Cell Therapies

Lyell Will Seek To Improve On Existing CAR-Ts Via Merger With ImmPACT

Lyell Will Seek To Improve On Existing CAR-Ts Via Merger With ImmPACT

 
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Lyell believes ImmPACT’s dual CD19/20-targeted CAR-T could offer better response rates than Yescarta or Breyanzi and will focus on IMPT-314 while terminating much of its own pipeline.

Japan Ventures Progress Cell And Gene Candidates For ALS, Severe Conditions

Japan Ventures Progress Cell And Gene Candidates For ALS, Severe Conditions

 
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Multiple Japanese ventures presented updates on their novel pipeline assets and modalities at BioJapan, including cell and gene therapies and combination treatments, despite lingering financing challenges.

Financing Is Improving, But Cell And Gene Therapy Firms May Be Last To Feel It

Financing Is Improving, But Cell And Gene Therapy Firms May Be Last To Feel It

 
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ARM’s Cell and Gene Meeting on the Mesa offered optimism that a biopharma financial market recovery is under way, but cell and gene therapies still are seen as risky investments.

Seraxis Takes Its Islet Cell Tech Into The Clinic

Seraxis Takes Its Islet Cell Tech Into The Clinic

 

Emerging Company Profile: The Maryland-based biotech is working on a functional cure for type 1 diabetes that is similar to Vertex’s VX-880 – but with some key differences.


Big Pharma Faces Cell And Gene Therapy Market Realities

Big Pharma Faces Cell And Gene Therapy Market Realities

 
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Big pharma executives at ARM’s Cell and Gene Meeting on the Mesa shared some of the practical challenges of bringing one-time treatments to market in hemophilia, cancer and beyond.

Manufacturers Eye Challenges Of Broadening Cell And Gene Therapy Access

Manufacturers Eye Challenges Of Broadening Cell And Gene Therapy Access

 
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With more advanced therapies gaining approval, companies at ARM’s Cell and Gene Meeting on the Mesa considered hurdles to making their products more broadly available and developing them for larger indications.

BioCentriq CEO On Next Phase Of Growth With GC Support

BioCentriq CEO On Next Phase Of Growth With GC Support

 
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In a video interview with Scrip, Syed Husain, CEO of the US-based cell therapy CDMO BioCentriq, talks about the company’s role in parent GC’s growth strategy and business priorities, the cell and gene therapy manufacturing market and his views on the US BIOSECURE Act.

Quick Listen: Scrip's Five Must-Know Things

Quick Listen: Scrip's Five Must-Know Things

 
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In this week's podcast edition of Five Must-Know Things: summer ADC dealmaking continues apace; a look at cell therapies in Japan; Pfizer’s new US digital consumer platform; Galapagos’s US point of care CAR-T study; and Novartis partners with Lindy on biologics delivery.


Progress Or Hype? A Decade Of Cell Therapy In Japan

Progress Or Hype? A Decade Of Cell Therapy In Japan

 
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After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.

Japan Cell Therapy Hopes Hit By HeartSheet Full Approval Hurdles

Japan Cell Therapy Hopes Hit By HeartSheet Full Approval Hurdles

 
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Despite initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges in gaining full approval in Japan, potentially providing learnings for other developers of regenerative medicines.

Quick Listen: Scrip's Five Must-Know Things

Quick Listen: Scrip's Five Must-Know Things

 
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In this week's podcast edition of Five Must-Know Things: global CEO remuneration; another late-stage loss for Merch KgaA; deals shift to smaller M&A, partnering; Bayer’s Parkinson’s bets bear fruit; and India looks to innovate CAR-T models.

Bayer's Bets In Parkinson's Start To Bear Fruit

Bayer's Bets In Parkinson's Start To Bear Fruit

 
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The German major is kicking off Phase II trials for a cell therapy and a gene therapy that could be gamechangers for the progressive neurodegenerative disorder that affects more than 10 million people worldwide.


Conditional Global-First Nod For SanBio's Cell Therapy for TBI

Conditional Global-First Nod For SanBio's Cell Therapy for TBI

 
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SanBio’s lead cell therapy asset has been on a bumpy journey to its global-first approval and while a nod has now come in Japan in a high-need indication, a commercial launch is conditional on additional data to establish product equivalence and manufacturing consistency. 

How Ochre Bio Bagged Boehringer For Its RNA-Based Regenerative MASH Therapies

How Ochre Bio Bagged Boehringer For Its RNA-Based Regenerative MASH Therapies

 

UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.    

Stock Watch: Advanced Therapies Deliver Fourth-Quarter Flop

Stock Watch: Advanced Therapies Deliver Fourth-Quarter Flop

 
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As drug pricing continues its ascent among hot button issues, the multi-million-dollar price tags for one-and-done advanced therapies, their justification and reimbursement all remain unaligned.

Scrip Asks…What Does 2024 Hold For Biopharma? Part 4: Transformative Technology

Scrip Asks…What Does 2024 Hold For Biopharma? Part 4: Transformative Technology

 

More than 75 industry executives and experts gazed into the crystal ball and shared with Scrip their predictions around transformative technologies. Perhaps unsurprisingly, AI was the dominant theme – but gene editing, cell therapies and new targeting modalities were also among the highlights.


The ‘Haves And Have-Nots’ Are Becoming Clearer In Cell And Gene Therapy

The ‘Haves And Have-Nots’ Are Becoming Clearer In Cell And Gene Therapy

 

2023 saw a number of gene therapy companies go to the wall, but those that can combine clinical significance and commercial success can build sustainable businesses.

A Neato Cell: Data Show Favorable Efficacy, Toxicity For Arcellx/Gilead Myeloma CAR-T

A Neato Cell: Data Show Favorable Efficacy, Toxicity For Arcellx/Gilead Myeloma CAR-T

 

Anito-cel showed strong efficacy in heavily pretreated patients despite characteristics predicting poorer performance, but none of the atypical neurotoxicities that have appeared with other BCMA CAR-Ts.

BioCardia Aims To Defy Precedent With A Cardiac Cell Therapy

BioCardia Aims To Defy Precedent With A Cardiac Cell Therapy

 

Heart disease seems impervious to cell therapy approaches. Is biomarker stratification the answer?  

CMS Wants To Help With Medicaid Outcomes-Based Reimbursement For Cell And Gene Therapy

CMS Wants To Help With Medicaid Outcomes-Based Reimbursement For Cell And Gene Therapy

 

Center for Medicare and Medicaid Innovation (CMMI) deputy director Ellen Lukens talked about the goals and challenges of a new voluntary program the agency will test with state Medicaid programs.