Fwd: | 09.01.11 | Dairy JV nabs India's excipients maker Brahmar; Fareva buys Pfizer plant

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Subject:	| 09.01.11 | Dairy JV nabs India's excipients maker Brahmar; Fareva buys Pfizer plant
Date:	Thu, 1 Sep 2011 10:49:52 -0400 (EDT)
From:	FiercePharmaManufacturing <editors@fiercepharmamanufacturing.com>
Reply-To:	editors@fiercepharmamanufacturing.com
To:	nbrauchitsch@yahoo.com

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September 1, 2011 Subscribe | Website | Jobs Refer FiercePharmaManufacturing to a Colleague This week's sponsors: Fierce Custom Publishing 510(k) Okta Today's Top Stories: 1. Dairy JV nabs India's Brahmar 2. Fareva moves into U.S. with Pfizer plant buy 3. BASF raises excipient, API prices 10% 4. CMOs to lay off more than 100 in NY, Ireland 5. New Promega plant to add capacity Spotlight: Baxter pumps up lyophilization capacity at Halle plant Also Noted: Pharma packaging to be $62B market by 2015; Batavia, Xendo ink manufacturing, marketing deal; Much more... News From The Fierce Network: 1. S&N takeover rumors rekindled 2. Facebook app shows how people swap germs 3. Beleaguered Xoma CEO Engle resigns 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. Webinars > Webinar: Active Directory & the Cloud for Biotech & Pharma Sept. 21, 2pm ET / 11am PT Events > PDA Europe: Pharmaceutical Cold Chain Management & Good Distribution Practice - 27-30 September 2011 - Berlin, Germany > 2015 Readiness Workshop - September 28-29, and October 26-27, 2011 - Lawrenceville, NJ > 9th Annual Cold Chain & Temperature Control Global Forum - September 26 -30, 2011 - Philadelphia, PA > Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA > BioProcess International Conference & Exhibition - Oct 31 - Nov 4 - Long Beach, CA > 13th Annual Contract Manufacturing for Pharma & Biotech Companies - December 5-7, 2011 - Philadelphia, Pennsylvania Marketplace > Capitalizing on the Outsourcing Option - New Fierce eBook Jobs > Associate Director/Director - Translational Medicine - Nonclinical Safety Assessment - Regulus Therapeutics 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. Today's Top Stories 1. Dairy JV nabs India's Brahmar By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn DMV-Fonterra Excipients (DFE), a joint venture pairing two large dairy groups, has struck a deal to acquire India's Brahmar Cellulose in a bid to become the primary go-to supplier of lactose excipients to pharma manufacturers around the globe. Manufacturers in India and around the globe use these purified lactose excipients as a filler in tablets, capsules and powders for medical inhalers. And DFE says it accounts for about half of the global sales of lactose excipients and 5% to 10% of oral tablet excipients. Dutch dairy company Royal FrieslandCampina and New Zealand dairy company Fonterra created the joint venture. They say the acquisition, completed for an undisclosed price, will make the JV the "sole manufacturer and supplier of the most commonly used diluents and superdisintegrants" needed by pharma manufacturers. "Long-term synergies will be achieved by combining DFE's current global market position and sales network with Brahmar Cellulose extensive product knowledge and market position in India," DFE CEO Jan Jongsma said. Taking out the competition should help shorten buyers' supply chains, but there's no word what it may do to their costs. - see the DFE release - get the story from in-PharmaTechnologist - read the article from the Economic Times Related Articles: FDA: 5 recalls traced to excipients in 2010 FDA system would speed excipient screening Read more about: excipients, DMV-Fonterra Excipients, India, Manufacturing Deals back to top 2. Fareva moves into U.S. with Pfizer plant buy By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn The big European contract manufacturer Fareva has now established a U.S. beachhead as it pursues plans to expand into the U.S. market. The pharma manufacturer has stepped in to buy one of Pfizer's ($PFE) manufacturing facilities in Virginia. In the deal, the 500 Pfizer workers who make Advil, Chapstick and other products will now work for Fareva, which has an arrangement in place to spruce up the facility with a $42 million upgrade and add about 90 new jobs over 5 years. Local economic development officials breathed an audible sigh of relief on the news. Pfizer had announced back in the spring of 2010 that it would shutter the plant as part of a big revamp planned for its manufacturing division. In acquiring the plant, Fareva also got the contract to continue supplying Pfizer. "We have been looking for the right