Biopharmaceutical News and Research

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Heptares announces strategic drug discovery collaboration with Pfizer

Heptares Therapeutics, the clinical-stage GPCR structure-guided drug discovery and development company and wholly-owned subsidiary of Sosei Group Corporation, announces that it has entered into a strategic drug discovery collaboration with Pfizer Inc. to research and develop potential new medicines directed at up to 10 G protein-coupled receptor (GPCR) targets across multiple therapeutic areas.

30 Nov 2015

Mallinckrodt sells CMDS business to Guerbet for $270 million

Mallinckrodt plc, a leading specialty biopharmaceutical company, announced today that it has closed the sale of its global contrast media and delivery systems (CMDS) business to Guerbet in a transaction valued at approximately $270 million.

28 Nov 2015

Green Cross' GCFlu Quadrivalent approved to protect against four influenza strains in South Korea

Green Cross Corporation, a South Korean biopharmaceutical company, announced today that South Korea's Ministry of Food and Drug Safety has approved GCFLU QUADRIVALENT (Influenza Virus Vaccine) for immunisation of adults to help prevent disease caused by seasonal influenza (flu) virus subtype A and B. GCFlu Quadrivalent is the first locally-manufactured vaccine to cover against four influenza strains.

26 Nov 2015

Green Cross' Biologics License Application for IVIG-SN submitted to FDA

Green Cross Corporation, a South Korean biopharmaceutical company, today announced that it has submitted its Biologics License Application for IVIG-SN (human normal immunoglobulin G for intravenous administration) to the United States Food and Drug Administration.

24 Nov 2015

Viking submits IND application to FDA to conduct VK2809 Phase 2 study in patients with LDL-C and fatty liver disease

Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration to conduct a Phase 2 study of VK2809 in patients with hypercholesterolemia and fatty liver disease.

17 Nov 2015

Positive data from AbbVie's HCV clinical development program presented at The Liver Meeting of AASLD

AbbVie, a global biopharmaceutical company, today announced data from the SURVEYOR studies of its investigational HCV regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment (SVR 12) in non-cirrhotic patients with chronic hepatitis C virus (HCV) infection.

17 Nov 2015

CASI reports net loss of $1.6 million for third quarter 2015

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, today reported financial results for the three and nine months ended September 30, 2015.

13 Nov 2015

Mallinckrodt Study Shows Acthar® Reduces Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus

Data presented yesterday by researchers for Mallinckrodt plc, a leading specialty biopharmaceutical company, suggest that H.P. Acthar® Gel (repository corticotropin injection) reduces certain measures of disease activity in patients with persistently active Systemic Lupus Erythematosus (SLE) who are receiving corticosteroid therapy.

10 Nov 2015

Idera begins enrollment in IMO-8400 Phase 2 clinical trial for treatment of dermatomyositis

Idera Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing Toll-like receptor (TLR) and RNA therapeutics for patients with cancer and rare diseases, today announced that the company has commenced enrollment in a Phase 2 clinical trial of IMO-8400, an investigational TLR 7, 8 and 9 antagonist, in patients with dermatomyositis. Dermatomyositis is a rare and debilitating inflammatory muscle and skin disease associated with significant morbidity, decreased quality of life and an increased risk of premature death.

10 Nov 2015

PAREXEL expands market access and clinical evidence services

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced expanded evidence-based services for biopharmaceutical products.

10 Nov 2015

Paratek initiates Omadacycline phase 3 clinical study in community acquired bacterial pneumonia (CABP)

Paratek Pharmaceuticals, Inc. has announced the dosing of the first patient in its Phase 3 clinical study of its lead drug candidate, omadacycline, for the treatment of Community Acquired Bacterial Pneumonia (CABP). This global Phase 3 study will assess the efficacy and safety of omadacycline compared with moxifloxacin in subjects with CABP.

