Generic Biotech is Coming to the US

This post on the Wall Street Journal blog discusses that soon enough generic biotech drugs will be coming to the US. This is evident with the latest deal with Mylan, a Pennsylvania based generics shop, and Biocan, an Indian biotech company.

Manufacturing generic drugs can be tricky, especially in terms of cracking the market for generic biotechs in a developed country like the US. This is why the partnership with an Indian firm makes sense. Soon enough we should see other companies following this trend.

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Could drug delivery methods prevent prescription abuse?

In an article at PharmTech, they look at how changing drug delivery methods could prevent prescription drug abuse. While changing the drug delivery method could stop abusers from taking the prescriptions, it would allow the doses to be available to those who still needed the drug therapies.

Erik Greb looks at how one company appears to be on the right track for this: Atlantic Pharmaceuticals (Atlanta, GA) wants to use its Smart/Script oral delivery technology to deter oxycodone abuse. Loading a drug into the Smart/Script technology renders it noncrushable and nonextractable in common injectable solutions, according to the company’s website. Smart/Script protects the drug until it reaches the gastrointestinal system, where it is released.

Do you think companies should work on changing drug delivery methods to prevent drug overdose?

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Exclusivity period for biologics

Obama believes that biologics should be able to face competition after seven years on the market instead of 12-14.

Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget wrote a letter to Rep. Henry Waxman stating

"Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs."

Read the full article here.

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Big Pharma will donate H1N1 vaccines

According to Pharmaceutical Technology, Sanofi-Aventis will donate at least 100 million doses of the H1N1 vaccine to the WHO for developing countries. Once production of the vaccine begins, they will also save 10% of production for developing countries.

The WHO responded:
"It is gratifying that vaccine manufacturers are demonstrating their solidarity with the WHO in protecting the health of the world's poorer people: influenza knows no boundaries and so to protect people in one country is to protect us all."

Read the full article 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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First Ever Biosimilar Approved in Japan

This post on GEN News discusses how Japanese regulatory authorities have approved the first ever biosimilar, and it is Sandoz biosimilar recombinant human growth hormone somatropin. This comes after Japan released guidelines for national regulatory of biosimilars that mimicked the EU's existing process.

The product will be marketed in Japan as Somatropin BS.C. Injection 5mg/10mg. This Sandoz biosimilar was previously approved in the US and Europe in 2006, but only approved in Japan now.

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Protein Sciences Corporation receives contract to make vaccines

The US Department of Health and Human Services has awarded Protein Sciences Corporation a $35 million contract to produce a swine flu vaccine. This method may be able to produce vaccines faster than the normal methods by looking into more advanced methods of production.

Secretary Kathleen Sebelius said:
“The technology has advanced in recent years to a point that we believe it could help meet a surge in demand for U.S.-based vaccine for seasonal and pandemic flu. We want to use the technology to help our nation respond to emerging infectious diseases.”

Read the full story 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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Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation

According to Patent Docs, "six of the top ten selling drugs by 2014 will be biologics. Today, half of the top ten best-selling drugs are conventional small molecule drugs, as shown in the table below; in terms of sales, these drugs account for about 61% of the revenues garnered by the top ten best-selling drugs."

Check out the chart : Top 10 Drug Products by Sales in 2008

But by 2014, the number of drugs sold that are biologics "are predicted to account for a 75% of the revenues, an almost 2-fold increase in the relative contributions of biologic drugs to the sector."

Check out the chart: Top 10 Drug Products by Sales in 2014

According to the article, "some traditional Big Pharma companies stand to benefit from their association (partnering) or acquisition of biotechnology companies, with Roche being a clear example as purveyors of three of the top ten predicted best-selling drugs in 2014."

For more information, please click here.

Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation

Gather with other professionals to discuss the emerging trends in Pharma, including biopharma strategy, R&D, product marketing, clinical studies-- join Future of BioPharma, today!

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Looking at the quality adjusted life year

Michael Hiltzik of the LA Times recently took a look at a health plan that would look at the comparative effectiveness of drugs based on the length of treatment that might extend someone. So how would this cost effectiveness work? The NICE came up with a measurement known as QALY. This system looks at the length of time a person's life is extended as well as the quality of life they would have. It is measured on a scale from 0(death) to 1(complete health).

However, Haltzik brings up the fact that there would be a few downfalls to this system: 1) Society's aversion to placing a monetary value on life, 2) The lack of empirical basis for 30,000 pound standard and 3) Whose values are being measured, the patients, community or public?

Read the full article here. 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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Delivery of Biologics & Beyond

According to forecasting firm EvaluatePharma, six of the top ten drugs and half of the top 100 drugs in 2014 will be biologics. Predictions for biologic blockbusters include products from Roche, Wyeth, Amgen, Abbott, J&J and Schering Plough, with the top selling product being Roche’s anti-cancer antibody drug Avastin at $9.2 billion in annual sales. This analysis shows overwhelming evidence on how important biological drug development is to pharma pipelines. Pharmaceutical companies need faster and more efficient ways to formulate biologics and to further expand pipelines and competitive advantages with needle-free delivery.

