WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST A safety scare and the pausing of AstraZeneca’s trial have sparked some reassessments of the race for a COVID-19 vaccine—and may affect the course of other shots using the same viral vector approach. But while clinical holds aren’t necessarily rare, the importance of getting it right and maintaining the global public’s trust in this moment are paramount to success. In a bid to do so, the CEOs of the leading vaccine developers have taken a joint pledge to not file for FDA approval until they’ve taken the time to successfully complete larger phase 3 studies. Those stories and more follow below. | |
|
Featured Story | By Nick Paul Taylor AstraZeneca has put clinical development of its COVID-19 vaccine on hold in response to an adverse event, sparking a reassessment of the race to bring a coronavirus prophylactic to market. read more |
| |
|---|
|
Top Stories Of The Week By Amirah Al Idrus BioNTech and partner Pfizer have been working on four vaccine candidates against COVID-19, snagging FDA fast-track tags for two of them and pushing one into a 30,000-patient phase 3 study. Now, the duo is adding a fifth shot on goal, slated to enter a phase 1/2 study this month. read more By Eric Sagonowsky Moderna and its investors amid the COVID-19 pandemic, starting with initial vaccine research back in January and progressing to a phase 3 trial this summer at record speed. Now, analysts with SVB Leerink think challenges and competition lie ahead, and they're cautioning investors to the risks. read more By Eric Sagonowsky In the wake of stunning news yesterday that AstraZeneca paused its phase 3 COVID-19 vaccine trial due to a serious safety issue, analysts across the biopharma landscape set out to answer questions, and lay out possible scenarios, about how the race could play out from here. read more By Arlene Weintraub Pfizer and its partner BioNTech said Wednesday that their most advanced COVID-19 vaccine candidate produced neutralizing antibodies against the virus in macaques, as well as T cell responses that are believed to be an indicator of a strong immune attack. The data formed the basis of the current phase 2/3 trial in people. read more By Nick Paul Taylor The CEOs of all the leading Western developers of COVID-19 vaccines have vowed to only file for FDA approval after demonstrating safety and efficacy in phase 3. The pledge comes amid reports that the Trump Administration is pushing for a vaccine to be approved before the November election. read more By Arlene Weintraub The French Competition Authority has levied fines against Novartis and Roche over allegations they improperly marketed macular degeneration drug Lucentis over Roche’s similar and less expensive drug Avastin. It couldn't come at a worse time for Novartis, which is trying to gain traction for its new eye drug, Beovu. read more By Angus Liu With last month’s $2.3 billion Japanese consumer health sale to Blackstone Group, Takeda has arguably achieved its $10 billion divestment goal. But the Japanese pharma is showing no sign of stopping with the selloffs anytime soon, having penned a new, $562 million deal with Cheplapharm focused on Europe and Canada. read more By Conor Hale LabCorp announced plans to launch a new at-home COVID-19 diagnostic that allows people to also get tested for the flu and respiratory syncytial virus from a single sample. read more By Beth Snyder Bulik Novartis has renamed AveXis to Novartis Gene Therapies in a nod to the significance of that business for its future. The swap also nixes a scandal-related name that dragged Novartis and its breakthrough gene therapy Zolengensma through the mud before being cleared of any wrongdoing by the FDA. read more By Ben Adams It’s a good day for Shanghai-based I-Mab, which has penned a $2 billion upfront-biobucks R&D deal with AbbVie while also nabbing $418 million from investors. read more By Fraiser Kansteiner On the heels of an April gene therapy expansion, Merck KGaA and MilliporeSigma are at it again, this time with a scheme to ratchet up antibody-drug conjugate manufacturing capacity through a $65 million addition to the company's Madison, Wisconsin, site, teeing up a new commercial building and 50 new hires. read more | | Webinar: Accelerating Pharma’s Evolution Towards a Perfect Omnichannel Engagement September 15, 2020 | 11am ET / 8am PT | Presented by: WNS Global Services This webinar reviews the current strategies to better engage with HCPs and patients and covers practical considerations for achieving a perfect omnichannel marketing experience. Panelists will also discuss about the enablers which makes omnichannel experience possible including the types of data needed, and the role AI and predictive analytics play. Register now. |
Resources Sponsored by: EVERSANA How independent drug launch and commercialization can lead to higher market capitalization. Sponsored by: AMRI Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development. Sponsored by: LexisNexis Risk Solutions Avoid severe compliance penalties by staying on top of evolving laws. Sponsored by: Quotient Sciences This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >> Sponsored by: Clarify Health In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy. Sponsored by: Benchling Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide. Sponsored by: Thermo Fisher Scientific Don’t oversimplify your solubility challenges. Sponsored by: Clinical Ink Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment Sponsored by: Thermo Fisher Scientific Download the whitepaper to learn more. Sponsored by: LexisNexis Risk Solutions Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information. Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization. Sponsored by: Oracle Health Sciences Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. 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: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. | 