Today's Rundown Ipsen's $1B bet on the ropes after interim phase 3 analysis Gilead mulls repositioning failed Ebola drug in China virus PwC report sees pharma-biotech deals 'to be extremely active in 2020' Summit Therapeutics loses R&D president after BARDA funding boost ATAI, DemeRx pursue 'neurochemical reset' for addiction in $22M JV Repurposing non-oncology drugs to treat cancer Epizyme scores FDA nod for rare cancer med Tazverik, but prices it for a future indication: analyst EuroBiotech Report—Roche SMA data, iOnctura, PDC*line, Targovax and Bayer FiercePharmaAsia—Amgen-Astellas JV; Hengrui's new chairman; coronavirus vaccine development Chutes & Ladders—Lonza seeking experience in CEO successor Featured Story | | | Friday, January 24, 2020 Ipsen has paused a phase 3 trial of palovarotene after an interim analysis found it is unlikely to meet its primary efficacy endpoint. The setback is another blow for the retinoic acid receptor gamma agonist, which has run into safety and efficacy problems since Ipsen acquired it in a $1.3 billion (€1.1 billion) takeover of Clementia Pharmaceuticals. |
|
|---|
|
Top Stories Friday, January 24, 2020 Gilead is considering repositioning NUC inhibitor remdesivir as a treatment for the coronavirus now sweeping across parts of China. The antiviral last made headlines when Gilead tested it, with little success, as a treatment for Ebola virus. Friday, January 24, 2020 A report out this week by PwC thinks that biotech could be in for a good year for deals as it sees the momentum from 2019 growing, although don’t expect many megadeals. Friday, January 24, 2020 What a difference a day makes in biotech: Yesterday, antibiotics player Summit Therapeutics was riding high after an $8.8 million cash infusion from the U.S. Biomedical Advanced Research and Development Authority. Friday, January 24, 2020 ATAI Life Sciences and DemeRx are setting up a joint venture to develop a one-and-done treatment for opioid use disorder that works by giving people a “neurochemical reset.” Ibogaine has previously been sold as a stimulant and antidepressant in France and has been studied in other countries as a treatment for addiction. Friday, January 24, 2020 Scientists at the Broad Institute and the Dana-Farber Cancer Institute screened thousands of existing drug compounds and unexpectedly found 49 they believe could be repurposed for treating cancer. They also identified novel targets that could aid in the development of new cancer drugs. Friday, January 24, 2020 Patients with epithelioid sarcoma previously had no targeted treatment options, but that'll change with Epizyme's approval for Tazverik. The FDA signed off on the drug Thursday, and the company plans a launch within 10 business days. Epizyme priced its rare cancer drug at $15,500 per month. Thursday, January 23, 2020 In this week's EuroBiotech Report, Roche's risdiplam clears another phase 3 SMA trial, Merck KGaA spinout raises cash and Korean VCs back PDC*line. Friday, January 24, 2020 Amgen is taking full control of a Japanese joint venture it formed with Astellas. Jiangsu Hengrui's Sun Piaoyang has stepped down as chairman but still retains control of the Chinese drugmaker. Moderna partners with NIH to develop an mRNA-based vaccine against the new coronavirus from China. And more. Friday, January 24, 2020 Lonza looking for replacement for former CEO Funk; Hengrui's longtime chairman Piaoyang set to step aside; Vyaire taps Agarwal as CEO. 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: 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: DocuSign A digital transformation is taking place in the life sciences industry, from research laboratories to manufacturing facilities. But there has always been a gap in these technologies. Download the whitepaper to learn how this challenge was addressed. Sponsored by: DocuSign This paper discusses some of the challenges that the GDPR will introduce, with a particular focus on its requirements for obtaining verifiable, unambiguous consent. Sponsored by: DocuSign Download this paper to learn how you can fully digitize all paper processes. By doing so, you will see shorter cycle times, reduced development costs, and greater customer satisfaction. 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: 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: 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 | 