Biotechnology Industry News
This newspage features a selected set of feeds from biotechnology industry information sources.
- Time for a new business model?
... - Why data exclusivity is the new patent protection15 September 2009, 12:00 am
... - Follow-on biologic drug competition – No need for new marketing exclusivities22 September 2009, 12:00 am
... - Pharmaceutical royalties in licensing deals: No place for the 25 per cent rule of thumb21 April 2009, 12:00 am
...
Drug Patent Expirations- DEBATE ON GENETICALLY MODIFIED ORGANISMS RESURFACES AS FAO HOLDS BIOTECHNOLOGY CONFERENCE IN MEXICO14 March 2010, 10:30 pm
Extract not available....
- Enzyme Research: New findings in enzyme research described from Genentech, Inc.14 March 2010, 12:54 pm
enzyme research described from Genentech, Inc. March 14th, 2010 Printer-Friendly Version State:California Country:United States Enzyme Research Biotechnology Business Biotechnology Company Cancer Enzymes Genentech Inc Kinase Medicinal Chemistry Oncology... - Don't table biotech bill in parliament, CPI to PM14 March 2010, 12:26 pm
a copy, the party's national secretary vehemently criticised the bill's main proposal to set up the Biotechnology Regulatory Authority of India (BRAI) under the ambit of the Ministry of Science and Technology which has drafted the bill. 'The bill that is... - Chicago News Cooperative: Support Network Seeks to Grow Biotech Companies14 March 2010, 3:08 am
Pasche knows little about starting a business or courting investors, but he is getting help for the Chicago-based biotechnology company he founded, TheraBionic. The small-business development office at Northwestern University, where Dr. Pasche was...
- FDAAA 2007 Terms to Ensure You Understand10 March 2010, 4:34 pm
As a result of the Food and Drug Administration Amendments Act of 2007 (FDAAA), a number of terms were either revised or created anew that have impact on quality systems and regulatory affairs. Now, in 2010, as the FDA begins to truly enforce the various new and changes rules and requirements in FDAAA, biopharmaceutical and device executives need to make sure they are using the most current terminology. New or revised terms include: adverse drug experience new safety information study* clinical ... - February SmarterCompliance Published26 February 2010, 4:41 pm
The February issue of my FDA newsletter SmarterCompliance has been published. Contents include: Challenges in Choosing an Auditor Designing a Records Management Training Program Drug and Biotech Warning Letter Trends Three Threshold Part 11 and Record Archiving Questions Managing Project Risk Proactively Featured Reading: The Imposter Downloads for subscribers include: EMA Site Master File guidance FDA guidance on using bayesian statistics in clinical trials FDA guidance on proprietary drug name... - CMOs and Records Risks16 February 2010, 3:49 pm
After a couple of different pharmaceutical firms received complete response letters from the FDA over the past few months, the editors at Contract Pharma asked me to write some general advice on how pharma firms that use contracted services like manufacturers and clinical sites can avoid running risks stemming from the contracted service and poor records management controls. You can see my article here: http://www.contractpharma.com/expertsopinion/2010/02/12/cmos_and_complete_response_letters In... - Pre-Order My New Book at Barnes & Noble11 February 2010, 4:35 pm
My publisher just notified me that Barnes & Noble has posted the pre-order page of my new book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine. You can save about $20 pre-ordering it now through the above link to Barnes & Noble. As soon as the pre-order is available through Amazon.com, I'll post that as well. And the dedicated book website will be available to everyone in May with the book's publication; current subscribers to my FDA newsletter...
- Investing in Innovative Medical Research2 March 2010, 3:23 pm
Each year, donors invest millions of dollars in organizations fighting diseases. Much of this money goes to support individual disease research and finding ways to help our loved ones and communities. But experts in medical research say not all of it is used effectively. This Issue Brief developed by Arabella Advisors and FasterCures explores strategies donors can employ to help improve the current medical research process and to support the search for breakthrough treatments and cures. ... - Translating the CTSA Forum25 February 2010, 7:35 pm
by Margaret Anderson, Executive Director, FasterCuresThe CTSA Industry Forum meeting, convened by NIH's Clinical and Translational Science Awards (CTSA) consortium, was chock full of the type of commentary and discussion that has come to define any medical research meeting you go to these days. It was a two-day meeting held at NIH February 17-18 to look at collaboration among academia, government, and industry. Many of the topics raised could have been the focus of a week-long discussion. There... - Statement from Margaret Anderson, Executive Director, FasterCures on the New NIH-FDA Partnership to Speed New Treatments to Patients25 February 2010, 2:33 pm
FasterCures applauds the U.S. Food and Drug Administration and the National Institutes of Health on launching an initiative that will fast-track the biomedical research and development process to deliver safe and effective treatments to patients sooner. This formalized effort to integrate and enhance two critical disciplines - translational science at the NIH and regulatory science at the FDA - that are fundamental to our medical research system, paves the way to an enterprise that will harness ... - Advance Excerpts from Mike Milken's Closing Keynote Remarks to be Presented at the Russia Forum, February 42 February 2010, 9:41 pm
Mike Milken on the Imperatives of Medical Science Because human capital represents more than three-quarters of the world’s real assets, it follows that investments in education and health by governments, industry and individuals will provide the greatest returns. Over the past two years, the world has seen net financial losses in the range of 10 to 20 trillion dollars. But if we could eliminate death and suffering from heart disease and cancer – not curing them, but simply turning them int...
