NIH funds research for three experimental ALS drugs

The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.

By Jacob Bell • Oct. 6, 2023

FDA panel finds KRAS drug data unreliable, in blow to Amgen

The negative panel vote likely means Amgen will need more data to support a full approval for its conditionally cleared lung cancer drug Lumakras.

By Ned Pagliarulo • Updated Oct. 6, 2023

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

Moderna claims positive results in early study for combo COVID, flu shot

The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.

By Delilah Alvarado • Oct. 4, 2023

Novartis’ closely watched rare disease drug scores in kidney disorder

Called iptacopan, the experimental medicine has now scored positive results in three late-stage clinical trials, the latest in an uncommon kidney disorder known as IgA nephropathy.

By Jacob Bell • Oct. 2, 2023

Structure boosted by early data for experimental obesity drug

Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug, reflecting investor enthusiasm for the weight loss medicines. 

By Ned Pagliarulo • Sept. 29, 2023

J&J cancer drug combo beats Tagrisso in closely watched trial

Interim results from a study called “Mariposa” found that a regimen of two J&J medicines improved progression-free survival versus AstraZeneca’s widely used therapy.

By Ned Pagliarulo • Sept. 28, 2023

BrainStorm’s ALS therapy not effective, FDA panel finds

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment to be effective for treating ALS. 

By Ned Pagliarulo • Updated Sept. 28, 2023

Immunovant data show potential for autoimmune disease drug

Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.

By Ned Pagliarulo • Sept. 26, 2023

Novartis radiopharmaceutical drug succeeds in first-line gut cancer study

Novartis has made a large investment in targeted radiotherapies, sparking competition from fellow pharma companies and young biotechs.

By Jonathan Gardner • Sept. 25, 2023

AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors

Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.

By Jonathan Gardner • Sept. 22, 2023

Seagen’s cancer drug succeeds in ‘must-win’ trial

Compared to chemotherapy, a combination of Seagen’s Padcev and Merck’s Keytruda was significantly better at keeping bladder cancer patients alive longer and their disease from progressing.

By Jacob Bell • Sept. 22, 2023

Latest trial win supports expanded use of Bristol Myers’ Opdivo in lung cancer

The drug, which is already cleared as a neoadjuvant lung cancer treatment, could better compete with Merck’s Keytruda if it gains approval in the adjuvant setting for non-small cell tumors.

By Delilah Alvarado • Sept. 22, 2023

FDA panel backs Alnylam drug despite doubts over benefit

“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.

By Jonathan Gardner • Updated Sept. 14, 2023

After IPO success, Acelyrin hits trial setback with inflammation drug

Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.

By Kristin Jensen • Sept. 12, 2023

Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

By Jonathan Gardner • Sept. 11, 2023

In advocates’ push for superbug funding, ‘$6 billion is nothing’

The PASTEUR Act could be heading for another setback, but advocates say they see a future for funding research into antimicrobial resistance.

By Karissa Waddick • Sept. 8, 2023

Alnylam says hypertension drug succeeded in mid-stage study

The trial found two higher doses of Alynlam’s RNAi therapy lowered blood pressure better than placebo. But analysts say results from a different study will be more important for the drug’s future.

By Jacob Bell • Sept. 7, 2023

Wave readies clinical testing for first RNA editing therapy

The biotech, one of several advancing RNA editing medicines, expects to obtain “proof-of-mechanism” data in patients with the inherited disorder alpha-1 antitrypsin deficiency by next year.

By Kristin Jensen • Updated Sept. 5, 2023

Roche claims study success for targeted drug in early lung cancer

The Swiss pharma said, without details, that it observed “unprecedented” results that could make Alecensa the first treatment specifically available after surgery for ALK-positive lung tumors.

By Ben Fidler • Sept. 1, 2023

FibroGen’s Duchenne drug fails second trial in latest study setback

The failure marks another Phase 3 miss for the drug, pamrevlumab, and follows a restructuring and CEO switch for the struggling biotech.

By Delilah Alvarado • Aug. 30, 2023

Bayer reports positive early data for Parkinson’s cell therapy

The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression. 

By Jacob Bell • Aug. 28, 2023

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

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