Delivery of Biologics & Beyond, taking place September 23-25th in Boston, brings together senior-level scientists and technology/product developers to share the newest advances and address your most pressing challenges in formulating and delivering biologics and nucleic acids. Explore the latest case studies, discover the drug delivery technology advances for needle-free delivery of large molecules, and establish what technologies hold the most promise for advancing your biologics and RNAi pipelines.

If you'd like to network with other individuals in the space of Biologics, join our LinkedIn group here.

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The Pharma Industry and Energy Usage

Pharmaceutical companies implementing environmental sustainability initiatives stand to gain immediate cost savings. These savings will not take years to appreciate; tremendous cost savings can be seen within the first 12 months. Here’s a snapshot of just some of the cost savings pharmaceutical companies have experienced in their first year of initiating sustainability programs:

• A pharmaceutical company making a strong move towards green chemistry has the potential to see up to a 40% hazardous waste reduction in one year.
• AstraZeneca’s green chemistry efforts have lowered their material and energy costs, reducing the cost of API generation by 80%
• Baxter’s EHS programs have generated cost savings of $4.4 million
• A recent in-depth analysis of Novartis’s energy efficiency and waste reduction programs have shown that the $20 million dollar investment was recouped in 10 months
• Novartis’s energy efficient pilot project for Penicillin V production has delivered annual cost savings of $5.1 million

In such troubling economic times, the millions of dollars in cost savings through going green will have a tremendous impact on your company’s bottom line and with shareholders. The Green Pharma Summit gathers the pharma industry’s green leaders, who will share with you successful strategies to implement sustainability programs so that your company can start benefiting from cost savings and efficiency improvements right away.


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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Big Pharma gets green kudos for carbon-tracking

Posted on Carbon Offsets Daily, Climate Counts recently released a scorecard for pharma. Great news, pharma outscored media on a one-to-100 scale, with higher scores indicating greater commitment to the environment, top drugmaker AstraZeneca tallied a 76, with Johnson & Johnson on its heels at 75. Twelve more pharma companies scored 50 or higher. By contrast, top-scoring media firm General Electric (which owns NBC) boasted a 71, and second-placer News Corp. got a 63. In third place, Disney came in with a measly 25.

Because AstraZeneca scored so highly, do you think other organizations in Big Pharma will follow?

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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Waxman pushes for biosimilars approvals now

Congressman Henry Waxman thinks President Obama should begin approving biosimlars before the bill passes. In his bill, he believes that biosimilars should have an exclusive five year exclusivity for biologics.

In a letter to the president, he wrote, "I urge the administration to consider what steps can be taken under existing authority to prepare and even begin to use a pathway for generic biologics."

Read the full story here.

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Swine Flu now pandemic, race for vaccine is on

An article at Yahoo! last week looks at how drug makers are racing to come up with the vaccine to prevent the swine flu. GlaxoSmithKline has stated its vaccine will be ready to go into large scale production within weeks. Sanofi-Aventis has also started working on their vaccine. Novartis' vaccine has yet to be tested on humans.

One concern for individuals around the world is how developing countries will obtain access to these vaccines. Countries with lots of available capital have already signed contracts with major Pharma, guaranteeing that their citizens will have access to the flu vaccine. Many poorer countries, who usually have poor healthcare systems, will be left in a scramble to find vaccines for their countries.

The WHO believes that the swine flu vaccine will be approved and ready for sale by September. For more information, read the full article 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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Innovative Clinical Trial Design and Management

The pharma industry is continually exploring new ways of improving drug developments and one area of focus is adaptive clinical trial designs. These innovative designs use accumulating data to guide potential modifications to the study as it progresses, without undermining the validity and integrity of the trial. The advantages of such designs include the reduced length and cost of clinical trials, lower patient numbers and the ability to stop a trial early where a drug has not shown efficacy.

'Innovative Clinical Trial Design and Management' published by Business Insights explores the major types of adaptive design and their role in dose-finding. The report investigates seamless Phase 2/3 trials and adaptive trials in pharmacogenomics, assesses the logistical implications of adaptive trial implementations and reviews the current regulatory standpoints of the FDA and EMEA. Detailed case studies of recent adaptive clinical trials are provided and the companies offering statistical expertise in this area are profiled. This report also includes a breakdown of potential cost and time savings offered by innovative designs throughout the clinical development process.

The globalization of clinical trials has arrived. As you know, the increasing use of comparator studies means that you’re playing by a new set of rules. At this critical junction, you can either evolve in 2009 to stay ahead of the curve or choose to play catch-up and try to deal with the challenges as they arise. The Global Congress on Comparator Studies conference gives you the unique opportunity to get ahead of the industry and establish your strategy for sourcing comparators and overcoming regulatory challenges in just two days.

Send an email here to find out how you can order this report and receive a 15% discount.

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Meetings Drive Business

This is why companies need to continue to invest in business meetings. Not only will those who attend gain new and fresh perspectives from other attendees, but they'll hear from top companies who have lived by the same philosophy. Investment in yourself and innovation are the key to your business. What have you done recently to invest in your business?

