Immune biotech dissolves

Today’s Big News

Sep 19, 2023

GSK shuffles R&D as research head John Lepore heads out the door 


FDA's single-trial guidance calls for the good, bad and ugly data to support effectiveness 


Histogen consigned to history after search for strategic solutions comes up short


Kinnate lays off 70% of staff, pulls back from programs to save cash after data disappointment


Guard argues new data render primary endpoint miss 'irrelevant,' tripling share price


Arcturus says sa-mRNA COVID boosters induced immune response in small ph. 1/2 study


Scancell enjoys stock bounce on back of phase 2 snapshot for DNA cancer vaccine 


Fierce Biotech Fundraising Tracker '23: Hyku hatches with $56M seed; Magnet makes money moves with $50M emergence

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Featured

GSK shuffles R&D as research head John Lepore heads out the door

GSK’s Senior Vice President and Head of Research John Lepore, M.D., has left the company at the same time the U.K. pharma undergoes a slight shuffling of its R&D operations.   
 

Top Stories

FDA's single-trial guidance calls for the good, bad and ugly data to support effectiveness

Biopharmas looking to submit a drug for approval to the FDA based on just one clinical trial better be thorough in the data they include—good and bad—and they should get in touch with the agency as early as possible.

Histogen consigned to history after search for strategic solutions comes up short

Two months after halting its remaining development program in a last-ditch attempt to conserve cash, Histogen has run out of options and will wind down.

Health Equity: IHI and Genentech on the Need for an Industry-Wide Approach

Two leaders supporting the Rise to Health Coalition discuss the need for coordinated and collective action across sectors to advance health equity

Kinnate lays off 70% of staff, pulls back from programs to save cash after data disappointment

Kinnate Biopharma is cutting deep. Months after its delayed cancer data disappointed investors, the biotech has revealed it is laying off 70% of its staff and narrowing its pipeline to stretch its cash reserves into the second quarter of 2026.

Guard argues new data render primary endpoint miss 'irrelevant,' tripling share price

Guard Therapeutics is mounting a bullish bounce back from the failure of its phase 2 kidney injury clinical trial. A primary endpoint failure brought the study to an early end, but the Swedish biotech branded that setback “irrelevant” Tuesday, arguing that longer-term efficacy assessments show its asset has a future. 

Arcturus says sa-mRNA COVID boosters induced immune response in small ph. 1/2 study

A dwindling COVID-19 vaccine market is not stopping Arcturus Therapeutics from pressing ahead with its own mRNA candidate, as the biotech touts new early data indicating its shot lights up the immune system.

Scancell enjoys stock bounce on back of phase 2 snapshot for DNA cancer vaccine

It’s been a good week for Scancell’s shareholders, as investors seized on early data from the biotech's phase 2 cancer vaccine trial to send its stock up 20%.

Fierce Biotech Fundraising Tracker '23: Hyku hatches with $56M seed; Magnet makes money moves with $50M emergence

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

Novo, Lilly's 'paradigm shifting' obesity drugs suffer from cost and coverage issues: docs' survey

A survey of 100 doctors in the U.S. who prescribe weight loss medications shows that more than 75% consider new obesity drugs from Eli Lilly and Novo Nordisk as “paradigm shifting.” But the physicians also have significant concerns about the cost of the treatments, patient eligibility for coverage and long-term safety risks.

Organon touts real-world success of its Jada system for stopping postpartum hemorrhage

The observational study showed that Jada was able to rapidly control postpartum hemorrhage—a major cause of maternal morbidity in the U.S.—including in women who had a vaginal delivery as well as those who underwent a C-section.

After TIGIT divorce, Novartis returns tislelizumab to BeiGene as PD-1 gains first European nod

Novartis has ended its major cancer immunotherapy collaboration with BeiGene more than two years after touting the benefits of having a PD-1 inhibitor.

Biofourmis rolls out expanded digital clinical trial platform

Biofourmis, a Boston-based digital therapeutics company, debuted an expanded version of its digital clinical trials platform designed to speed drug development and increase patient diversity.
 
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