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NIH suspends operations in its Clinical Center Pharmaceutical Development Section

Friday, June 5, 2015 10:55 AM

The NIH Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. FDA representatives inspected the PDS and found a series of deficiencies that will require the NIH Clinical Center to take a number of corrective actions.

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Takeda consolidates U.S. vaccine sites in Massachusetts

Thursday, June 4, 2015 01:35 PM

Takeda Pharmaceutical will consolidate its Vaccine Business Unit (VBU) operations by establishing global and regional hubs as the organization continues to grow and advance its important vaccine programs in norovirus, dengue and seasonal influenza.

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FDA approves Cipla’s Lopinavir/ritonavir for AIDS in infants and young children

Thursday, June 4, 2015 01:18 PM

Cipla, a global pharmaceutical company, has received FDA approval for Lopinavir/ritonavir (LPV/r) 40mg/10mg oral pellets for paediatric specific treatment for infants.

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Baxter, Mayo and Velocity launch Vitesse Biologics

Wednesday, June 3, 2015 12:35 PM

Baxter Ventures, the Mayo Clinic and Velocity Pharmaceutical Development (VPD) have formed Vitesse Biologics. Vitesse is a unique collaboration model initiated by Baxter Ventures to focus on the development of antibody and protein-based therapeutics in immunology, hematology and oncology.

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Actavis receives FDA approval for Viberzi (eluxadoline) for adult IBS-D

Thursday, May 28, 2015 03:01 PM

Actavis’ Viberzi (eluxadoline) has been approved by the FDA as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist and a kappa receptor agonist.

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ORIG3N, LabCorp collaborate

Wednesday, May 27, 2015 12:20 PM

ORIG3N, a Boston-based biotechnology company, is collaborating with Laboratory Corporation of America Holdings (LabCorp), a healthcare diagnostics company. LabCorp has invested in ORIG3N and will provide storage for LifeCapsule, ORIG3N’s induced pluripotent stem cell (iPSC) storage, at its biorepository facilities as well as perform genetic testing on the stored cells. LabCorp's experience will help to accelerate the development of LifeCapsule's specimen repository. 

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Tim Dietlin joins as partner in Heidrick & Struggles' healthcare and life sciences practice

Friday, May 22, 2015 01:29 PM

Heidrick & Struggles, a provider of executive search, leadership consulting and culture shaping worldwide, has strengthened its healthcare and life sciences expertise among global practices by adding Tim Dietlin to the firm's Chicago office.

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FDA approves Invega Trinza, only four-times-a-year treatment for schizophrenia

Thursday, May 21, 2015 02:27 PM

The FDA has approved under Priority Review Janssen Pharmaceuticals’ New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza. Invega Trinza, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. Priority Review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

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Forum Pharmaceuticals relocates headquarters to Waltham, Massachusetts

Wednesday, May 20, 2015 03:15 PM

Forum Pharmaceuticals, a biopharmaceutical company focused on the development and delivery of innovative medicines to treat serious brain diseases, has relocated its corporate headquarters to a 112,500-square-foot, state-of-the-art facility located in Waltham, Mass. The move consolidates Forum’s operations into a single centralized location that houses corporate offices, clinical development and research laboratories. Previously, Forum conducted business from two locations in Watertown, Mass. and Brighton, Mass. The company also maintains a small European office in the Netherlands.

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CluePoints announces U.S patent allowance for SMART Engine

Monday, May 18, 2015 02:33 PM

CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that the U.S. Patent and Trademark Office has granted a Notice of Allowance for Application No. 13/452,338, a patent which covers the company's SMART engine. The patent provides broad coverage for CluePoints' proprietary methodology that supports a risk-based approach to data monitoring in clinical trials.

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FDA sued by advocacy groups seeking hepatitis C trials data

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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