NEWS

• Savara Pharmaceuticals Initiates Phase 2 Clinical Trial Of AeroVanc For MRSA Lung Infection In Cystic Fibrosis Patients

  Savara Pharmaceuticals announced today that the first patient has started study drug treatment in a Phase 2 clinical trial evaluating the safety and efficacy of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis (CF) patients.

• Ablynx's Anti-IL-6R Nanobody, ALX-0061, Shows Excellent 24 Week Safety And Efficacy Results In A Phase II Clinical Trial In Rheumatoid Arthritis

  Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.

• Portola And Lee's Pharmaceutical Enter Into Agreement To Expand Phase 3 APEX Study Of Betrixaban Into China

  Portola Pharmaceuticals, Inc. and Lee's Pharmaceutical (HK) Ltd. (HKSE: 0950) today announced an agreement to jointly expand the Phase 3 APEX study of betrixaban into China, with an option for Lee's to negotiate for the commercial rights to the drug in China.

• ERT Expands Corporate Presence In Japan

  ERT, a global technology-driven provider of health outcomes research services to biopharmaceutical organizations, medical device companies and contract research organizations (CROs), recently announced significant milestones that reinforce its position as a leading eClinical trial solutions provider in Japan.

• Astrazeneca Announces Top-Line Results Of OSKIRA-4 Phase IIb Study Of Fostamatinib As A Monotherapy For Rheumatoid Arthritis

  AstraZeneca recently announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA).

• Theravance Announces Initiation Of Phase 2b Study With Its LAMA Candidate, TD-4208, For The Treatment Of COPD

  Theravance, Inc. (NASDAQ: THRX) announced the initiation of a dose ranging Phase 2b study with TD-4208 as a nebulized aqueous solution in patients with moderate to severe COPD.

• Dynavax To Initiate Phase 1 Studies For TLR-9 Agonist For Asthma

  Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will advance AZD1419, a proprietary second-generation TLR-9 agonist for asthma, into Phase 1 clinical studies.

• Novartis To Start Construction Of New Biotechnology Facility In Singapore With An Investment Of Over USD 500 Million

  ​Novartis announced recently the construction of a new state-of-the-art biotechnology production site in Singapore with an investment valued at over USD 500 million. The new facility will focus on drug substance manufacturing based on cell culture technology.

• Orion Receives Positive Phase II Study Results Of A New Levodopa Product For Parkinson's Disease

  ODM-101, a new levodopa product currently developed by Orion for the treatment of Parkinson's disease, has successfully completed Phase II Proof of Concept trial. The key results indicate that ODM-101 was more efficacious than the reference product Stalevo® in the treatment of advanced Parkinson's disease patients. The study included more than 100 patients in Europe.

• Bayer's Investigational Riociguat Meets Primary Endpoint In Phase III Study Of Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

  Bayer HealthCare today announced data from the Phase III CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.

• Results From Five Phase III Studies Presented For GSK's Two Candidate Quadrivalent Influenza Vaccines

  GlaxoSmithKline plc (GSK) recently announced that results from five Phase III studies investigating its two candidate quadrivalent influenza vaccines (QIVs) were presented at the Influenza Vaccines for the World (IVW) congress in Valencia, Spain and the Infectious Diseases week (IDweek) congress in San Diego, USA in October.

• Phase IIa Laquinimod Trial Results Show Positive Data For Potential Use In Active Crohn's Disease

  Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the presentation of Phase IIa clinical data for investigational laquinimod in moderate to severe Crohn's disease (CD).

• Arena Pharmaceuticals Initiates Phase 1 Multiple Dose Clinical Trial Of APD811 For Pulmonary Arterial Hypertension

  Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation of dosing in a Phase 1 multiple dose clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin (IP) receptor for the treatment of pulmonary arterial hypertension (PAH).

• Aeras Signs Agreement With GSK To Jointly Advance TB Vaccine

  Aeras announces that it has signed an agreement with GlaxoSmithKline Vaccines, S.A. (GSK) to jointly advance the clinical development of an investigational tuberculosis (TB) vaccine containing GSK’s proprietary M72 antigen and AS01E adjuvant.