ARCA Biopharma May Patent Methods to Treat Heart Failure

Colorado-based ARCA Biopharma has been given a "notice of allowance" by the U.S. Patent and Trademark Office for some methods to treat heart failure patients, officials for the biotechnology company announced Monday. Dailycamera.com reports that ARCA submitted the patent application, “Methods for Treatment with Bucindolol Based on Genetic Targeting,” to help the company in its genetically targeted therapies for patient with heart failure and other cardiovascular conditions.

Learn more: Broomfield-based ARCA Biopharma on verge of patent approval

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WSJ: Bristol-Myers Squibb Announces Split-Off Of Mead Johnson

The Wall Street Journal reports that drug giant Bristol-Myers Squibb Co. said on Sunday it would split off its Mead Johnson Nutrition Co. business so that it can focus on its bio-pharmaceutical business.

Under the terms of the deal, New York-based Bristol, which has an 83% economic interest in Mead, will give Bristol shareholders roughly $1.11 in Mead shares for each $1 in Bristol shares they tender. The ratio will be determined by a 10% discount to the daily volume-weighted average prices of Bristol-Myers Squibb and Mead Johnson common shares over a three-day period in early December.

New York-based Bristol said the deal, which it expects will be accretive to earnings per share beginning in 2010, is part of its divestment strategy that would allow it to transition from a traditional drug company into a biopharmaceutical company.

For more information about this story, please click here.

Bristol-Myers Squibb Announces Split-Off Of Mead Johnson

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Glaxo Wins FDA Approval to Sell H1N1 Vaccine

NBC reports that Glaxo has won FDA approval to sell the popular H1N1 vaccine. The British company said on Tuesday the Food and Drug Administration had approved a modified version of its FluLaval seasonal flu vaccine containing the new H1N1 strain.

The green light clears the way for it to fill a order for 7.6 million doses from the U.S. government.

We, as always, would love to hear your thoughts.

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Nabi BioPharm Begins Study on Nicotine Vaccine

Nabi Biopharmaceuticals announced that it is participating in an investigator initiated Phase IIb study to evaluate the safety and efficacy of NicVAX(R) (Nicotine Conjugate Vaccine) when co-administered with varenicline as an aid to smoking
cessation and relapse prevention. This study will be conducted by The Research
School CAPHRI of the Maastricht University Medical Center in Maastricht, The
Netherlands and will be funded primarily by The Netherlands Organization for
Health Research and Development and Maastricht University with Nabi providing
some additional support.

"In our proof-of-concept trial, NicVAX demonstrated that high levels of
anti-nicotine antibody in response to NicVAX immunization increases the ability
of smokers to quit smoking and remain abstinent," said Dr. Raafat Fahim,
President and Chief Executive Officer of Nabi Biopharmaceuticals.

For more on NicVax, please click here.

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Complimentary Webinar Archive Available: Overcoming the Challenges of Government Pricing, Compliance Reporting and Medicaid Rebate Processing

About the web seminar:
All pharmaceutical product manufacturers who sell to various agencies of the federal government and/or who participate in Medicaid, 340B, Medicare or other public sector reimbursement programs face significant requirements and challenges with respect to their government-mandated pricing calculations and compliance reporting processes. Huge penalties and fines can be levied for miscalculating or incorrectly applying the various government price types to government-contracted sales and/or for compliance reporting mistakes.

The Seminar will address the complexities and challenges associated with automating Government Pricing and Medicaid Rebate system(s) as well as the pros and cons of using a packaged-software approach versus a custom-development approach. An overview of a leading-edge enterprise solution, developed as a fully-integrated component of the SAP® Enterprise Resource Planning (ERP) System, will be presented, accompanied by a live software demonstration and followed by a Question & Answer discussion of the issues.

What you will learn:
• An appreciation of the historical and legal background and context for the government-mandated price calculations and compliance reporting requirements;
• An understanding of the various price types that must be calculated, used in sales transaction processing and reported under each corresponding government program;
• Why automating and managing these processes using a packaged solution, based upon a fully-integrated enterprise architecture, is the lowest risk and lowest Total Cost of Ownership (TCO) approach;

About the speaker:

Sanjay Shah, C.P.A., is the President/CEO and Chief Solution Architect of Vistex, Inc., a global SAP Software Solution Partner.

