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Today's Rundown

Featured Story

Pharmas with up-and-coming JAK inhibitors face 'shrinking' potential after FDA crackdown

With new FDA safety restrictions on JAK inhibitors—specifically Pfizer's Xeljanz, AbbVie’s Rinvoq and Lilly’s Olumiant—the next generation of JAK therapies could face an uphill battle to the finish line.

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Top Stories

Roche inks $3B biobucks deal for Adaptimmune's T-cells

Roche is making a big play in off-the-shelf cell therapies, putting up a potential $3 billion in biobucks for Adaptimmune to develop up to five cancer targets. Roche's Genentech unit will dish out $150 million upfront to Adaptimmune to develop and commercialize allogeneic cell therapies for up to five shared cancer targets, the companies said Tuesday.

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SPAC Attack: The 10 biggest in biotech

During the pandemic, special purpose acquisition companies were popping up like weeds ready to spread out in the biotech garden. Things have slowed down, but dozens of shell companies are still waiting for the right biotech to strike.

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FDA slaps clinical hold on BioMarin gene therapy trial after tumors seen in mice 

The gene therapy space has taken yet another hit. Labor Day, just days after the FDA convened a panel to discuss the cancer risk of gene therapies, BioMarin revealed the regulator has slapped a clinical hold on a phase 1/2 study over a safety signal seen in mice. 

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Exelixis stunned by death of Chief Medical Officer Schwab, sales lead Berndt

Oncology biotech Exelixis is mourning the deaths of two key members of its company after losing its sales leader and CMO in the same week.

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Amgen, AstraZeneca dig into data from phase 3 asthma trial, emerging with evidence of efficacy in hard-to-treat subgroup

Piece by piece, Amgen and AstraZeneca are building the case for their potential asthma blockbuster. The latest brick to fall into place comes from a new slice of phase 3 data, which suggests tezepelumab may be particularly effective in a subgroup of severe asthma patients. 

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Pliant's lung disease drug is getting where it needs to be, but efficacy data is years out

Pliant Therapeutics’ anti-fibrotic drug seems to have engaged its target in a mid-stage lung disease clinical trial, which was enough to excite investors and push the biotech's shares up. But the company's watchers will have to wait to see if the drug actually works to correct idiopathic pulmonary fibrosis, or IPF.

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Roche, hoping to move on from recent failure, pens $190M NeuExcell Huntington's disease pact

Roche, like so many others in the field, has seen major setbacks in trying to hunt new drugs for Huntington’s disease, but it’s brushing off a recent flop and signing up with a new partner in the hopes of trying again.

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Journey Colab scores $12M to move psychedelics-based addiction treatment into clinic

Psychedelics-focused biotech Journey Colab bagged $12 million to start its first human trial in 2022. The funding will push its lead program, a treatment based on a hallucinogenic compound found in some species of cactus, into phase 1.

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AI analysis of COVID patients' chest CT scans predicts ventilator need with 84% accuracy: study

The AI algorithm could help hospitals not only determine how many ventilators they’ll need, but also be more precise and proactive as they plan out each COVID patient’s treatment.

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Meet Neffy, the friendly epinephrine nasal spray from ARS Pharma awaiting FDA approval

Friendly epinephrine? Meet Neffy, ARS Pharmaceuticals’ nasal spray epinephrine to treat severe allergic reactions to food, medicines and insect bites. Neffy, now awaiting FDA approval, aims to flip the script on past epinephrine autoinjector marketing that focused on fear around the severe reactions called anaphylaxis.

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Google, Mayo Clinic build new type of AI algorithm to map interactions between areas of the brain

The new algorithm could help guide placement of brain-stimulating devices to treat neurological conditions ranging from epilepsy to Parkinson’s disease to obsessive compulsive disorder.

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Resources

Whitepaper: Applications of Digital Twins in Clinical Trials for Alzheimer’s Disease

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.

Webinar: Let A Digital Sherpa Uncomplicate The Path for Patients

Topple barriers to getting patients started on therapy. Guide them with mobile.

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.

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