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Friday, March 7, 2014

DRUG DISCOVERY & DEVELOPMENT


DRUG DISCOVERY & DEVELOPMENT Presents an Educational Webcast

11:00 a.m. ET; 8:00 a.m. PT • Wednesday, August 28, 2013 • Duration: 1 Hour

REGISTER NOW

Bioluminescence

Webcast Spotlight

resonance energy

Join us and learn about:

transfer has been long established as

• Promega's novel NanoBRET™

the principal

technology using NanoLuc™

method to monitor

and HaloTag ®

dynamic protein-

• Application of NanoBRET™

protein interactions

for measuring protein-protein

in living cells. However, the

interactions in living cells

application of BRET

• The new CLARIOstar ® high

is in general

performance multimode

hampered by its

microplate reader

limited dynamic range due to the

• The revolutionary new LVF

poor spectral

Monchromator™ from BMG

separation of donor

LABTECH

and acceptor. In

• Wavelength scanning in

this webcast we will

luminescence assays

introduce

• How to enhance all of your

NanoBRET™ using a donor/accpetor

assays with the CLARIOstar ®

combination

microplate reader.

consisting of NanoLuc™ luciferase and Halotag ® labeling technology.

The superior brightness of NanoLuc™ makes it ideally suited as an energy donor for BRET applications and allows the use of a novel red-shifted Halotag ® ligand as acceptor. The resulting increase in spectral separation between donor and acceptor translates into significantly improved dynamic range compared to current Rluc/YFP based BRET technology, which makes NanoBRET™ more suitable for the development of HTS compatible cell based protein-protein interaction assays.

For the NanoLuc ® BRET assay, two emission signals need to be measured at two different wavelength ranges. To get the best performance in this assay, wider bandwidths are preferred. Therefore, microplate readers that used filters with wider bandwidths always performed better in this assay than those instruments that used grating-based monochromators, which have fixed or adjustable bandwidths of < 25nm.

Until Now.

This webcast will highlight the performance of the NanoLuc ® BRET Assay from Promega on the new CLARIOstar ® multimode microplate reader from BMG LABTECH. Among many other great features, the CLARIOstar ® has a revolutionary new type of LVF Monochromator™ that has adjustable bandwidths from 8 to 100 nm.

PANELISTS MODERATOR

Tim Studt

E.J. Dell, Ph.D.

Thomas

Editorial Director

International

Machleidt, Ph.D.

Drug Discovery &

Marketing Director

Head of Cell

BMG LABTECH,

Biology,

Development

GmbH

Advanced Technology Group Promega Corporation

REMINDER: Attend this live webcast and pose your critical questions to the panel of experts during the live Q&A session during the broadcast.

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Monday, January 6, 2014

Happy Holidays !!!

Happy Holidays !!! to Everyone and a Prosperous New Year 2014 !!!


We thank you for your support and we do not forget !!!

Tuesday, May 1, 2012

People & Power - Drug Money

Pharma Net Blogger

Investing in Pharmaceutical Companies

The pharmaceutical companies seem to be immune to the economic ups and downs that countries across the world go through. Illness and disease are an ongoing thing in life and it is due to this reason that the pharmaceutical companies have always been in business and were least affected by the economic ups and downs that have been experienced by different countries in the recent past. The global economies have been affected by recession, and most of the industries have been affected by the impact of recession. Banks have declared bankruptcy, automobile industry has got affected and even the service sector has laid-off so many people and this has all been a result of the recent recession.

However, the pharmaceutical industry has been able to sustain itself very well during all this time and continues to do so. Although e have seen mergers and acquisitions happening even in the pharmaceutical industry, yet the effect of recession on this industry has been much less when compared with the other industries.

For people thinking about investing in the pharmaceutical companies, there are a few pointers they might wish to know:

· Investing in this companies is not fool proof however if you compare it with any other industry, it would surely be rated as one of the most secure investments.

· Recession has not spared any segment or industry in the market today, each and every industry has felt the impact of the economic slowdown however all the different industries have felt the impact in varying degrees. The pharmaceutical industry has been affected the least but it too has not been able to totally escape the impact of recession.

· Illness and diseases are surely not affected by recession and that is one reason why the pharmaceutical companies have been able to comfortably sustain themselves during the economic slowdown. We have seen pharmaceutical companies merging and have also seen many people being laid off in this industry. Despite of these facts the pharmaceutical industry has shown less fluctuations in comparison to the banking and automobile industries.

· Investing in the pharmaceutical companies is still considered to be a very safe option in comparison to the automobile or banking sector. The reason for this is that the automobile industry has seen the shut down and merging of certain companies and the banking sector has seen the acquisition of many banks and also the filing of bankruptcy by some eminent banks in the past few years. While the pharmaceutical companies have also shown signs of being affected by the economic slowdown the magnitude of impact on pharmaceutical companies has been very low.