opportunity to expand our manufacturing footprint into North America and establish our pharmaceutical and cosmetics businesses in the United States," said Fareva CEO Bernard Fraisse. "The Henrico County site has a talented and motivated workforce and state-of-the-art manufacturing, packaging and warehousing facilities that are a perfect fit for growing our commercial portfolio in this region." Based in Luxembourg, Fareva employs 5,500 and reported $1.2 billion in 2010 revenues. The company operates 28 manufacturing facilities in Europe and around the world. - read the Henrico Citizen story Related Articles: Pfizer shows sustainability/cost balance at packaging plant Pfizer plant prepped before demolition to contain killer API Read more about: Pfizer, Manufacturing Plant, Fareva back to top 3. BASF raises excipient, API prices 10% By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn Germany's BASF plans a 10% price hike worldwide on pharmaceutical excipients and active pharmaceutical ingredients. The company blamed continued increases in costs for raw materials, energy and labor for the increase, which is the second 10% mark-up for BASF this year. Any existing price contracts remain in force. The price hike covers BASF's entire portfolio of excipients, the company said in a statement, including binders such as Kollidon, coatings such as Kollicoat, and solubilization agents Cremphor and Lutrol. The generic APIs affected by the hike include commonly used ingredients like ibuprofen, caffeine and pseudoephedrine. BASF has been economizing wherever it can, trying to remain competitive on price, spokesman Ralf Fink told in-Pharma Technologist. "However, the significant cost increases of the past quarters cannot be offset by any short-term measures," Fink said. Acknowledging that price increases "are truly a burden to the overall industry," Fink wouldn't say whether he thought BASF's competitors would follow suit with their own prices. The BASF increases take effect today. - see the release from BASF - get more from in-Pharma Technologist Related Article: Raw material sourcing meets cGMP testing, distribution Read more about: raw materials, API, excipients, BASF back to top 4. CMOs to lay off more than 100 in NY, Ireland By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn Two contract manufacturers plan triple-digit job cuts, with a combination of layoffs and voluntary buyouts. Contract Pharmaceuticals is winding down its Buffalo, NY, plant, purchased from Bristol-Myers Squibb ($BMY) in 2005. By the end of the year, another 128 workers will be laid off. Meanwhile, United Drug plans 150 job cuts at a plant in Ireland as part of a recently announced streamlining program. In Buffalo, Contract plans two stages of layoffs. Forty-seven jobs will be cut at the end of November, and the remaining employees will be let go by year's end. As Outsourcing-Pharma points out, these cuts represent three-fourths of the plant's remaining 161 employees. The Buffalo operations will be consolidated with a Contract plant in Ontario. At the time the Buffalo plant was slated for closure, 260 employees worked there. The company had bought the 415,000-square-foot plant from BMS thinking it could attract enough business to justify the expansion, but the faltering economy interfered with those plans, according to executives. United Drug attributes its cuts to government decisions to cut healthcare spending. The CMO said austerity moves have significantly pinched sales, forcing it to shed jobs and make other streamlining moves; it announced plans to restructure earlier this month. "We are embarking on a business transformation program in order to remain competitive in the market," a spokesperson told Outsourcing-Pharma. "Up to 150 full- and part-time staff may be impacted by the changes." The exact number of employees cut depends on the outcome of United Drug's voluntary redundancy program and on its ability to move staffers to posts elsewhere in the business. - see the Outsourcing-Pharma news - get more, also from Outsourcing-Pharma Related Articles: U.S. tax reform or not, offshore beckons The other dark side of Merck's 13,000 layoffs Cut jobs not likely to reappear Read more about: Contract Manufacturer, layoffs, Contract Pharmaceuticals, United Drug back to top 5. New Promega plant to add capacity By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn Promega is building a new cGMP facility that will turn out FDA-regulated molecular biology products. The 260,000 square-foot plant will bring 100 people onto the company's payroll, Contract Pharma reports. Based in Madison, WI, the company plans to use most of the new