 | An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist - Tuesday, July 26th, 1 pm ET / 10 am PT
Join us as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process.
Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more Register today. |
Today's Top Stories
1. Nonprofit poised to reap rewards from Vertex's pioneering CF drug
2. Government officials try to simplify the rules on human research
3. Analysis: Grim stats on CNS drugs demand fresh approach to development
4. Medicis inks $58M dermatology pact with India's Lupin
5. Raptor shares plunge following report of Ph3 success Also Noted: GE Capital Healthcare Financial Services
Spotlight On... Pfizer's Icagen buyout draws investor lawsuit
Aegerion recruits BMS vet as new CMO; Cevec and QRxPharma raise fresh funds and much more... More Fierce Life Sciences News:
1. Mayo Clinic eyes future trials recruitment with heath data exchange
2. St. Jude to cut 450 Swedish jobs
3. FDA data analysis reveals adverse drug combo
| Sponsor: 510(k) FierceLive! Webinars > An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist
Events > Rutgers Mini MBA: BioPharma Innovation Program
> Skill-building and Summer Fun in Boston!
> Online Pharmaceutical & Healthcare Marketing MBA for Executives
> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA
> 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
> AdvaMed 2011- Register Now and Save 300! - September 26-28, 2011 - Washington, DC
> CBI's Pharma/Bio Forum on Preclinical Development - September 26 - 27, 2011 - Boston, MA
> 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD
> Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA
> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA
> BIO China 2011 - October 12-13 - Shanghai, China
> PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD
Marketplace > Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years
> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative
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. Nonprofit poised to reap rewards from Vertex's pioneering CF drug
Venture philanthropy has become a hot topic in biotech, particularly as venture cash has grown increasingly difficult to obtain. Nonprofits like the Cystic Fibrosis Foundation have proven willing to finance early-stage long shots to advance significant new therapies. And as Nature reports, the CFF and others have strings attached to the cash. In the CFF's case, that string could soon lead to a new income stream--provided Vertex's closely watched VX-770 makes its way to an approval next year. The foundation has spent $75 million over the past 12 years on VX-770. That's just a small piece of the nonprofit cash now flowing to new drug programs. And with NIH grants hard to come by, the philanthropies are asking for--and getting--some significant promises of payback. "The charities are providing funds at the time when the risk is the very highest," Ken Schaner, an attorney at Schaner & Lubitz, tells Nature. "But yes, they expect a return." Back in 2000, Schaner helped forge a deal between the CFF and Aurora BioSciences. Vertex ended up buying Aurora and gained the VX-770 program in the bargain. That was one of the first such venture deals between a nonprofit and a biotech company. And it helped create a model for others that followed. It was Schaner who helped create the "interruption license," which requires drug developers to hand back a program if they lose interest in it. - here's the article from Nature Related Articles:
Vertex, CF Foundation alliance expand in $75M deal
Herper: Vertex CF saga a harbinger for targeted drug R&D Read more about: vertex, Biotech Venture Capital, VX-770, Cystic Fibrosis Foundation Therapeutics
back to top |
2. Government officials try to simplify the rules on human research
Acting under a mandate from President Obama to weed out unnecessary regulations, government officials have come up with a new set of rules governing federally-financed research involving humans. These new regulations tinker with the "Common Rule," a set of guidelines on consent, oversight and the protection of human subjects which have been in place for more than 20 years. And while some of the proposals could simplify drug studies, others would extend the reach of government involvement. The New York Times' Andrew Pollack focuses on one key change as an example of how these new rules could facilitate human drug studies. A single institutional review board would be allowed to supervise drug studies which occur at multiple sites, simplifying a process that now requires a board review at each of the sites. The Washington Post reports that the newly revised "Common Rule" would allow researchers to use a single website to report adverse events, rather than be held responsible for reporting the same event to multiple agencies. But the Times also notes that the new rules, which are now being made available for public comment ahead of final approval, would extend the reach of these regulations to all studies conducted by an institution which gets federal money. That way all studies at a university receiving NIH grants, for example, would be subjected to the federal rules, including studies solely funded by a drug company. And researchers would need to get the consent of volunteers before they could use tissue specimens in future studies, a rule driven by sequencing technology which makes it impossible to make any tissue truly anonymous these days. "I think this will really have quite a significant response from the research community," Heather Pierce, from the Association of American Medical Colleges, tells the Post. "I think it will be seen as moving human-research oversight into the 21st century." "These are the first substantial changes that have been made to the rules governing human subjects in decades, so this is really quite a historic moment," Kathy Hudson, deputy director of the National Institutes of Health, told reporters. - read the story in the New York Times
