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A biotech shelves its Huntington's drugs after trial failures

Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.

FDA turns back Keytruda, delaying immunotherapy's arrival in early cancer

Merck & Co.'s drug could've been the first immunotherapy approved in the so-called neoadjuvant setting. Its rejection might indicate a higher bar for others with similar ambitions.

Akebia tries for FDA approval of anemia drug after mixed data

The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain.

5 FDA approval decisions to watch in the second quarter

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.

UniQure says hemophilia gene therapy likely not cause of study volunteer's cancer

The determination, made by UniQure and an independent lab, could ease safety concerns spurred by the patient's diagnosis in December.

FDA approves first CAR-T cell therapy for multiple myeloma

Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma.

Pfizer and Lilly's pain drug hits setback in negative committee vote

In a Thursday meeting, advisers to the Food and Drug Administration concluded the companies didn't have a strong enough plan to mitigate the risks associated with tanezumab.

AstraZeneca, under fire, tries to repair image with new vaccine data

Updated results show the vaccine is only slightly less effective than AstraZeneca originally reported. But an unusual break with a study committee may damage perception of the shot.

UPDATED: March 25, 2021 at 2:15 p.m.

Slaoui steps down from two more biotechs after harassment claim

The former Warp Speed leader resigned from leadership roles at VaxCyte and Centessa Pharmaceuticals after being fired by GlaxoSmithKline over harassment allegations. 

US stops rollout of Lilly's first COVID-19 antibody over variant concerns

Treatments from Lilly and Regeneron that combine two different antibodies should be used instead, according to health officials.

Bristol Myers gets late-stage win in test of new type of immunotherapy

When given together with Opdivo, Bristol Myers' new drug kept skin cancers from progressing, a rare clinical victory for a combination of immunotherapies that puts the pharma a step ahead of several rivals. 

Drugmakers flock to Vineti's fix for a cell, gene therapy problem

A group of drug companies, including Novartis, Takeda and Roche's Genentech, have agreed to collaborate with Vineti to usher in new identification standards for complex medicines.

Moncef Slaoui, who led US Warp Speed effort, accused of sexual harassment

Slaoui was fired as board chair of Galvani Bioelectronics following an investigation by the company's majority shareholder GlaxoSmithKline, which said the claims were substantiated.

UPDATED: March 24, 2021 at 5:53 p.m.

Regeneron joins Lilly in proving lower-dose antibody drugs can thwart COVID-19

The findings could help boost the supply and reach of Regeneron's COVID-19 antibody drug, which, despite limited use, is now backed by convincing data showing it can prevent hospitalization.  

Roche stops giving Huntington's disease drug in closely watched study

A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals. 

AstraZeneca may have used 'outdated' data to describe vaccine's efficacy, NIH says

The British drugmaker said it will release updated data from the large U.S. trial within 48 hours, but the puzzling episode is another communication misstep for the company.

José Baselga, prominent cancer researcher, dies at 61

The head of AstraZeneca's oncology R&D changed the paradigm of breast cancer care by helping bring the targeted treatments Herceptin and Perjeta to patients. 

Crunching the numbers on a busy first quarter for biotech IPOs

Seven gene or cell therapy developers have now gone public in the first quarter, outpacing each of the past three years. Biopharma Dive examined the class of 2021's performance. 

AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas

A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad. 

UPDATED: March 22, 2021 at 9:44 a.m.

FDA won't review Novo diabetes drug in latest case of regulatory pushback

Novo Nordisk said the FDA requested more data before starting review for a high dose of the Danish company's treatment semaglutide, extending a string of recent setbacks for drugmakers in the U.S.

Roche immunotherapy notches a win in early lung cancer, pressuring Merck

New results could make Tecentriq the first immunotherapy available in the post-surgery setting, adding pressure on Merck & Co.'s Keytruda to succeed as well.

With new results, Sarepta's 2nd gene therapy holds steady

Stung by a clinical trial miss in Duchenne muscular dystrophy, the biotech now has promising, if early, data to back a gene therapy for a different rare neuromuscular disease.

AbbVie's approval delay raises further concerns about JAK drugs

An FDA request for more data, which comes on the heels of troubling results from a safety study of Pfizer's Xeljanz, could push back by three months AbbVie's plans to get Rinvoq approved in psoriatic arthritis.

EU, UK throw support behind AstraZeneca's vaccine amid reports of rare blood clots

The two drug regulators each believe the benefits of the shot outweigh the risks after investigating rare and unusual clotting events that have led more than 20 countries to halt vaccinations.

A first-of-its-kind mRNA drug falls short in cystic fibrosis

A treatment that sprays synthetic messenger RNA into the lungs failed to help cystic fibrosis patients, a blow to efforts to use the technology for more than vaccines.