space for manufacturing, including fixed production lines and flexible manufacturing areas. The plant will help Promega grow, particularly in products for diagnostics makers, such as sample prep systems and reagents used in medical tests, the company said. "Molecular biology opens doors not only to new understanding of life, but to practical applications that enhance the health of our citizens," CEO Bill Linton said in a statement. "This building is our next step in expanding our product supply capabilities worldwide." Promega is using environmentally friendly construction practices in building the new facility. Geothermal heating and cooling, bio-retention stormwater ponds, and dark-sky compliant lighting are among them. - read the release from Promega - get more from Contract Pharma Related Article: CDI, Promega to collaborate on in vitro assays Read more about: cGMP, Promega back to top Also Noted Webinar: Active Directory & the Cloud for Biotech & Pharma Sept. 21, 2pm ET / 11am PT Biotech and pharmaceutical companies are leaders cloud/SaaS technology adoption. This webinar will discuss the pros and cons of extending Active Directory to Cloud/SaaS Apps for single sign-on and automated provisioning/de-provisioning. Register today. TODAY'S SPOTLIGHT... Baxter pumps up lyophilization capacity at Halle plant Baxter ($BAX) has once again expanded the freeze-drying capacity at its BioPharma Solutions contract manufacturing facility in Halle, Germany. Increased pharma demand for cytotoxic contract manufacturing prompted the investment, the company said. Report > The pharmaceuticals packaging market is expected to hit $62 billion by 2015, according to a new study from Freedonia Group, with 70% of demand coming from U.S., Japan and Western Europe, but China, India and Brazil will grow quickly as well. Report > Batavia Bioservices has inked a deal to take over Xendo's bioprocess manufacturing, and the two companies will team up on marketing efforts. Story > EMD Millipore, a division of Merck KGaA, has agreed to buy Amnis, which makes high-speed cell imaging instrumentation for flow cytometry uses. News > Vivalis increased first-half sales by 165% and cut its net loss after landing two new licensing agreements for its EB66 technology used in vaccine production. Story > France's Roquette wrapped up a capital-investment plan at its Lestrem facility, which makes injectable carbohydrates for use in parenteral drug manufacturing. Piece > Contract manufacturing in Brazil is set to grow quickly, especially the manufacturing of APIs, market research firm RNCOS says in a new report. Report > The Consumer Healthcare Products Association lodged some criticisms of the FDA's draft guidance on nanotechnology, including the agency's definition of the term. Article Webinars > Webinar: Active Directory & the Cloud for Biotech & Pharma Sept. 21, 2pm ET / 11am PT Biotech and pharmaceutical companies are leaders cloud/SaaS technology adoption. This webinar will discuss the pros and cons of extending Active Directory to Cloud/SaaS Apps for single sign-on and automated provisioning/de-provisioning. Register today. Events > PDA Europe: Pharmaceutical Cold Chain Management & Good Distribution Practice - 27-30 September 2011 - Berlin, Germany PDA Europe: Pharmaceutical Cold Chain Management & Good Distribution Practice - Addresses Transportation Issues for the emerging Middle Eastern and African markets, featuring Guest Speakers from India. Conference, Exhibition, Training Course  > 2015 Readiness Workshop - September 28-29, and October 26-27, 2011 - Lawrenceville, NJ Learn business and technical aspects of tracking and tracing serialized product through the supply chain with GS1 Standards. Unique hands on training uses computerized simulation to explore different supply chain scenarios and help you get ready for 2015 pedigree. Register Now! > 9th Annual Cold Chain & Temperature Control Global Forum - September 26 -30, 2011 - Philadelphia, PA The 9th Annual Cold Chain & Temperature Control Global Forum will examine the modern cold chain - including all temperature range products and their regulatory requirements - as well as evolving sectors such as Medical Devices & Diagnostics, Generics, APIs, Clinical and Biologics and cell therapies. It is set to take place September 26 -30 in Philadelphia. See what else is new on the cold chain agenda here. > 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 > BioProcess International Conference & Exhibition - Oct 31 - Nov 4 - Long Beach, CA BPI is your one stop industry resource for driving down costs, improving quality, achieving rapid, robust and resilient process development and manufacturing - and is the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing. Learn more, view the agenda or download the brochure. You can even get sneak peek at the caliber of content by downloading presentations. > 13th Annual Contract Manufacturing for Pharma & Biotech Companies - December 5-7, 2011 - Philadelphia, Pennsylvania This conference will be taking an in-depth look at the future of strategic CMO outsourcing, assessing risk management of quality systems, audit process to ensure GMP, and tools to expedite your supply chain process, amongst other things within the pharma and biologics outsourcing field. Learn more. 