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Today's Rundown

 

    

Thank you to Catalent for sponsoring Fierce Biotech's ESMO 2021 news coverage.

 

Featured Story

Fierce Biotech's 2021 Fierce 15

COVID-19 was inevitably the focus of Fierce 15 last year. This year, it’s pretty much more of the same as we see how the sector has and continues to navigate the pandemic while raising cash, running trials, hiring staff, keeping them safe, and making deals during an incredibly difficult 18 months.

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Top Stories

Pfizer tests oral COVID-19 antiviral for preventing infection in people living with patients

Looking to be the dominant player in COVID-19, Pfizer is kick-starting a phase 2/3 clinical trial for an oral therapeutic antiviral for adults who have been exposed to the coronavirus.

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Mystery suitor lines up $11B Acceleron acquisition: report

Which large pharma company is preparing to splash $11 billion to acquire Acceleron? That is the question raised by an article in Bloomberg, which reports an unidentified large pharma company is in advanced talks about a takeover.

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Sponsored: Navigating the complexities of oncology clinical trials in an increasingly competitive landscape

With the shift from traditional chemotherapy agents to innovative immuno-oncology drugs and cell and gene therapies, oncology clinical trials have increased in complexity.

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How to rescue Big Pharma drug castoffs from the scrap bin through nonprofit partnerships: report

If a potentially promising treatment sits idle in a Big Pharma's stockroom, shouldn’t patients have access to it? That’s a question asked by nonprofit think tank The Milken Institute, which is out with a new report Friday pitching a path forward for medicines that could offer hope to patients but have been shelved for business reasons.

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Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success

Rare diseases demand a modern recruitment approach grounded in uncovering the ideal, medically-eligible patient population with the highest propensity for study enrollment and retention.

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With a phase 3 fail, Biohaven learned the hard way why AstraZeneca dropped a CNS drug in 2018

AstraZeneca put the breaks on the drug after midstage studies in 2016, and Biohaven thought it was good enough to continue developing. Now, the biotech is looking at a late-stage fail in multiple system atrophy, and Biohaven awaits results in a separate trial in ALS.

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Pfizer stumbles close to finish line in growth hormone race, extending the lead of rival Ascendis

Pfizer’s bid to defend its growth hormone franchise against a new, more convenient competitor has hit a snag. The FDA has pushed back approval of Pfizer’s once-weekly prospect, giving rival Ascendis Pharma a longer window in which to convert physicians and patients from current daily options without competition.

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Delix raises $70M to test psychedelic analogs for treating brain disorders in clinical trials next year

Delix Therapeutics wants to take the positive, neuroplasticity effects of psychedelics but quash their hallucinogenic and addictive qualities to treat brain disorders. The biotech now has $70 million to take two treatment candidates into the clinic next year to see if analogs to psychedelics can be effective therapies delivered orally and at home.

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Syndax and Incyte, both reeling from cancer drug setbacks, pen chronic graft-versus-host disease collab

Syndax Pharmaceuticals and Incyte have both been hit by several oncology drug setbacks in the past year but are coming together with an R&D collaboration focused on a different target.

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Biogen used charity giving to illegally boost multiple sclerosis drug sales, Humana lawsuit says

For years, federal prosecutors have gone after drug companies for allegedly using charity contributions as a way to boost sales. Biogen was among the pharma players to ink a federal settlement, but, now, insurance giant Humana is targeting the company’s charity giving with a new lawsuit.  

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Novel 'nanosized' drug carriers tamp down HIV in the brain and other remote tissues in mice

Researchers led by the City of Hope have developed a novel drug-delivery system that can carry an anti-HIV drug cargo into the brain and other remote tissues in mice, locking the virus into a dormant state. They believe the advance could ultimately be applied to a range of diseases.

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Novo Nordisk to smarten up its disposable insulin pens with digital diabetes devicemaker Biocorp

Biocorp’s Mallya digital device clips directly onto prefilled insulin injectors and logs delivery amounts and times by linking to a smartphone via Bluetooth.

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Nominations for Fierce Healthcare's 2021 Women of Influence

We are putting out the call for nominations to honor women across the healthcare industry—from physicians and CEOs to researchers and tech company execs—who are shaping the way healthcare of the future will be delivered.

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Resources

Whitepaper: Big Challenges for Small Sponsors: Competition in Oncology Research

Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles.

Whitepaper: Applications of Digital Twins in Clinical Trials for Neurological Disorders

Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes.

Whitepaper: Evaluating current manufacturing platforms for recombinant AAV production

Choose the right AAV platform for your viral vector-based therapy

Whitepaper: The Value of Precision Medicine Informatics Initiatives Research Findings

Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives.

Whitepaper: Challenging Tradition: The Argument for Integrated Commercialization to Improve Operational Agility

Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how.

Whitepaper: High-yield NK cell culture for allogeneic cell therapy applications

Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications.

Whitepaper: Going from Process R&D to Clinical APIs Quickly and Effectively

Read four customer success stories and four success factors that helped move pharmaceutical customers of Cascade Chemistry by Aceto quickly and effectively to clinic with trial-ready APIs.

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.

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.

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.

Events