| 04.04.23 | 2 deaths halt Gossamer’s BTK inhi bitor program; Cure Ventures unveils with $350M

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IND-Enabling Studies: How to Meet Regulations and Avoid Clinical Holds

While relying solely on your nonclinical laboratory can be tempting when conducting IND-enabling studies, it’s important to provide significant input and oversight to ensure regulatory compliance. Watch our on-demand webinar to learn how to prepare so that your studies meet FDA guidelines.

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Today's Big News

Apr 4, 2023

Gossamer halts work on BTK inhibitor after 2 patient deaths

Cure Ventures unveils inaugural $350M fund with focus on diligent seed rounds to de-risk new science

Scorpion snags $553M deal with Pierre Fabre for 2 preclinical lung cancer assets

Facing a crowded market for BTK inhibitors, Oncternal bows out

VBI Vaccines pares down pipeline and staff to focus on hepatitis B programs

Freeline keeps up cadence of quarterly cuts, canning another 30% of its staff months after last layoffs

OncoSec faces setback as blinded review reverses early impression, revealing Keytruda combo study flop

Sumitomo Pharma tidies up 7 units into 1 combined U.S. entity in spring cleaning


A message from Digital Pharma Innovation

Featured

Gossamer halts work on BTK inhibitor after 2 patient deaths

By Annalee Armstrong

Gossamer is ending development of a lymphoma med after reports of two deaths and other serious adverse events in a phase 2 trial that was paused in March citing the “benefit/risk profile observed to date.”

Cure Ventures unveils inaugural $350M fund with focus on diligent seed rounds to de-risk new science

By Max Bayer

Cure Ventures has unveiled its inaugural $350 million fund, exceeding expectations as the company looks to drive forth a seed-round-focused investment strategy. The firm is led by three seasoned biotech and pharma investors, with dozens of years of combined experience.

Scorpion snags $553M deal with Pierre Fabre for 2 preclinical lung cancer assets

By Gabrielle Masson

French pharma Pierre Fabre is offering up $553 million in biobucks to work with Scorpion Therapeutics on developing and potentially commercializing two of the biotech’s preclinical candidates.

Facing a crowded market for BTK inhibitors, Oncternal bows out

By Annalee Armstrong

Oncternal Therapeutics’ pursuit of the BTK inhibitor market has come to an end after the company took a critical look at the prospects of commercial success for its blood cancer treatment.


A message from Digital Pharma East

VBI Vaccines pares down pipeline and staff to focus on hepatitis B programs

By Annalee Armstrong

With an eye towards someday developing a “functional cure” for hepatitis B, VBI Vaccines is triaging the rest of its programs and sending 30-35% of staff out the door.

Freeline keeps up cadence of quarterly cuts, canning another 30% of its staff months after last layoffs

By Nick Paul Taylor

Freeline Therapeutics staffers could be forgiven for starting to dread quarterly financial results. Three months after disclosing plans to cut ties to 30 employees, the gene therapy biotech has outlined another round of layoffs and the narrowing of its pipeline focus in its fourth-quarter results.

OncoSec faces setback as blinded review reverses early impression, revealing Keytruda combo study flop

By Nick Paul Taylor

OncoSec Medical’s six-year pursuit of potentially pivotal data on its Keytruda combination has delivered a last-minute twist. After touting an 18.8% investigator-assessed response rate, the biotech has revealed that the final result per blinded independent central review (BICR) fell well short of the bar for success.

Sumitomo Pharma tidies up 7 units into 1 combined U.S. entity in spring cleaning

By Annalee Armstrong

Sumitomo Pharma is doing a little bit of spring cleaning to bring a handful of biopharma units under one consolidated company to be named Sumitomo Pharma America.

Fierce Biotech Fundraising Tracker '23: Adcendo starts off April with €31M series A extension; OncoVerity tacks on $30M

By Gabrielle Masson,Max Bayer,Annalee Armstrong

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

Returning the complement: Protein's role in pathway could bolster new Alzheimer's approach

By James Waldron

It seems like every week brings another potential avenue to explore in combating Alzheimer's. The most recent update comes courtesy of the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard, which pinpointed a brain protein that could offer a fresh target.

Ahead of Pfizer buyout, Seagen's Padcev gains Keytruda combo nod in first-line bladder cancer

By Fraiser Kansteiner

While Merck & Co.’s Seagen buyout wasn't fated to be, the companies’ clinical courtship in cancer has blossomed into a swift approval at the FDA.

Butterfly nets AI ultrasound clearance for spotting signs of lung disease

By Conor Hale

Using a six-second video clip, Butterfly's software aims to spot the signs of excess wetness in the lungs that can hinder the ability to breathe.

Seeking full approval in Alzheimer's, Eisai dives into prominent Leqembi side effect

By Fraiser Kansteiner

Eisai's new Leqembi analyses, which debuted at the 2023 annual meeting of the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD), offer more context around the tough conversations patients and caregivers may need to have with their doctors before going on treatment. Plus, the new data will inform Eisai’s bid to translate its speedy green light into a full, traditional FDA approval.

FTC reverses course, orders Illumina to unravel Grail deal

By Conor Hale

The DNA sequencing giant now has six months to completely divest its holdings in the company. The $8 billion acquisition deal closed in August 2021 before receiving a final sign-off from regulators. Illumina has maintained that it has kept Grail’s operations at arms’ length.

ACA benchmark premiums rise 3.4% for 2023 as rate of new insurers slowed: study

By Robert King

Average premiums for Affordable Care Act plans increased by more than 3% for 2023 as the rate of new insurer entrants slowed, a report found.

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