Boston Scientific Announces FDA Clearance and CE Mark for WallFlex(R) Fully Covered Esophageal Stent

Complete portfolio of Company's WallFlex Stent family of self-expanding metal stents now available in U.S., Europe and other international markets

FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets

Experts to Re-examine Guidance for Platelet Testing

LAKE ZURICH, Illinois, November 17 - Fenwal, Inc., a global medical technology company focused on improving
blood collection, separation, safety and availability, announced today that
the U.S. Food and Drug Administration has cleared the Verax Platelet PGD(R)
test as a quality control test to detect bacterial contamination in whole
blood-derived, pooled platelets prior to transfusion. Fenwal is the exclusive
global distributor of the test, which was developed by Verax Biomedical of
Worcester, Mass.

Daval International Awarded Orphan Drug Designation for Motor Neurone Disease Treatment

LONDON - Following the provision of clinical and scientific data to the US Food and Drug Administration (FDA), privately owned UK company Daval International Limited (www.davalinternational.com) has been informed that its innovative anti-inflammatory agent AIMSPRO(R) has been awarded an Orphan-Drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS).

FDA Grants Priority Review for Shire’s velaglucerase alfa for Type 1 Gaucher Disease

CAMBRIDGE, Massachusetts -

- FDA Issued Action Date of February 28, 2010 Under the Prescription Drug User Free Act (PDUFA)

Simbionix Introduces the Next Generation in Bronchoscopy Training

CLEVELAND, Ohio - Simbionix, the world’s leading developer of medical simulation systems, introduces it’s new advanced simulator, the GI-BRONCH Mentor, a comprehensive solution for virtual reality training of GI Endoscopy and Flexible Bronchoscopy.

FDA Determines VYVANSE(R) was Properly Granted Five-Year Market Exclusivity

DUBLIN - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the Food and Drug Administration (FDA), following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R). The five-year exclusivity period for VYVANSE expires on February 23, 2012. VYVANSE is covered by United States patents which remain in effect until June 29, 2023.

Novel Cardio-Pulmonary Support Device LIFEBRIDGE(R) From Germany Gains FDA Clearance

AMPFING, Germany -

- LIFEBRIDGE Medizintechnik gets Go-ahead on the US Market

German based LIFEBRIDGE AG has received clearance from the U.S. Food and Drug Administration (FDA) for a compact, lightweight, mobile heart-lung machine, a first for any manufacturer worldwide.

EPIX Pharmaceuticals Announces FDA Approval of a Physician-Sponsored IND for Fourth 6-month Open Label Extension of PRX-03140 for Alzheimer’s Disease Patient

WELLESLEY HILLS, Massachusetts -

The FDA has approved a Physician-Sponsored IND and continuation of the fourth 6-month open label extension of PRX-03140, a novel 5HT4 partial agonist for the potential treatment of Alzheimer’s Disease. The patient was enrolled initially in a two week Phase 2a study in August 2007 where she received 100 mg per day of PRX-03140 in combination with her normal daily dose of Aricept(R) (10 mg). Based on the marked progress during the original two week study, the patient’s daughter sought continued compassionate use of PRX-03140 for her mother and a protocol was submitted to the FDA and approved. The progress seen in the first 2-week study has continued during the past two years (19 months of dosing) and four FDA approved 6-month open label extensions. The latest open label extension will be administered under a new Physician-Sponsored IND under the supervision of Dr. Lucy Hornstein(1). “When I was approached by the patient’s daughter to continue the compassionate use therapy of PRX-03140 for her mother, I was compelled by the progress her mother had experienced and the overall apparent safety of the drug,” notes Dr. Hornstein.

New Multicenter Study Finds That Cardiac Function Measured During Stress Testing With Cheetah Medical’s BIOREACTANCE(R) Noninvasive Technology Offers New Insights Into Heart Failure

TEL-AVIV, Israel and PORTLAND, Oregon -

- Bioreactance-based Noninvasive Measurements During Exertion Identified Abnormalities of Cardiovascular Function and Might be Useful for Indexing Disease Severity, Prognostication, and for Tracking Responses to Treatment in Clinical Practice and Trials

Oncolytics Biotech(R) Inc. Reaches Special Protocol Assessment Agreement With the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers

CALGARY, Canada -

- Company to Host Conference Call

Oncolytics Biotech Inc. (”Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The SPA is an agreement between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is adequately designed to provide the necessary data, that depending upon outcome, could support a license application submission for REOLYSIN.

Merck Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States

GENEVA - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, Merck Serono’s proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Cladribine Tablets has the potential to be the first orally administered disease-modifying therapy available for people living with relapsing MS, as all disease-modifying therapies currently approved for the treatment of MS are parenteral therapies.

Simbionix USA Corporation’s Innovative Development Division Releases Two New Breakthrough Technologies

CLEVELAND, Ohio - Simbionix USA Corporation, the world’s leading developer of medical simulation systems, just released two new products: a new Laparoscopic Essential Tasks Module for its LAP Mentor(TM) and a breakthrough technology for patient-specific simulation based on actual patient data - the PROcedure Rehearsal Studio(TM).