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. ©2011 FierceMarkets This email was sent to nbrauchitsch@yahoo.com as part of the FiercePharma email list which is administered by FierceMarkets, 1900 L Street NW, Suite 400, Washington, DC 20036, (202) 628-8778. Refer FiercePharmaManufacturing to a Colleague Contact Us Editor: George Miller. Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. Advertise Advertising/Lead-Generation: Ryan Willumson. Request a media kit. 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Fwd: | 08.09.11 | Array strikes $713M Genentech pact; Biogen, Abbott tout promising MS data

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Subject:	| 08.09.11 | Array strikes $713M Genentech pact; Biogen, Abbott tout promising MS data
Date:	Tue, 9 Aug 2011 12:23:05 -0400 (EDT)
From:	FierceBiotech <editors@fiercebiotech.com>
Reply-To:	editors@fiercebiotech.com
To:	nbrauchitsch@yahoo.com

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August 9, 2011 Sign up for free: Subscribe | Website | Jobs | Mobile app Refer FierceBiotech to a Colleague This week's sponsor is Myriad RBM,Inc. Today's Top Stories 1. Array adds $713M cancer drug pact with Genentech to deal roster 2. Biogen, Abbott tout promising MS data from PhIIb daclizumab trial 3. Report: FDA approval for Roche's melanoma drug vemurafenib 'imminent' 4. Investor panic could spell tougher times for biotechs 5. Corey Goodman's upstart biotech garners a $5M Series A Also Noted: Fierce Custom Publishing Spotlight On... Intercept nails $165M diabetes pact with Servier Lexicon reports positive data on tumor drug; Watchdogs oppose loosening FDA's conflict rules; and much more... More Fierce Life Sciences News: 1. Stanford's SPARK hosts ideas so 'crazy' they just might work 2. At the box office, bad boy pharma on top 3. Gene discovered that regulates the timing of our tickers 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: 510(k) Events > Online Pharmaceutical & Healthcare Marketing MBA for Executives > PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC > PDA 2011 Combination Products Workshop - Sept. 21-22, 2011 - Washington, DC > Pharmaceutical Strategic Alliances - Sept 21-23, 2011 - New York, NY > CBI's Pharma/Bio Forum on Preclinical Development - September 26 - 27, 2011 - Boston, MA > AdvaMed 2011- Register Now and Save 300! - September 26-28, 2011 - Washington, DC > 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD > Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA > 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" - Oct 6, 2011 > 19th Annual BioPartnering Europe - 9-11 October 2011 - London, UK > US Conference on Rare Diseases and Orphan Products - October 11-13, 2011 - Washington, DC > PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD > BioNetwork West 2011 - Oct. 24-26 - The Ritz Carlton Laguna Niguel, CA 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 FierceBiotech Jobs * Post a classified ad: Click here. * General ad info: Click here Today's Top News 1. Array adds $713M cancer drug pact with Genentech to deal roster By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn Array BioPharma ($ARRY) has added another high-profile pact to its roster of big-name collaborations. Genentech has stepped in with an upfront payment of $28 million and a promise of up to $685 million in milestones so it can snag the rights to develop ARRY-575, a preclinical ChK-1 program that will be combined with a similar program of Genentech's and pushed into Phase I. Genentech plans to match ARRY-575 with another Phase I compound, RG7602 or GDC-0475. Genentech will be responsible for the development costs and is also committed to a double-digit royalty stream on the early-stage program. However, the companies also noted that not all the financial details are being disclosed. Genentech's clinical goal is to show that a pair of ChK-1 inhibitors will strip the body's natural defenses against DNA damage, allowing chemotherapy drugs to do their intended work without