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March 27, 2020


As the world saw about 200,000 new cases of COVID-19 this week, researchers began to deliver some of the first clinical data for prospective therapies—with some disappointments. The hyped anti-malaria drug hydroxychloroquine couldn’t beat placebo in a Chinese study, while repurposed HIV and influenza antivirals also underperformed. But hope remains as Big Pharma companies gear up to donate millions of chloroquine tablets should the drug prove effective, and Gilead cited overwhelming demand for its remdesivir. Elsewhere, the FDA authorized the first hand-held and point-of-care tests for the disease, and unlocked gas therapy and ventilator alternatives. Our top reads of the week are below.


Featured Story

Novartis, Mylan and Teva to supply tens of millions of chloroquine tablets to fight COVID-19

As efforts to discover new COVID-19 medicines roll on, President Donald Trump and others this week focused attention on the decades-old malaria drug chloroquine. Bayer got things rolling with an initial donation of the drug, and now Novartis, Mylan and Teva are taking steps to deliver tens of millions of tablets.


Top Stories Of The Week

Biopharma's leading treatment hopes against COVID-19

As the biotech industry tries to match the pace of the COVID-19 pandemic with its own research response, we at FierceBiotech are rounding up the industry’s attempts to combat the virus after infection.

Top COVID-19 aspirants chloroquine, AbbVie's Kaletra and a flu drug disappoint in clinical tests

Malaria drug chloroquine, AbbVie’s HIV combo therapy Kaletra and an influenza med called Arbidol are among top candidates that physicians are repurposing for the treatment of COVID-19. Despite backing from officials, though, the three have disappointed separately in two clinical trials in mild Chinese patients.

Biopharma's no-holds-barred fight to find a COVID-19 vaccine: The full list

The hunt is well underway for medicines to combat COVID-19, but it will be longer for vaccines than it will be for drug treatments. Here’s a guide to the 35 vaccines in development against COVID-19, including Moderna Therapeutics' phase 1 RNA shot, Pfizer and BioNTech's candidate hard on its heels and a host of preclinical prospects.

FDA greenlights first 45-minute, point-of-care coronavirus diagnostic test

The FDA has authorized its first rapid, point-of-care diagnostic for the novel coronavirus—allowing physicians in hospitals, clinics and emergency rooms to test a sample for the disease in about 45 minutes.

Coronavirus tracker: Merck to donate thousands of masks in NJ; White House prepping COVID-19 guidelines

With healthcare workers in the U.S. strapped for supplies amid the novel coronavirus outbreak, Merck & Co. is helping out with a donation of around 300,000 masks to the state of New Jersey. Meanwhile, the Trump administration is piecing together county-level guidelines to deal with the COVID-19 response. 

Special Report—The top 15 biopharma licensing deals of 2019


2019 will likely go down as a landmark year for biopharma partnering, at least when looking at the sums involved.

Gilead halts emergency access to COVID-19 contender remdesivir amid 'overwhelming demand'

Since the early days of the current coronavirus outbreak, Gilead Sciences’ experimental antiviral drug remdesivir has been hailed as a leading hope. That halo has apparently overwhelmed the Big Biotech, which has temporarily stopped granting patients emergency access to remdesivir due to an “exponential increase” in requests.

Lilly slashes clinical trial activities in response to COVID-19

Eli Lilly is slashing its clinical trial activities in response to the COVID-19 pandemic. With the novel coronavirus putting healthcare systems under tremendous strain, Lilly has decided to delay most trial starts and pause enrollment in most ongoing studies.

FDA opens up Bellerophon's gas therapy for COVID-19, stock rockets

Using a regulatory pathway that allows patients with life-threatening conditions to use unapproved therapies, the FDA has granted “emergency expanded access” to Bellerophon Therapeutics’ inhaled nitric oxide delivery system for treating the novel coronavirus.

Roche pleads for global harmony as it supercharges production of Actemra, COVID-19 tests

China’s use of Roche's Actemra for some COVID-19 patients has put the arthritis drug in the spotlight and set it up for a surge in demand. Roche is trying to stay ahead of that curve by upping production, even as it tests it on COVID-19. 

Biogen parts ways with employee who hid coronavirus symptoms and lied her way back to China

A Biogen employee who allegedly concealed her coronavirus symptoms on a flight back to China may face criminal charges. But first, the biotech has decided it wants nothing to do with the rogue staffer. “She is no longer an employee of Biogen,” the biotech said in a statement.

Pharma marketing in the time of COVID-19? Some halts, some hopes, but mostly uncertainty

While there is no business as usual anymore, pharma marketing is mostly staying the course for now in the shadow of COVID-19. A survey of ad agencies and communications firms that handle pharma clients found both slowdowns and bright spots, but mostly lots of question marks as the situation continues to unfold.

Astra, Daiichi's Enhertu shows early promise in HER2 lung cancer

After earning an FDA nod for breast cancer in December four months ahead of schedule, AstraZeneca and Daiichi Sankyo’s HER2-targeting antibody-drug conjugate Enhertu is showing some early promise in a phase 1 trial in other cancer types. The antibody-drug conjugate produced a 55.6% objective response rate in HER2-positive non-small cell lung cancer patients.


Enrollment Showcase

What's the value of an MBA to healthcare and the life sciences?


Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide. Download the guide. 


Resources

[Whitepaper] Ensuring the Greatest Return From Your Poorly Soluble Molecule


Poorly soluble molecules hindering your workflow?

[On Demand] Tufts-eClinical Solutions Data & Analytics Survey Results


Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor.

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow


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.

[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.

[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.

[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.

[Whitepaper] Create A More Compelling Program Development Dossier With Metabolomics


Metabolomics can help you streamline your drug development process by providing the framework to make a stronger, more confident, and more valuable case for a molecule in a shorter timeframe.

[eBook] 9 Ways to Enhance Healthcare Customer Experiences


Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing.

[Whitepaper] The ROI of Document Delivery


3 ways you may be overspending on scientific literature access, and how to fix them.

[Whitepaper] Manufacturing Cytotoxic and Non-Cytotoxic


When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed.  Outsourcing to a CMO with experience in multiproduct facilities can be an option.

[Whitepaper] Measure the Right Things at the Right Time: Using A Metric Maturity Model to Optimize Performance Measurement


Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way.

[Whitepaper] Navigating Today’s Healthcare Transformation: The Evolution of Payers


Read about the innovative ways payers are making smart moves in the healthcare game.

[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.