Mirati matches Amgen with updated data for KRAS-blocking cancer drug

Fresh study results showed similar rates of response and progression-free survival with Mirati's experimental adragasib as with Amgen's approved Lumakras. The new data might raise safety questions, however. 

By Ned Pagliarulo • Updated May 27, 2022

3 cancer drug studies to watch at next month's ASCO meeting

Detailed results from important studies of AstraZeneca’s breast cancer drug Enhertu, Gilead’s Trodelvy and Roche’s TIGIT blocker are among the most anticipated late-breaking data set to be presented next month.

By Ben Fidler , Ned Pagliarulo • May 26, 2022

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Responding to outbreak, Moderna starts early work on monkeypox vaccine

One day after the U.S. began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus.

By Jonathan Gardner • May 24, 2022

Springworks shares fall despite drug trial's success

The biotech plans to seek FDA approval for its soft-tissue tumor treatment after positive study results. But investors still sent the stock down by nearly 10%.

By Ned Pagliarulo • May 24, 2022

Pfizer, Lilly bolster cases for experimental ulcerative colitis drugs

The two companies are each developing new types of medicines that they hope can soon win FDA approval for treating the autoimmune disease.

By Ned Pagliarulo • May 24, 2022

Pfizer says 3 doses of its COVID-19 vaccine works in youngest children

The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.

By Jonathan Gardner • May 23, 2022

Biohaven hits setback as it moves beyond migraine

The company's experimental treatment for spinocerebellar ataxia is one of several drugs meant to form the pipeline of the "New Biohaven" that will be spun out after Pfizer's planned acquisition.

By Jacob Bell • May 23, 2022

Concert drug helps regrow hair in study, boosting shares

There are no treatments specifically approved for alopecia areata. Concert follows Pfizer and Eli Lilly in reporting positive late-stage results for drugs the companies are developing for the autoimmune disorder.

By Ned Pagliarulo • May 23, 2022

Trial setback casts doubt on a biotech's respiratory virus drug

As vaccines for respiratory syncytial virus progressed, Enanta used its hepatitis C know-how to develop an antiviral pill. Yet data in lower-risk patients raise questions of whether it can work.

By Jonathan Gardner • May 19, 2022

Scientists home in on cause of Duchenne gene therapy side effect

An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials.

By Jonathan Gardner • Updated May 18, 2022

Gilead, having resolved manufacturing issues, forges ahead with HIV drug

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

By Jacob Bell • May 17, 2022

Bristol Myers' Opdivo comes up short in bladder cancer trial

The top-selling immunotherapy failed to improve survival in first-line urothelial carcinoma, a tumor type that's proved difficult to treat with drugs like Opdivo.

By Ned Pagliarulo • May 16, 2022

Key Bristol Myers drug holds up in long-term psoriasis study

Deucravacitnib, forecast by Bristol Myers to hit $4 billion in peak sales, is under FDA review with an approval decision due by September. The agency's view of its safety will be key to its future.

By Jonathan Gardner • May 12, 2022

In first, Verve gets clearance to test base editing inside the body

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K., too. 

By Kristin Jensen • May 11, 2022

Roche cancer immunotherapy fails another trial, casting doubt on emerging drug class

A treatment combination involving Roche's anti-TIGIT medicine tiragolumab missed its goal in a Phase 3 lung cancer study that was viewed as a proof point for the drug class.

By Ben Fidler • May 11, 2022

J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies.

By Ned Pagliarulo • May 9, 2022

Argenx drug succeeds in trial, beats sales forecasts

The biotech reported positive results from a study meant to expand Vyvgart's use to another immune disorder, while sales from the drug's first quarter on the market exceeded expectations.

By Kristin Jensen • May 5, 2022

Pfizer cleared to restart hemophilia gene therapy trial

While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023.

By Jonathan Gardner • May 3, 2022

FDA rejects two China-developed cancer drugs

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

By Jonathan Gardner • May 2, 2022

Vertex surprised by FDA halt of diabetes cell therapy study

The regulator determined Vertex had "insufficient information" to test higher doses of the therapy, which showed promise in the first two patients treated.

By Ned Pagliarulo • May 2, 2022

Ionis, AstraZeneca change a key trial, fueling more questions about a genetic heart disease

The partners increased the size and length of a large study in transthyretin amyloidosis cardiomyopathy, a decision that has implications for Alnylam, which is testing two of its drugs for the disease. 

By Ben Fidler • May 2, 2022

Lilly's closely watched diabetes drug scores in obesity trial

Called tirzepatide, the drug significantly lowered weight loss in a large study, findings that add to growing evidence that a class of medicines originally meant for diabetes may effectively treat obesity.

By Jonathan Gardner • April 28, 2022

Roche stumbles in latest setback for an emerging group of breast cancer drugs

The Phase 2 failure marks the second negative result in two months for a closely watched group of medicines, known as SERDs, that are being developed by several large pharmaceutical companies.

By Jonathan Gardner • April 25, 2022

How a surprise finding made an Alnylam study one of biotech's most 'polarizing' trials

A study testing Alnylam's drug Onpattro in a deadly heart condition was once seen as a sure bet. Now the trial is the source of much debate, and its outcome could influence how future treatments for the disease are developed.

By Ben Fidler • April 25, 2022

FDA panel supports agency push to raise approval bar for certain cancer drugs

Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.

By Jonathan Gardner • April 22, 2022