interference from the protein kinase. "Combining both companies' programs will maximize our chances for success in developing and commercializing this novel cancer therapy," says Array CEO Robert Conway. "We believe ChK-1 inhibition is a key strategy for enhancing the efficacy of chemotherapeutic and other agents in cancer patients." Boulder, CO-based Array has had considerable success attracting some of the biggest names in the industry to partner on programs. Its drugs are allied with Novartis, Amgen, Eli Lilly and AstraZeneca, to name a few. Its lead drugs are ARRY-162, a mid-stage cancer treatment partnered with Novartis, and its solely-owned ARRY-520 for multiple myeloma. Array and Genentech have been partnered for the last 7 years and one of their drugs, GDC-0068, is in Phase Ib. - see the Array release - check out the Reuters story Related Articles: Array BioPharma axes 70 as it cuts back on discovery work Array shares spike on $467M Novartis cancer pact Amgen delivers $60M upfront for Array diabetes pact Read more about: Genentech, Cancer, Cancer Drugs, Array BioPharma back to top 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. 2. Biogen, Abbott tout promising MS data from PhIIb daclizumab trial By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn Biogen Idec and its partner Abbott Labs have taken the wraps off the top-line data from a Phase IIb study of daclizumab, touting some promising results for the once-monthly treatment of multiple sclerosis as they push ahead with an ambitious late-stage program. Researchers said that the 150-mg dose arm demonstrated a 54% reduction in the annualized relapse rate, with "highly statistically significant" data recorded on secondary endpoints. The news marks another upbeat turn of events for the new executive team running Biogen Idec, which has been buoyed by promising data on key programs. And it's a big plus for Abbott as well, which acquired Facet and the big stake in daclizumab for $450 million last year. The companies recruited 600 patients for the study. Researchers studied two doses injected once every four weeks in Phase IIb, with the 150-mg arm reporting better results on the primary endpoint than the 300-mg group. Investigators also noted the "cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 (69% (for 150 mg); 78% (300 mg); in the number of new or newly enlarging T2 hyperintense lesions at one year (70%; 79%); and in the reduction in the proportion of patients who relapsed (55%; 51%). DAC HYP also showed a trend toward improvement in quality of life measures at one year."   Doug Williams, Biogen Idec's EVP of R&D, expressed enthusiasm about the results. "The exciting results for DAC HYP, along with previous clinical data, support our continued investigation of this candidate as a promising new approach to treating multiple sclerosis," he said in a statement. "DAC HYP's convenient once-monthly, subcutaneous administration, combined with a strong efficacy profile, suggest that it may provide an attractive option for MS patients. We hope to confirm the results of SELECT in our second registrational trial, DECIDE." Daclizumab is an antibody which binds to CD25, a receptor found on T cells that are believed to be abnormally activated in autoimmune conditions, such as MS. - here's the release Related Articles: Biogen hands over $30M milestone on daclizumab progress Facet seeks new bids after Biogen offer flops Biogen turns hostile in $356M bid to acquire Facet Read more about: Abbott Labs, Biogen Idec, daclizumab back to top 3. Report: FDA approval for Roche's melanoma drug vemurafenib 'imminent' By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn Quoting sources, Reuters reports that Roche's remarkable experimental melanoma drug vemurafenib appears headed for an early approval by the FDA. Roche filed for an approval in May, putting it in line for a final decision by November 11. But encouraged by some dramatic evidence that the drug significantly cut the risk of death versus chemotherapy, the news service's source says that an approval may be just around the corner. "We are getting the sense that approval is imminent," the source told Reuters. Vemurafenib, which will be named Zelboraf on the market, is likely to join a roster of new cancer drugs to gain FDA approval. The agency approved Bristol-Myers Squibb's melanoma drug Yervoy last March with an approval for J&J's prostate cancer therapy Zytiga arriving just weeks later. Peak sales of vemurafenib have been estimated at more than $700 million a year. Roche's vemurafenib was advanced by Plexxikon, a biotech that was bought out last March by Daiichi Sankyo in a $935 