Roche says Tecentriq immunotherapy reduces risk of liver cancer recurrence

While the company did not reveal specific study data, the results could help Tecentriq become the first drug approved for adjuvant liver cancer treatment.

By Jonathan Gardner • Jan. 19, 2023

Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK

The biotech’s results appear competitive to past data for RSV shots being developed by GSK and Pfizer. Moderna plans to follow those companies in asking for FDA approval.

By Delilah Alvarado • Jan. 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

Large study of J&J’s HIV vaccine stopped after shot found ineffective

The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections.

By Ned Pagliarulo • Jan. 18, 2023

FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

By Jacob Bell • Updated Jan. 6, 2023

Novocure shares soar on positive lung cancer data

A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.

By Jonathan Gardner • Jan. 5, 2023

Roivant reveals positive data for IBD drug, intensifying rivalry with Prometheus

The results left Wall Street analysts torn about which company holds the advantage as both race to get a new type of therapy to market.

By Jacob Bell • Jan. 4, 2023

10 clinical trials to watch in the first half of 2023

Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s, while a pair of high-priced acquisitions could be put to the test.

By BioPharma Dive staff • Jan. 3, 2023

Pfizer advances diabetes, obesity drug hopeful into mid-stage testing

The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen.

By Kristin Jensen • Dec. 21, 2022

FDA halts planned trial of Entrada Duchenne drug

Shares in the Boston-based biotech fell on the news, which comes shortly after a deal with Vertex around another type of muscular dystrophy.

By Gwendolyn Wu • Dec. 20, 2022

Doubts around cancer drug target persist after Gilead, Arcus study results offer ‘mixed picture’

While long anticipated trial data were technically positive, analysts questioned whether drugs aimed at ‘TIGIT’ will prove a meaningful treatment addition.

By Ned Pagliarulo • Dec. 20, 2022

Government spending bill would tighten FDA oversight of accelerated drug approvals

The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.

By Jonathan Gardner • Dec. 20, 2022

Madrigal shares triple on positive NASH study results

The company said its experimental drug helped patients with the fatty liver disease while also improving fibrosis. One analyst called the readout a “major win” for Madrigal and the NASH field.

By Jacob Bell • Dec. 19, 2022

Third Harmonic halts study of lead drug over safety risk

The biotech, previously a success story this year, will end development of its chronic hives treatment and search for alternative drug candidates. 

By Ned Pagliarulo • Dec. 15, 2022

Kymera shares jump on Sanofi’s decision to advance protein-degrading drug

Early data from a small, Phase 1 study exceeded Kymera’s expectations and, the biotech’s CEO claimed, offer “clinical validation” for its scientific approach. 

By Ned Pagliarulo • Dec. 14, 2022

Moderna vaccine succeeds in early-stage skin cancer study with Merck’s Keytruda

The positive data are the most significant findings for the mRNA developer’s pipeline of experimental treatments outside of infectious diseases, where it has reaped billions from COVID-19 vaccine sales. 

By Jonathan Gardner • Dec. 13, 2022

At ASH, Regeneron plays catch-up with its next cancer drugs

Two bispecific antibodies are “foundational” to the company’s plan to build an oncology business, according to a top executive. But Regeneron will have to surpass a crowd of competitors. 

By Ben Fidler • Dec. 12, 2022

J&J’s next myeloma drug, Argenx’s second act and a new question for Bluebird: 3 ASH takeaways

The year’s biggest meeting on blood diseases kicked off this past weekend. Here are three of the most important storylines to emerge from the past few days of presentations.

By Ned Pagliarulo , Ben Fidler • Updated Dec. 12, 2022

[Podcast] Thinking Big for Small and Mid-Sized Biotechs

This podcast series explores how to help small and mid-sized companies get innovative treatments to the people who need them.to help small and mid-sized companies get innovative treatments to the people who need them.

By BioPharma Dive's studioID • Updated Dec. 15, 2022

Pharvaris, pushing through trial pause, sees shares surge with new study results

Though the FDA halted testing of the biotech’s pill for hereditary angioedema in August, enough patients were already enrolled to accrue results that sent shares soaring. 

By Ben Fidler • Dec. 9, 2022

Novartis gets second trial win for blockbuster hopeful

The company plans to seek broad approval of the oral medication, iptacopan, next year after it met its primary endpoint in a new pool of patients with the rare blood disease PNH.

By Kristin Jensen • Dec. 8, 2022

Relmada sinks further as depression drug fails second large trial

The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result. 

By Ben Fidler • Dec. 8, 2022

Prometheus shares soar on new data for inflammation drug

Having scored positive results in two key studies for ulcerative colitis and Crohn’s disease, Prometheus now intends to advance the drug, called PRA023, into pivotal testing.

By Jacob Bell • Dec. 7, 2022

Esperion, without data, says cholesterol pill lowered heart risk in study

The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.

By Ned Pagliarulo • Dec. 7, 2022

MEI, Kyowa stop lymphoma drug trials after FDA meeting

The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

By Jonathan Gardner • Dec. 6, 2022

Novartis prostate cancer drug succeeds in study key to company’s sales hopes

The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.

By Ned Pagliarulo • Dec. 5, 2022