Plus Fierce’s top stories
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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

After nearly two full years of the COVID-19 pandemic, the biopharma industry has shown it knows how to keep the wheels turning—at least when it comes to securing approvals for new drugs. We profiled each of the FDA’s 55 official green lights from 2021, including Pfizer’s COVID vaccine Comirnaty and Biogen’s controversial Alzheimer’s therapy Aduhelm. But what’s to come in 2022? The top 10 most-anticipated clinical data readouts of the coming year include potential blockbusters, to be sure, but also high-risk, high-reward candidates trying to push the boundaries of drug treatment. Those stories, plus our top reads of the past week, follow below.

 

Featured Story

Novavax gathers its COVID-19 vaccine data for long-delayed FDA filing

Novavax spent much of 2021 working to file its COVID-19 vaccine with U.S. regulators but falling short of its own deadlines. As the year came to a close, the company celebrated the fact that it was nearly there. 

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Top Stories Of The Week

Ovid lands AstraZeneca in a comeback licensing deal, the first in a series

After shedding its lead asset in Angelman syndrome, Ovid Therapeutics has spent the past eight months figuring out its next steps. Now, the central nervous system disease-focused biotech is back with the first stage in that comeback: a deal to license a library of AstraZeneca’s preclinical candidates for epilepsy and other neuropathic conditions.

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2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs

Each year, many scientists and other experts working in the biopharma industry see years of their work culminate in FDA approvals. With the COVID-19 crisis stretching into its third year, the 2021 batch of new drug approvals clearly demonstrates that the sector has learned how to operate in a pandemic.

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Fierce Biotech’s top 10 data readouts in 2022

There are a number of potential blockbuster drugs on the list, but it’s not all about revenue potential. Many of the compounds are high-risk, high-reward candidates trying to push the boundaries of drug treatment.

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Bristol Myers Squibb, Amgen and Pfizer approach steepest patent cliffs among large drugmakers

Biopharma companies are constantly combating patent expirations. But Bristol Myers Squibb, Amgen and Pfizer in particular will be the most negatively impacted from expected exclusivity losses by 2030.

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Johnson & Johnson ships another bispecific off to FDA, this time in multiple myeloma

Johnson & Johnson has shipped bispecific multiple myeloma candidate teclistamab off to the FDA for a potential approval. Bispecifics have been getting a lot of buzz—and cash—from the Big Pharma crowd this year, as this class of medicine has the potential to tackle cancer in more than one way.

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Biogen's roller coaster 2021 takes another surprising turn with report of $42B Samsung buyout interest

Samsung Group is in talks to buy Biogen in a deal that could be worth $42 billion, the Korea Economic Daily reported Wednesday, citing investment banking sources. Biogen has been laboring to launch its controversial Alzheimer’s drug, Aduhelm, and suffering from declining revenues as generics eat away sales of its flagship multiple sclerosis drug, Tecfidera.

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AstraZeneca taps Ionis to join crowd of companies gunning for rare heart disease in deal worth billions in biobucks

Ionis’ heart disease drug has had many names over the years, and, now, it has yet another plus a Big Pharma partner in AstraZeneca and billions in potential biobucks down the line. Eplontersen is the drug at the heart of the deal, formerly known as IONIS-TTR-LRx and at one time as AKCEA-TTR-LRx.

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Pfizer, GSK and Teva lead 2022's round of January drug price hikes: GoodRx

One thing many pharma companies declined to include in their New Year's resolutions? Lowering the prices of expensive brand name drugs. Within the first few days of the year, drugmakers have raised U.S. list prices on more than 400 meds, GoodRx reports.

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Thermo Fisher nets cell and gene protein producer PeproTech for $1.85B

Thermo Fisher Scientific started off the new year with a new member to its family, closing a $1.85 billion acquisition to build out its recombinant protein catalog. 

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Don't spam us, healthcare professionals plea, as they seek quality over quantity from pharma marketers

Reaching out to doctors with more digital content during the pandemic? Think quality over quantity, a new Accenture study on pharma-HCP interactions suggests.

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Roche nets U.S. green light for rapid, home-based COVID test

Roche has secured its first FDA emergency green light for a rapid, over-the-counter COVID-19 test, as the U.S. government looks to boost at-home screenings in the face of the spreading omicron variant. 

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Novo Holdings buys sterile injectables maker Ritedose for undisclosed price

Ritedose, which specializes in blow-fill-seal technology and has been focusing on the outsourced sterile compounding market for drugs in short supply, employs about 400 people at its Columbia, South Carolina, campus.

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Degrading a protein nexus oncogenes rely on to drive prostate cancer

Scientists at the University of Michigan describe a novel PROTAC degrader of a protein nexus that several cancer-promoting genes depend on to drive prostate cancer. In mouse models, the drug showed synergies with Pfizer and Astellas' Xtandi.

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Resources

Research: How Buffer Prep Services Alleviate Sudden Spikes in Campaign Volume

Learn how a CDMO partnered with Thermo Fisher Scientific to manage high-volume process liquid and buffer preparation scale-up. Download the free case study from Thermo Fisher Scientific

Whitepaper: QC for ex vivo manipulated cell lines and tissues

A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants.

Whitepaper: Modernizing Key Clinical Trial Processes with Artificial Intelligence

Webinar: Using Next Best to Elevate your Omnichannel Marketing Strategy

Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making.

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.

Whitepaper: Enhance the cost-effectiveness of your cGMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.