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Chinese approval for bronchial thermoplasty system
Therapeutics : 28 October, 2013
Alair bronchial thermoplasty system to be used in China for the treatment of patients with severe asthma
Severe asthma treatment with bronchial thermoplasty
Therapeutics : 06 September, 2013
US medical journal publishes results of five years study into the use of the Alair Bronchial Thermoplasty system from Boston Scientific on severe asthma patients
Sangamo BioSciences agrees to acquire Ceregene
Therapeutics : 27 August, 2013
Sangamo BioSciences signs a definitive agreement to acquire Ceregene, a privately held biotechnology company focused on developing adeno-associated virus (AAV) gene therapies.
Health Canada approves ThromboGenics' JETREA for the treatment of symptomatic vitreomacular adhesion
Therapeutics : 19 August, 2013
Health Canada approves ThromboGenics' JETREA (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA).
Final patient completes Phase 2 clinical study with PSX1002 in moderate to severe COPD
Therapeutics : 19 August, 2013
Prosonix completes all patient dosing sessions and follow-up procedures in the company's Phase 2 clinical study with PSX1002.
Cardium enters into stromal cell agreement for wound healing With Orbsen Therapeutics
Therapeutics : 07 August, 2013
Cardium Therapeutics is entering into an agreement with Orbsen Therapeutics and the National University of Ireland, Galway, to utilise Cardium's Excellagen pharmaceutically-formulated gel as a delivery agent for Orbsen's proprietary stromal cell therapy in pre-clinical studies for the potential treatment of diabetic foot ulcers.
Life Technologies enters into an exclusive license with Novartis for Dynabeads
Therapeutics : 01 August, 2013
Life Technologies signs a long-term supply and exclusive licensing agreement with Novartis for immunotherapeutics involving T cells modified to express chimeric antigen receptors for the treatment of cancer.
Eisai gains positive CHMP opinion for Zonegran (Zonisamide) paediatric licence variation
Therapeutics : 29 July, 2013
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Zonegran (zonisamide) as a once-daily, adjunctive treatment of partial seizures (the most common form of epilepsy) with or without secondary generalisation in children aged six and above.
OncoSec Medical reveals positive immune response data from Phase II study of DNA-based immunotherapy
Therapeutics : 23 July, 2013
OncoSec Medical, a company developing the advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumours, is reportng interim immune response data from the company's Phase II study of ImmunoPulse in patients with metastatic melanoma.
FDA grants fast track designation to ELND005 for the treatment of neuropsychiatric symptoms in Alzheimer's Disease
Therapeutics : 18 July, 2013
The US Food and Drug Administration has granted Fast Track Designation to the development programme for Transition Therapeutics' ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer's disease (AD).
Boston Biomedical opens Cambridge headquarters in the USA
Therapeutics : 15 July, 2013
Boston Biomedical relocates the company's headquarters to Cambridge, Massachusetts, USA.
CSL Behring presents Phase I results of recombinant fusion protein linking coagulation factor VIIa with albumin
Therapeutics : 05 July, 2013
CSL Behring presents Phase I data of the company's recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam, The Netherlands.
Pharmacokinetic results indicate rVIII-SingleChain may have advantages for treatment of Haemophilia A
Therapeutics : 04 July, 2013
CSL Behring reveals that pharmacokinetic results for the company's novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life over octocog alfa (the comparator).
OncoSec Medical completes enrollment of phase II metastatic melanoma trial
Therapeutics : 20 June, 2013
OncoSec Medical, a company developing an advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumour cancers, is completing patient enrollment in a Phase II clinical trial of ImmunoPulse for metastatic melanoma patients.
NICE issues new draft treatment guidance for patients with diabetic macular edema
Therapeutics : 17 June, 2013
The United Kingdom's National Institute for Health and Care Excellence (NICE) issues draft guidance recommending pSivida's ILUVIEN for the treatment of pseudophakic patients (those who have undergone prior cataract surgery) with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
MannKind completes Phase 3 clinical study of AFREZZA in patients with Type 1 diabetes
Therapeutics : 03 June, 2013
MannKind reports that follow-up visits have been completed for the patients enrolled in Study 171, a Phase 3 clinical study of AFREZZA (insulin human [rDNA origin]) inhalation powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation inhaler.
MRI Interventions, IMRIS and Tocagen combine technologies to precisely deliver cancer drug to brain tumours
Therapeutics : 31 May, 2013
MRI Interventions and IMRIS are announcing that a surgical team at a leading US neuroscience institution has delivered the investigational gene therapy drug Toca 511 directly into a glioblastoma brain tumour using real-time intraoperative MRI (iMRI) guidance within an IMRIS VISIUS Surgical Theatre.
