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Today's Rundown

Featured Story

Pfizer, BioNTech share clinical data linking favored COVID-19 vaccine to improved tolerability

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.

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Top Stories

Astellas' Audentes reports 3rd death in gene therapy trial

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.

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MD Anderson's Hwu takes up vacant CEO post at scandal-hit Moffitt Cancer Center

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.

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Sponsored: Why Ethical Procurement Matters for Human Biospecimens

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.

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Virtual FDA AdComm for Alkermes' ALKS 3831 adds new focus on drug-drug interactions

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.

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Lilly partner AbCellera adds bispecifics platform to antibody arsenal

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.

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Merck's oral cancer drug targeting STING boosts PD-1 immune blockade in mice

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.

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FiercePharmaAsia—China's price-slashing round; Takeda's Japan cuts; Sinopharm's COVID-19 vaccine price

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.

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Chutes & Ladders—Rome Therapeutics taps Celgene vet Zaller for CSO role

Rome Therapeutics names Zaller as CSO: Klick Health gives Grant the CEO role; Aerin Medical taps Brokaw as chief exec.

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Enrollment Showcase

Bioscience Certificate Pathways Advancing Knowledge, Skills, & Careers

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.

Resources

Whitepaper: Top 7 Data Points from Medical Claim Forms to Drive Market Development

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.

Report: Decentralized Trials - Where Does the Industry Stand?

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."

Whitepaper: Navigating the Changing Clinical Trial Landscape

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.

Whitepaper: Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs

How to select the right dosage form for your Phase I clinical supply.

Whitepaper: Quality by Design: A Holistic Approach to Drug Development

Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker.

Webcast: DRUG ABUSE LIABILITY ASSESSMENT: Are you taking an integrated approach?

Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment

Executive Summary: Keys to a Successful Rapid Commercial Launch

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.

Whitepaper: More Powerful Analytics Capabilities

Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI.

eBook: Navigating the Insulin Affordability Act

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.

Whitepaper: Reducing the Complexity and Costs of Channel Planning and Logistics

Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

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.

Whitepaper: Learn How Collaboration (Not Competition) Will Bring Better Pediatric Medicines to Market

Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

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.

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

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.

Events