- Patent On Lysine-Producing Bacterium Killed For Lack of Best Mode11 March 2010, 8:28 pm
Earlier, the International Trade Commission (ITC) ruled that the importation and sale of certain lysine feed products did not violate section 337 of the Tariff Act of 1930 as amended, 19 U.S.C. § 1337. The Commission found that (1) the asserted claims of Ajinomoto’s U.S. Patents 5,827,698 and 6,040,160 are invalid under 35 U.S.C. § [...]Related posts:A Divisional Patent Application By Any Other Name Is … Not A Divisional After Amgen tried to get a judgment against Hoffman-La Roche..... - Small Business Patent Data Collection Act of 201011 March 2010, 7:32 pm
Sen. Mary Landrieu (D-LA) is Chairwoman of the Senate Small Business Committee. Sen. Landrieu has introduced The Small Business Patent Data Collection Act of 2010 after concerns about how the Senate patent reform bill will impact small businesses. Small businesses represent 99.7 percent of all employers, employing 1/2 of the U.S. labor force. The bill directs [...]Related posts:The Patent Reform Act of 2010: A Substitute S. 515 Here comes the Patent Reform Act of 2010 in the... Hearing T... - Butting into Face9 March 2010, 4:37 pm
I have blogged in the past about non-traditional trademarks. However the recent case of North Face and South Butt begs the discussion of trade dress and hence a comparison of the case in question with the precedents is unavoidable to glean whether South Butt does infringe North Face’s trade dress amongst other issues. Almost everybody in [...]Related posts:Non-Traditional Trademarks Trademarks have been in existence since as early as 5000... Book Review Monday: Gray Markets: Prevention, Det... - The Patent Reform Act of 2010: A Substitute S. 5155 March 2010, 8:45 pm
Here comes the Patent Reform Act of 2010 in the form of an Amendment in the Nature of a Substitute to S. 515 (“Amendment to S. 515”). I know, you’ve heard all this before with the Patent Reform Act of 2009, the Patent Reform Act of 2008, the Patent Reform Act of 2007, the Patent [...]Related posts:Congressional Budget Office: Patent Reform Act Will Cost $3 million According to the Congressional Budget Office, the increase in direct... Hearing Today on H.R. 1260, the “Patent Ref...
- Hatch-Waxman Boot Camp13 March 2010, 5:40 am
American Conference Institute (ACI) will be holding its Hatch-Waxman Boot Camp conference on May 24-25, 2010 in San Diego, CA. ACI faculty will help attendees: • Understand the interplay of the PTO and FDA in the patenting of drugs and biologics; • Learn about the essentials of the FDA approval process and its link to biopharmaceutical patents; • Develop an in-depth and practical knowledge of Hatch-Waxman protocols, including: Orange Book listings, bioequivalency, exclusivities, the 30-mon... - Webinar on Obviousness after KSR13 March 2010, 5:36 am
Strafford will be offering a webinar entitled "Obviousness Standard for Patents Post-KSR: Strategies to Withstand USPTO Obviousness Rejections and Attacks on Patent Validity" on April 14, 2010 from 1:00 - 2:30 PM (EST). Ronald Cahill of Nutter McClennen & Fish, Karen Canaan of CanaanLaw; and Kevin Meek of Baker Botts, will review how the obviousness standard has been applied by the court and the USPTO since the Supreme Court's decision in KSR v. Teleflex, and outline best practices for paten... - Biotech/Pharma Docket12 March 2010, 5:59 am
By Suresh Pillai -- DC District Court Remands Pfizer PTA Suit to USPTO Last week, the U.S. District Court for the District of Columbia remanded Pfizer Inc.'s challenge of the USPTO's calculation of patent term adjustment (PTA) back to the U.S. Patent and Trademark Office. This action by the District Court, following the Federal Circuit's decision in Wyeth v. Kappos, suggests that the agency will now be responsible for reconsideration of all patent term adjustments requested for patents that issu... - House Bill Seeks to Codify President's Stem Cell Order12 March 2010, 5:55 am
By Donald Zuhn -- On Tuesday, Representative Diana DeGette (D-CO) introduced legislation (H.R. 4808) that would amend the Public Health Service Act to provide for human embryonic stem cell research. H.R. 4808 would codify President Obama's Executive Order 13505, which permitted federal funding of research conducted with human embryonic stem cell lines. It was therefore fitting that the bill was introduced on the one-year anniversary of the President's reversal of limits imposed by the Bush Admin...