Prosonix initiates a Phase 2 clinical study of orally inhaled monotherapy for COPD
Therapeutics : 28 May, 2013
Prosonix is initiating a Phase 2 clinical study with PSX1002 that will assess its effect on lung function and the safety of a range of doses in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Nordion looks to divest Targeted Therapies business to BTG
Therapeutics : 28 May, 2013
Nordion is entering into an agreement to divest the company's Targeted Therapies business to BTG, an international specialist healthcare company based in London, United Kingdom, for a cash purchase price of $200 million.
pSivida launches chronic DME treatment in Germany
Therapeutics : 09 May, 2013
pSivida's ILUVIEN, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema (DME), is now commercially available in Germany.
Neuralstem receives FDA approval to treat final cohort in NSI-189 Phase Ib MDD trial
Therapeutics : 24 April, 2013
Neuralstem receives approval from the Food and Drug Administration (FDA) to begin dosing the third and final cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD).
Qiagen enters companion diagnostics collaboration agreement with Lilly
Therapeutics : 15 February, 2013
Qiagen enters into a master collaboration agreement with Eli Lilly for the development and commercialization of companion diagnostics for pairing with Lilly investigational and approved medicines across all therapeutic areas.
Recombinant vaccine from Protein Sciences gains FDA approval
Therapeutics : 21 January, 2013
The US Food and Drug Administration approves Protein Sciences' vaccine Flublok for the prevention of seasonal influenza in adults 18 to 49 years of age.
Ethris forges research based alliance with Shire to develop RNA-based therapeutics
Therapeutics : 07 January, 2013
Ethris agrees to initiate a research based alliance with Shire that is focused on the development and commercialisation of novel RNA-based therapeutics.
First-in-class treatment launches in Norway for most common form of epilepsy
Therapeutics : 07 January, 2013
Eisai is launching Fycompa (perampanel) in Norway as a treatment for partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older (Ref 1).
Allergan acquires SkinMedica
Therapeutics : 21 December, 2012
Allergan completes the acquisition of SkinMedica and paid approximately $350 million (subject to certain adjustments) for the business, which includes a variety of 'physician dispensed' non-prescription aesthetic skin care products and prescription products.
Cardio3 BioSciences to begin world's First Phase III trial in regenerative medicine for heart failure
Therapeutics : 23 November, 2012
The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases, receives authorization from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C3BS-CQR-1 in Belgium.
New evidence shows EndoBarrier Therapy influences key hormones for blood sugar control
Therapeutics : 24 October, 2012
GI Dynamics reveals data presented during the 20th United European Gastroenterology Week (UEGW), which adds to the growing body of clinical and preclinical evidence of the influence EndoBarrier Therapy may have on key intestinal hormones that control appetite and glucose metabolism.
GenVec works with Naval Medical Research Center to advance malaria programme
Therapeutics : 04 October, 2012
GenVec signs an agreement worth approximately $3.5 million with the Naval Medical Research Center (NMRC) to support malaria vaccine development.
Quintiles and Sinclair IS Pharma sign ten year Mexican partnership deal
Therapeutics : 14 September, 2012
Quintiles signs Sinclair IS Pharma a 10-year collaboration and licensing agreement for Quintiles (Rowfarma Mexico) to commercialize Sinclair’s portfolio of dermo-cosmetic products and medical devices in Mexico.
Quotient and Pulmatrix completes COPD proof-of-concept clinical programme
Therapeutics : 05 September, 2012
Quotient Clinical and Pulmatrix, a clinical stage biotechnology company creating novel inhaled therapeutics, complete an early clinical programme to achieve proof-of-concept data in COPD patients for PUR118, Pulmatrix's lead iCALM (inhaled dry powder cationic airway lining modulator) therapeutic.
New trial compares TIF procedure to PPI therapy to treat GERD
Therapeutics : 29 June, 2012
EndoGastric Solutions (EGS) is beginning the start of the TIF versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD Symptoms (TEMPO) trial.
Portugal grants ILUVIEN marketing authorization for chronic DME treatment
Therapeutics : 07 June, 2012
The National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saude, Infarmed) is granting marketing authorization to pSivida's ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Eisai receives positive CHMP opinion for Fycompa for partial onset epilepsy
Therapeutics : 29 May, 2012
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Eisai's Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.
Karolinska University Hospital partners GE Healthcare to advance cell therapy
Therapeutics : 24 May, 2012
Karolinska University Hospital Sweden and GE Healthcare Life Sciences are entering into a joint research collaboration to drive advances in technologies and workflows for use in the rapidly emerging field of cell therapy.