- and see the Washington Post's report Related Articles:
2010: The (government) check is in the mail
Study: Biomedical research funding is slowing
New bill boosts federal funding for biotech Read more about: federal funding, Obama Administration, human research
back to top |
3. Analysis: Grim stats on CNS drugs demand fresh approach to development
It's no secret that neuropsychiatric diseases like schizophrenia, depression and Alzheimer's present one of the toughest challenges to drug developers. Ken Kaitin and Christopher Milne at the Tufts Center for the Study of Drug Development crunched the numbers in their database to see just how tough it is, and came up with a daunting set of figures. Writing in Scientific American's August issue, the pair says that it takes an average of 18 years to go from the bench to the marketplace with a CNS drug, and that's for the 8.2% of therapies that survive the series of development hurdles (compared to 15% for drugs overall). Slightly less than half of the CNS drugs that make it to late-stage studies survive Phase III, compared to a 66% average. And regulatory review time takes an average of 1.9 years compared to 1.2 years. There are some new moves that should help improve chances, including a standardized trial database and new incentives for the field from the NIH. But add it all up and the stats illustrate why some Big Pharma companies no longer want to even try to go it alone here, according to the authors. And they say there's an inescapable conclusion: In place of individual efforts, developers, scientists and other organizations will need to create networks to push new CNS drugs through to approval. - here's the analysis in Scientific American from Tufts Related Article:
Report: Approval success rates higher for smaller firms Read more about: central nervous system, schizophrenia, Alzheimer's, depression
back to top |
4. Medicis inks $58M dermatology pact with India's Lupin
The media blitz focused on Medicis CEO Jonah Shacknai in the wake of the bizarre death of his girlfriend hasn't prevented the company from completing new development pacts. While a U.S. subsidiary of India's Lupin settled a legal squabble with Medicis Pharmaceutical over the right to sell a generic version of Solodyn extended release in the U.S., the Indian company inked a separate $58 million pact giving the U.S. biotech rights to its formulation technology for multiple programs. Lupin gets $20 million upfront and $38 million in promised milestones in the licensing pact, which also gives Lupin a royalty stream and Indian rights to the drugs Medicis develops using the technology. The Medicis deal follows a similar pact Lupin signed with Salix. "This partnership is a fairly long-term one and the products to be developed are from a variety of segments, although Medicis primarily works in [the] dermatology sector," Lupin's Nilesh Gupta tells Reuters. Medicis, which markets acne and wrinkle treatments, was founded by Jonah Shacknai in the late 1980s. Shacknai has been at the center of a media scrum for the past two weeks as police investigate the mysterious death of his girlfriend shortly before his son died from injuries he sustained in an apparent accident. - see the story from Reuters
- check out the report from the Business Standard
- and here's a Los Angeles Times profile on Shacknai Related Articles:
Medicis shares drop on death at CEO's house
Anacor inks $160M acne drug pact with Medicis
Medicis inks $104M licensing pact for botox therapy Read more about: India, Medicis, Lupin, Solodyn
back to top |
5. Raptor shares plunge following report of Ph3 success
Raptor Pharmaceutical says that its late-stage study of a new therapy designed to treat people with a rare genetic disease hit its primary endpoint. But even though the biotech company ($RPTP) says the study of the drug met that goal, its stock had plunged 24% in late-morning trading. RP103 is designed to give nephropathic cystinosis patients a drug that would only have to be taken every 12 hours, a big step up from Cystagon, the standard therapy which has to be downed four times a day. Investigators for Raptor say that the drug proved non-inferior among the 41 patients recruited for the study, setting up a planned regulatory filing at the FDA. Researchers reported 7 serious adverse events, but said that only one could be attributed to the experimental drug. "We are obviously very excited to have successfully met our primary endpoint of this study," said Christopher Starr, CEO of Raptor. Starr may be less happy with the company's stock performance. Shares of the Novato, CA-based developer had dropped to $5.32 shortly before noon, down from Friday's close of $6.96. - here's the Raptor release Related Article:
