CRISPR Tx cuts 2 cancer programs

Today’s Big News

Dec 5, 2023

Novartis' Pluvicto readout is causing trouble for Eli Lilly’s $1.4B radiotherapy buy 


Roche’s bid to build a better Piqray yields phase 3 breast cancer win, opening door to regulators


Awaiting FDA ok for exa-cel, CRISPR Tx cuts 2 cancer programs and expands into autoimmune disease


Axcella gets the ax: Flagship-founded biotech closes doors after 12-year run


Replimune shares halve as skin cancer drug fails to CERPASS phase 2


ReNAgade lays off 10% of its team 6 months after launching with $300M


Genentech's MS drug on partial hold in US after liver enzyme elevations in 2 patients


Merus shares dip as interim lung cancer data reveal 3 patient deaths


Sanofi spins up AI pact, inking $140M deal to apply Aqemia’s physics algorithms to drug discovery


Odyssey raises epic $101M to push programs off to clinical sea


Alto's precision psychiatry approach further validated as 2nd med improves depression symptoms

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Featured

Novartis' Pluvicto readout is causing trouble for Eli Lilly’s $1.4B radiotherapy buy

Eli Lilly has pushed back the deadline of its tender offer for radiotherapy company Point Biopharma’s shares for a second time. According to two senior executives, Lilly’s current predicament is caused not by any internal factors but by Point’s rival, Novartis.
 

Top Stories

Roche’s bid to build a better Piqray yields phase 3 breast cancer win, opening door to regulators

Roche’s pitch to reset the standard of care in a breast cancer population has cleared a late-phase hurdle. The drugmaker’s attempt to improve on Novartis’ Piqray and deliver a first-line PI3K inhibitor has yielded a improved progression-free survival (PFS) in phase 3, teeing up talks with regulatory authorities.

Awaiting FDA ok for exa-cel, CRISPR Tx cuts 2 cancer programs and expands into autoimmune disease

Days away from an FDA decision on a sickle cell gene therapy, CRISPR Therapeutics is ditching its “first-generation” allogeneic CAR-T candidates and expanding into autoimmune disease.

Talking cancer immunotherapy with Cell Signaling Technology

CST fellow Amrik Singh outlines some of the key progress being made around CAR-T therapy and the impact that this highly specialized technique can have on cancer patients, even those who have been previously unresponsive to other forms of treatment.

Axcella gets the ax: Flagship-founded biotech closes doors after 12-year run

The Flagship-founded Axcella Health is closing its doors, with stockholders approving the dissolution of the metabolic modulator biotech yesterday.

Revolutionizing the clinical trial patient experience with IQVIA

IQVIA’s new technologies are changing clinical trials, reducing the administrative burden on staff and improving insights for sponsors.

Replimune shares halve as skin cancer drug fails to CERPASS phase 2

Replimune’s RP1 is an “active agent” according to CEO Philip Astley-Sparke, but it didn’t achieve the primary endpoints of complete response or overall response in a phase 2 trial of patients with a type of skin cancer.

ReNAgade lays off 10% of its team 6 months after launching with $300M

RNA biotech ReNAgade Therapeutics is laying off roughly 10% of its team after launching six months ago with $300 million. The company said at the time that the immediate focus would be prioritizing an early list of programs.

Genentech's MS drug on partial hold in US after liver enzyme elevations in 2 patients

After heralding data last month showing that the multiple sclerosis candidate fenebrutinib may have crossed the blood-brain barrier, Genentech revealed quietly last week that the program has been placed on a partial clinical hold by the FDA in the U.S.

Merus shares dip as interim lung cancer data reveal 3 patient deaths

Shares of Merus fell 6% Monday morning as an interim update for a bispecific therapy revealed three deaths in the lung cancer portion of an ongoing trial.

Sanofi spins up AI pact, inking $140M deal to apply Aqemia’s physics algorithms to drug discovery

Another day, another artificial intelligence (AI) deal. Tuesday was Sanofi’s turn to partner up, striking a deal worth up to $140 million to work on the discovery of small molecules with its compatriot Aqemia.

Odyssey raises epic $101M to push programs off to clinical sea

Odyssey Therapeutics has raised an $101 million series C to help get its next-gen precision immunomodulators and oncology medicines into the clinic.

Alto's precision psychiatry approach further validated as 2nd med improves depression symptoms

Another of Alto Neurosciences’ machine learning-derived, biomarker-based depression therapies has improved symptoms, boosting the case for the biotech’s precision psychiatry approach.

‘Kid-first’ startup BrainChild wants to shift the paradigm on pediatric cancer drugs

BrainChild Bio, a newly-launched spinout of Seattle Children’s Hospital, is focused on childhood central nervous system cancers. Rather than starting with regulatory approval for its drugs in adults, the company will aim for a greenlight for peds patients first.

Fierce Biotech Layoff Tracker 2023: ReNAgade lays off 10% six months after launching with $300M; Gilead's Kite cuts 7% in refocus

We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech.

Fierce Biotech Fundraising Tracker '23: Odyssey raises $101M series C; Seismic snags $121M

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

Deep brain stimulation implants improve cognition for traumatic brain injury patients in small study

For the first time, according to researchers, an implanted device has successfully demonstrated long-term improvements following a traumatic brain injury.

As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

During an enterprise business review Tuesday, J&J laid out a range of expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast more than 10 drugs with peak sales potential of at least $5 billion, plus another 15-plus products with sales potential of at least $1 billion.

Chiesi, buffing up environmental credentials, works with BBC to spread message about greener inhalers

Chiesi is working with the BBC to show off its climate-conscious credentials, partnering with the British broadcaster on a web series episode about redesigning inhalers to reduce their environmental impact.

CVS Health rebrands healthcare services business as it plots long-term growth strategy

After spending nearly $20 billion to pick up Signify Health and Oak Street Health this year, CVS rebranded its health services business to "CVS Healthspire" as it plots its long-term growth strategy.
 
Fierce podcasts

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'The Top Line': Fiercest Women in Life Sciences, meet the Fierce 50

In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. The list comprises 10 trailblazers changing the leadership landscape in pharma, biotech and medtech.
 

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Improving efficiency and productivity in biologics manufacturing is a longstanding goal within today’s industry, especially now as new and increasingly complex molecules are fundamentally changing technological and operational approaches to drug development. Process intensification can help accelerate this pace of innovation through advanced process development techniques and high productivity manufacturing platforms.

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A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers, which involves an intricate set of activities and disciplines that, if done incorrectly, could result in delays and failures that impact the overall success of your end product. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer.
 

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