Keeping these few pointers in mind the general feeling in the investment market is that the pharmaceutical companies are a decent investment with safe return, especially in today's economically slow pace. Therefore most people are now skeptical about investing in other industries and choose to invest in the pharmaceutical companies so that they can experience the safety of their investment and not be bothered about a sudden shut down.

To find out more about investing in pharma companies you can go to http://www.medisan.com/. They also provide with many information and tips investing.

Article Source: EzineArticles.com

Are pharmaceutical companies using African babies as guinea pigs?-Africa Today-02-21-2012

Pharma Net Blogger

Major Pharmaceutical Companies

Pharmaceutical companies have a major social responsibility while performing on a profitable motive. Several public platforms are shared by major pharmaceutical companies for this very purpose.

The pharmaceutical industry has several issues to contend with for profitable survival. The United States does not have regulations for drug prices, but several other regulations monitor the functioning of pharmaceutical companies in the country. Fierce competition from illegal drug imports is also an issue that cannot be ignored by major pharmaceutical companies.

There are several associations that represent pharmaceutical manufacturers. The International Federation of Pharmaceutical Manufacturers and Associations is an organization that is at the apex. It is a non-profit and non-governmental organization. Its members are several research based pharmaceutical, biotech and vaccine companies from both USA and other countries as well.

Organizations such as these, work for a global policy environment that is conducive to innovation in the pharmaceutical field. A survey of major pharmaceutical manufacturers indicates that collectively the industry has almost 700 medicines in the pipeline. These medicines are aimed at providing relief to people suffering from various diseases like HIV/AIDS, cancer, heart diseases and stroke among others.

The existence of a platform like an international association provides opportunities to major pharmaceutical companies to have collaborative relationships among themselves and foster industry growth in such a manner that provides avenues for overall improvement in public health while being commercially profitable.

One of the major pharmaceutical companies is Eli Lily, a global player. Their specialties include drugs for cancer, cardiovascular diseases, neurological disorders, endocrinal disorders, diabetes and several infectious diseases. Cephalosporin, erythromycin, insulin and Prozac are among Eli Lily's major pharmaceutical breakthroughs. Pfizer is another major pharmaceutical company that has contributed a lot to alleviate human and animal suffering. Based in New York, Pfizer has been around since 1849.

Parke-Davis, Proctor & Gamble, Bristol-Myers Squib, Johnson & Johnson, 3M Company, Mars Incorporated, Bayer AG, Quest Diagnostics, Tyco International and Cardinal Health Incorporated are a few of the major pharmaceutical companies in the USA.

Pharmaceuticals [http://www.Pharmaceuticals-Web.com] provides detailed information on Pharmaceuticals, Pharmaceutical Companies, Pharmaceutical Jobs, Pharmaceutical Naming and more. Pharmaceuticals is affiliated with Mexican Online Pharmacy.

Article Source: EzineArticles.com

Bill Maher - Anti-Pharma Rant

Pharma Net Blogger

The Rise of the Indian Pharmaceutical Companies

The Indian Pharmaceutical industry is the 4th largest industries in the world. It consists of around 20,000 businesses. Pharmaceutical companies in India are on a roll both on domestic as well as international grounds. Pharmaceutical companies boast of skillful workforce along with the latest technology in use. These features help to expand their market and business overseas.

The latest trend in the pharmaceutical business is the tie-ups between Multi National Companies and Indian Pharmaceutical companies. These MNCs turn to their Indian counterparts to achieve cost-efficiency in terms of R & D. Besides offering skill and technology, offer affordable Research and Development facilities. For example, mergers and acquisitions between MNCs and Indian pharmaceutical companies are common for research on third world diseases like cancer, AIDS, etc.

Moreover, India is gradually moving up from being just a service provider to a value-add in profits. Here, MNCs purchase / license new products or share Intellectual Property. Pharmaceutical companies of India are slowly becoming a popular destination for collaborative research and development.

Adding to this is the success of the Indian pharmaceutical industry as an exporter of high quality generic drugs. The companies owe this success to the system of product patents which were introduced on 1stJanuary, 2005. Now, the Indian pharmaceutical industry exports drugs to approximately 65 countries around the world with the United States as its biggest market. The industry's export was worth US 3.75 billion dollars and growing at a compound annual rate of 22.7% according to the National Pharmaceuticals Policy for 2006.

However, the these companies can hope to achieve more by discovering untapped markets both in India as well as abroad. Another area that calls for attention is the Research & Development department. The government needs to invest more for Research & Development as innovative drugs are high on demand.

Also, the relationship between pharmaceuticals and biotechnology in India needs to be more cemented. This is because biotechnology has a lot of room for growth with the rise in vaccines and bio - services. Lacks of funding and skilled employees are the obstacles for the development of biotechnology in Indian pharmaceutical companies. However, a wind of change is expected as the drugs go off patent, giving the Indian pharmaceutical companies an opportunity to upgrade their manufacturing capabilities.

To conclude, the companies have a lot of potential in store. It is estimated that the Indian pharmaceutical industry will soon enter the top 10 list of the pharmaceutical industries in the world.