Prior to founding Vistex, Mr. Shah spent several years as a Platinum Consultant in SAP America’s Professional Services Organization and in SAP AG’s Product Development Organization. That experience provided him with a comprehensive and unique understanding of the functionality gaps in SAP’s “core” offering as well as SAP’s product development strategy. Mr. Shah also worked in finance/accounting management at a major global manufacturing company.

Complimentary Archived Recording

https://www1.gotomeeting.com/register/286708561

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Biopharm Regulatory Reform Summit

Biopharm Regulatory Reform Summit

December 2-3, 2009 - Washington, DC

Impending legislation coupled with new FDA initiatives, leave many companies wondering what to expect as we head into 2010. Biotechnology and Pharmaceutical corporate decision-makers are seeking guidance on what they can do now to protect their business model in the short term and ensure its sustainability in the long term. The BioPharm Regulatory Reform Summit, held in Washington D.C. on December 2nd & 3rd, brings together the FDA, the Biotechnology Industry Organization, the Agency for Healthcare Research and Quality and other senior industry executives to create a strategic action plan for 2010 to effectively respond to healthcare reform and the changing political and economic landscape.

Event Site: http://bit.ly/4EUQd0
Brochure: http://bit.ly/16q73f
Registration: http://bit.ly/2BOKUb

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PanThera Biopharma wins $1.6 million contract for botulism antidote research

Honolulu Advertiser reports today that The Department of Defense has been awarded a one-year, $1.6 million contract to Honolulu-based PanThera Biopharma for research into a small molecule antidote to treat botulism, the company announced today.
Advertisement

Medical countermeasures against botulism are biodefense priorities for protecting both military and civilian populations against bioterrorism, PanThera said on its Web site.

PanThera said its objective is to create a medical solution that is affordable, easy to use and store for stockpile.

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Europe's Top 5 Biotech Hotspots

Fierce Biotech has compiled their list of the top 5 biotech hotspots in Europe.

They are as follows,

• United Kingdom

• Norway

• Sweden

• Germany

• Czech Republic

From Fierce Biotech:

This year, for the first time, FierceBiotech looked into the development scene solely in Europe to see which countries have hatched the best programs to support drug discovery and innovation. That doesn't mean simply listing the largest clusters. Switzerland has had one of the best track records in Europe for developing a homegrown drug development industry, but it's done it all with private capital and virtually no public support. Eastern European countries which have been late to the biotech party have the furthest to go to catch up. But in places like the Czech Republic and Hungary they're pushing ahead quickly, anxious to leapfrog into the global mainstream. All of these project initiatives bear close observation in the U.S., where public support for biotech has been a prominent feature in a slate of key states.

For more information about the countries chosen by Fierce Biotech, please visit the article.

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Keryx Biopharmceuticals Announce Phase 2 Study of Single-Agent Cancer Treatment

RTTnews.com announced today that Keryx Biopharmaceuticals Inc. has announced updated clinical results from a Phase 2 study of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, as a single-agent treatment for advanced metastatic renal cell carcinoma or RCC.


Keryx Biopharma Announces Updated Clinical Results From Phase 2 Study Of KRX-0401 - Quick Facts

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Can-Fite Announces Positive Results from its Psoriasis Phase II Trial with CF101

Reuters reports that those who suffer from Psoriasis may soon have relief. Can-Fite BioPharma, a biotechnology company traded on the Tel Aviv Stock Exchange, an Israeli Biopharmaceutical company, announced today that its 75-patient Phase II clinical study with CF101 to treat patients with moderate to severe Psoriasis has successfully met its primary objectives.

Patients in this double-blind study were randomly assigned to 1, 2 or 4 mg of
CF101 or placebo twice daily. The drug was taken orally as a monotherapy for 12
weeks.

Dr. Michael David, Head of the Department of Dermatology, Rabin Medical Center,
the study principal investigator said: "The study data is impressive and
promising. CF101 is a unique small molecule orally bioavailable drug with an
impressive safety profile based on accumulated experience in more than 700
patients. There is a market need in Psoriasis for small molecule drugs and I am
confident that Can Fite should progress with the clinical development of CF101
based on the study data."

For more information, please visit the original article.

Can-Fite Announces Positive Results from its Psoriasis Phase II Trial with CF101

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Biologics and RNA Drug Delivery LinkedIn Group Newsletter

Welcome to the August edition of the Biologics and RNA Drug Delivery LinkedIn Group Newsletter. This month, we’re looking at the latest news in the industry and preparing for the Biologics and RNA Drug Delivery Conference in Boston at the end of September! See the bottom of the newsletter for an exclusive discount for you, the LinkedIn Group members.

