green. Pharmaceutical companies are discovering that going green is not just for altruistic reasons, but that going green actually has benefits to the bottom line. Going green saves and makes money. If you'd like to network with other professionals who are working in the Green Pharma field, join our Green Pharma LinkedIn Group!


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Friday, July 10, 2009

Explore mission critical vaccine development updates

The recent H1N1 flu pandemic has further illustrated the necessity to quickly develop vaccines in response to a global health crisis. The Vaccines Development Forum has added all new content to address rapid vaccine product in response to the world’s current pandemic. Explore the most mission critical updates and advances in the H1N1 flu vaccine rapid development with case studies and expertise from The National Institute of Health, GlaxoSmithKline, Vical, and CSL Limited.

Register today to get real time access to the industry’s response to the latest global health crisis and cutting-edge case studies on developing innovative and profitable vaccines to shave years off of your vaccine development timelines.

To connect with more professionals in the Vaccines field, join our Vaccines Development Forum Group on LinkedIn or join us in Boston September 23-25 for the Vaccines Development Forum.


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Thursday, July 9, 2009

Biotech Drug Copies Could Be Held Up 13 Years Under Senate Plan

Catherine Larkin of Bloomberg.com reports that Biotechnology drugs made by Amgen Inc. and Biogen Idec Inc. couldn’t be copied and sold for lower prices for 13 1/2 years after they’re marketed, or twice the time urged by President Barack Obama, under a Senate proposal...Generic copies of these treatments are needed to help cut costs in the overhaul of the nation’s $2.5 trillion health- care system, according to Obama.

In an email to Catherine Larkin, Katie Huffard executive director of the Coalition for a Competitive Pharmaceutical Market, a Washington- based organization of employers, insurers and consumer groups that have lobbied for generic drugs, said “At a time when policy makers are looking to lower health costs so more Americans can afford care, Senator Kennedy and others want to go in the opposite direction by keeping monopoly pricing."

What do you think about this issue? Will biosimiliars eventually have to wait 13 years?


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Wednesday, July 8, 2009

Drug approvals in Europe

The Life Science Leader has a new article out about the challenges to getting drugs approved in Europe. It can often take years to get a new drug to the market, from finding the right molecule to fully adhering to the regulatory environment.

Some of the challenges laid out by the article include:
- Need for a Transatlantic Regulatory Integration
- Urgent Need for Developing a Sentinel Network for Enhancing Drug Safety Landscape
- Need for Fast-Tracking Framework

The article calls for a global initiative to design and evaluate clinical trials. Read the full article here. What do you think?


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Tuesday, July 7, 2009

Pharma 2020: Challenging business models - Which path will you take?

I came across this great publication from PricewaterhouseCoopers that takes a look at the main trends dictating the need for a more collaborative approach for Pharma 2020. The paper also evaluates the advantages and disadvantages of the alternative business models and how each stands up against the challenges facing the industry. Take some time to read this 15 page report as I am sure you will find it informative. Enjoy!


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Value-Driven Pharma

The 2009 Value-Driven Pharma Conference is the first and only conference focusing specifically on the paradigm shift in payors’ criteria on placing value on drugs. This program was created directly through insight and feedback from professionals in both pharma and payor perspectives relating to value-driven drug benefit design and the changes the pharmaceutical industry is undergoing as a result.

With this, we have been able to develop a program packed with discussions on how to productively respond to the changing economics of drug “value” metrics to remain competitive. Extend your company’s reach – attending Value Driven Pharma will give you access to the industry’s motivators and influencers. The distinguished speaker faculty features:

• Tom Daschle, Former Senate Majority And Minority Leader, UNITED STATES SENATE
• Allan Korn, MD, FACP, Chief Medical Officer and Senior Vice President for Clinical Affairs, BLUE CROSS BLUE SHIELD ASSOCIATION (BCBSA)
• Edmund Pezalla, MD, MPH, National Medical Director For Pharmacy, AETNA PHARMACY MANAGEMENT
• Luis T. Gutierrez, Jr., President, Commercialization Services, COVANCE INC
• Cynthia J. Pigg, Executive Director, ACADEMY OF MANAGED CARE PHARMACY
• Art Small, MD, Director, Value Based Healthcare, GENENTECH INC
• Lida Etemad, PharmD, MS, Senior Director, PDL Development, UnitedHealth Pharmaceutical Solutions, UNITED HEALTHGROUP

If you are interested in joining a group of professionals focusing on Value Driven Pharma, follow us on Twitter or join our LinkedIn group.


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Monday, July 6, 2009

Prototype for biobanks being developed in Europe

According to Genome Web, the EU has just finished reviewing 300 biobanks, and will now take this to develop a prototype for an international biobank system. The Biobanking and Biomolecular Resources Research Infrastructure will put this in place for all of the European biobanks which consists of 51 institutions and 190 associated organizations. They hope to have this completed by 2010. Read the full article here.

If you're interested in networking with other professionals in the biorepository field, join us here at the Biorepositories LinkedIn Group!


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Thursday, July 2, 2009

Vical's H1N1 vaccines tested

According to SignOnSanDiego.com, Vical has tested their H1N1 flu vaccines on animals, and found the tests to be successful. Their delivery method is unique, injecting genetic material, such as DNA or RNA, that expresses a protein that induces an immune response. This method is successful on animals, but has not yet been marketed for humans.

The Vaccines Development Forum has released their updated agenda, which includes new sessions that will specifically discuss how the vaccines field is responding to the need of rapid vaccine development for the H1N1 vaccine. Check out the PDF here.

To connect with more professionals in the Vaccines field, join our Vaccines Development Forum Group on LinkedIn or join us in Boston September 23-25 for the Vaccines Development Forum.


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Wednesday, July 1, 2009

Morphotek working with Synageva BioPharma

The Philadelphia Business Journal reports that Morphotek Inc. said Wednesday that it will collaborate with Synageva BioPharma Corp. on the development of therapeutic monoclonal antibodies for the potential treatment of various forms of cancer and infectious disease.

Terms were not disclosed.

Exton, Pa.-based Morphotek, a subsidiary of Eisai Corp. of North America, said Synageva will use its proprietary Synageva Expression Platform.

Morphotek specializes in developing treatments for cancer, inflammation and infectious disease.


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