Pharmaceutical companies of India are growing its pharmaceutical business to keep the feet stuck in world pharma industry.

Article Source: EzineArticles.com

Swine flu win-win game for pharmaceutical companies

Pharma Net Blogger

Pharmaceutical Companies

Pharmaceutical companies are companies licensed to discover, manufacture and distribute pharmaceutical medicines or drugs. Currently there are about 200 major pharmaceutical companies in the world and some of them use biotechnology to produce drugs. This particular technique uses biological systems or living organisms to obtain derivatives. Drugs thus obtained are typically known as biopharmaceuticals, which are turning out to be another important aspect for the companies. In recent times technology has developed more efficient methods and informatics systems through which the companies study diseases that cause infections and other symptoms. This study is further used to invent new medicines by identifying active ingredients of traditional medicine.

Pharmaceutical companies have full-fledged laboratories that are equipped with latest infrastructure, wherein chemists and scientists work continuously to identify factors such as genetics and cellular structure that play an important role in various diseases. Establishing this facility is an expensive affair. The companies are required to have post approval, sales surveillance and a license from the government prior to clinical test of the drugs. Clinical testing involves three stages, of which the first stage determines the safety and tolerability of the drug. The second and third stages determine the effectiveness of these drugs. Extensive drug tests are done on animals before they are administered to humans.

Physicians play a major role in the sales of medicines of pharmaceutical companies. It is through their prescriptions, that medicines reach patients and have a potential for widening the market. Hence, these companies advertise and market their products to the physicians first. Pharmaceutical marketing is complex and requires indigenous discipline.

Some of the major pharmaceutical companies that are known all over the world are Pfizer, Glaxosmithkline and Sanofi-Aventis. These companies patent all their products, as the risk of forgery is substantially large in this field. Development in the field of medicine has enabled doctors to provide solutions for diseases, which were incurable earlier. Pharmaceutical companies play the role of lifesavers.

Pharmaceuticals [http://www.Pharmaceuticals-Web.com] provides detailed information on Pharmaceuticals, Pharmaceutical Companies, Pharmaceutical Jobs, Pharmaceutical Naming and more. Pharmaceuticals is affiliated with Mexican Online Pharmacy.

Article Source: EzineArticles.com

The real Drug Pushers (Pharmaceutical Companies)

Pharma Net Blogger

How Web Document Management Software Empowers Pharmaceutical Companies

In the pharmaceutical industry the clock is ticking at the rate of warp-speed "drug years." Pharmaceutical industries have 8 (possibly up to 12 years) to discover, conceptualize, define, develop and commercialize--as opposed to market--pre-market drug information. This process of course results in a financial tab of about $200-$900 million dollars--numbers that are subject to vary depending on your sources and on the amount of time taken for the various phases of drug development. At any rate however the monetary costs of a new start-to-finish drug (and more so for failed drugs) are likely to be impressively enormous. No matter how you look at it the pharmaceutical wallet becomes reciprocally thinner as the "drug-years" clock continues to tick.

Drug Patents: How can pharmaceutical companies achieve the greatest patent advantage without compromising patients?

Another motivating factor for pharmaceutical industries to rush the clock are patent laws. Drug patents, of course, create a window--a very large window if strategized correctly--to a monopolized gain on the sale of a new drug. Current laws place patent years at around 17 so if a company spends 11 years in the development phases it has exactly six uninterrupted years to achieve market gain to the fullest--no easy task for even the BIG guys.

Both financial costs and patent pressures cause pharmaceutical companies to rush, to lose their opportunity for sales completely, or worst case scenario, to cause eventual problems, even death, for patients. How can pharmaceutical companies achieve the greatest patent advantage without compromising patients?

Enter Web Document Management

Web document management, when utilized in small, medium, or large pharmaceutical companies and in conjunction with their satellites and CROs can literally shave drug years off the pharmaceutical clock. Web document management solutions combined with web process, quality, regulatory, training and submissions preparation solutions can subtract even more drug years leaving more free-for-all patent time. Best of all however these solutions systematize and automate solutions, trend information and make it easier to get quality, regulation, training, documentation and all company processes under control so that patients stay safe and pharmaceutical companies gain.

As in so many instances technology steps in and effortlessly ties two endeavors together with increased effectiveness on both ends of the spectrum.

One Solution at a Time: Start with Web Document Management

For pharmaceutical companies that cannot invest in all of these solutions at once, start with a web document management solution. A web document management solution will and should be able to manage tens of thousands and even hundreds of thousands of documents from lab notebook entries, study data, biomarkers, formulation studies, statistical analyses, GLP compliance docs, patent analyses, lead generation reports, market analysis, financial statements, manufacturing scenarios, patent filings, product commercial path scenarios, IND submission strategies, toxicology reports, templates, etc., etc.