- Social Media Intern is Here to Help Pharma Avoid Social Media Faux Pas!13 March 2010, 11:11 am
... - Patient "Unadvocate" Lays Siege to sanofi-aventis VOICES Facebook Page. Where's S-A's Social Media VOICE?11 March 2010, 2:01 pm
... - Making Sense Out Pharma DTC Spending Trends9 March 2010, 8:43 pm
... - Use of Patient Testimonials in DTC & Social Media Advertising8 March 2010, 6:01 pm
...
- Grassley Tells PBMs To Disclose Ties To Pharma12 March 2010, 2:04 pm
In his latest attempt to probe the pharmaceutical industry, US Senator Chuck Grassley has written two big pharmacy benefit managers, as well as a trade group, asking them to provide information about their financial relationships with drugmakers. This week, he sent letters to Express Scripts, CVS Caremark and the Pharmaceutical Care Management Association (click on [...]... - Comparative Effectiveness & A Lack Of Comparisons12 March 2010, 1:41 pm
An analysis of comparative effectiveness studies finds that only 32 percent, which were published in leading medical journals, compared the effectiveness of existing drugs. Instead, few compared meds with non-pharmacologic interventions, while only 19 percent examined safety and 2 percent eyed cost effectiveness, according to the study in this week’s Journal of the American Medical [...]... - ‘Little Women’ Talk To The FDA About Gardasil12 March 2010, 1:21 pm
The controversy over the Gardasil vaccine for HPV, which can lead to cervical cancer, has never really gone away and this morning six women will hold a teleconference with several FDA officials to discuss numerous adverse events they say they have collected from various countries in hopes of convincing the agency to take a tougher [...]... - Up And Down The Ladder… Job Changes12 March 2010, 1:00 pm
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. [...]...
- Ampicillin May Help in the Treatment of Torsion Dystonia12 March 2010, 4:01 am
Photo: Dystonia DreamsIn the latest issue of the journal Disease Models & Mechanisms, scientists report of ampicillin's potential in the treatment of early-onset torsion dystonia. Torsion dystonia (also called idiopathic or generalized torsion dystonia) is a movement disorder characterized by sustained muscle contractions, usually producing twisting and repetitive movements or abnormal postures. It is not fatal, but severely debilitating, eventually necessitating the use of wheelchair... - BIO Whitepaper: Biotech Chemical Platforms to Create Green Jobs12 March 2010, 3:38 am
© WTL photosThe Biotechnology Industry Organization (BIO) has released a white paper on the growth and jobs potential of green chemicals and briefed Congressional staff on the commercial status of industrial biotechnologies for algae applications, biobased products, and advanced biofuels. The white paper, Biobased Chemicals and Products: A New Driver of U.S. Economic Development and Green Jobs (pdf file), indicats that the biobased chemicals and plastics industry accounts for over 5,700 dire... - Publish Your Print Flyers on the Biotech Weblog8 March 2010, 6:37 am
Lately, I've been receiving a number of email requesting to plug their products and events on this blog. I would like to take this opportunity to inform our readers about the advertising options available on the Biotech Weblog. For advertisers, you may want to know that the Biotech Weblog is open for sponsorship as well. Consider it akin to having print flyers made and distributed worldwide. You don't even need to think about flyer templates. Talk to our advertising staff about the diffe... - More on Barley Protein for Fish Feeds6 March 2010, 6:25 am
© chromaluxIn a previous entry, we've highlighted a research on a novel process to concentrate the protein in standard field barley for use as an alternative to fishmeal as a protein source in commercial fish feeds. I've received a couple of emails inquiring whether this product is already available in the market. No, I believe they are still far from getting sold off Discount Pet Supplies shops. The researchers have been able to formulate trout feeds with varying levels of barley pr...
No comments yet... Be the first to leave a reply!