Top Stories Wednesday, November 9, 2016 Late last night, seemingly in an effort to minimize exposure to the news as the U.S. election dominates, small cap Arrowhead Pharmaceuticals announced that the FDA has hit the biotech with a clinical hold for a small test of its hep B med ARC-520, which has previously been touted as a possible cure for the infection. Tuesday, November 8, 2016 CureVac has raised another $29.5 million to fund the advance of its mRNA pipeline. The fresh funding comes one year after CureVac tapped The Bill & Melinda Gates Foundation and others for $110 million. Wednesday, November 9, 2016 Innate Pharma has posted a look at Phase I/II data on a combination of its lirilumab and Bristol-Myers Squibb’s Opdivo in head and neck cancer. The mix outperformed historic trials of Opdivo in isolation but by less than some hoped, causing the share price of Innate to slide then bounce back as investors digested the data. Wednesday, November 9, 2016 Bristol-Myers Squibb has added another study to its burgeoning roster of combination trials featuring PD-1 drug Opdivo. The latest deal will see Bristol-Myers add Opdivo to an existing trial of Infinity Pharmaceuticals’ PI3K-gamma inhibitor IPI-549 in solid tumors. Wednesday, November 9, 2016 California has been ground zero in the industry battle against state drug pricing laws, and pharma can now declare victory. After a tough, expensive campaign, voters soundly rejected a contentious ballot measure, Prop 61, that would have clamped down hard on drug prices. Tuesday, November 8, 2016 While scientists have long studied mutations of the RAS oncogene as a target for new cancer drugs, they have been unable to pinpoint a drug that safely blocks its effects. Now, a team from the University of Illinois at Chicago has identified a monobody that can block the oncogene’s activity. Wednesday, November 9, 2016 Branded drugmakers may have one less tool to delay generic competitors--and, crucially, biosimilar versions of some of the industry's top-selling products--with Tuesday’s decision by the FDA to amend citizen petition rules. | This week's sponsor is Catalent. | |  | eBook | Healthy Aging: Improved Dose Forms for Aging Population
As healthy aging becomes a bigger concern in the U.S., manufacturing companies are finding a new opportunities to serve this audience as they turn increasingly to OTC treatments. Download this eBook to learn how a successful partnership between OTC brands and manufacturing companies can improve health outcomes for the growing population of empowered seniors. |
| | | Kite Pharma plans to start a rolling submission of its BLA for CAR-T candidate KTE-C19 with the FDA for aggressive non-Hodgkin lymphoma in December. Release Ocular Therapeutix says in its Q3 today that it is preparing to resubmit its NDA for Dextenza for eye pain after ophthalmic surgery in the U.S. by year’s end. Statement Small cap Sorrento Therapeutics has now closed its acquisition of Scilex. Release | |
|
Resources Presented By: Lenovo Get the stats you need to start down the path to a more secure infrastructure, today. Presented By: Lenovo What's the first step to a better patient experience? The patient experience starts well before the exam room or even reception - it begins as soon as your patients pull into the parking structure. Presented 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. Presented by: DocuSign The patients who rely on your scientific leadership are expecting more. Presented 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. Sponsored By: Salesforce Life sciences companies, like many industries today, face new challenges across the board. Read More. Presented By: ISR Reports Make essential outsourced bioprocessing decisions by staying informed of industry outsourcing practices and contract manufacturer usage patterns with ISR’s Bioprocessing Services and Technologies Market Trends and Outsourcing Dynamics report. Presented By: ISR Reports ISR’s Biosimilars in the US Oncology Market (2nd Edition) report provides data and insights from 101 US-based, board-certified oncologists/hematologist oncologists as to their expectations, fears, and aspirations for biosimilars in oncology. Presented By: ISR Reports Pinpoint the information oncologists find most valuable and the best sales channels for delivering specific types of data/information. Presented by: Covance The role of health economic data has never been more important. Presented by: Covance Leading manufacturers increasingly employ stakeholder research early in development to better identify the needs of patients and providers. Presented By: ISR Reports ISR’s Bioprocessing Market Trends and Outsourcing Dynamics: 2016-2021 report provides an overview of the current market dynamics for bioprocessing as well as an outlook on what the marketplace will look like in five years. Presented By: ISR Reports ISR’s CRO Quality Benchmarking – Phase II/III Service Providers (8th Edition) report provides a Consumer Reports-style analysis of Phase II/III CRO service quality from hundreds of users who rated 44 Phase II/III CROs across 26 critical dimensions of quality. Presented by: Patheon Can you avoid a risky trial-and-error approach to find the right path for your poorly soluble molecule by utilizing a CDMO? Download this complimentary Whitepaper to learn more! Presented by: Biotech Primer This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. Sponsored by: Veeva Systems Gartner research on short- and long-term strategies for IDMP compliance. | 