The web document management solution should also provide web-based collaboration features, the technology to quickly scan paper documents into the system, a user-friendly interface, tracking/audit trail features, 21 CFR Part 11 compatibility, revision controls, reporting features and compatibility with training software controls. The system should also be compatible with common ERP solutions.

Conclusion

When used correctly technology (such as the increasingly popular web document management software solutions) is always an enabler and essentially allows pharmaceutical companies the ability to get the data they need faster so that the right decisions can be made for both patients and the interests of the company and its employees. Pharmaceutical regulatory, quality, IT and management representatives should select four or five web document management software vendors and compare them seriously. The web document management software vendor chosen could be the means of a pharmaceutical company's success after its next successful IND.

Marci Crane is a copywriter at MasterControl in Salt Lake City, Utah. For more information about web document management in pharmaceutical environments, please feel free to contact a MasterControl representative.

Article Source: EzineArticles.com

Thursday, September 1, 2011

Fwd: | 09.01.11 | IOM: Vaccines cause very few side effects


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September 1, 2011

Events

Marketplace

Jobs

Today's Top Stories


1. IOM: Vaccines cause very few side effects

By Maureen Martino Comment | Forward | Twitter | Facebook | LinkedIn
The IOM has conducted an exhaustive survey of almost 1,000 research studies and concluded that vaccines are tied to very few and usually mild side effects. The expert panel examined 8 common vaccines: MMR, DTaP, varicella for chickenpox, influenza, hepatitis B, meningococcal, tetanus-containing vaccines and the HPV vaccine, according to Reuters.
The IOM determined the vaccines weren't tied to an increased risk of autism or Type 1 diabetes. Side effects did include high fevers, allergic reaction and seizures, but in most cases they subsided quickly. "Despite looking very hard, it was really hard to find that vaccines cause injuries and the injuries they do cause are generally pretty mild and self-contained," said committee chair Ellen Wright Clayton, director of the Center for Biomedical Ethics and Society at Vanderbilt University in Nashville, in an interview with Reuters.
An increasing number of parents are skipping their kids' vaccinations due to misguided fears about serious side effects. Lower vaccination levels have led to outbreaks of whooping cough and measles in recent years. The IOM may ease the concerns of some parents, but it's unlikely to sway the staunchest anti-vaccine crusaders.
"The big take-home message is that we found only a few cases in which vaccines can cause adverse side effects, and the vast majority of those are short-term and self-limiting," added Clayton.
- here's the full IOM report
- take a look at the Reuters story
Related Articles:
Report: Higher income parents increasingly forgoing kids' vaccinations
Study: No benefit to spreading out vaccines
Read more about: vaccine safety
back to top


2. CDC: Teen HPV vaccination rates lagging

By Maureen Martino Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=75&ms=MzYyNTk4MwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTE0MTgwMjE1S0&mt=1&rt=0" name="api_addthis_com_oexchange_CVyTPw050bW0jgEfMIZBFw" >Twitter | Facebook | LinkedIn
The CDC says HPV vaccination rates continue to lag those of other vaccines recommended for teenagers. Just 49% of teens got one dose of the HPV shot, and only 32% of girls got all three recommended injections. That's up just 5% from the previous year. Comparatively, 63% of kids got the meningitis shot, and 69% received the Tdap vaccine. Blacks and Hispanics were less likely to receive the third HPV dose compared with whites. Additionally, girls living in poverty were also less likely to complete the HPV series, according to the CDC release.
Each year, 6 million men and women are infected with HPV, which can eventually cause cervical cancer and other diseases. Gardasil and Cervarix prevent the most common strains of the virus, but all three doses must be given to achieve maximum protection.
"...[T]he HPV results are very concerning," noted Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases. "Our progress is stagnating, and if we don't make major changes, far too many girls in this generation will remain vulnerable to cervical cancer later in life. Now that we have the tools to prevent most cervical cancers, it is critical that we use them." The study was published in the CDC's Morbidity and Mortality Weekly Report.
- see the CDC release
- here's more from HealthDay
Related Articles:
Patient education needed for HPV vaccines, cancer screenings
Study: Support of mandatory HPV vaccine declines after negative news coverage
HPV shot provides sustained protection against pre-cancerous growths
Read more about: Cervarix, HPV, Gardasil
back to top


3. Infant rotavirus shots benefit the unvaccinated

By Erica Teichert Comment | Forward | Twitter | Facebook | LinkedIn
Researchers have found that vaccinating infants against rotavirus may help protect the unvaccinated children and adults around them.
In a CDC study published in The Journal of Infectious Diseases, there were fewer rotavirus-related hospital admissions after the vaccine was introduced in 2008 than from 2000 to 2008. Ben Lopman, one of the scientists involved in the study, believes this is due to infant vaccinations.
"Our study showed that the burden of rotavirus--severe enough to require hospitalization--in older children and adults is larger than we were previously aware," Lopman said, according to Medical News Today. "And by vaccinating infants, we can indirectly prevent this burden of disease, thereby amplifying public health and economic benefits of infant vaccination."
In addition, fewer hospitalized rotavirus patients led to lower overall costs. "We estimate that 15% of the total 66,000 averted hospitalizations and 20% of the $204 million in averted direct medical costs attributable to the vaccination program were among unvaccinated 5-24 year-olds," according to the study, as quoted by CBC.
- read the CBC News article
- here's more from Medical News Today
Related Articles:
Rotavirus vax campaign would save millions of lives
Merck's rotavirus vaccine makes big impact
Read more about: rotavirus
back to top


