Today's Rundown 'We can do better': BIO's first breakdown of diversity in member companies Vertex drops VX-961 to continue search for perfect pain drug Mammoth Biosciences nabs $45M for CRISPR drugs, diagnostics work GeNeuro raises €17.5M for multiple sclerosis clinical trial University of Pennsylvania researchers nab grant for CAR-T prostate cancer test Improving CAR-T therapy for cancer by regulating 2 proteins California court orders Johnson & Johnson to pay $344M over pelvic mesh marketing claims EuroBiotech Report—Ipsen's woes, AstraZeneca, Roche, GSK in TB and Sanofi FiercePharmaAsia—Coronavirus drugs?; Sanofi Korea vaccine bribery probe; Novartis' China plan Chutes & Ladders—Ex-Takeda exec Ivarsson joins Moderna as CDO Featured Story | | | Friday, January 31, 2020 The Biotechnology Innovation Organization has been plugging away at improving diversity in its member companies for years, setting up and ratifying a group of diversity goals in June 2017. Now, the industry group has published its first “state of the industry” report and the results are encouraging—somewhat. |
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Top Stories Friday, January 31, 2020 Vertex has stopped development of VX-961 after getting a look at phase 1 data. The NaV1.8 inhibitor failed to meet Vertex’s desired pharmacokinetic and tolerability profile, leading it to dump the drug and outline plans to move a follow-up candidate into the clinic. Friday, January 31, 2020 Mammoth Biosciences has banked a $45 million second funding round as it looks to double down on its next-gen gene-editing tech. Friday, January 31, 2020 GeNeuro has sold stock at a knock-down price to fund a multiple sclerosis trial. The €17.5 million ($19.3 million) private placement averts a cash crunch and sets GeNeuro up to test temelimab in MS patients whose disability progresses without relapses. Friday, January 31, 2020 The University of Pennsylvania, which has helped pioneer cell therapy approaches to blood cancers, has nabbed an ACGT grant to help battle solid tumors. Friday, January 31, 2020 By manipulating two proteins that are responsible for stimulating CAR-T cells, CD28 and 4-1BB, scientists at the University of North Carolina at Chapel Hill have found new ways to either dial up the cells’ cancer-killing effect when needed or to dampen their activity to avoid severe side effects. Friday, January 31, 2020 Johnson & Johnson has been ordered to pay $344 million in a landmark state court judgment over deceptive marketing practices for its pelvic mesh products. One of the first rulings of its kind, the verdict is the culmination of a multistate investigation and a lawsuit brought by the California Department of Justice in May 2016. Thursday, January 30, 2020 In this week's EuroBiotech Report, Ipsen's $1 billion bet hits more problems, AstraZeneca regains brazikumab and Roche dumps hepatitis B drug. Friday, January 31, 2020 AbbVie's HIV drug Kaletra and Gilead's Ebola therapy remdesivir might work against the new coronavirus, Chinese scientists say. A Sanofi exec in South Korea was arrested in a vaccine bribery probe. Novartis aims to double its China sales in five years. And more. Friday, January 31, 2020 Moderna nabs Ivarsson as CDO; Passage takes on VC vet Goldsmith as chief executive; biotech insider Reid named CEO at Decibel. | | [Webinar] Accelerating Approval for Cell and Gene Therapies Thursday, February 27 | 12pm ET / 9am PT Developers of cell and gene therapies can run into complex clinical and regulatory hurdles when bringing treatments to patients. Join experts from Cardinal Health Regulatory Sciences to explore critical factors that can help reduce the risk of failure and increase speed to market. |
Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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Resources Sponsored by: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms. Sponsored by: Benchling As emerging modalities transform the needs of life science R&D, how can biotech and pharma companies use modern software approaches to increase productivity and reach breakthroughs faster? Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: ICON Clinical Research Ltd The beginning of this digital transformation is well underway and is likely to accelerate. Read our white paper, “Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D,” to learn more. Sponsored by: snapIoT, Inc. Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials. Sponsored by: EVERSANA How are your launch strategies can convert “innovation” into value for patients? Sponsored by: Amazon Web Services From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks Sponsored by: Metabolon Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Asia-Pacific Healthcare Compliance Certificate Program March 9-12, 2020 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. Middle East Healthcare Compliance Certificate Program March 23-26, 2020 | 