million deal. The drug took center stage at ASCO last June as a poster child of sorts for drugs developed to target the molecular drivers of cancer growth. - here's the report from Reuters Related Articles: Roche's vemurafenib plays a starring role at ASCO Globe highlights targeted cancer drugs from Pfizer, Roche ahead of ASCO Roche cancer programs angle for a starring role at ASCO Read more about: Roche, Melanoma, vemurafenib back to top 4. Investor panic could spell tougher times for biotechs By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn The big message delivered from yesterday's stock market rout was simple: shun risk. Flee to safety. And that kind of investment recipe does not benefit an industry like biotechnology. For biotechs, for whom red ink and high risk are staples of any business plan, it likely meant even less of an appetite for IPOs, which can only make raising fresh funds harder. Biotech IPOs haven't exactly been met with great enthusiasm this year, but going public has at least been an option for some. For biotech companies that are already public, the pain triggered by investor panic was spread far and wide. The Nasdaq Biotech Index has plunged by almost a quarter in the past few weeks. That was in line with the 22% drop in the Massachusetts biotech index tracked by the Boston Globe. The Amex ^BTK has melted from 1340 to 1068--yesterday's close--in just 7 short days. So where the Dow was badly mauled, biotechs were being bludgeoned. Big Pharma companies, which like many multinationals have long been cautious in the wake of the 2008 financial crisis, have been hoarding huge reserves of cash. According to the Star-Ledger, Johnson & Johnson is sitting on $3 billion in cash. Merck has $1 billion in cash on the books. There is a silver lining to the black cloud over Wall Street. A turnaround could push Big Pharmas to spend more of their reserves on new drug deals. And investors looking for bargains could well turn to the biotech sector once the angst has died down a bit. Things were also starting to look up this morning as the Dow jumped more than 200 points and the battered ^BTK surged 3%. - read the story from the Boston Globe - here's the report from the Star-Ledger Related Articles: Forbes columnist: Vegas rules apply to biotech investing Are biotech's tough times over? Dendreon releases death-eaters into biotech sector stocks Read more about: business development, Biotech Stock, investment back to top 5. Corey Goodman's upstart biotech garners a $5M Series A By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn Corey Goodman's fledgling microbiome biotech, Second Genome, has raised $5 million in a small but tidy A round that brought in two new investors. Advanced Technology Ventures and Morgenthaler Ventures have jumped on board a bandwagon of venture groups that includes Wavepoint Ventures, Seraph Group and some individual seed investors. Their money will back an ambitious plan to pursue microbiome-based personalized medicines for a slate of gastrointestinal diseases, including irritable bowel syndrome, inflammatory bowel disease, antibiotic-associated diarrhea and necrotizing enterocolitis. As Ron Leuty at the San Francisco Business Times notes, Second Genome's big idea is to compare the microbiome in healthy guts with diseases ones--analyzing 59,000 bacteria to see which are spurring disease--so they can identify a personalized treatment. And Goodman, a noted academic turned Bay Area biotech entrepreneur, has been gaining support for the upstart. "Over the past decade we have witnessed the enormous impact that personalized medicine can have on patient care," said Goodman, who co-founded the company--formerly known as PhyloTech--and acts as chairman of the board. "Our ability to analyze the entire microbiome and to identify signatures gives us a key set of tools to unlock the potential of microbiome?based personalized medicine in major disease areas." - read the Second Genome release - here's the story from the San Francisco Business Times Related Articles: A drug development revolutionary advocates radical change in R&D New biotech venture firm targets private/public deals Promising stem cell start-ups merge, add $11.5M Pfizer's biotech leader makes an unexplained exit  Read more about: Biotech Venture Capital, personalized medicine, Corey Goodman, Second Genome back to top Also Noted 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. SPOTLIGHT ON... Intercept nails $165M diabetes pact with Servier Intercept Pharmaceuticals has struck a $165 million deal with Les Laboratoires Servier to collaborate on new TGR5 agonists for diabetes and other metabolic