4. New strain of H5N1 lacks vax protection

By Erica Teichert Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=138&ms=MzYyNTk4MwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTE0MTgwMjE1S0&mt=1&rt=0" name="api_addthis_com_oexchange_JMSNUaD4pWtowK2ciPo4w" >Twitter | Facebook | LinkedIn
Scientists have discovered a mutant strain of the bird flu, which has been observed in China and Vietnam, and the variant is different enough that current vaccines won't protect against it.
So far, the strain is contained within poultry and birds, but H5N1-2.3.2.1--the name given to the new strain--could transfer to people. "There is a human H5N1 vaccine candidate that is a (WHO) recommended vaccine...But it doesn't confer full protection against the (new variant)," said virologist Malik Peiris of the University of Hong Kong, as quoted by Reuters. The news outlet noted 8 people have been infected with H5N1 in Cambodia this year, and all have died.
H5N1 previously made headlines when the virus spread to 63 countries from 2003 to its peak in 2006. Reported cases of the flu strain have risen consistently since 2008.
- check out the Reuters coverage
- and here's the Chron post
Related Articles:
Scientists easily create hybrid virus
Computing method offers shortcut to right flu vax
Smallpox vax highly effective against bird flu


Also Noted


TODAY'S SPOTLIGHT... Emory University receives $26M from NIH

The NIH has awarded Emory University a $26 million grant for its work on HIV/AIDS vaccines. The university will work to develop a vaccine in the next 5 years with the help of such partners as the Yerkes National Primate Research Center, Mt. Sinai School of Medicine, La Jolla Institute of Allergy and Immunology, University of Nebraska and Louisiana State University Health Sciences Center. Item
Vaccine Research
Researchers have discovered a potential vaccine that would protect against rabies and Ebola in a single jab. According to Thomas Jefferson University scientists, the candidate has showed promising results in mouse trials and could make a significant impact in developing nations where both diseases put people at risk. Item | Piece
Israeli biotech BiondVax is beginning its Phase II universal flu vaccine trial for Multimeric-001. The trial will include 120 patients who are 65 years of age and older and will start in October. BiondVax release
HCM City Pasteur Institute is in the home stretch for its dengue fever vaccine in connection with Sanofi Pasteur. The vaccine will start its final clinical trial in Vietnam next month. Item
Vaccine has published the results of Emergent BioSolutions' ($EBS) Phase Ia anthrax vaccine trial, noting the good responses from BioThrax with 1 mg of CPG 7909 in the 69-person trial. Emergent release
Scientists have found a link between a bovine viral diarrhea virus and bleeding calf syndrome, which causes low blood cell counts and bone marrow depletion in newborn calves. The study was published in Veterinary Research. Release
Vaccine Market
Selecta Biosciences has garnered a malaria vaccine subcontract from Science Applications International with support from NIAID. In addition, the company has named Takashi Kei Kishimoto as its new chief scientific officer. Article
And Finally... Russia's chief sanitary inspector Gennady Onishchenko believes his country is being cast aside by UNICEF's polio vaccination efforts, and that possibility is dangerous for the nation's biotech industry. Item

Events


> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA

Keynoted by Dr Robert Langer of MIT, this is a strategic level event for pharma and biotech BD&L executives to meet a wide range of drug delivery companies with the latest technologies. Fierce readers receive 15% off with code FBEL. Register or learn more: click here

> Vaccine Development and Approval: Phase 2 and Beyond - November 7-8, 2011 - Philadelphia, PA

The unique demands of vaccine trials require discussion among all stakeholders with clarification of expectations and sharing of lessons learned. This conference will provide an opportunity to present key issues and case studies from industry and regulatory professionals on such topics as adaptive designs for vaccine trials, regulatory expectations, new pathways to approval and data challenges. Address Issues and Challenges of Vaccine Development from Phase 2 to Licensure. Register Today!

Marketplace


> Capitalizing on the Outsourcing Option - New Fierce eBook

Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.

Jobs


> Associate Director/Director - Translational Medicine - Nonclinical Safety Assessment - Regulus Therapeutics

Regulus Therapeutics Inc. is a biopharmaceutical company leading the discovery and development of innovative new medicines based on microRNAs. Regulus seeks a motivated 6 plus years of drug development experience to join our efforts in translating microRNA biology into human therapeutics. The position requires proven ability to work in a fast-paced biotech environment. Read more.

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.

