To view this email as a web page, click here

WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

Some of the world’s largest drugmakers will work together on COVID-19 antibody therapies, giving up confidential manufacturing secrets. With permission from the Justice Department’s antitrust watchdogs, AstraZeneca, Genentech, Amgen and GlaxoSmithKline, plus Eli Lilly and its partner AbCellera, will share info on capacity and raw materials, but won’t be able to talk pricing or production costs. It’s not the only place where Big Pharma is forming a united front: executives declined en masse to attend a White House meeting this week on drug prices, after Trump pushed an order to link Medicare prices to lower drug costs seen overseas. Those stories plus our top reads of the week follow below.

Featured Story

Moderna stock sinks as patent case spurs concern for COVID-19 vaccine

A patent court has sided with Arbutus Biopharma in its dispute with Moderna, raising concerns that the intellectual property dispute could stymie COVID-19 vaccine development. The news sent shares in Moderna down 9% despite it being unclear whether the patent is relevant to its COVID-19 vaccine. 

read more

Top Stories Of The Week

AstraZeneca, Lilly, GSK and more will share COVID-19 antibody secrets to speed manufacturing scale-up

Six drugmakers working on COVID-19 antibody treatments want to swap information and scale up production before those therapies win approval—and now they have Justice Department approval to share their need-to-know secrets.

read more

FDA authorizes first COVID-19 test for screening people without symptoms

The FDA has authorized LabCorp's test for broad-based screening—including for people who have not shown any symptoms and those that do not suspect they have come into contact with someone with the disease.

read more

Pfizer lays out COVID-19 vaccine commercial strategy for pandemic and beyond

With its trials and pricing set, Pfizer has pulled back the curtain on the long-range commercial strategy for its COVID-19 vaccine. During its earnings call Tuesday, execs laid out two phases, pandemic and seasonal, with some combination of the two likely to play out over the next several years.

read more

Columbia team pinpoints potent antibody cocktail for COVID-19

Researchers at Columbia University have isolated a cocktail of antibodies from COVID-19 patients they say could offer a new and potentially potent option for treating and preventing the disease. Some of the antibodies target areas of SARS-CoV-2 that are not addressed by drugs currently in development, they said.

read more

Pharma execs, upset by Trump's drug pricing executive orders, refuse White House meeting

President Donald Trump seems to have hit a nerve with his Friday executive orders on drug pricing. As pharma companies work to battle the pandemic, executives declined to attend a White House meeting Tuesday on drug prices, according to media reports.

read more

Pfizer, BioNTech start their COVID-19 vax phase 3, squaring off with Moderna

Pfizer and German biotech partner BioNTech have on the same day as rival Moderna kick-started a late-stage effort for their “best” attempt at an mRNA pandemic vaccine.

read more

AstraZeneca's 3-in-1 COPD inhaler Breztri gets FDA green light to play catch-up with GSK's Trelegy

With data from a second phase 3 trial, AstraZeneca has finally convinced FDA regulators that its new three-in-one COPD offering, Breztri, deserves a place on the U.S. market just as GlaxoSmithKline's rival med Trelegy does. It has won an FDA nod for Breztri as a COPD maintenance therapy.

read more

GSK culls a host of pipeline meds after failures, prioritization

GlaxoSmithKline is making headlines for its COVID-19 vaccine work, but it has quietly swept away a series of pipeline assets amid its quarterly results posted Wednesday morning.

read more

AstraZeneca's Farxiga backs up kidney disease trial stop with new top-line data

AstraZeneca has shaken up the lucrative heart failure market with diabetes med Farxiga after a major approval earlier this year. But in kidney disease, another blockbuster market, Farxiga also sports impressive data, and it could spell a big FDA nod to come. 

read more

Resources

Whitepaper: High-Loaded Dosage Forms: Novel Platform Expands Spray-Dried Dispersion Utility

A novel spray-dried dispersion platform has been developed to faciliate high drug load applications

eBook: Cambrex eBook - Small molecules: 2020 vision

The industry trend of outsourcing to CDMOs continues. With more services, capabilities, facilities, and employees than ever before, our experts have contributed more articles to our biggest eBook yet.

White Paper: Patient Switching Behaviors Impact on Adherence and Engagement: A Predictive Analytics and Machine Learning Approach to Improving Hub Performance and Patient Outcomes

How predictive analytics and machine learning have the potential to transform healthcare by predicting “Patient Switching Behaviors.”

Whitepaper: You've Decided on a Multiparticulate Dosage Form. Now What?

Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project.

Whitepaper: Learn How to Navigate Pediatric Clinical Trials Under the New RACE Act

Collaboration across the industry will be key to meeting the demands of the RACE Act and ensuring pediatric patients receive the care and treatments they need.

Executive Summary: Overcoming Manufacturing Challenges for Accelerated Drug Development

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.

Presentation: Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

Executive Summary: Strategies for Flexible Manufacturing

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.

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.