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

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

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

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

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

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

Startup Mariana raises $175M for radiopharmaceutical drug research

The Series B round makes Mariana one of the best funded private companies in a growing group of biotechs working on new radiopharmaceutical therapies.

By Delilah Alvarado • Sept. 7, 2023

Biogen, continuing executive revamp, finds a new research head

Jane Grogan, an industry veteran who worked at Genentech for over 15 years, will take over the role starting Oct. 2. She’ll fill a seat that's lacked a permanent replacement since the departure of Al Sandrock.

By Jacob Bell • Sept. 6, 2023

J&J sends blood pressure drug back to Idorsia

The decision is the latest in a series of setbacks for the Actelion spinout and ends a lucrative partnership that began in 2017.

By Kristin Jensen • Sept. 6, 2023

Fresh off $4B deal, Nimbus gears up for ‘third chapter’ with new fundraise

The Boston biotech has sold two experimental drugs — a liver disease medicine and a TYK2 inhibitor — to Gilead and Takeda respectively.

By Gwendolyn Wu • Sept. 6, 2023

Nestle gives up on peanut allergy treatment after sluggish sales

The FDA-approved therapy, called Palforzia, was little used, leading Nestle to abandon a business it had secured in a $2.6 billion deal three years ago.

By Delilah Alvarado • Sept. 5, 2023

Star Therapeutics adds another $90M to grow its galaxy of drug startups

The hub-and-spoke biotech has raised more than $190 million in total to fund drug development for rare autoimmune and blood conditions.

By Gwendolyn Wu • Sept. 5, 2023

FDA documents hint at ‘uphill battle’ for broad approval of Sage’s depression drug

The newly posted documents show the agency had concerns about the side effects experienced by people with clinical depression who took Sage’s drug, Zurzuvae.

By Jacob Bell • Sept. 1, 2023

Sage, reeling from depression drug decision, to lay off 40% of workforce

Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.

By Kristin Jensen • Aug. 31, 2023

Intarcia, a former biotech unicorn, gets new life with startup deal

I2o Therapeutics, now led by former Intarcia head Kurt Graves, licensed the diabetes treatment Intarcia has spent more than a decade developing.

By Gwendolyn Wu • Aug. 30, 2023