©2011 FierceMarkets This email was sent to nbrauchitsch@yahoo.com as part of the FierceVaccines email list which is administered by FierceMarkets, 1900 L Street NW, Suite 400, Washington, DC 20036, (202) 628-8778.
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Wednesday, August 10, 2011

Fwd: | 08.09.11 | Will Valeant snap up Medicis?; Yervoy could soon face Roche rival



-------- Original Message --------
Subject: | 08.09.11 | Will Valeant snap up Medicis?; Yervoy could soon face Roche rival
Date: Tue, 9 Aug 2011 13:19:54 -0400 (EDT)
From: FiercePharma <editors@fiercepharma.com>
Reply-To: editors@fiercepharma.com
To: nbrauchitsch@yahoo.com


If you are unable to see the message below, click here to view.

August 9, 2011

Subscribe | Website | Jobs | Mobile
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This week's sponsors:
IBM Webinar
Fierce Custom Publishing
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Today's Top Stories:
1. Will Valeant manage to snap up Medicis?
2. Merck, Pfizer among corporate cash stashers
3. Pharma feels threatened by U.S. austerity
4. Yervoy may soon face Roche rival
5. Genentech unloads buildings to Gilead

Spotlight:
Study: Revlimid interaction may explain side effects

Also Noted:
KV Pharma completes generics-unit sale; Gedeon Richter wins dispute over buyout; Much more...

News From The Fierce Network:
1. QIAGEN submits PMA for companion Dx
2. Roche deals API plants in SC, CO
3. Gene regulates the timing of our tickers


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2012 is Almost Here: Prepare Your Compliance Systems and Processes for the Physician Payments Sunshine Act
August 30th, 1pm ET/ 10am PT

Beginning in 2012, pharmaceutical, biotechnology and medical device companies will be required to monitor, analyze and report on Health Care Professional (HCP) spending as never before. There’s no time to waste – while reporting isn’t due until 2013, data must be captured throughout 2012 to ensure reporting compliance. Register Now!

Sponsor:Kru Research

Events

> Online Pharmaceutical & Healthcare Marketing MBA for Executives
> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL
> Optimizing Dosing for the Safe and Effective Use of Drugs in Patients with Renal Impairment - September 19-20 - Washington, DC
> e-Patient Connections 2011 Conference - Sept 20-21 - Philadelphia, PA

Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative
> Capitalizing on the Outsourcing Option - New Fierce eBook

Jobs

> Regional BD Director
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

Capitalizing on the Outsourcing Option - New Fierce eBook

Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.

Today's Top Stories

1. Will Valeant manage to snap up Medicis?

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

While announcing second-quarter earnings yesterday, Medicis Pharmaceuticals CEO Jonah Shacknai said he plans to get back to his normal schedule soon following a series of personal tragedies that kept him away from the office. Shacknai has been with his family since he lost both his 6-year-old son--who died after an accidental fall--and his girlfriend under "bizarre" and still unexplained circumstances. Now into the picture steps acquisition-hungry Valeant Pharmaceuticals, which, according to Wall Street Journal sources, has approached Medicis about a possible buyout.

The WSJ notes Medicis stock has been underperforming lately as the investigation into the girlfriend's death continues, thereby making the company a potential bargain. So, Valeant might be able to pursue its goal of dominating the dermatology market by snapping up Medicis at an attractive price. Some Medicis products--such as the acne treatment Solodyn--would be natural additions to Valeant's stable.

The timing might be right for Valeant for other reasons. During the conference call about Medicis' earnings, Shacknai sounded as if he might be open to a change, although he declined comment on the buyout talk. "At a time like this, you do a lot of introspective thinking," Shacknai said (as quoted by 10News). "We have obviously had an extraordinarily difficult time. We have undertaken some tragedies, some losses that one couldn't imagine experiencing in a lifetime."

But then again, Shacknai took great pains to thank his co-workers and board of directors for their support, adding that these difficult weeks have made him appreciate his "cohesive, capable and experienced executive team" even more. He started Medicis himself back in 1988. "I expect to be on my normal calendar in the office doing all the things I had done previously," Shacknai promised during the call.

- check out the WSJ piece
- see the 10News story
- get more from the San Diego Business Journal

Related Articles:
Medicis shares drop on death at CEO's house
Medicis CEO's son dies after last week's accident

Read more about: Valeant, Medicis Pharmaceutical, Jonah Shacknai
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Reach and Engage Empowered Patients and Digital Health Consumers! www.2011epatient.com


2. Merck, Pfizer among corporate cash stashers

By Tracy Staton Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=116&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_37Ad5a84dEpFo7YvTn9A" >Twitter | Facebook | LinkedIn

World markets in free fall mode; rioting in London; intransigent U.S. politicians; no wonder investors are rushing to buy gold. Next, they'll be burying cash in coffee cans in the backyard. But actually, big drugmakers are one step ahead of the cash-hoarders. They've already been squirreling their money away.

