FDA panel wants omicron booster update
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Today's Rundown

Catalent Trending Topic: Cell & Gene Therapy
Read on to understand how the industry is addressing gene therapy and cell therapy research and development.

Featured Story

'Science doesn't care' about markets: ARCH raises nearly $3B amid tough times for biotechs

ARCH Venture Partners has raised nearly $3 billion in a new venture fund, a glimmer of hope as biotechs large and small lick their wounds amid a market downturn that's lasted more than a year. The early investment firm was able to secure roughly a billion more dollars this time around compared to its previous fund.

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Top Stories

Fierce NextGen: Despite another key trial failure, Alzheimer's therapy developers find reason for optimism

As Genentech’s Greg Rippon, M.D., detailed his company’s failed Alzheimer’s disease study, his fellow panelists nodded solemnly. They’d all been there before.

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'Science at its hardest': FDA panel recommends incorporating omicron variant into future COVID boosters

FDA advisers voted 19-2 on Tuesday to recommend incorporating the omicron variant into future vaccine compositions. What exactly those compositions look like will be left to the FDA.

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Steeling itself for undruggable challenges, Astellas inks $180M deal to bolster mitochondria R&D unit

Astellas has ventured off the beaten path for its latest R&D deal, heading to Pittsburgh to partner with low-profile Generian on the discovery of small molecules against undruggable targets. The pact pairs Generian with Mitobridge, an Astellas unit focused on compounds that target mitochondrial function.

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Fierce Next Gen: Sanofi's platforms chief sets out ambition to cut drug discovery by years with AI

Big Pharma has long touted the game-changing potential of artificial intelligence to improve drug development. But what does it mean in practice?

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ReCode breaks the mold with $120M financing, bringing clutch of Big Pharmas along for ride

ReCode Therapeutics has stuck to a formula of $80 million funding rounds, but thanks to investments from the venture arms of Bayer and Amgen, the genetic medicine and mRNA biotech is breaking the mold with a $120 million extended series B.

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Chasing AnaptysBio and Lilly, MiroBio rounds up $97M for autoimmune checkpoint agonist clinical trials

Medicxi, OrbiMed and other VCs have joined forces to help MiroBio flip immune checkpoint R&D on its head, committing $97 million to support development of BTLA and PD-1 autoimmune programs that put the British biotech on turf targeted by AnaptysBio and Eli Lilly.

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After FDA efforts finally get rolling, Santhera DMD drug sidelined by manufacturing delay

Regulatory efforts were finally rolling along at Santhera Pharmaceuticals for its Duchenne muscular dystrophy treatment. But now, a manufacturing snag has set the timeline for an FDA inspection back, and the company will need to go back to the agency to figure out a new timeline.

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89Bio adds blood lipid lowering potential to NASH drug’s ambitions

89bio has hailed mid-stage data as proof that its prospective NASH drug can also lower high blood lipid levels. A study of the drug, called pegozafermin, met its primary endpoint of demonstrating statistically significant reductions in triglycerides—a type of lipid found in the blood.

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Bayer opens $140M cancer research center, adds 50 jobs in hopes of becoming top oncology company

Bayer has opened a new U.S. cancer research and innovation center at the tune of $140 million—a move that will add 50 new jobs—as the German pharma attempts to become a top 10 oncology company by 2030.

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Clinical trial data surge driving demand for management tech, Medidata says

Clinical trials are generating more data than ever and researchers need systems capable of recording, storing and managing the additional information, says tech firm Medidata.

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Bayer to open digital AI marketplace for analyzing CT, MRI scans

Bayer is diving into the radiology AI market, which the drugmaker estimates will grow by more than 25% per year between now and 2025.

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Merck launches healthcare startup incubator for AI developers

Merck has begun taking applications for a new biotech accelerator program and is on the hunt for startups offering a special focus on artificial intelligence and machine learning.

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Resources

eBook: 12 Pitfalls in Europe

For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed.

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: Medical Affairs Metamorphosis II: Medical Affairs’ Evolving Role as Insight Generator

Medical Affairs plays a critical role in generating insights to inform strategic decisions, but that role is changing. This paper explores why, and how MA teams can stay ahead of the curve.

Article: 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.

eBook: Streamline HCP interactions management

Don’t miss these critical considerations when evaluating your HCP interactions management program.

White Paper: Jump Start for Biotech: New Lab Startup Guide

Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals.

eBook: Download the Cell Therapy Handbook

Explore the new cell therapy handbook from Thermo Fisher Scientific.

Whitepaper: Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

eBook: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?

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