This week's sponsor is Premier Research. | | Discovering the Great Potential of Immuno-Oncology Drugs Immuno-modulating agents have been around a long time, but for limited uses. New immuno-oncology pathways promise big advances against a wider range of cancers. Register now for our May 23 webinar. Premier Research. It's what we do. Best. | Featured Story Monday, May 8, 2017 Sanofi has teamed up with Exscientia to discover and develop bispecific small molecules that treat diabetes and its comorbidities. The agreement will see Sanofi hand over up to €250 million ($274 million) in return for small molecules designed to hit two targets involved in glucose control, NASH, weight management and other areas relevant to diabetics. |
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| This week's sponsor is Sensors Expo & Conference 2017. | | | Monday, May 8, 2017 Kite Pharma was off by 15% in morning trading after it announced the death of a patient in late April of cerebral edema—the very same fatal outcome that beset rival Juno’s Rocket trial, killing five people and its CAR-T program for JCAR015. |
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| Tuesday, May 9, 2017 Not a week seems to go by without a CRO sale rumor: Chiltern, INC Research and PPD (which in fact was recapitalized last week) are two of the most recent, and now the Wall Street Journal is adding Parexel to that list. |
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| Monday, May 8, 2017 Biosimilars development in the U.S. is still rapidly growing and shifting. We discuss the key issues sponsors face today – from nonclinical testing to commercialization – along with considerations for a strategic regulatory approach. Tuesday, May 9, 2017 In what is becoming an increasingly common pattern, Takeda has signed up to a collab with a small and very young biotech with an option to buy the company down the road. |
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| Tuesday, May 9, 2017 Biopharmas from Scotland, Canada and the U.S. have come together in a new pact deisgned to deliver intracellular candidates for two drug targets. |
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| Tuesday, May 9, 2017 The FDA has rejected a filing for approval of TherapeuticsMD’s treatment for vaginal pain during sexual intercourse because of the lack of 12-month safety data. The news leaves TherapeuticsMD looking down the barrel of an expensive, time-consuming safety study for TX-004HR unless it can persuade FDA to accept another route to approval. |
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| Tuesday, May 9, 2017 Biotech billionaire Patrick Soon-Shiong has been through the media wringer in the last few months, so will welcome an FDA green light that will draw attention back to his immuno-oncology programs. |
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| Monday, May 8, 2017 Engineered T-cell therapies, a promising way to “prime” a patient’s immune system against cancer, don’t work for everyone. Scientists from the Medical University of South Carolina found one possible explanation that can be targeted: blood platelets. |
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| Monday, May 8, 2017 Abbott announced the CE mark and launch of its smartphone-compatible insertable cardiac monitor, designed to help physicians remotely diagnose arrhythmias, such as atrial fibrillation, and guide their therapy decisions. |
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| Tuesday, May 9, 2017 Sanofi may be late to the pricing-pledge party but it’s come up with some benchmarks that beat its rivals. Rather than limiting price hikes to less than 10%, the French drugmaker promises to keep any price increases at or below an official U.S. health inflation measure that’s projected to hit 5.4% in 2017. |
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| This week's sponsor is MedNet Solutions. | | WHITE PAPER: Data Safety Monitoring Boards & eClinical This FREE White Paper explores Data Safety Monitoring Boards & Data Monitoring Committees, their role in managing patient risk, and how eClinical systems simplify their work. DOWNLOAD. | | Alnylam has taken on former Moderna head of R&D non-clinical Peter Smith as its new SVP of early development. Release Kymab has taken on immunologist and former Novartis and Merck Serono executive Sonia Quaratino as its first chief medical officer. Statement Preclinical cancer biotech Aravive Biologics has poached Astellas' VP of oncology medical sciences Stephen Eck as its president and CEO. Release | |
| Resources Presented By: Covance The ICH GCP E6 guideline has been revised to address the complexities associated with today’s clinical trials, and this concise white paper will help you understand the recent guideline changes. Learn how use of risk-based monitoring can help you comply with the guidelines and achieve efficiency in clinical trial design, implementation and reporting. Sponsored By: Veeva To thrive in a fiercely competitive market, life sciences companies need to set themselves apart by designing and executing the best trial and successfully deliver drugs to market first. Learn how a modern EDC can help. Sponsored By Reprints Desk Puzzled by Scientific Literature Access? Here is your guide for navigating knowledge management’s twists and turns! If yours is a small- or medium-sized biopharma business, we can help you putting the pieces together. Learn the secrets of top knowledge management experts who will show you how to search, discover, acquire and manage knowledge in new ways. Presented By: Covance The recent evolution of immunotherapies and their potential applications have greatly impacted patients’ options for effective oncology treatments. These advances have been powered in part by the use of biomarkers, companion diagnostics (CDx) and complementary diagnostics. Read the white paper. Sponsored By: DocuSign DocuSign’s eSignature solutions modernize healthcare and life science organizations by eliminating paper and antiquated signature processes while meeting compliance requirements and reducing costs and errors. Sponsored By: DocuSign The patients who rely on your scientific leadership are expecting more. Sponsored By: DocuSign The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company. Chief Medical Officer Summit in Emerging Biotechs 5th Annual May 10-11, 2017 | Boston, MA Drug Development Boot Camp® 2017 November 15-16, 2017 | Boston, MA FierceBiotech 2nd Drug Development Forum September 25-27, 2017 | Boston, MA Medical Sensors Design Conference May 8-9, 2017 │ Boston Marriott Newton │ Newton, MA 8th Transparency and Aggregate Spend West May 23-24, 2017 | San Diego, CA MIXiii-BIOMED 2017 May 23-25, 2017 | Tel Aviv, Israel Life Sciences Event of the Year! DIA 2017 Global Annual Meeting FierceBiotech Executive Breakfast- Tackling the Drug Price Problem: A Town Hall Debate June 21, 2017 | San Diego, CA Rational Combinations 360° in Immuno-Oncology June 28-29, 2017 | New York, NY 2017 BIO International Convention: The Largest Global Biotech Partnering Event of the Year June 19-22 | San Diego, CA |