Intercept, after biotech rollercoaster ride, agrees to buyout by Alfasigma

Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.

By Jonathan Gardner • Sept. 26, 2023

FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show

A panel of expert FDA advisers is meeting today to discuss the treatment, and whether Brainstorm’s data provide “substantial evidence” of its effectiveness.

By Ned Pagliarulo • Sept. 25, 2023

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Novo Nordisk parent backs cell therapy manufacturing facility

The Novo Nordisk Foundation’s planned manufacturing facility will help both private companies and academic researchers develop new cell therapies.

By Jonathan Gardner • Sept. 21, 2023

Cell therapy developer closes funding round to support diabetes program

More than $50 million in venture funding has now gone into Seraxis, which is among a series of biotechs trying to fundamentally alter diabetes treatment.

By Kristin Jensen • Sept. 21, 2023

Genentech takes up a deal to make ‘molecular glue’ drugs

Targeted protein degradation has emerged as one of the more competitive areas of pharmaceutical research in recent years as scientists develop new ways to reach difficult-to-drug targets.

By Gwendolyn Wu • Updated Sept. 20, 2023

Roche’s Genentech bets on radiopharmaceuticals in partnership with PeptiDream

The new deal expands on a yearslong partnership between the two drug developers to advance targeted radioisotopes for certain cancers.

By Delilah Alvarado • Sept. 20, 2023

Histogen plans to wind down operations after failing to find a partner

All but two employees will be gone by Sept. 30 as the company seeks shareholder approval for a dissolution plan.

By Kristin Jensen • Sept. 19, 2023

Kinnate lays off 70% of staff, reorganizes pipeline

The company is restructuring its workforce and discontinuing programs, including its monotherapy combination of its drug exarafenib with Pfizer’s Mektovi. 

By Delilah Alvarado • Sept. 19, 2023

Startup Airna emerges from stealth to bring RNA editing to a rare disease

Airna is one of several biotechs that have set their sights on alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.

By Gwendolyn Wu • Sept. 19, 2023

Orchard nears FDA decision on rare disease gene therapy

Three years after gaining European approval, Libmeldy is now under U.S. review with a deadline set for March.

By Jonathan Gardner • Sept. 18, 2023

Accurate biomedical knowledge: Why it’s paramount, yet elusive

Biomedical data analysis without core knowledge = statistically significant nonsense. Be better.

Sept. 18, 2023

Making us more human: Applying artificial intelligence to your clinical resourcing and talent acquisition strategy

With the rise of ChatGPT and artificial intelligence (AI), there are many ways the clinical staffing industry can use AI advantageously while removing the stigma that the rise of technology can be dehumanizing.

Sept. 18, 2023

RayzeBio, Neumora price some of biotech’s largest IPOs this year

The IPO pricings come after a big day for Wall Street, which saw the SoftBank-owned chip maker Arm pull off the year’s largest new stock offering.

By Gwendolyn Wu • Updated Sept. 15, 2023

Flagship-backed Generate raises $273M as its first drugs move to the clinic

Since 2019, Generate has raised nearly $700 million in private financing and has now brought a monoclonal antibody into Phase 1 testing.

By Gwendolyn Wu • Sept. 14, 2023

Moderna aims for the stars again with ambitious drug development plan

The biotech is telling investors it expects to launch as many as 15 new products in five years, a bold goal that will require a lot to go right to pull off.

By Kristin Jensen • Sept. 13, 2023

Actio, a precision medicine startup, launches with $55M and a mouse lab partnership

The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.

By Ned Pagliarulo • Sept. 12, 2023

2Seventy CEO Leschly to step down as company cuts staff, spending

Citing “near-term headwinds,” the cancer cell therapy developer will lay off 176 employees and pare back spending.

By Ned Pagliarulo • Sept. 12, 2023

After IPO success, Acelyrin hits trial setback with inflammation drug

Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.

By Kristin Jensen • Sept. 12, 2023

New startup Arialys takes aim at the immune system, hoping to create neuropsychiatry drugs

Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.

By Jacob Bell • Sept. 12, 2023

With latest fundraise, Rome Therapeutics works to drug the ‘dark genome’

Johnson & Johnson and Bristol Myers Squibb have joined a group of new investors backing Rosana Kapeller’s startup, which launched in 2020 after incubating with GV.

By Gwendolyn Wu • Sept. 12, 2023

Ex-Sanofi executive Sibold joins Madrigal as new CEO

Bill Sibold will replace Paul Friedman as head of the NASH drug developer as it attempts to win approval of what could be the first medicine for the liver disease. 

By Ned Pagliarulo • Sept. 11, 2023

Maximizing the power of ctDNA analysis with ultrasensitive molecular tools

Ultrasensitive technologies help researchers harness the potential of circulating tumor DNA analysis.

Sept. 11, 2023

AstraZeneca, seeking new drug targets, taps a genomics biotech and its AI technology

The deal will give the pharma’s Alexion unit access to Verge Genomics’ platform, which uses human tissue data to find drug targets for diseases that degrade the nerve system.

By Delilah Alvarado • Sept. 8, 2023

Otsuka partners with Shape in deal to design eye gene therapies

Shape uses machine learning and high throughput screening to identify new AAV capsids in ways the company’s CEO compares to the generative AI tools Midjourney and DALLE-2.

By Ned Pagliarulo • Sept. 8, 2023

Seagen partners with Nurix to create new kind of cancer drug

The alliance, which aims to combine Seagen’s antibody expertise with Nurix’s targeted protein degradation research, comes as the larger biotech awaits its acquisition by Pfizer to close. 

By Jonathan Gardner • Sept. 7, 2023