Merck kicks off Phase 3 tests for PCSK9 cholesterol pill

The company plans to enroll roughly 17,000 people in three Phase 3 trials of the drug, including a large cardiovascular study set to begin later this year.

By Delilah Alvarado • Aug. 25, 2023

Novo, with new data, builds case for using Wegovy to protect heart health

After trial results showed the obesity drug can prevent heart attacks, the company now has data indicating it can help people with heart failure, too.

By Jonathan Gardner • Aug. 25, 2023

Explore the Trendline➔

Immunology

Promising new mechanisms of action are driving significant pharmaceutical company investment into drugs for immune diseases like psoriasis and Crohn’s.

By BioPharma Dive staff

Roche’s surprise study results spur new optimism for TIGIT drugs

Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers. 

By Jonathan Gardner • Aug. 23, 2023

Fulcrum rejoins sickle cell drug race as FDA lifts study hold

The biotech, which aims to develop an alternative to existing medicines and emerging gene-based treatments, will focus further testing on sicker patients.

By Ben Fidler • Aug. 22, 2023

FDA partially halts leukemia studies of Gilead cancer drug

The hold is the latest setback for a drug that was the center of Gilead’s $5 billion acquisition of biotech Forty Seven in 2020.

By Jonathan Gardner • Aug. 21, 2023

Moderna builds case for updated COVID shot ahead of latest booster push

But the demand for booster shots ahead of an expected surge of infections this fall remains an unanswered question weighing heavily on Moderna’s future outlook. 

By Jonathan Gardner • Aug. 18, 2023

Merck says drug acquired in $1B buyout scores in large kidney cancer study

The treatment, which Merck picked up through a 2019 acquisition of Peloton Therapeutics, helped delay disease progression in patients with advanced renal cell carcinoma. 

By Jacob Bell • Aug. 18, 2023

Boehringer moves Wegovy competitor into late-stage testing

The German pharmaceutical company is launching three Phase 3 trials of an obesity drug called survodutide, which like Wegovy targets the GLP-1 receptor

By Ned Pagliarulo • Aug. 17, 2023

Gilead antibody drug shows signs of potential in early lung cancer

A combination of Trodelvy and Merck’s Keytruda appears active against lung tumors, but has a high bar to clear and faces competition from AstraZeneca and Daiichi Sankyo.

By Jonathan Gardner • Aug. 17, 2023

FDA lifts hold on Arcellx’s Gilead-partnered cancer cell therapy

The agency had paused testing after a patient death, but is now permitting more types of bridging treatment to help keep participants’ disease at bay.

By Jonathan Gardner • Aug. 15, 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

Novartis says drug helps control chronic hives in studies

The studies are another example of drugmakers exploring how so-called BTK inhibitors can be used to treat diseases outside of blood cancer. 

By Kristin Jensen • Aug. 9, 2023

Novo obesity drug protects heart health in large trial

2023 was a breakout year for GLP-1 drugs, which have shown dramatic weight loss benefits. Study results in August proved Novo’s Wegovy could protect the heart, too, a finding that may change obesity treatment.

By Jonathan Gardner • Updated Aug. 8, 2023

How the right technology and tools can accelerate progress in rare disease clinical trials

The need for more research into rare diseases is clear, but researchers face significant challenges. Fortunately, technology has created opportunities to innovate in clinical trials for rare diseases.

Aug. 7, 2023

Amgen says KRAS drug met goal in late-stage colon cancer trial

The company disclosed the study result alongside second quarter earnings showing Lumakras sales were flat versus the same period one year prior.

By Ned Pagliarulo • 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

Lilly adds to case for Mounjaro’s weight-loss benefits with new study data

The results showed that enrollees who’d already lost weight after diet and exercise shed pounds after receiving Mounjaro, while those who stopped treatment gained weight back. 

By Jonathan Gardner • July 27, 2023

FDA declines to review Biohaven’s latest drug in setback to pipeline

While the FDA doesn’t think the brain disease treatment merits an evaluation, Biohaven is still pushing for one and has requested a further meeting.

By Delilah Alvarado • July 27, 2023

Moderna, Merck advance cancer vaccine into late-stage test

The companies are enrolling people with melanoma in a Phase 3 trial aimed at testing whether the shot can prevent disease recurrence.

By Jonathan Gardner • July 26, 2023

Stoke faces new doubts in search for ‘Spinraza for epilepsy’

Shares fell after the biotech’s Dravet syndrome treatment missed investor expectations. But Stoke CEO Ed Kaye claims the company now better understands its drug and how to test it.

By Ben Fidler • July 25, 2023

Bavarian Nordic to scrap RSV vaccine after study setback

The shot failed to meet a key goal of Bavarian Nordic’s Phase 3 study, a finding that separates it from marketed vaccines developed by Pfizer and GSK.

By Delilah Alvarado • July 24, 2023

Gilead drug acquired in $5B buyout fails key blood cancer trial

Treatment with magrolimab proved ineffective in a Phase 3 study in myelodysplastic syndrome, adding to doubts about so-called CD47 inhibitors as well as Gilead’s deal strategy.

By Ben Fidler • July 24, 2023

Vir, struggling to build on COVID success, says flu antibody fails key study

The setback cut shares of the once high-flying infectious disease drug developer in half, adding to the challenge facing new CEO Marianne De Backer.

By Delilah Alvarado • July 20, 2023

An Arch-backed biotech pushes its depression drug into late-stage testing

Neumora Therapeutics said its oral medication, which works differently than other antidepressants, was significantly better than placebo at treating major depressive disorder in a mid-stage study.

By Jacob Bell • July 18, 2023

Lilly Alzheimer’s drug slowed disease by roughly half a year, new results show

New data presented Monday at a research conference support Lilly’s case for donanemab, while documenting its risks in greater detail.

By Jacob Bell • July 17, 2023