| 11.24.21 | Kura slams breaks on trial after death; Pfize r’s readout of $250M Ionis be t leaves questions unanswered

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Webinar: A Systems Model of Gene Therapy for Sickle Cell Disease

Tuesday, November 30 | 2pm ET / 11am PT

Stem cell gene therapy is an emerging experimental therapy for SCD with the potential for lifelong cure but it is an expensive multi-step treatment regimen. This webinar is ideal for scientists and decision makers in drug R&D who want to leverage systems pharmacology for drug discovery and development. Register Now.

Editor’s note: Fierce Biotech will not publish on Thursday or Friday in observance of the Thanksgiving holiday. We’ll be back in your inbox on Monday, Nov. 29.

Today's Rundown

FDA halts phase 1b Kura Oncology trial in acute myeloid leukemia following patient death Chasing Regeneron, Pfizer posts data on $250M cardiovascular bet Acorda CMO hits the exit, landing Pharnext job with oversight of phase 3 neurological disorder trial Sponsored: Cross-Functional Strategies For the Development and Launch of New Products Data manipulation expert Elisabeth Bik compares the tales of 2 accused biotechs: Cassava and Athira Merck buzzes Dragonfly for 2nd immunotherapy candidate in $700M pact month after Bristol Myers' 6th opt-in Reify Health taps into renewed drive to improve clinical trial diversity, releasing new tool to give drug sponsors more insight Medtronic's surgery robot rollout hits supply chain speed bumps Kymera's first-in-class protein degrader shows potential to boost cancer immunotherapy Sanofi coughs up $180M to settle Pompe disease royalty payment dispute UCB latest drugmaker to restrict 340B access to contract pharmacies

Featured Story

FDA halts phase 1b Kura Oncology trial in acute myeloid leukemia following patient death

By Kyle LaHucik

A patient has died in a Kura Oncology phase 1b trial in people with acute myeloid leukemia leading the FDA to place a clinical hold on the study. The investigational oral treatment was potentially associated with differentiation syndrome, an adverse event that the biotech's management said is "part and parcel of this mechanism of action."

This week's sponsor is New Product Planning.

Chasing Regeneron, Pfizer posts data on $250M cardiovascular bet

By Nick Paul Taylor

Pfizer has reported top-line results on its $250 million antisense bet. The phase 2b clinical trial of the cardiovascular disease drug met its primary endpoint but, with Pfizer still considering next steps and yet to share data, it is unclear whether the asset can muscle in on a market targeted by Regeneron.

Acorda CMO hits the exit, landing Pharnext job with oversight of phase 3 neurological disorder trial

By Nick Paul Taylor

Acorda Therapeutics is losing another employee. After seeing colleagues depart in waves of layoffs in recent years, Acorda Chief Medical Officer Burkhard Blank is leaving to take up a position at Pharnext.

Data manipulation expert Elisabeth Bik compares the tales of 2 accused biotechs: Cassava and Athira

By Annalee Armstrong

Fierce Biotech caught up with one of the scientists who spotted irregularities in Cassava’s research after the issue was flagged in a citizens petition to the FDA.

Merck buzzes Dragonfly for 2nd immunotherapy candidate in $700M pact month after Bristol Myers' 6th opt-in

By Kyle LaHucik

Merck wants in on another immunotherapy program from its $695 million collaboration with Dragonfly Therapeutics. The biotech has been popular around Big Pharma in the past two months with Bristol Myers Squibb licensing its sixth drug from Dragonfly just last month.

Reify Health taps into renewed drive to improve clinical trial diversity, releasing new tool to give drug sponsors more insight

By Kyle LaHucik

Inclusion of underrepresented groups in clinical trials has long been an issue in the drug development world, with minority populations comprising small percentages of studies supporting new drug approvals. Reify Health has released a new tool to help drug sponsors increase their diversity efforts in clinical trials.

Medtronic's surgery robot rollout hits supply chain speed bumps

By Conor Hale

On a quarterly earnings call with investors, Martha described the launch as currently holding in a “limited-release phase.”

Kymera's first-in-class protein degrader shows potential to boost cancer immunotherapy

By Angus Liu

Kymera Therapeutics showed its STAT3 degrader significantly inhibited tumor growth in mice bearing colorectal cancer and B-cell lymphoma. The drug also appeared to sensitize tumors to anti-PD-1 cancer immunotherapy.

Sanofi coughs up $180M to settle Pompe disease royalty payment dispute

By Angus Liu

As Sanofi's Pompe disease franchise fuels its growth in rare diseases, the company has inked a $180 million settlement related to a license for a key medicine.

UCB latest drugmaker to restrict 340B access to contract pharmacies

By Robert King

UCB became the ninth drugmaker to cut off sales of 340B-discounted products to contract pharmacies despite an ongoing legal feud between several drugmakers and the federal government.