2016

Evotec, Merck to collaborate on target discovery technologies

Thursday, December 1, 2016

Evotec has announced the signing of a set of collaboration agreements with the life science business of Merck, which will combine Merck’s portfolio of genome editing technologies with Evotec’s versatile screening platforms and disease expertise. Evotec will leverage Merck’s comprehensive collection of genetic reagents such as viral CRISPR and shRNA libraries to enable new target discovery programs using its capabilities for phenotypic screening in primary and induced pluripotent stem (iPS) cells, as well as its in vivo disease models. Bringing together the complementary offerings, the two companies aim to provide fast and validated workflows to clients seeking to explore a new target space within complex disease models.

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Wiley launches new Spectra Lab applications for analytical data

Thursday, December 1, 2016

Wiley has launched Wiley Spectra Lab Desktop edition and Wiley Spectra Lab Server edition, providing flexible options, enhanced features and essential tools for any organization managing analytical data. In addition to providing access to a collection of 2.3 million curated reference spectra, the Desktop edition allows scientists to build their own knowledge bases. The Server edition takes this one step further, providing everything the desktop has to offer combined with centralized storage and controlled access for the whole organization.

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Regulatory Update, December 2016

Thursday, December 1, 2016

FDA Publishes Final Guidance Documents

The FDA published these final guidance documents. Interested parties may submit electronic or written comments on these guidance documents as instructed for the first document and with the indicated Docket Number included in the comments.

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Why we need to redefine the “team” in rare disease trials

Thursday, December 1, 2016

Achieving a sponsor’s goals, though of utmost importance, should only be one area of emphasis during a clinical trial. One must also consider the broader team of stakeholders—the patients, their caregivers and their physicians. This is never more true than in the study of rare diseases.

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First new HIV vaccine efficacy study in seven years has begun

Tuesday, November 29, 2016

The first HIV vaccine efficacy study to launch anywhere in seven years is now testing whether an experimental vaccine regimen safely prevents HIV infection among South African adults. The study, called HVTN 702, involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. HVTN 702 aims to enroll 5,400 men and women, making it the largest and most advanced HIV vaccine clinical trial to take place in South Africa, where more than 1,000 people become infected with HIV every day.

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Biodata innovation centre and new sequencing facility launched in the U.K.

Tuesday, November 29, 2016

The U.K. Prime Minister Rt Hon Theresa May has joined key stakeholders from across the life sciences sector to open the Wellcome Trust Sanger Institute’s new Bridget Ogilvie Building and the Biodata Innovation Centre at the Wellcome Genome Campus in Cambridge.

The Sanger Institute is one of the world’s leading genome centers and a major U.K. scientific success story. Together these new buildings will house one of the world’s most advanced gene sequencing facilities and a unique innovation space for global genomics and biodata businesses. These buildings will be home to a powerful collaboration between academia, businesses large and small, charities and Government.

The Ogilvie Building houses the Sanger Institute’s genome sequencing facility which has expertise in sequencing genomes from humans, pathogens and many other species with samples arriving from all corners of the world. It also houses the Genomics England sequencing operation which is delivering the 100,000 Genomes Project. The project will enable the NHS to become the first mainstream health service in the world to offer genomic medicine as part of routine care.

“The UK is recognized across the world for being the first nation to introduce whole-genome sequencing at scale in routine care environments. The Ogilvie facility is central to that achievement and opens the way to the virtuous circle of treating patients with genomic medicine leading to knowledge creation leading to advanced therapies leading to superior health outcomes.”

Sir John Chisholm, executive chairman of Genomics England, said, “The Biodata Innovation Centre houses start-up companies in the field of genomics emanating from local academic research, as well as cutting edge companies attracted from around the world—already businesses have moved to the Centre from the U.S., Europe and Asia—to collaborate with the UK’s best scientists.

“Genomes and biodata are an important part of all our futures. The Campus is home to research institutes, spin-out and start-up companies, academic-industry partnerships and Genomics England; all dedicated to driving and leading pioneering research and innovation and discourse in the sphere of genomes and biodata.

“The new buildings mark the next major step in the progression of our vision for this Campus as a global hub for genomics and biodata. We have an ambition to translate and commercialize research findings, as well as inform and enable the NHS to integrate genomics into clinical care.”

Professor Sir Mike Stratton, director of the Wellcome Trust Sanger Institute and chief executive of the Wellcome Genome Campus, said, “Genome sequencing is already changing the face of medicine, making possible more accurate and personalized treatments than ever before. Wellcome is delighted to build on its support of over 20 years standing with the launch of the Sanger Institute’s new sequencing and business incubation centers, which will accelerate further the application of genomics to human health and create significant economic benefits for the U.K.”

Dr Jeremy Farrar, Wellcome’s director, said, “It is an honor to open these buildings as they truly represent cutting edge British science and business in the modern era. What I’ve seen on the Wellcome Genome Campus is an excellent example of research from across the U.K. and around the world coming together with commerce to deliver benefits for everybody including patients in the NHS. We want the U.K. to be the ‘go to’ place for scientists, innovators, businesses and investors. This really is a very good example of that.”

Report: Healthcare companies must embrace new funding sources

Tuesday, November 29, 2016

Although the life sciences industry remains an attractive investment area, the healthcare sector has seen a decline in venture investments, particularly for early-stage investments, as pricing pressures, stringent regulations, rising development costs, reimbursement issues, and declining R&D productivity have proved significant barriers, said business intelligence provider GBI Research.

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BenevolentAI, Janssen partner on artificial intelligence

Tuesday, November 29, 2016

BenevolentAI, a British artificial intelligence (AI) company, has announced significant progress in one of its key ambitions: to improve and innovate the drug development process using AI technology and provide the best medicines to the right patients. BenevolentAI has signed an exclusive license for a series of novel clinical stage drug candidates with Janssen, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The agreement was facilitated by the Johnson & Johnson Innovation Centre in London.

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