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All News Consumer Pharma New Drugs Pipeline Clinical Trials

September 2007

September 4

ViaCell Announces ViaCyte Collaboration with EMD Serono, Inc. Positive Bioequivalence Study Results Trigger Milestone Payment for Eurand InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191 AstraZeneca Enhances Clinical Research Capabilities in China With First Clinical Pharmacology Unit Pharmexa Loses European Patent Appeal for Broad Claims to Telomerase-Based Cancer Vaccines Shire Voluntarily Withdraws a Limited Portion of Daytrana (Methylphenidate Transdermal System) Patches Omnicom Acquires Leading Healthcare Marketing Communications Firm in China Noven Provides Update on Daytrana Methylphenidate Transdermal System Canon Communications Acquires Engel Publishing Partners from Euromoney Institutional Investor PLC, Expanding Its Market Reach to Global Pharmaceutical Manufacturing Sector

September 6

AstraZeneca Launches and Prices a $6.9 Billion Bond Issue FDA Approves First Generic Versions of Coreg Pfizer Oncology Initiates Global Phase III Trial to Evaluate Sunitinib Malate Combined with Erlotinib in Advanced Non-Small Cell Lung Cancer China Aoxing Pharmaceutical Company Receives Government Approval for Increased Ownership of its Main Operating Subsidiary, Hebei Aoxing; Amends Terms of the Acquisition Agreement American Oriental Bioengineering Completes Acquisition of Changchun Xinan Pharmaceutical Group Company Ltd. Biogen Idec Announces Strategic Updates at Investor Meetings Elliott 'Extremely Dissatisfied' With Genzyme Bid for Bioenvision; Believes Offer Significantly Undervalues Company Youth Drug Use at a Five Year Low, New Survey Shows New Jersey High Court Denies Nationwide Class-Action Status to Insurance Companies Seeking Vioxx Reimbursements CDC Report Shows Largest One-Year Increase in Youth Suicide Rate in 15 Years

September 7

Wyeth and Nycomed Announce Court Denial of Preliminary Injunction Theravance Retains Full Ownership of Gastrointestinal Motility Dysfunction Program and TD-1792 Antibiotic Ablynx and Boehringer Ingelheim Announce Major Global Strategic Alliance to Discover, Develop and Commercialize Novel Nanobody Therapeutics Sens. Grassley, Kohl Say Public Should Know When Pharmaceutical Makers Give Money to Doctors Enzo Biochem, Inc. Files Appeal to Federal Court Decision Publicis Groupe Announces Intention to Delist its American Depository Receipts (ADRs) from the New York Stock Exchange and to Deregister and Terminate its Reporting Obligations under the U.S. Securities Laws Pozen/AstraZeneca Announce Start of the PN 400 Phase III Program Isis and Alnylam Launch Regulus Therapeutics, a Joint Venture to Discover, Develop, and Commercialize microRNA Therapeutics Novartis to Defend Its Intellectual Property Rights for Famvir Despite an "at-risk" Generic Launch in US Statement of Eli Lilly and Company on Dr. David Egilman Settlement: This Week, Pharma Bloggers Criticize Merck’s Vioxx Studies, Pfizer’s Third Breach of Confidential Data, and the Bush Administration

September 10

Palatin Technologies Announces Reacquisition of Full Rights to Bremelanotide Program MedImmune Resolves FDA Observations Regarding Manufacturing Process for FluMist BioVascular, Inc. Merges with Revitus and Acquires First-In-Class Platelet Count Reducer Repligen Announces Settlement with ImClone In Erbitux Lawsuit United BioSource Acquires Interest in Leading Adaptive Design Technology Service Provider Sanofi-aventis Announces Settlement of Average Wholesale Price Civil Suits With the U.S. Department of Justice Relating to Anzemet $52.5 Million Settlement Against Sepracor Inc. Approved Pfizer Issues a Dear Healthcare Professional Letter to Inform Healthcare Professionals of the Presence of Ethyl Methanesulfonate in Viracept Statement by Commissioner von Eschenbach on the Release of the Strategic Framework Document on Import Safety

September 11

Nabi Biopharmaceuticals Announces Sale of Nabi Biologics to Biotest AG Evotec Sells its Chemical Development Business to Aptuit for GBP 31.5m (approx. EUR 46.4m; US$ 63.9m) in Cash Alcon Waives Minimum Acceptance Condition for WaveLight AG Biovail Says Settlement With Maris, BAS Expected to Be Helpful in Suit Against Hedge Funds and Others Merck & Co., Inc. Announces Completion of NovaCardia, Inc. Acquisition Aptuit to Acquire CPD Business of Evotec AG Vote for the Most Admired Pharmaceutical, Biotechnology, and Specialty Companies Adverse Drug Events Reported to FDA Appear to Have Increased Markedly FDA - MedWatch - Rocephin (ceftriaxone sodium) - Dear Healthcare Provider Letter Clarifying Potential Risk Associated With Concomitant Use Of Rocephin With Calcium Containing Products GlaxoSmithKline Responds to JAMA Articles

September 13

Isis Enters Broad Collaboration With Ortho-McNeil, Inc. for the Discovery, Development and Commercialization of Antisense Drugs to Treat Metabolic Diseases Angiotech Receives Favourable Patent Decision from New Zealand's Intellectual Property Office First Consulting Group (FCG) Announces Sale of FirstGateways Business to MedPlus, Inc. FDA To Continue Its Review of Requests for Release of Clinical Hold on Alvimopan (Entereg) FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol New Licence for Cubicin (daptomycin), the First in a Novel Class of Antibiotic, is Announced Today for the Treatment of Serious Bloodstream and Heart Infections Caused by the Most Problematic UK Organisms, Including MRSA Canadian Court Finds Infringement of Lipitor Crystal Form Patent IFRS Information - First Half of 2007 Physicians Urge Kennedy, Dodd to Support Curb on Financial Conflicts of Interest on FDA Advisory Committees Cephalon Reinforces Important Prescribing and Dosing Information for Fentora

September 28

Simcere Pharmaceutical Group Acquires a 51% Stake in Boda Pharmaceutical Co., Ltd. Celera Announces Clinical Milestone Payment from Merck Novartis and Massachusetts Institute of Technology in New Partnership Aimed at Transforming Pharmaceutical Manufacturing Eisai Announces Establishment of New Pharmaceutical Marketing Subsidiary in Belgium Alcon Gains 76.9 Percent of WaveLight Shares and Will Move Forward with Acquisition Idenix Pharmaceuticals Restructures to Concentrate Efforts on HCV and HIV Programs OIG Releases Report of FDA’s Oversight of Clinical Trials, Concludes Improvement of Information Systems and Processes is Needed Bristol-Myers Squibb Finalizes Settlement of Previously Disclosed Federal Investigation into Pricing, Sales and Marketing Practices Canadian Federal Court Upholds Viagra Patent FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products Mayo Clinic Study Finds FDA Warning Against Anti-Nausea Drug Droperidol Unnecessary FDA-MedWatch -Gadolinum Based Contrast Agents: Dear Healthcare Professional Letter Issued Regarding Boxed Warning And Revisions to Warning Section of Prescribing Information

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