To view this email as a web page, click here

WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

At the virtual J.P. Morgan Healthcare Conference, Pfizer CEO Albert Bourla described the company’s “out of the box” manufacturing, as its partner BioNTech projects 2 billion COVID-19 doses delivered in 2021. Still, newly emerging strains of the coronavirus continue to cause worry—however the FDA says today’s vaccines will probably still work, though some tests may become less accurate. Also, new data from Eli Lilly’s donanemab immunotherapy showed it could help clear amyloid plaques out of the brains of Alzheimer’s patients. Those stories follow below, and check out our full JPM week coverage at Fierce Pharma andFierce Biotech.

Featured Story

Lilly hails Alzheimer's win with donanemab, boasting 'significant slowing of decline'

The amyloid theory continues to grasp at life as Eli Lilly has unveiled new phase 2 data from donanemab that show it can help Alzheimer’s disease patients by clearing these plaques out of the brain.

read more

Top Stories Of The Week

JPM: How did Pfizer up its COVID-19 vaccine capacity? 'Out of the box manufacturing,' CEO says

Earlier this week, Pfizer partner BioNTech upped the pair’s 2021 COVID-19 output projection to 2 billion doses for 2021, up from a previous estimate of up from a previous estimate of 1.3 billion. But how will the companies get there? By doing things “very differently and very out of the box in manufacturing,” CEO Albert Bourla explained Tuesday.

read more

BioNTech CEO applies COVID-19 vaccine's mRNA tech to multiple sclerosis

The new vaccine technology mRNA is making waves these days as COVID-19 shots based on it deliver efficacy that’s unrivaled by other platforms. BioNTech's Pfizer-partnered vaccine Comirnaty is one of those vaccines. Now, the German biotech’s CEO, Ugur Sahin, has led a study showing an mRNA vaccine was effective against multiple sclerosis in mice.

read more

FDA warns new coronavirus variant could trigger false negatives among gold-standard tests

The FDA is alerting healthcare professionals that mutations in the novel coronavirus’s genetic code—such as the type powering the fast-spreading variant identified in the U.K.—can trigger false negative results in gold-standard COVID-19 tests.

read more

JPM: 'Very soon,' says Johnson & Johnson CEO as world waits for its COVID-19 vaccine data

J&J is in the “final stages” of data analysis for its phase 3 COVID-19 vaccine trial, CEO Alex Gorsky said Monday. And that could be a "game-changer," as Operation Warp Speed's Moncef Slaoui recently put it. The company's one-dose regimen could accelerate and simplify a faltering immunization push.

read more

Synairgen's inhaled interferon for COVID-19 enhances short, harmless version of virus entry point: study

Interferon increases levels of the cell surface protein ACE2, which serves as the entry point for COVID-19, raising concerns that Synairgen and others developing inhaled interferon-based treatments might ultimately fail. Now, a U.K. team has discovered interferon only raises levels of a short form of ACE2 that may actually be protective.

read more

Look out, pharma. A 'tidal wave' of side effect reports is coming amid COVID-19 vaccine rollouts

With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace for a wave of side effect reports, experts say. And it won't just intensify adverse-event tracking, but the threat of lawsuits, too.

read more

Matching Sinopharm, fellow Chinese biotech Sinovac sees 78% COVID-19 vaccine efficacy

A little over a week after Sinopharm nabbed the world’s first full approval from Chinese regulators on a 79% efficacy showing for its COVID-19 vax, fellow Chinese native Sinovac, using similar tech, has shown pretty much the same numbers.

read more

JPM: Deal-making still a 'top priority' at Bristol Myers as CEO eyes midsize buys

Even after shelling out $74 billion for Celgene and $13.1 billion for MyoKardia, Bristol Myers Squibb still has “significant financial flexibility” for deal-making. Specifically, the company's shopping for "midsize bolt-on deals" that look a lot like the MyoKardia buy, CEO Giovanni Caforio said.

read more

JPM: CureVac's new pharma partner Bayer says its COVID-19 vaccine not just an also-ran

German biotech CureVac shouldn’t be discounted from being a major COVID-19 vaccine player despite being at the tail end of the race to market.

read more

Roche's Actemra, Regeneron's Kevzara win U.K.'s favor in COVID-19 after study shows 24% drop in death risk

The potential benefit of IL-6 inhibitors like Roche’s Actemra and Sanofi and Regeneron’s Kevzara in COVID-19 patients was recognized by scientists early on during the pandemic, but clinical trials have produced mixed results. Now, backed by new data, U.K. scientists are recommending both drugs as key to ending the pandemic.

read more

JPM: Boehringer partners with Google to bring quantum computing to biopharma R&D

Through a new partnership with Google, Boehringer Ingelheim hopes to harness quantum computing to simulate the body’s molecular mechanics.

read more

Moderna poaches Amgen vet as CCO, jump-starting commercial team as it rolls out COVID-19 vaccine

Moderna tapped veteran Amgen executive Corinne Le Goff to head up marketing and sales as it rolls out its COVID-19 vaccine. Formerly senior VP and president of Amgen's U.S. business, Le Goff will add commercial heft to the biotech, which has never before launched a product.

read more

Boehringer Ingelheim quietly culls decades-old hypertension med after October recall

Three doses of Boehringer Inghelheim’s hypertension med Catapres, also known as clonidine hydrochloride, are in short supply, according to a notice posted to the FDA’s website Wednesday. But with a plethora of generics on tap, that’s no problem for patients, BI figures. Now, the company’s decided to quietly cull the decades-old product.

read more

Resources

Webinar: Using SPOT™ & CHO-BC® During Cell Line Development for Titers up to 9 g/L

Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards.

Whitepaper: Success in Rare Diseases: Understanding the Rare Disease Ecosystem

Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.”

Whitepaper: Accelerate innovation and manufacturing to better serve patients

A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields.

Survey: Cell and Gene Clinical Supply Needs Market Research

Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity.

Whitepaper: Gene and Cell Therapy: A New Age of Medicine

Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine.

eBrief: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

Whitepaper: The Future of Pharmacovigilance

Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality.

Whitepaper: Survey Reveals Demand for Clinical Trial Innovation in the Wake of COVID-19

The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement.

Whitepaper: Companies Need An Effective Remote Workforce Cloud Strategy To Survive

A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

eBook: CMC Considerations for Successful Early Drug Development

This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.

Webinar: Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization

In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

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.

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.

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.