Billions of Big Pharma cash sits in figurative coffee cans around the world, waiting for executives to feel ready to spend. Some companies are saving up for the right acquisition to come along. Unfortunately for the U.S. economy, some plan to invest their money in emerging markets. Some are in the midst of share buybacks that will return a lot of their cash to shareholders as they try to soothe investors through their patent-cliff fears.

But others are just saving up. And that's natural in the current environment. "Companies feel like they don't have strong confidence that things will be better in the next year," job-market watcher John Challenger told the Star-Ledger. "Why take risks right now?"

Among the cash-rich drugmakers are Merck, which has stashed away an additional $1 billion this year. Johnson & Johnson has added another $3 billion to its stores, the newspaper reports, giving it some $27 billion on hand. Pfizer has beaucoups cash--$24 billion as of last week--especially in the wake of its $2.375 billion Capsugel sale. It's spending some of that money on shareholder dividends.

- see the article from the Star-Ledger
- read the New York Post story 

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Read more about: Pfizer, Merck, Johnson & Johnson, Big Pharma
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3. Pharma feels threatened by U.S. austerity

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

All the talk of deficit-cutting in Washington has drugmakers spooked--and has industry lobbyists working overtime. Pharma companies are fighting potential new Medicare drug rebates. Whispers about pulling the direct-to-consumer advertising tax deduction have surfaced again. As the next stage of cuts looms, who knows what other ideas Washington will come up with?

And the U.S. cost moves come amid austerity measures elsewhere, especially in Europe, where even richer countries such as Germany have targeted drug prices for reductions. So, the U.S. threats seem even more dire; after all, prices have tended to be higher there than in other countries, and that's helped drugmakers suffering from price negotiations elsewhere.

But as the Wall Street Journal Health Blog reports, analysts aren't as worried about U.S. austerity. Some of the potential cuts won't affect pharma directly: Medicare spending moves, for instance. If the government cuts reimbursements for cancer-drug therapy, oncologists will feel the hurt first. Sure, doctors may press for discounts up the line, but they can't mandate price cuts.

What's more, some drugmakers are more insulated from government cuts. Roche and Novartis, for instance, Sanford C. Bernstein analysts said (as quoted by the WSJ). Merck, Sanofi and Pfizer may also have a measure of protection.

- read the Health Blog post 

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Read more about: Medicare, drug prices, Big Pharma, reimbursement
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4. Yervoy may soon face Roche rival

By Tracy Staton Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=67&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_VbBW7RIjhBhbaVsA0kJQ" >Twitter | Facebook | LinkedIn

Roche's new melanoma treatment, dubbed Zelboraf, may get an early entry into the market. Sources tell Reuters the experimental drug could be approved as early as next week, months ahead of schedule. Apparently, some recently released data, which showed Zelboraf significantly cut the risk of death when added to chemotherapy, has inspired the FDA to move more quickly on the application.

That would mean earlier-than-expected competition for Bristol-Myers Squibb's Yervoy, the breakthrough melanoma drug approved in March. Yervoy has been a boon for BMS, coming out of the gate with unexpectedly strong sales. Its sticker price of $120,000 hasn't appeared to deter uptake one bit, at least not yet.

The two meds aren't exactly head-to-head rivals: Roche's drug targets a particular gene mutation that affects about half of all melanoma patients, so its potential market is somewhat smaller than Yervoy's, which works by stimulating patients' immune systems. In fact, they could become a melanoma-fighting cocktail if in-process trials prove the combination successful. Analysts have predicted that Zelboraf sales will peak at around $732 million, while Yervoy sales are expected to reach more than $1.4 billion.

- read the Reuters story

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Read more about: Roche, Bristol-Myers Squibb, Yervoy, melanoma
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5. Genentech unloads buildings to Gilead

By Tracy Staton Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=105&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_5CPGejfmuM6GOgy4aR8A" >Twitter | Facebook | LinkedIn

Genentech is selling off a small piece of its Oceanside, CA, campus to Gilead Sciences. The deal involves two buildings and 55 employees, all of whom will keep their jobs, the San Diego Union-Tribune reports. That must be a relief to the Genentech folks, who well know that parent company Roche is in the middle of a cost-cutting push.

According to the Union-Tribune, Gilead will pick up a facility where about 30 scientists work on processes for producing experimental drugs. The other building is a manufacturing plant where 25 employees turn out batches of drugs for clinical trials. Gilead plans to use its new facilities to make batches of an experimental cancer drug--that work is currently outsourced to a contract manufacturer--and to develop a production process for another in-development therapy.

The terms of the deal weren't disclosed, but Gilead said in a statement it expects the transfer to close during the third quarter.

Genentech says the sale isn't the beginning of a wholesale unloading of Oceanside property. "Genentech is totally committed to Oceanside," spokeswoman Robin Snyder told the newspaper. "We want to be really clear about that."