ailments. "We are very happy to enter into this collaboration with Intercept which will allow us to further expand our diabetes and metabolic disease franchise," stated Dr. Emmanuel Canet, head of Servier R&D. "TGR5 is a target of great interest with its effects on GLP-1 that complement those of other classes of marketed diabetes drugs." Release @FierceBiotech: Is the FDA writing a recipe for the failure of biosimilars in the U.S.? Report | Follow @FierceBiotech   @JohnCFierce: ATV and Morgenthaler line up behind Second Genome, a Corey Goodman biotech, with a small but tidy $5M Series A. | Follow @JohnCFierce @MaureenFierce: Several Russian companies have establish a $113M joint venture designed to develop innovative treatments in the country. News | Follow @MaureenFierce > Lexicon Pharmaceuticals announced this morning that LX1032 or telotristat etiprate posted positive mid-stage data demonstrating its potential for reducing symptoms associated with tumors. Story > A group of healthcare watchdogs led by Gary Schwitzer says they're vehemently opposed to any relaxation of the FDA's conflict of interest rules for advisory committee members. The group offered a list of experts who could fill empty AdComm spots. Story > Human Genome Sciences has hired Craig Parker as senior vice president of strategy and corporate development. Parker had been CEO and co-founder of Vega Therapeutics. Release > NeurogesX has entered into a $20 million loan agreement with Hercules Technology Growth Capital. Release > Apricus Biosciences say it is filing for an approval of its ED drug Vitaros in Latin America. Release Pharma News @FiercePharma: Study finds Revlimid's interaction w/Pgp affects blood levels, so dosing might need tweaks. Article | Follow @FiercePharma  > Pharma feels threatened by new US austerity push. Article > Merck, Pfizer among cash stashers as markets gyrate. Story Biotech Research News > Gene discovered that regulates the timing of our tickers. News > DoD gives NeoStem $1.7M to develop adult stem cells for osteoperosis. 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 support 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... Contrary to widespread belief chimps have an altruistic side, researchers say. Some had speculated that altruism had to be a human trait that developed as humans evolved. Release Events * Post listing: Click here. * General ad info: Click here. > 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. > PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC This Conference offers a unique opportunity to join FDA representatives and industry experts in face-to-face dialogues. FDA speakers provide updates on the current state of efforts impacting global regulatory strategies. Industry professionals will present case studies on how they employ global strategies in their daily processes. Click here. > PDA 2011 Combination Products Workshop - Sept. 21-22, 2011 - Washington, DC This workshop focuses on the device design validation requirements of FDA's Quality System Regulation and the international harmonized quality standard ISO 13485:2003 which may be applied during the life-cycle of a combination product. Click here. > Pharmaceutical Strategic Alliances - Sept 21-23, 2011 - New York, NY IS THIS BIG PHARMA'S LAST DECADE? Hear from leading executives such as Biogen's CEO George Scangos, BMS's CEO Lamberto Andreotti and J & J's Tom Heyman at PSA, the only conference to deliver detailed strategic analysis on the biopharma subjects you need to understand now. www.windhover.com/psa > CBI's Pharma/Bio Forum on Preclinical Development - September 26 - 27, 2011 - Boston, MA Enhance your capabilities of utilizing biomarkers, translational research and toxicity detections within global regulations. The forum provides a unique platform for industry professionals to manage successful partnerships throughout the preclinical R&D process. Register now: www.cbinet.com/preclinical. > AdvaMed 2011- Register Now and Save 300! - September 26-28, 2011 - Washington, DC Whether you focus on compliance or business development, marketing, finance or regulatory affairs, AdvaMed 2011 is where medical device and diagnostic industry stakeholders come to do business, share best practices, and influence policy. Don't miss out. Early registration ends Aug. 5th. www.AdvaMed2011.com > 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD This interactive forum will closely examine the latest developments, preparation and use of inspection standards and practical aspects of manual and automated methods along with the regulatory and compendial requirements that govern them. Click here. > Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA PDA, ISPE, the FDA and EMA have created a joint conference dedicated to teaching the principles of ICH Q10. This will be a unique opportunity to learn principles from companies that implemented a Pharmaceutical Quality System across the product lifecycle according to the ICH Q10 model. Click here. > 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" - Oct 6, 2011 "Cancer Immunotherapy: A Long Awaited Reality" is a unique, single-day conference event that unites founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy. For information, please email info@mdbpartners.com or contact Michael Becker or Janet Dally of MD Becker Partners at phone (267) 756-7094. To register or for more information, visit www.regonline.com/mdbpartners > 19th Annual BioPartnering Europe - 9-11 October 2011 - London, UK Take your place at the table with global leaders, put your company in the spotlight and help define the future of medicine. Join us for BioPartnering Europe in London this October. Visit: http://www.techvision.com/bpe > US Conference on Rare Diseases and Orphan Products - October 11-13, 2011 - Washington, DC The Rare Diseases and Orphan Drugs Summit 2011 is the first annual program representing a collaboration among academic researchers, clinical researchers, pharmaceutical and biotechnology companies, regulatory and health agencies, patient organizations, payors and venture capital/private equity concerns to address the need for effective therapies for rare diseases. Learn more. > PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD This conference will gather industry professionals to network and benefit from a program that demystifies the underlying science of microbiology and seeks to solve the problems that our industry faces. The agenda will include presentations from regulatory and industry representatives globally. Click here. > BioNetwork West 2011 - Oct. 24-26 - The Ritz Carlton Laguna Niguel, CA BioNetwork is the key industry biopharma partnering event that provide the essential meeting place for pharma and biotech companies to develop relationships and move programs forward. Get 25% off with code 10386XZ88EN. For more info and to register now, visit www.bionetworkus.com, call 888-482-6012. Marketplace * Post listing: Click here. * General ad info: Click here. > 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 * Post listing: Click here. * General ad info: Click here. > 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 FierceBiotech Jobs 50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at http://www.fiercebiotech.com/jobs. ©2011 FierceMarketsThis email was sent to nbrauchitsch@yahoo.com as part of the FierceBiotech email list which is administered by FierceMarkets, 1900 L Street NW, Suite 400, Washington, DC 20036, (202) 628-8778. Refer FierceBiotech to a Colleague Contact Us Editor-in-Chief: John Carroll. Executive Editor: Ryan McBride. Managing Editor: Maureen Martino. Publisher: Arsalan Arif. VP, Sales: Ryan Willumson. Advertise Advertising/Lead-Generation: Ryan Willumson. 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Fwd: 58 sessions, 600+ stakeholders, the biggest Cold Chain event in the world!

-------- Original Message --------

Subject:	58 sessions, 600+ stakeholders, the biggest Cold Chain event in the world!
Date:	Tue, 9 Aug 2011 12:00:57 -0400 (EDT)
From:	FiercePharmaManufacturing <editors@fiercepharmamanufacturing.com>
Reply-To:	editors@fiercepharmamanufacturing.com
To:	nbrauchitsch@yahoo.com

This week's FiercePharma Manufacturing is brought to you by IQPC.

The Cold Chain and Temperature Management Global Forum is fast approaching and the early bird price is about to end on August 19! Book a full access pass< /strong> which includes the Two Day Conference, Five Workshops, Focus Day and Welcome Reception and save $2,403! Click here to register now! The Cold Chain & Temperature Management Global Forum is among the worlds biggest and is the best place to be if you operate as an international Cold Chain specialist. Don't miss out on networking with over 600 industry stakeholders and professionals, and with 58 sessions to choose from this is your greatest opportunity to gain the skills and contacts you need to excel in your field and give your knowledge an international edge. Book today. Call 1-800-882-8684, visit www.ColdChainPharma.com,or email cbecker@iqpc.com.au. Regards, Courtney Becker-James Event Director Cold Chain IQ (a division of IQPC) P.S Don’t miss such a great early bird offer! Book today by calling 1-800-882-8684 or visiting www.ColdChainPharma.com!

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