Today's Rundown FierceBiotech’s top 5 data readouts in 2020 Pfizer cans early-stage trials for cancer, sickle cell targets Life after Novartis: Jimenez joins board of Bayer-backed cell therapy startup Sorrento rejects $1B buyout bid from unnamed private equity firm Adrangi mounts short attack on 'worthless' drugs of Sanofi ally Acceleron's PAH drug sotatercept hits the mark in phase 2 Tracking not just data, but individual symptoms: BioIntelliSense exits stealth with FDA-cleared wearable Shkreli faces new FTC, N.Y. crackdown for allegedly thwarting Daraprim generics Merck KGaA antes up €250M to bridge R&D with manufacturing Featured Story | | | What are some of the bigger data points for 2020? We share what we think will be the five most pivotal readouts for their respective companies (and stockholders). |
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Top Stories Tuesday, January 28, 2020 As Pfizer posts its full-year financials today, as usual it’s also sneaked in several dropped projects from its pipeline. Tuesday, January 28, 2020 Joe Jimenez has (another) new gig. The ex-Novartis boss joined the board of Century Therapeutics, a startup working on off-the-shelf cell therapies that emerged last July with $250 million from the likes of Versant Ventures and Bayer’s VC arm. The move comes barely a year after Jimenez left his previous board position at uBiome. Tuesday, January 28, 2020 Sorrento Therapeutics has rejected a takeover offer from an unidentified private equity fund. News of the original bid sparked a surge in Sorrento’s sagging stock price, but the board has ruled the offer undervalues the biotech. Tuesday, January 28, 2020 Sahm Adrangi's Kerrisdale Capital has trained its sights on Principia Biopharma, arguing the pipeline of the Sanofi partner is “worthless.” The short seller thinks Principia’s approach to the treatment of autoimmune diseases is “misguided” and likely to lead to clinical failures. Monday, January 27, 2020 Acceleron’s sotatercept outdid placebo at reducing pulmonary vascular resistance in patients with pulmonary arterial hypertension, a rare disorder in which patients have high blood pressure in the arteries of the lungs. The phase 2 study also hit a handful of secondary endpoints, including tests measuring how far patients can walk in six minutes. Tuesday, January 28, 2020 A new digital health startup is exiting stealth mode with its advanced, long-lasting patient monitoring device—and touting a quick FDA clearance. Using a combination of sensors, its BioSticker aims to identify distinct actions such as coughing, sneezing or vomiting. Tuesday, January 28, 2020 The past few years have been tough on biotech chief and "most hated man in America" Martin Shkreli after a 2017 fraud conviction landed him behind bars. Despite that sentence—and the hefty civil penalty that came with it—Shkreli isn't nearly out of the woods, yet. Monday, January 27, 2020 Merck KGaA has big plans for a site in Switzerland where it intends to knit together biologics development and manufacturing. | | [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. |
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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 | 