FDA expands use of Neurocrine drug to Huntington’s patients

Analysts expect the approval of Ingrezza in Huntington’s patients with a movement disorder known as chorea to intensify a commercial battle between Neurocrine and Teva.

By Jacob Bell • Aug. 21, 2023

Appeals court rules to limit abortion pill access

Federal judges said recent changes by the FDA to loosen prescribing rules for mifepristone should be rolled back. Biotech leaders have warned the case could undermine the agency’s authority.

By Delilah Alvarado • Updated Aug. 17, 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

FDA won’t hold advisory meeting for Bluebird’s sickle cell gene therapy

The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review. 

By Kristin Jensen • Aug. 16, 2023

In a year with few biotech IPOs, ‘crossover’ financings are hard to find

Investors known for funding the final private financing round before a biotech company goes public have pulled back as the IPO window remains shut.

By Gwendolyn Wu • Updated Aug. 16, 2023

Gilead allies with targeted drug startup Tentarix in latest research bet

San Diego-based Tentarix will receive $66 million in cash and equity from Gilead, which holds an option to acquire up to three of the company’s subsidiaries.

By Ned Pagliarulo • Aug. 15, 2023

Radiopharmaceuticals for cancer: Making radiation precise

More than a dozen startups have joined a few publicly traded biotechs and larger pharmaceutical firms in what’s become one of the most competitive areas in drug research.

By Ben Fidler • Aug. 15, 2023

Taysha gets cash lifeline from new investor RA Capital

The $150 million in fresh funds will help Taysha keep the lights on well into 2025 and support testing of an experimental gene therapy for Rett syndrome.

By Ned Pagliarulo • Aug. 14, 2023

Why high-tech solutions require high-touch service to create value in today’s complex drug development landscape

Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.

Aug. 14, 2023

The rise of the new pharma marketer in an evolving commercial model

Meet the pharma marketer of the future, primed for personalization and powered by technology.

Aug. 14, 2023

A biotech scraps two cancer trials in latest setback for emerging drug class

ALX Oncology’s decision to end studies in leukemia and myelodysplastic syndrome follows a similar setback from Gilead and casts further doubt on drugs known as CD47 inhibitors.

By Jonathan Gardner • Aug. 11, 2023

Family of Henrietta Lacks sues Ultragenyx over use of HeLa cell line

The lawsuit, filed in Maryland district court, claims the biotech unjustly profited from using HeLa cells to develop AAV vectors for its gene therapy products.

By Delilah Alvarado • Aug. 11, 2023

Amylyx ALS drug sales tick higher after fast US launch

In Europe, however, the biotech is appealing a negative decision from regulators that has for now blocked its path to market there.

By Ned Pagliarulo • Aug. 11, 2023

HIV cell therapy startup Addimmune heads to Wall Street via blank-check merger

The deal will help fund a cell-based treatment that completed Phase 1 testing last year and is designed to provide a “functional cure” for patients with HIV infections.

By Ben Fidler • Aug. 10, 2023

Novo adds another obesity drug in $1B deal for startup Inversago

The acquisition follows a similar-sized, obesity-focused buyout by Eli Lilly last month and hands Novo a weight-loss medicine already in mid-stage testing. 

By Kristin Jensen • Aug. 10, 2023

Alltrna raises $109M for ‘transfer RNA’ drug vision

The Flagship-backed company claims its technology can create genetic drugs that work broadly to treat diseases caused by “stop” mutations.

By Gwendolyn Wu • Aug. 9, 2023

Emergent to lay off around 400 in pivot away from contract manufacturing

The job cuts will affect “all areas of the company” and, combined with other cost-reduction efforts, lead to annualized savings of over $100 million, Emergent said.

By Jacob Bell • Aug. 8, 2023

Biopharma sector still growing despite layoff wave, Stifel report finds

The investment bank estimates that, while many smaller biotechs are laying off staff, larger companies are still growing from early 2021 levels.

By Ben Fidler • Aug. 7, 2023

Sage considers cuts after FDA’s split decision on depression drug

Analysts are now questioning whether Sage’s partner Biogen will hand back rights to the drug, which was approved for postpartum depression but not major depressive disorder.

By Jacob Bell • Aug. 7, 2023

Ikena acquires cancer startup Pionyr after Gilead passes on buyout

The all-stock deal comes months after Gilead waived an option to buy Pionyr, and gives Ikena some needed breathing room in a tough market.

By Delilah Alvarado • Aug. 7, 2023

Claudin 6 (CLDN6) T Cell engagers for CLDN6-positive solid tumors

As research evolves for new oncology treatments, companies including Context Therapeutics are developing potential therapies focused on the emerging novel oncology target Claudin 6 (CLDN6). 

Aug. 7, 2023

FDA approves Sage, Biogen drug for postpartum depression, but rejects wider use

The agency turned back the companies' attempt to also win clearance for major depressive disorder, limiting its market potential.

By Jacob Bell • Aug. 4, 2023

Regeneron gets ‘clarity’ in plan to defend top-selling eye drug, but is set back elsewhere

The surprise rejection of a high-dose form of Eylea could be resolved earlier than anticipated. But some of the company’s pipeline projects have stumbled.

By Ben Fidler • Aug. 4, 2023

Agios turns to Alnylam for help with rare disease push

The biotech is acquiring rights to an RNA interference medicine Alnylam invented for a rare blood disorder, continuing a corporate makeover that began in 2020. 

By Kristin Jensen • Aug. 3, 2023

Gilead-backed cell therapy startup Kyverna adds fresh funds for new strategy

A treatment licensed from the NIH and in clinical testing for lupus is the startup’s lead program, while its founding “Treg” cell therapy research matures, according to CEO Peter Maag.

By Ben Fidler • Aug. 3, 2023

Karyopharm cuts staff amid push to broaden use of blood cancer drug

The biotech, which has struggled to grow sales of its medicine Xpovio, is laying off 20% of its staff and focusing on late-stage studies in endometrial cancer and myelofibrosis.

By Delilah Alvarado • Aug. 2, 2023