Do you plan on attending any of the Pharma conferences we have coming up such as Green Pharma, MDRx or Global Congress on Comparator Studies? What would you look to gain from those experience?

Meetings Drive Business

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Vaccines Studies open to developing countries

According to an article at Fierce Vaccines, the University of Sienna and Novartis Vaccines and Diagnostics will be partnering to educate and develop vaccines for the developing world. Groups of doctors, largely from African and Asian countries, will team together to figure out what is best when it come to developing vaccines in their country such as:

Key factors like engineering a vaccine's resistance to high temperatures and use of local storage facilities would be built into the research programs, pushing the researchers to come up with treatments that are ideal for that environment. And these new experts on vaccine development will be free to work with any developers.

Professor Ranuccio Nuti, coordinator of the Technical-Scientific Committee states:
"Clinical research and development of vaccines, along with immunology, infectivology and biostatistics, are some of the core subjects that will be addressed during the program. Our aim is to provide these medical professionals with the knowledge necessary to meet the demands arising in the area of neglected diseases as well as to prepare them to react proactively to situations such as the recent outbreak of the H1N1 virus in Mexico."

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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Sustainable Syntheses

Ann M. Thayer of Chemical and Engineering News reports that pharmaceutical and fine chemicals manufacturers will see benefits if they begin developing greener processes. According to her article, "Process chemistry and green chemistry have common goals: generating less waste and emissions, minimizing material and energy use, and operating more safely under more benign conditions. Greater attention to reagent, solvent, and reaction choices by these chemists is making process development even greener."

By sharing their knowledge of green practices with pharmaceutical industry, pharma may learn new processes that could save more than just a few dollars.

Sustainable Syntheses



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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New Law Restricts Financial "Gifts" to Medical Professionals

According to this article in TimesArgus a new law which will come into effect on July 1st will restrict almost all forms of financial contributions between drug makers and physicians that prescribe the medication. This has come into effect after evidence was found that these gifts heavily influence the prescribing patterns of doctors. Representatives from pharma companies oppose the law, stating that these relationships between interactions with doctors and prescribers are necessary to explain new treatments and medication. What are your thoughts on this?


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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AARP calling for legislation on Biosimilars

In a recent article at the American Medical News, the AARP is reminding Congress of the rising prices of drugs and the toll it is taking on seniors that rely on the Medicaid Part D as their insurance. The high prices are causing people to alter their dosages due to the high costs of the drugs, especially after these individuals fall into the "doughnut hole". They believe that bringing biologics to the market will allow those taking medicine to save money. The poorer subscribers to Medicare Part D, about four million beneficiaries, don't have to worry about this. AARP is calling for the lawmakers to expand the gap and allow more subscribers to fall into this category. Read the full article here.

The AARP will also be joining us at this year's Business of Biosimilars event, presenting "Main Street Perspective: What Patients and Consumers Want from Biosimilars and Biogenerics." If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.

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CROs 2009 Workshop Video

For those who missed the workshop last month in Orlando, we are providing unlimited access to this timely workshop to all Partnerships attendees and their colleagues. And since we understand your training and travel budgets are limited at this time, this video workshop is completely free of charge.

Simply click the link below to watch the video at your leisure, and feel free to pass along to your CRO colleagues.

http://www.iirusa.com/cropartners/BDWorkshop.xml

If you are in business/corporate development, sales, marketing, client relations, account management, operations or project management at a CRO or other outsourcing provider, this video workshop will help you achieve your professional development goals including:

• Demonstrate value to Sponsors who are increasingly pushed to make decisions based solely on cost
• Understand how downsizing in pharma will make micro-managing a thing of the past as CROs take over as the ‘doer’
• Access the right people (decision makers) in an organization to approach for new business opportunities -- and getting them to return your call
• And much more....

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Vaccine Shrinks Tumors and Slows Recurrence in Skin Cancer

According to this article in ABC News researchers have created a vaccine that shrinks tumors and cuts the chances of the disease ever returning again. In a recent clinical trial, more than half of the patients who got the vaccine saw their tumors minimize in size compared to those you didn't receive it. This is one of the first "promising" cancer vaccines. Take a look at the full article 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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Biosimilars proving to match regular drugs

At Pharmacy Europe, they look at the results of the biosimilar epoetin zeta, which was tested against epoetin alfa.

The results were as follows:
A study was performed to assess these different product formulations by using and comparing an array of analytical techniques for product characterisation, including reversed-phase high-performance liquid chromatography (RP-HPLC). The RP-HPLC analysis demonstrated that the presence of polysorbate 80 in the formulation of epoetin alfa caused considerable peak interference, with chromatograms of epoetin alfa samples showing greater fragmentation of the main epoetin peak compared with epoetin zeta. The epoetin zeta formulation offers some advantages over epoetin alfa in terms of the drug product analysis performed according to the methods used in this study.

This could be further proof that biosimilars are a viable alternative for patients. Read the full article here.

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

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