Merck Serono Growth Hormone Injection Device easypod(R) Approved in Japan

GENEVA - Merck Serono, a division of Merck KGaA Darmstadt, Germany, today announced that the Japanese health authorities, the Pharmaceutical and Medical Devices Agency (PMDA), have granted a marketing authorization for easypod(R) in Japan. Easypod(R) was developed for exclusive use with cartridges of Saizen(R) (somatropin), Merck Serono’s human recombinant growth hormone for the treatment of growth hormone deficiency.

/C O R R E C T I O N — Merck Serono S A/

GENEVA - In the news release, “Merck Serono Growth Hormone Injection Device easypod(R) Approved in Japan” issued on 16 Sep 2009 07:00 GMT, by Merck Serono S A SWX:SEO over PR Newswire, we are advised by a representative of the company that the last sentence of the fourth paragraph has been changed from “In Japan, easypod(R) will be launched in September 2009″ to “In Japan, easypod(R) will be launched in the course of 2009″ as originally issued inadvertently. Complete, corrected release follows:

Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17

PHILADELPHIA -

- INTUNIV, the First Nonscheduled alpha-2A receptor agonist indicated for ADHD, Demonstrated Improvement in a Range of ADHD Symptoms That can be Disruptive, Such as Inattention, Arguing With Adults, Hyperactivity, Impulsivity, and Losing One’s Temper

Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials

CAMBRIDGE, Massachusetts - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today reported that it has completed its submission of a New Drug Application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the U.S. Food and Drug Administration (FDA). The Company also announced positive results from the final two Phase III studies of velaglucerase alfa, with both studies reaching all of their primary and secondary endpoints.

Pitavastatin is Non-Inferior to Atorvastatin and Simvastatin and Demonstrates Sustained Efficacy and Tolerability Over 52 Weeks

BARCELONA, Spain -

- Pitavastatin Represents Long-Term Treatment Option for Patients With Primary Hypercholesterolaemia or Combined Dyslipidaemia

Bavarian Nordic A/S - Half Year Interim Report 2009

KVISTGAARD, Denmark - Today Bavarian Nordic published the company’s half-year interim report 2009. The full financial statements are available on the company’s website: www.bavarian-nordic.com. Below is an extract of the most significant matters in the report as well as events after the balance sheet date.

Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device

SIOUX FALLS, South Dakota -

Sanford Health (www.sanfordhealth.org), a comprehensive health care provider in the Upper Midwest, announced today a spinal implant developed by Sanford Clinic Neurosurgeon, Wilson Asfora, MD, Sanford Clinic Neurosurgery & Spine, has received United States Food and Drug Administration (FDA) 510(k) market clearance as a lumbar intervertebral body fusion device. On August 14, 2009, the FDA gave 510(k) clearance to the Asfora Bullet Cage, a product which is designed for use in posterior lumbar interbody fusion surgeries to treat degenerative disc disease. The Asfora Bullet Cage will be manufactured and sold by Medical Designs, LLC, a Sioux Falls company owned by Dr. Asfora.

Bavarian Nordic in Negotiations With the US Authorities for the Further Development of IMVAMUNE(R)

KVISTGAARD, Denmark - Bavarian Nordic A/S (OMX: BAVA) announced today that the US authorities have initiated negotiations for a new contract to develop a freeze-dried version of the IMVAMUNE(R) smallpox vaccine. This potential new project will have no influence on the ongoing RFP-3 BARDA (Biomedical Advanced Research and Development Authority) contract for the procurement of 20 million doses of IMVAMUNE(R) and the licensure of the current liquid-frozen formulation, but represents an additional business opportunity.

Smith & Nephew Takes Single Injection PMA to Next Stage

RALEIGH and DURHAM, North Carolina -

Smith & Nephew (NYSE: SNN; LSE: SN) Biologics & Spine is proceeding to the next stage in the approval process for the U.S. launch of DUROLANE(R) Single Injection, Stabilized Hyaluronic Acid.

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

LEXINGTON, Massachusetts -

- Treatment Protocol Accepted and Rolling Submission of New Drug Application Initiated

The European Commission Approves Samsca(TM) (tolvaptan), Europe’s First and Only Oral Vasopressin Antagonist for Hyponatraemia Secondary to Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

TOKYO, Japan and UXBRIDGE, England - Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Europe Ltd. (OPEL) announced today that the European Commission has approved the Marketing Authorisation Application for the company’s oral once-daily medication Samsca(TM)(tolvaptan), a selective V2-vasopressin receptor antagonist, for the treatment of hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults. Samsca is the first oral vasopressin receptor antagonist available in Europe.

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

PHILADELPHIA - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for INTUNIV(TM) (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date.