9 Nov 2015

AACR rapid and dramatic responses in TRK fusion patients

Loxo Oncology, Inc., a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced new results from its Phase 1 open-label, dose-escalation trial of LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK) signaling molecules, and the first preclinical data for its RET and FGFR programs. The data are being presented at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

9 Nov 2015

Nightstar announces $35 million Series B financing round

NightstaRx Ltd, a biopharmaceutical company specialising in developing gene therapies for inherited retinal dystrophies, announces a $35 million Series B financing round. The round was led by New Enterprise Associates, one of the world's leading venture capital firms.

9 Nov 2015

Circulating protein predicts risk of chronic kidney disease

Make room, cholesterol. A new disease marker is entering the medical lexicon: suPAR, or soluble urokinase-type plasminogen activator receptor.

6 Nov 2015

MD Anderson Cancer Center, CytomX to study probody-enabled CAR-NK cell therapies

CytomX Therapeutics, a biopharmaceutical company developing investigational Probody™ therapeutics for the treatment of cancer, today entered into a collaboration with The University of Texas MD Anderson Cancer Center to research Probody-enabled chimeric antigen receptor natural killer (CAR-NK) cell therapies, to be known as ProCAR-NK cell therapies.

6 Nov 2015

Johnson & Johnson signs definitive agreement to purchase Novira Therapeutics

Johnson & Johnson today announced a definitive agreement to acquire Novira Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company developing novel therapies for curative treatment of chronic hepatitis B virus (HBV) infection.

4 Nov 2015

Alnylam presents positive ongoing phase 2 open-label extension data for Patisiran and Revusiran

Alnylam Pharmaceuticals, Inc. has announced new results from its ongoing Phase 2 open-label extension (OLE) studies with patisiran and revusiran, investigational RNAi therapeutics targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR amyloidosis).

3 Nov 2015

$Viking begins VK5211 Phase 2 trial in patients recovering from hip fracture$

Viking begins VK5211 Phase 2 trial in patients recovering from hip fracture

Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced the initiation of dosing in the company's Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture.

3 Nov 2015

CureVac raises €100M to enable rapid expansion of mRNA development platform, clinical-stage pipeline

CureVac, a clinical-stage biopharmaceutical company pioneering the field of mRNA-based technology, today announces that it has raised about $110 million (€100 million) to enable accelerated expansion of its industry-leading messenger RNA (mRNA) development platform and clinical-stage pipeline.

3 Nov 2015

Mallinckrodt announces approval of INOmax for cardiovascular surgery in Australia and Japan

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that INOmax (nitric oxide) for inhalation has received regulatory approval in Australia and Japan for pulmonary hypertension in conjunction with heart surgery.

30 Oct 2015

Biopharmaceutical News and Research

Heptares announces strategic drug discovery collaboration with Pfizer

Mallinckrodt sells CMDS business to Guerbet for $270 million

Green Cross' GCFlu Quadrivalent approved to protect against four influenza strains in South Korea

Green Cross' Biologics License Application for IVIG-SN submitted to FDA

Viking submits IND application to FDA to conduct VK2809 Phase 2 study in patients with LDL-C and fatty liver disease

Positive data from AbbVie's HCV clinical development program presented at The Liver Meeting of AASLD

CASI reports net loss of $1.6 million for third quarter 2015

Mallinckrodt Study Shows Acthar® Reduces Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus

Idera begins enrollment in IMO-8400 Phase 2 clinical trial for treatment of dermatomyositis

PAREXEL expands market access and clinical evidence services

Paratek initiates Omadacycline phase 3 clinical study in community acquired bacterial pneumonia (CABP)

AACR rapid and dramatic responses in TRK fusion patients

Nightstar announces $35 million Series B financing round

Circulating protein predicts risk of chronic kidney disease

MD Anderson Cancer Center, CytomX to study probody-enabled CAR-NK cell therapies

Johnson & Johnson signs definitive agreement to purchase Novira Therapeutics

Alnylam presents positive ongoing phase 2 open-label extension data for Patisiran and Revusiran

Viking begins VK5211 Phase 2 trial in patients recovering from hip fracture

CureVac raises €100M to enable rapid expansion of mRNA development platform, clinical-stage pipeline

Mallinckrodt announces approval of INOmax for cardiovascular surgery in Australia and Japan

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