Today's Rundown Incyte sinks as itacitinib fails pivotal test in acute GVHD Durect shares rocked by midstage psoriasis flop, shifts focus to liver disease Novan crushed by phase 3 failures of antiviral gel New year, new name, new CEO for synthetic biology co. Intrexon After midstage flop, Janssen says thanks but no thanks to Provention Bio drug Illumina calls it quits after FTC blocks its $1.2B offer for PacBio FiercePharmaAsia—AZ-Daiichi's fast Enhertu nod; Astellas' 2 partnered approvals, CAR-T buy Chutes & Ladders—AstraZeneca's Pangalos honored with knighthood Featured Story | | | Friday, January 3, 2020 A phase 3 trial of Incyte’s itacitinib in treatment-naive acute graft-versus-host disease has missed its primary endpoint, wiping around $2 billion off the biotech’s market cap. The failure of the JAK1 inhibitor is another blow to Incyte’s efforts to expand its commercial portfolio beyond Jakafi. |
|
|---|
|
Top Stories Friday, January 3, 2020 Durect’s stock nose-dived more than 30% yesterday on the news that its phase 2 plaque psoriasis hope failed to beat out a sham treatment. Friday, January 3, 2020 Novan’s antiviral SB206 has failed to beat placebo in two phase 3 trials in patients with molluscum contagiosum. The setback wiped 74% off Novan’s value and left its cash runway looking precariously short, but the biotech plans to start another trial in the belief it still has a path to approval. Friday, January 3, 2020 Two years after hiving off its healthcare assets into a subsidiary, Intrexon is bringing those assets back into the fold as it changes its focus, sheds its non-healthcare work and names a new CEO. Friday, January 3, 2020 Janssen will not be buying back the rights to a drug it shipped out to Provention Bio back in 2017 after it failed to move the needle in Crohn’s disease. Friday, January 3, 2020 DNA sequencer makers Illumina and Pacific Biosciences of California called off their $1.2 billion merger that’s been in the works for over a year after the Federal Trade Commission challenged the transaction and described it as “monopolist.” Friday, January 3, 2020 Daiichi Sankyo and AstraZeneca gained FDA nod for Enhertu just two months after a priority review tag. Astellas and Seattle Genetics won an FDA go-ahead for bladder cancer drug Padcev as Atellas' Pfizer-partnered Xtandi added a new prostate cancer indication to its label. And more. Friday, January 3, 2020 AstraZeneca R&D chief Pangalos receives knighthood; Fountain taps Zhen as new CEO; Jones joined McCann Health as creative head. 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. |
|
|---|
|
Resources 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: Outer Edge Technology, LLC Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud. Sponsored by: Colorcon Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication. 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: Clarivate Analytics Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead. Sponsored by: Thermo Fisher Scientific Are you facing costly delays in your API scale-up? 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. 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: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Asia-Pacific Healthcare Compliance Certificate Program March 9-12, 2020 FierceBiotech Executive Breakfast at the J.P. Morgan Healthcare Conference 2020 January 14, 2020 | The Fairmont Hotel | San Francisco, CA 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL 4th Annual Gene Therapy for Rare Disorders March 30 – April 2, 2020 | Boston, MA 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 | 