| 10.12.23 | Novo's kidney trial win scrutinized by dialysis giant; BioNTech channels Daiichi with $70M deal for ADC

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Today’s Big News

Oct 12, 2023

After Novo’s Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

BioNTech takes another leaf out of Daiichi playbook, paying $70M for HER3-directed ADC

EU orders Illumina to split from Grail as penance for closing $8B deal

Biogen's Aduhelm headache returns as appeals court revives part of investor lawsuit

Almirall signs $210M deal to use EpimAb's platform to develop bispecifics for immunology

Boston Scientific nabs diabetic neuropathy nod for spinal cord stimulators

After FDA snub, Lilly's mirikizumab looks to regain momentum with phase 3 Crohn's win

PepGen gains a little pep in its step as FDA lifts hold on myotonic dystrophy trial


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After Novo's Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

By Fraiser Kansteiner

Based on the inclusion criteria for Novo Nordisk’s chronic kidney disease trial, dialysis bigwig DaVita believes there may only be “limited application” of the study’s findings to the overall CKD population.

BioNTech takes another leaf out of Daiichi playbook, paying $70M for HER3-directed ADC

By Nick Paul Taylor

BioNTech is flattering Daiichi Sankyo through imitation. Six months after picking up an Enhertu rival, the German biotech has paid $70 million upfront for an antibody-drug conjugate (ADC) directed at a second receptor targeted by Daiichi.

EU orders Illumina to split from Grail as penance for closing $8B deal

By Conor Hale

The European Commission officially ordered Illumina to cut ties with the cancer blood test developer Grail, more than a year after vetoing its acquisition and amid ongoing court battles.

Biogen's Aduhelm headache returns as appeals court revives part of investor lawsuit

By Eric Sagonowsky

One single comment from a conference call was enough for an appeals court to revive part of an investor lawsuit centered on Biogen's Aduhelm.

Webinar: Organofluorine Chem in Pharma Intermediates & APIs

Wednesday, October 18, 2023 | 11am ET / 8am PT

Join industry experts for an exciting glimpse into the future of pharmaceutical innovation! Gain a comprehensive understanding of the latest strategies in organofluorine-based drug synthesis and learn key insights for staying ahead of the curve in this rapidly evolving landscape. Register now.

Almirall signs $210M deal to use EpimAb's platform to develop bispecifics for immunology

By James Waldron

Almirall will have exclusive global rights to any resulting therapies from the collaboration in return for milestone payments totaling up to $210 million as well as a slice of the royalties.

Boston Scientific nabs diabetic neuropathy nod for spinal cord stimulators

By Andrea Park

Boston Scientific is hopping on the bandwagon as the latest developer of a spinal cord stimulation system to receive FDA approval for diabetic neuropathy pain relief.

After FDA snub, Lilly's mirikizumab looks to regain momentum with phase 3 Crohn's win

By Zoey Becker

A majority of Crohn's disease patients experienced a clinical response and clinical remission after treatment with mirikizumab, the company said. The results provide a boost after mirikizumab's surprise manufacturing-related FDA rejection in April.

PepGen gains a little pep in its step as FDA lifts hold on myotonic dystrophy trial

By Annalee Armstrong

A phase 1 study for PepGen’s myotonic dystrophy therapy has been cleared for launch in the U.S. after a five-month FDA clinical hold.

Hyperfine wins FDA nod to expand MRI image-sharpening AI

By Andrea Park

The latest nod marks Hyperfine’s eighth FDA clearance in the span of three years for its MRI scanner-on-wheels.

Pfizer, playing catch-up with Novartis, bags FDA approval for drug combo in lung cancer

By Angus Liu

Pfizer is expanding the reach of its BRAF-MEK combo as the pharma giant looks to further build up its oncology presence.

Astria scratches dealmaking itch, paying Ichnos $15M to join eczema race led by Amgen, Sanofi

By Nick Paul Taylor

Ichnos Sciences has finally found a buyer for its OX40 eczema program. Astria Therapeutics has taken the other side of the deal, paying $15 million upfront to secure a spot at the back of a race led by Amgen and Sanofi.

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Fierce Diversity, Equity & Inclusion Forum

November 14-15, 2023 | Free Virtual Event

The Fierce Diversity, Equity, and Inclusion Forum is back again this year and better than ever. We are collaborating with our Fierce Healthcare Editorial Team to expand the topics and audience for this exciting program across two days. Providing a wide range of strategies and best practices for pharma and biotech companies looking to improve their diversity efforts across all areas of their business.Register now!

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Economic and regulatory factors are making biopharma supply chains more complex in the EU. This paper explores strategies that biopharma companies can use to better manage complexity, cost, and risk.

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