Pulmonx Announces New President and CEO Michael A. Baker to Lead Interventional Pulmonology Company

REDWOOD CITY, California -

Pulmonx, an emerging leader in interventional pulmonology and in the development of device therapies for the treatment of emphysema announced today that Michael A. Baker has joined the company as President and CEO and that he has been elected as a member of its board of directors.

GONAL-f Approved in Japan for Ovulation Induction in Infertile Women

GENEVA, Switzerland - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that the Japanese Ministry of Health, Labor and Welfare has granted approval to extend the indication of GONAL-f(R) (follitropin alfa for injection) to infertile women suffering from irregular or no ovulation (oligoovulation or anovulation) due to a dysfunction in the hypothalamic- pituitary system or polycystic ovarian syndrome. GONAL-f is a recombinant follicle-stimulating hormone currently approved in Japan for the treatment of male infertility.

Unisense FertiliTech A/S Receives CE Mark of Approval for EmbryoScope(TM) Embryo Monitoring System

AARHUS, Denmark - Unisense FertiliTech A/S ( www.fertilitech.com) announces that the EmbryoScope(TM) Embryo Monitoring System and EmbryoSlide(TM) tray have received CE approval as class IIa medical devices for use in IVF. Unisense Fertilitech A/S also received the DS/EN ISO13485:2003 and AC:2007 quality system certificate for production, installation and servicing of IVF incubators and related accessories

Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease

LEXINGTON, Massachusetts - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease.

FDA Approves Multaq(R) for Patients With Atrial Fibrillation or Atrial Flutter

PARIS -

- Multaq(R) Approved to Reduce the Risk of Cardiovascular Hospitalization in Patients With Atrial Fibrillation or Atrial Flutter

Living Cell Technologies’ Diabetes Clinical Trial Authorized by New Zealand Government

SYDNEY and AUCKLAND, New Zealand -

Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced that the New Zealand Minister of Health, the Honourable Tony Ryall, has authorized LCT’s New Zealand Phase I/IIa clinical trial of DIABECELL(R) for insulin dependent diabetes.

Neurim Pharmaceuticals Reports Long Term Efficacy and Safety for Circadin(R) for Insomnia in Elderly Patients

SEATTLE - Neurim Pharmaceuticals (www.neurim.com) presented today the preliminary results of a large-scale Phase III study of Circadin(R) 2mg, prolonged release melatonin in insomnia, demonstrating long term efficacy and safety in elderly patients. The results were reported in the Late Breaking Abstracts session of SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies, (APSS) held at Seattle, Washington. The SLEEP meeting attracts the largest audience of sleep specialists in world.

Agendia Supports Genentech’s Citizen’s Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards

HUNTINGTON BEACH, California, and AMSTERDAM - Agendia, a world leader in molecular cancer diagnostics, today announced its strong support of Genentech’s Citizen’s Petition. Filed on December 5, 2008, Docket No. FDA-2008-P-0638-0001/CP petitions that all in vitro diagnostic tests be held to one set of scientific and regulatory standards. In response, on May 28, 2009, Agendia formally submitted a letter of support to the U.S. Food and Drug Administration (FDA). The Genentech petition and other documents submitted in support of and in opposition to the petition can be accessed here: www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-P-0638

HRA Pharma Granted European Marketing Authorization for ellaOne(R)

PARIS - Next Generation Emergency Contraceptive Will First be Launched in UK, Germany and France as Company Expands International Operations

Nerviano Medical Sciences Receives Approval From the FDA to Enter Phase I Clinical Trials for Their Polo Like Kinase (PLK) Inhibitor

NERVIANO, Italy - The FDA has approved an Investigational New Drug (IND) application by Nerviano Medical Sciences to begin a phase I clinical study with its selective PLK-1 small molecule inhibitor for the treatment of cancer. PLK-1 is a mitotic kinase required for the proliferation of cancer cells. This new compound is orally bioavailable, highly efficient and well tolerated in preclinical models of cancer after repeated dosing. This unique inhibitor adds another promising candidate to the pipeline of innovative cell cycle targets with different mechanisms of action in clinical development which have been discovered and developed by NMS. These include inhibitors of CDK, Aurora and CDC-7. An IND for an inhibitor of CDC-7 was approved by the FDA in January this year and the first patients were treated with the compound in April. NMS CDK and Aurora inhibitors are in phase I and II clinical development, respectively, and are starting to show promising activity in specific patient populations.

Novagali Pharma Announces FDA Clearance of IND for Phase III of Catioprost(R), its Cationic Emulsion of Latanoprost in Patients With Glaucoma

EVRY, France - Novagali Pharma, a French pharmaceutical ophthalmic company, announces today that the Company’s Investigational New Drug Application (IND) to conduct a Phase III clinical trial of Catioprost(R) (Nova21027), for the treatment of glaucoma has been granted by the U.S. Food and Drug Administration (FDA). Catioprost(R) is a topical ocular proprietary BAK-free formulation of latanoprost which furthermore benefits from the ocular surface protection properties of Novasorb(R), its patented technology based on cationic emulsion.