First patient screened in recombinant single-chain factor VIII study
Therapeutics : 28 February, 2012
CSL Behring is reporting the first patient has been screened in its recombinant coagulation single-chain factor VIII (rFVIII) trial, part of the AFFINITY clinical trial programme.
CESAR partners Saladax on 5-FU dosing for colorectal cancer
Therapeutics : 15 February, 2012
Saladax Biomedical is collaborating with the Central European Society for Anticancer Drug Research (CESAR) in a single arm study of metastatic colorectal cancer patients treated with the chemotherapy drug 5-fluorouracil (5-FU) and whose dose will be optimised based upon actual 5-FU blood levels.
BrainStorm reports clinical safety data for NurOwn treatment
Therapeutics : 19 January, 2012
BrainStorm Cell Therapeutics reports that the data from the initial patients in its ALS Phase I/II human clinical trial treated with its NurOwn technology did not present any significant side effects and that the NurOwn treatment has so far proven to be safe.
Temperature management unit revives Hajj pilgrims from heat stroke
Therapeutics : 16 January, 2012
Saudi Arabia Ministry of Health purchased six Zoll intravascular temperature management (IVTM) systems to treat pilgrims suffering from heat stroke during the annual Hajj pilgrimage to Mecca during November 2011.
Aethlon Medical reveals therapeutic device strategy for breast cancer
Therapeutics : 21 September, 2011
Aethlon Medical is introduicng HER2osome, a novel medical device strategy to inhibit the progression of HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein.
Selective coronary vasodilator targets coronary artery disease patients in Europe
Therapeutics : 27 January, 2011
Rapidscan Pharma Solutions (RPS) EU receives marketing authorization for Rapiscan (regadenoson) - a selective coronary vasodilator for use as a pharmacological stress agent in the diagnosis of coronary artery disease (CAD) – the single most common cause of death and disability in Europe (Ref 1).
Clinical trial studies autologous platelet-rich plasma treatment for tennis elbow
Therapeutics : 23 December, 2010
Biomet’s subsidiary, Biomet Biologics completes the required 230 subject enrollment for its Recover Kit clinical trial which aims to study the use of the Recover Kit device, which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis).
NanoBio to develop intranasal vaccine for Respiratory Syncytial Virus
Therapeutics : 02 December, 2010
NanoBio is receiving a $6 million grant from the Bill and Melinda Gates Foundation to support the development of a safe and effective intranasal vaccine for Respiratory Syncytial Virus (RSV).
Oncos Therapeutics completes major HealthCap investment
Therapeutics : 03 May, 2010
Oncos Therapeutics, a biotech company developing new cancer therapeutics based on its next generation oncolytic viruses, completes a euros 4 million investment from HealthCap.
NanoBio looks to develop nanoemulsion-based HBV vaccine
Therapeutics : 22 April, 2010
NanoBio is planning to develop an intranasal vaccine for the treatment of hepatitis B (HBV).
Cardium agrees deal with bioRASI to develop Generx product candidate
Therapeutics : 24 February, 2010
Cardium Therapeutics enters into an agreement with bioRASI, an international contract research organization, to assist Cardium in the evaluation of Generx clinical development opportunities within major newly-industrializing markets in Eastern Europe, Asia and Latin America, for patients with chronic coronary artery disease who are either not optimal candidates for or do not have access to costly angioplasty/stenting or cardiac bypass surgery procedures.
GI Dynamics' EndoBarrier type 2 diabetes treatment receives CE mark approval
Therapeutics : 24 December, 2009
GI Dynamics receives European CE mark approval for the EndoBarrier, which is a non-surgical therapy to treat type 2 diabetes and obesity.
Trauma Surgery meeting to be introduced to Open Abdominal Therapy System
Therapeutics : 02 October, 2009
KCI is demonstrating its Open Abdomen Negative Pressure Therapy System to practitioners a Conference of the American Surgery of Trauma Association
Cardium develops new formulation enhancements for wound healing
Therapeutics : 11 May, 2009
Cardium Therapeutics and its subsidiary Tissue Repair Company (TRC) is introducing new formulation enhancements for its Excellarate product candidate that are designed to simplify and broaden the use of Excellarate for diabetic ulcers.
Long term anticoagulant therapy study completes patient treatment
Therapeutics : 23 March, 2009
Boehringer Ingelheim announces that the last patient has completed treatment in the Phase III Randomized Evaluation of Long term Anticoagulant therapy (RE-LY) study.
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