FDA reversal sets up high-stakes hearing on Sarepta gene therapy

The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held.

By Ned Pagliarulo • March 17, 2023

Esperion in dispute with Daiichi over drug milestone payment

The companies disagree over what qualifies for a payment of up to $300 million that’s associated with inclusion of heart data on the cholesterol drug’s label.

By Kristin Jensen • March 16, 2023

Explore the Trendline➔

Cell therapy

Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.

By BioPharma Dive staff

Healthcare companies may turn to big banks after SVB’s fall

SVB’s unraveling created a hole in life sciences financing that could be filled by bigger banks, but might hamper access to quick, short-term cash for startups.

By Sydney Halleman • March 15, 2023

With focus on fibrosis, startup Mediar draws big pharma backing

Novartis joined venture investor Sofinnova in leading an $85 million investment in the startup that also involved Pfizer, Eli Lilly and Bristol Myers Squibb.

By Gwendolyn Wu • March 15, 2023

SVB’s failure was contained. Its effects on biotech could still linger.

“A generation of founders is now scarred,” one biotech CEO said, as small drugmakers grapple with the longer-lasting effects of SVB’s stunning collapse.

By Ben Fidler , Gwendolyn Wu • March 14, 2023

Switch Therapeutics launches with $52M to capitalize on RNA medicine ‘era’

The company’s name comes from its goal of developing drugs that only “switch” on in target cells, potentially enabling more precise therapies.

By Gwendolyn Wu • March 14, 2023

Amylyx’s ALS drug sales impress Wall Street

In its first full quarter on the market, Amylyx’s Relyvrio generated nearly $22 million in revenue, or about five times what some analysts forecast last month.

By Jacob Bell • March 13, 2023

‘What a mess’: How biotech startups grappled with SVB’s collapse

The bank’s failure caused some companies to question whether they could pay employees, while forcing many others to take steps to calm nervous investors.

By Ben Fidler • March 13, 2023

Regulators take over Silicon Valley Bank

The California Department of Financial Protection and Innovation closed the embattled bank and appointed the FDIC as receiver, regulators said Friday.

By Anna Hrushka • March 10, 2023

Canadian royalty investor buys into first-of-its-kind Type 1 diabetes drug

DRI Healthcare, which owns royalties on top-selling drugs like Eylea and Stelara, is paying $100 million for a piece of the Provention Bio drug Tzield that the FDA approved last year.

By Gwendolyn Wu • March 9, 2023

Merck pays $50 million for early-stage Epstein-Barr vaccine

Opko’s acquisition of ModeX paid off with a Merck deal that could earn the vaccine and immunotherapy developer hundreds of millions of dollars. 

By Jonathan Gardner • March 8, 2023

J&J-backed startup launches with $100M to build better brain drugs

Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines. Its most advanced drug is already in early-stage human testing.

By Jacob Bell • March 7, 2023

Flagship’s latest startup emerges with a plan for ‘smarter biologics’

Ampersand Biomedicines claims to be developing a way to make medicines that act only at the site of disease and spare healthy tissue.

By Gwendolyn Wu • March 7, 2023

GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating diabetes to pain. But biotech startups say there’s still room to develop more.

By Gwendolyn Wu • March 7, 2023

Adaptimmune acquires struggling cell therapy rival following layoffs

The planned merger between Adaptimmune and TCR2 will extend their cash runway by two years, as a biotech downturn continues to pressure companies.

By Jonathan Gardner • March 6, 2023

Cancer drug startup Cargo raises $200M to solve CAR-T relapse

The biotech is developing a CAR-T therapy for lymphoma that targets a different protein flag than currently available cell treatments.

By Ned Pagliarulo • March 1, 2023

Amid industry turbulence, Chroma raises fresh funding to edit the epigenome

As many drug startups struggle to gain cash, Chroma has raised another $135 million to back its research, a new twist on genetic medicine.

By Gwendolyn Wu • Updated March 1, 2023

Vertex tiptoes further into Duchenne research with Tevard deal

An alliance with the startup brings Vertex an RNA-based medicine for the disease, adding to a portfolio that already includes a gene editing treatment.

By Ben Fidler • Feb. 28, 2023

Following another trial failure, a brain biotech considers ‘strategic alternatives’

Aptinyx has joined a lengthy list of drugmakers looking to cut costs and explore strategic options after hitting setbacks in key clinical studies.

By Jacob Bell • Feb. 28, 2023

Theravance, under pressure from activist investor, cuts back research, trims staff

The company is laying off 17% of its workforce and stopping work on inhaled JAK inhibitors in its latest restructuring move.

By Ned Pagliarulo • Feb. 28, 2023

How life sciences benefits from broader healthcare transformation

Digital transformation has much to offer life sciences as well as healthcare — and the synergies between the two can further optimize the power of digital health, clinical trials and patient outcomes.

Feb. 27, 2023

EQRx, having redrawn strategy, to trim workforce by 18%

Part of a plan to lower spending, the workforce reduction will involve layoffs as well as leaving positions unfilled after employees depart.

By Ned Pagliarulo • Feb. 24, 2023

Roche hands rights to lung cancer drug back to Blueprint

Weeks after the Swiss drugmaker wrote off Gavreto’s accounting value, the biotech will regain responsibility for its commercialization.

By Jonathan Gardner • Feb. 24, 2023

FDA approves Sanofi’s long-lasting hemophilia drug

Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.

By Jacob Bell • Feb. 23, 2023

Moderna shares sink amid COVID forecasts, trial news

The biotech expects to earn at least $5 billion from sales of its COVID vaccine this year, which would be about one-third of what it made in 2022.

By Delilah Alvarado • Feb. 23, 2023