Raptor reports results from two programs Read more about: Raptor Pharmaceutical, RP103
back to top |
Also Noted | This week's sponsor is GE Capital Healthcare Financial Services. |  |
SPOTLIGHT ON... Pfizer's Icagen buyout draws investor lawsuit Law firms began circling Pfizer's $6-a-share buyout deal for Icagen hours after the acquisition left shareholders scrambling to deal with a price that fell well below their expectations. Now Michael Rauscher has emerged as the first investor to get to the courts, filing a claim that the buyout deal--which cost Pfizer close to $50 million for the shares it didn't already own--significantly undervalued the company. More investor suits are expected. Report  @FierceBiotech: Bristol-Myers snapping up Amira Pharma for $325M. Item | Follow @FierceBiotech
@JohnCFierce: Government pledging to overhaul rules on human research. From the NYT. Story | Follow @JohnCFierce @RyanMFierce: John Halamka has a very lucid explanation for why Harvard Med School needs a full time CIO, NGS demands, storage, etc. Blog post | Follow @RyanMFierce @MaureenFierce: FDA rejects new use for J&J immune disorder drug Simponi. News | Follow @MaureenFierce > Aegerion Pharmaceuticals reports that it has recruited Bristol-Myers Squibb veteran Dr. Mark Sumeray as its new chief medical officer. The biotech added that one of its board members plans to resign. Story > Germany's Cevec Pharmaceuticals says that it has raised $8.5 million in new venture cash to back its vaccines platform. Cevec release > Australia's QRxPharma says it has raised A$35 million following its NDA for a new combo pain therapy. Release Pharma News @FiercePharma: Merck amps up in China with Simcere JV. Report | Follow @FiercePharma > J&J blockbuster hopefuls get EMA recommendation More > Roche, Novartis cancer meds win EMA approval Item > Teva gets a taste of its own patent-challenged medicine Article > Will pharma fight Express-Medco deal? Story > Forest taps lobbyist to aid Solomon at HHS News Biotech IT News > FDA data analysis reveals adverse drug combo. Article > Harvard Med School CIO Halamka exiting big job. Story > Biomax Informatics expands deal with Royal DSM. More > Mayo Clinic eyes future trial recruitment with health data exchanges. Report > Bioinformatics upstart Intervention Insights secures $7.2M. Article Medical Device News > Nevro lands $58M for pain devices. More > St. Jude to cut 450 Swedish Jobs. Report > King's College spins out Centron Diagnostics. Story > Imperial Innovations invests $6.5M in Stanmore Implants. Article > Drew Medical's Dinkel banned from Medicare business. News And Finally... Investigators say that a U.S. study of a Japanese herbal remedy for hot flashes failed to demonstrate the same benefits reported in Japan, where it is a regulated pharmaceutical. TU-025 is a mixture of cinnamon bark, peach pit and botanicals. Story > An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist Join us Tuesday, July 26th, 1 pm ET / 10 am PT as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process. Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more. Register Today
| > Rutgers Mini MBA: BioPharma Innovation Program > Skill-building and Summer Fun in Boston! Boston offers exciting summer options for visitors of all ages. You could see a movie in the local park, listen to a concert on City Hall Plaza, or learn to paint on the waterfront. So why not explore Boston in August and build your professional skills at the same time? > 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. > Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA Led by Pfizer and Novartis, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > 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 > 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 > 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. > 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. > 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 > BIO China 2011 - October 12-13 - Shanghai, China Organized by the Biotechnology Industry Organization (BIO) and Shanghai Zhangjiang Hi-Tech Park (Z-Park), BIO China will bring together executives from biotechnology, pharmaceutical companies and investment firms from North America, Europe and Asia to meet and explore business opportunities with China's emerging biotech sector. Registration Now Open. > 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.
| > Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years With a surge in remote monitoring devices, mHealth developers are clamoring to build M2M applications that can transmit patient data in real time. Download this whitepaper today to learn more about developing apps for pharma-manufacturing and beyond. Download this white paper today! > 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.
| > 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 | |
This email was sent to nbrauchitsch@yahoo.com as part of the FierceBiotech email list which is administered by 
No comments:
Post a Comment