Theorem Clinical Research

Boehringer Ingelheim

Boehringer Ingelheim, CureVac collaborate on lung cancer immunotherapy

Thursday, September 18, 2014 01:39 PM

Boehringer Ingelheim and CureVac, a clinical stage biopharmaceutical company based in Tubingen, Germany, have announce an exclusive global license and development collaboration. The new collaboration focuses on CureVac's CV9202, a novel investigational therapeutic mRNA vaccine in early clinical development for the treatment of lung cancer.

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TransCelerate releases recommended approach for protecting personal data in Clinical Study Reports

Wednesday, September 3, 2014 08:20 AM

TransCelerate BioPharma has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others.

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FDA advisory committee recommends approval of Tiotropium Respimat COPD

Thursday, August 21, 2014 10:31 AM

The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted (10 yes, three no) t/news-online/company/Boehringer+Ingelheimhat existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.

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Peter Hirth joins Trovagene's scientific advisory board

Friday, August 15, 2014 10:34 AM

Trovagene, a California-based developer of cell-free molecular diagnostics, has hired K. Peter Hirth, Ph.D., who joins the company's scientific advisory board. A pioneer in the field of personalized medicine, Hirth led the organizations that developed both Sutent and Zelboraf; two successful targeted cancer therapeutics.

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FDA approves Jardiance to treat type 2 diabetes

Friday, August 1, 2014 01:33 PM

The FDA has approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.

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Zealand Pharma, Boehringer Ingelheim collaborate on novel peptide medicines

Wednesday, July 30, 2014 12:43 PM

Zealand Pharma, specializing in the discovery, design and development of peptide medicines, and Boehringer Ingelheim have announced a new global R&D collaboration. The collaboration covers a novel therapeutic peptide project from Zealand’s portfolio of preclinical programs. The aim is to develop novel medicines for improved treatment of cardio-metabolic diseases. The target is undisclosed.

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Boehringer Ingelheim to make available detailed clinical trial data

Wednesday, May 14, 2014 01:32 PM

In order to add to scientific and medical progress, Boehringer Ingelheim has launched a program to make clinical study data and other clinical study-related documents more widely accessible for approved products or after termination of a drug development program.

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Hydra Biosciences, Boehringer Ingelheim to collaboration worldwide

Friday, April 25, 2014 10:52 AM

Hydra Biosciences, a privately held biopharmaceutical company based in Cambridge, Mass., and Boehringer Ingelheim have entered into a worldwide collaboration to research and develop small-molecule TRPC4/5 inhibitors for the treatment of central nervous system (CNS) diseases and disorders.

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Icon’s Firecrest training recognized by TransCelerate BioPharma

Monday, April 14, 2014 10:13 AM

Icon,a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that its Firecrest training meets TransCelerate BioPharma’s minimum criteria for International Conference on Harmonization Good Clinical Practice (ICH/GCP) training.

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Transcelerate Biopharma recognizes CCRC, CPI certification for good clinical practice

Wednesday, January 15, 2014 11:19 AM

The Association of Clinical Research Professionals (ACRP) has learned that TransCelerate Biopharma now recognizes certification through the Certified Clinical Research Coordinator (CCRC) and Certified Physician Investigator (CPI) programs of ACRP's affiliate, the Academy of Clinical Research Professionals, as evidence of Good Clinical Practice (GCP) training.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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