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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

Moderna began dosing its first patient with its second mRNA-powered shot for HIV, less than six weeks after getting underway with its initial vaccine candidate—a clear start in the race for a new type of breakthrough against AIDS. Meanwhile, AstraZeneca’s anti-inflammatory sinus drug Fasenra is already late to the game when it comes to treating nasal polyps, and it’s now falling further behind after an FDA rejection. And for biopharma’s overall R&D spending, it's been years of strong investments as companies geared up for COVID-19. Fierce Biotech’s list of the largest budgets, plus this week’s top stories, follows below.

Featured Story

Moderna hits the gas as it begins dosing of 2nd HIV vaccine

Moderna has started dosing in a phase 1 trial for the second of two HIV vaccines it's developing, showing that it's all gas, no breaks for the mRNA-focused biotech as it races Excision BioTherapeutics for a breakthrough HIV therapy. The start of dosing comes roughly six weeks after it launched human trials for its first vaccine.

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Top Stories Of The Week

AstraZeneca's Fasenra hit with FDA rejection, falling further behind GSK's Nucala in nasal polyps

AstraZeneca’s Fasenra is already late to the game in nasal polyps. Now, the drug is being pushed back even further—if it can eventually get there.

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Top 10 pharma R&D budgets in 2021

Roche will not be beaten when it comes to pharma R&D. The company lands at No. 1 on our Pharma R&D budget list once again, but who else made it?

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It's #FierceMadness: Zepzelca kicks Lumakras, Enspryng tops Vyvgart—and it's over to you for the big vote

It’s March, so it’s time for some #FierceMadness. We’re looking for the best of the best in drug names—and with Jazz' Zepzelca, Roche's Enspryng, AbbVie's Qulipta and Novartis' Leqvio advancing from the play-in round, we have our full bracket for your voting pleasure.

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BMS-Nektar's Opdivo combo fails phase 3 in upset to once-largest licensing deal in biotech history

Bristol Myers Squibb and Nektar Therapeutics said a phase 3 trial of the biotech's bempegaldesleukin combined with the Big Pharma's checkpoint inhibitor Opdivo in patients with untreated unresectable or metastatic melanoma failed. The drug was part of BMS' commitment of up to $3.6 billion to Nektar in 2018, which was the largest licensing deal in biotech history at the time.

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Top Pfizer, Moderna execs at odds on need for 4th COVID-19 vaccine dose

Top executives at pandemic juggernauts Pfizer and Moderna are at odds on the need for a fourth COVID-19 vaccine dose. One says a second booster is needed “right now,” while the other thinks a fourth mRNA shot may only be essential for older adults and the immunocompromised. 

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We have achieved peak biotech formation. It's time for 'musical chairs'

For patients, there’s never been a better time for medical innovation. But how many biotechs is too many?

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Moderna CEO Bancel set for a soft landing as his golden parachute swells to $926M

Moderna CEO Stéphane Bancel's golden parachute now clocks in at $926 million, the company revealed in its proxy report earlier this week. The news comes after a transformational year for the company as its revenues went from $803 million in 2020 to $18.5 billion last year amid its worldwide COVID-19 vaccine launch.

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Dexcom's next-gen G7 diabetes sensor scores European approval

Designed to be 60% smaller than its predecessor, Dexcom’s mainstay G6, the low-profile G7 includes a combined sensor and transmitter that connects it to smartphones and smart watches. The CE mark covers adults, pregnant women and children ages two and up.

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Biogen takes full control of troubled Aduhelm in revamped Eisai deal

Even before a highly anticipated coverage decision, Eisai has decided to abandon Aduhelm amid a dismal commercial outlook, bowing out of the marketing of the controversial Alzheimer’s disease drug that it co-developed with Biogen.

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2 new molecules help destroy leukemia cells by targeting protein key to tumor 'seeds'

Researchers found two new small-molecule inhibitors that help fight off acute myeloid leukemia cells by targeting a protein key to the survival of leukemia tumor "seeds." Meanwhile, a different team of researchers found "one of the most essential genes" required for AML cell survival, potentially paving the way for another treatment option.

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Stevanato's growth spree rolls on with China plant purchase, plans for 270 jobs

A week after Italian vials manufacturer Stevanato announced a $95 million deal with the U.S. government to expand operations at its facility under construction in Fishers, Indiana, the company says it has acquired a plant in Zhangjiagang, China, which it will expand to 32,000 square feet.

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Resources

Paid Marketplace: United Cargo: Providing comprehensive solutions for the most critical shipments

The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now.

Industry Report: The Top Four Barriers to Successful KOL Engagement

Read why many MSLs are still challenged in developing integrated strategies to increase the volume of meaningful engagements. Download this industry report to find out what the top challenges are and suggestion strategies to solve them. Download now.

eBook: Leveraging Clinical Data for Study Success

The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates.

Whitepaper: Autologous CAR T-Cell Manufacturing: Semiautomatic, Closed, Modular Workflow

Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow.

eBook: EMEA Regulatory Roadblocks around Decentralized Trials

Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research.

Whitepaper: Top 5 Challenges Of Decentralized Clinical Trials And How To Overcome Them

How to overcome top challenges faced in decentralized trials.

Case Study: Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Whitepaper: Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

Webinar: The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Whitepaper: Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Events