- see the Gilead release
- get the Union-Tribune story

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Read more about: Genentech, Gilead Sciences, California
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Also Noted

TODAY'S SPOTLIGHT... Study: Revlimid interaction may explain side effects

A new trial found Revlimid interacts with P-glycoprotein in a way that affects blood levels of the drug, and the researchers suggest its dosage may need to be tweaked because of their finding. Report

@FiercePharma: Study finds Revlimid's interaction w/Pgp affects blood levels, so dosing might need tweaks. | Follow @FiercePharma

> KV Pharmaceutical wrapped up the $60 million sale of its generics unit to Zydus Pharmaceuticals and Zynesher Pharmaceuticals. Report

> Contract manufacturer Aenova plans to lease a SkyePharma manufacturing business near Lyon, France. News

> Hungary's Gedeon Richter said Genefar had been ordered to pay it $40 million for breach of contract in a dispute over the failed buyout of Polpharma. Story

> Gastrointestinal specialist Salix Pharmaceuticals saw its second-quarter profit beat analyst estimates on growing sales of its diarrhea drug Xifaxan. Item

> Endo Pharmaceuticals raised its forecast for sales and earnings as it reported Q2 income of $54.6 million on $607 million in sales. Article

> A start-up has released a software tool to help pharmaceutical companies track comments on Facebook, now that the social media site is enabling two-way communication on drugmakers' pages. Release

> Pfizer and AstraZeneca filed separate patent suits against India's Hetero Drugs, one involving a Viagra copycat and the other concerning a generic version of Nexium. Story

> Bachem said it had renewed a longstanding agreement with AstraZeneca to supply the drug Goserelin. Report

> A Maryland oncologist pleaded guilty to using a misbranded drug after administering cancer meds bought outside the U.S. Piece

Biotech News

@FierceBiotech: Is the FDA writing a recipe for the failure of biosimilars in the U.S.? Report | Follow @FierceBiotech  

@JohnCFierce: So Lexicon says its Ph2 study for LX1032 showed signs of efficacy, reducing symptoms of gastro-related tumors. | Follow @JohnCFierce

@MaureenFierce: Several Russian cos. have establish a $ joint venture designed to develop innovative treatments in the country. | Follow @MaureenFierce

> Biogen, Abbott tout promising MS data from PhIIb daclizumab deal. Story

> Array adds $713M cancer drug pact with Genentech to deal roster. Report

Biotech Research News

> Gene discovered that regulates the timing of our tickers. News

> DoD gives NeoStem $1.7M to develop adult stem cells for osteoporosis. More

> Scientists discover possible genetic route to killing pain. Details

> Standford's SPARK hosts ideas so "crazy" they just might work. Story

> Researcher find faulty gene responsible for some ovarian cancers. Report

> Texas Gov. Perry supports adult stem cells after undergoing procedure. Article

Manufacturing News

> At the box office, bad boy pharma on top. Details

> UPS sees new tech, distribution models for supply chain. Story

> Roche deals API plants in SC, CO. Article

> Merck pushes pharma to top jobs-cutter. More

> NSF expands into chemical reference standards. Report

And Finally... Soy tablets do little to stave off bone loss among menopausal women, according to new research, and don't help with hot flashes, either. Report

Events

> Online Pharmaceutical & Healthcare Marketing MBA for Executives

Saint Joseph's University offers an expanded portfolio of globally accessible AACSB-accredited programs ideal for working professionals in the pharma, biotech, medical device, diagnostics and healthcare sectors. Apply now; our September Cohort begins 9/8. Visit sju.edu/epharma or call 800-SJU-EMBA.

> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL

Medicaid Drug Rebate Program Summit is where manufacturers meet with all the government officials including CMS, VA, 340B, DoD, USDOJ and OIG for compliance and operations answers to healthcare reform questions. Register with a 25% off the standard rate by clicking here: www.medicaiddrugrebates.com

> Optimizing Dosing for the Safe and Effective Use of Drugs in Patients with Renal Impairment - September 19-20 - Washington, DC

Patients with renal impairment are at increased risk for developing drug related adverse events. In these patients drug dosage needs to be closely monitored and adjusted to reflect altered pharmacokinetics (PK) and pharmacodynamics (PD) parameters. This conference will explore ways to facilitate drug development and optimize dosing in renal impairment. Register by August 31 and SAVE $150!

> e-Patient Connections 2011 Conference - Sept 20-21 - Philadelphia, PA

Bigger than before, we are gathering experts from life sciences, public health, hospitals and also doctors and nurses to benchmark best practices for reaching and supporting digital health consumers. Save $300 with code FIERCE. Learn more at www.epatient2011.com.

Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

This FierceMedicalDevices eBook examines the background situation, current position and the future of the CDRH’s revision of the 510(k) premarket notification process. Click here to download today.

> Capitalizing on the Outsourcing Option - New Fierce eBook

Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.

Jobs

> Regional BD Director

We are considering candidates for a Regional Business Development (BD) Director to join our BD team! The ideal candidate should have specific experience calling on and selling into the R&D and clinical development/operations and study start up side of the industry, including but not limited to Phase I-IIIB as well as Phase IV post marketing surveillance, outcomes research and patient registry programs. Learn more.

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.


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