Pfizer, BioNTech share clinical data linking favored COVID-19 vaccine to improved tolerability Astellas' Audentes reports 3rd death in gene therapy trial MD Anderson's Hwu takes up vacant CEO post at scandal-hit Moffitt Cancer Center Sponsored: Why Ethical Procurement Matters for Human Biospecimens Virtual FDA AdComm for Alkermes' ALKS 3831 adds new focus on drug-drug interactions Lilly partner AbCellera adds bispecifics platform to antibody arsenal Merck's oral cancer drug targeting STING boosts PD-1 immune blockade in mice FiercePharmaAsia—China's price-slashing round; Takeda's Japan cuts; Sinopharm's COVID-19 vaccine price Chutes & Ladders—Rome Therapeutics taps Celgene vet Zaller for CSO role Featured Story | By Nick Paul Taylor Pfizer and BioNTech have published clinical data on the COVID-19 vaccine they advanced into phase 3. The early clinical data link the phase 3 candidate to a far lower rate of adverse events than another prospect, explaining Pfizer and BioNTech’s decision to move it into late-stage testing. read more |
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Top Stories By Nick Paul Taylor Audentes Therapeutics has reported a third death in a clinical trial of its gene therapy against a rare genetic neuromuscular disorder. The Astellas Pharma subsidiary said it “remains committed” to the program despite the rising death rate in the higher-dose cohort of the phase 1/2 clinical trial. read more By Ben Adams One of the world’s most renowned tumor immunologists, Patrick Hwu, M.D., is set to become the new chief at the Moffitt Cancer Center eight months after its former chief stepped down over alleged Chinese influence. read more By BioIVT While the response to COVID-19 and other disease indications drives science forward, regulatory guidelines that ensure the safe and ethical treatment of patients continues to be critically important. read more By Ben Adams Alkermes has a tentative fall date with a virtual FDA review committee that will focus on potential drug-drug interactionsfor its experimental schizophrenia and bipolar med. read more By Amirah Al Idrus Canada’s AbCellera is already a go-to partner for big biopharma antibody discovery efforts, inking deals with the likes of Merck, Pfizer, GlaxoSmithKline and Eli Lilly. Now, it’s adding another tool to its offerings: a bispecifics platform that can combine any two of the antibodies it discovers. read more By Angus Liu Merck's experimental STING agonist MK-1454 only showed modest efficacy in cancer, and it had to be administered straight into tumors, limiting its application even more. Now scientists at the New Jersey pharma have developed a novel oral STING drug that has shown promise in mice. read more By Angus Liu Eli Lilly, Pfizer and Merck are among Big Pharma companies that lost contracts in China's latest bulk procurement bidding process. Takeda is offering some Japanese staffers early retirement and is reportedly near a deal to sell its domestic OTC business. Sinopharm's chief disclosed an upper price limit for its COVID-19 vaccines. And more. read more By Kyle Blankenship Rome Therapeutics names Zaller as CSO: Klick Health gives Grant the CEO role; Aerin Medical taps Brokaw as chief exec. read more Enrollment Showcase | Presented by: Biotility Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more. |
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Resources 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. 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: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment 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: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. 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: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. 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: 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 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. Drug Development Immersion: Live, Online Course October 21-22, 2020 | 9am - 3:30pm ET BioBasics 101: The Biology of Biotech for the Non-Scientist: Live, Online Course November 12-13, 2020 | 9am - 3:30pm ET Drug Development Boot Camp® VIRTUAL 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now | Due to COVID19 provisions – training will be conducted VIRTUALLY | Same excellent total immersion training in new medicine development will be made available to experts who want to make a difference to patients. | 