We have some exclusive video from last year’s Drug Delivery Partnerships event on the future of drug delivery in the pharmaceutical and biotech industry, and the importance of increased pipeline innovation.

Click here to watch it:

http://bit.ly/tu8I1


We invite you to participate in the following discussion question:

What needle-free biological delivery mechanism do you think holds the most promise for improved patient adherence?

http://bit.ly/1a24pS


We also have Twitter! Be sure to follow us for the latest news in drug delivery

http://www.twitter.com/drugdeliveryiir


There are industry breakthroughs in Biologic & RNA drug delivery every day- and we hope that you use this group to keep on top of them! Read on for some of the latest headlines in the drug delivery space:


Protein therapeutics worth $77bn by 2011, says RNCOS

http://bit.ly/dEAkb


Microneedle patch could boost compliance

http://bit.ly/zjPaB



New liquid protein tech could improve drug delivery

http://bit.ly/Sggh6



RXi presents RNA delivery data

http://bit.ly/ES5Lc



Researchers target siRNA delivery

http://bit.ly/vaHWL



We’re gearing up for the Biologics & RNA Drug Delivery event, taking place September 23-25 in Boston, MA. As a member of this LinkedIn group, we’re offering you an exclusive discount of 20% off when you register for the event using the discount code XP1412LINK. To find out more about the conference, download the brochure here:

http://bit.ly/ezMgy


Cheers,

The Biologics Drug Formulation, Development & Delivery Professionals Team

http://bit.ly/4009b5

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Cloud Services for Biopharma R&D

Fierce Biotech reports today that Biopharma research and development organzations need to be mindful when purchasing a cloud computing service.

Cloud computing--a data-crunching force multiplier that allows companies to draw on resources across the Internet, either on the fly or as a dedicated service--is potentially disruptive to companies because it changes the dynamic of who owns the capital assets, turning traditional IT infrastructure models on their heads.

Be cautious, but be open-minded," says Rick Franckowiak, director for systems engineering at the Pharmaceutical Research & Development IT organization of Johnson & Johnson. Likewise: "Be careful," says Brian Boruff, vice president for cloud computing at systems integration consultancy Computer Sciences Corp., a cloud service provider.

Read more: Fierce Cloud Services for Biopharma R&D

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MONOVISC Approved for Canadian Market

Chris Reidy of Boston.com reports that Anika Therapeutics Inc. said it has received regulatory approval to distribute a treatment for osteoarthritis of the knee in Canada.

The treatment is MONOVISC, a single injection viscosupplement for the treatment of osteoarthritis of the knee, Bedford-based Anika said in a press release.

"MONOVISC has been broadly available in the European Union since the second quarter of 2008," said the Anika press release, which noted that the company is moving forward on its goal to receive approval for MONOVISC in the United States.

How long until the United States has MONOVISC available to patients?

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Biopharma is on the move this week

This recent post on CNBC discusses how there has many major moves in the Biopharma industry this week and this has been good for many that hold biopharma stocks. Some of the major moves in the biopharma space include the following:


Human Genome Sciences and Orexigen showed their Lupus and diet drug data.

Onyx Pharmaceuticals was a surprise guest with its mid-stage breast cancer results on Wednesday.

Celgene announced it had stopped a multiple myeloma study early because the drug appears to be working so well.

Will next week be just as exciting in the biopharma industry/

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Biopharma IPO Is a Healthy Sign

The Wall Street Journal reports today that Cumberland Pharmaceuticals had, by traditional standards, a poor initial public offering last week but a closer look at the offering shows success.

Cumberland's revenue grew 25% in 2008. It has another product coming to market soon that could redouble that growth. But 70 times earnings is a dizzying valuation all the same.

Cumberland's product portfolio makes the rich multiple all the more impressive. Its biggest current product, Acetadote, is an intravenous version of a drug treating Tylenol overdoses. The oral form of the drug is generically available. According to the prospectus, protection from competition comes not from patents, but from "trade secrets and proprietary know-how" as well as marketing exclusivity, granted by the U.S. Food and Drug Administration, that expires in 2011.

Will we see Cumberland's offerings pick up for the remainder of 2009 and early 2010?

Biopharma IPO Is a Healthy Sign

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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.


Join us on Twitter!

This is the global drug delivery partnerships meeting place, focusing on bringing together professionals seeking the latest strategies, industry updates, and networking opportunities to help position your company for a successful partnership/collaboration. Join us today!

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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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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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