J&J study data show dramatic benefit to multiple myeloma cell therapy

A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs.

By Ned Pagliarulo • April 19, 2023

Vaxcyte strengthens case for experimental pneumococcal vaccine

The company reported positive results from a second Phase 2 study of a shot that’s meant to challenge vaccines from Pfizer, Merck and GSK.

By Delilah Alvarado • Updated May 3, 2023

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

Patient-centered clinical trials improve recruitment and retention

Let’s face facts. Patient enrollment in clinical trials is time-intensive & costly. We must do better.  

April 17, 2023

Navigate the complexities of cell and gene therapies

See how the effective use of CMC expertise helped guide a biopharma company’s development of a CGT product.

April 17, 2023

Moderna, Merck data support claim of cancer vaccine’s promise

Data presented at AACR suggest a personalized shot made with messenger RNA may amplify the effects of a widely prescribed cancer immunotherapy.

By Jonathan Gardner • April 16, 2023

New data raise more doubts about Moderna’s flu vaccine

The shot appears to generate an immune response that matches or exceeds existing vaccines, but investigators aren’t yet sure how well it can prevent illness.

By Jonathan Gardner • April 11, 2023

Merck, Eisai report pair of study setbacks for cancer drug combo

Phase 3 trials testing Merck’s Keytruda with Eisai’s Lenvima in colon and skin cancers didn’t show a survival benefit, denting the partners’ plans to expand the drugs’ use.

By Ben Fidler • April 7, 2023

In NEJM, full Pfizer data show RSV vaccine’s protection

Shots from Pfizer and GSK could soon become the first approved for the common respiratory infection. Results published in the high-profile medical journal give a closer look at the former.

By Delilah Alvarado • Updated April 6, 2023

Cytokinetics to end late-stage study of ALS drug

The decision comes after an external group of advisers who got an interim look at the data found Cytokinetics’ drug had “no effect” on the study’s goals.

By Jacob Bell • March 31, 2023

J&J abandons RSV vaccine in major strategy shift

The pharma, once a frontrunner in the race to develop the first vaccine for the respiratory virus, said it will end a 23,000-person study of its experimental shot amid a restructuring of its infectious disease division.

By Christopher Newman • Updated March 29, 2023

Viking joins obesity drug development race with early study data

The biotech is working on a dual-acting weight loss treatment that could compete with medicines from Novo Nordisk, Eli Lilly and others.

By Jonathan Gardner • March 28, 2023

Intra-Cellular shares rise on depression study’s success

The biotech’s drug lumateperone scored in a late-stage study of patients with either bipolar or major depressive disorder — results which some analysts called a “clear win.”

By Jacob Bell • March 28, 2023

Novartis, following Lilly, claims success in early breast cancer study

The Swiss drugmaker believes the findings could support an approval of Kisqali in adjuvant breast cancer and, potentially, broader use than Lilly’s rival drug Verzenio.  

By Jonathan Gardner • March 27, 2023

ALS drugmakers, encouraged by recent FDA feedback, set their sights on a key protein

A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.

By Jacob Bell • Updated March 31, 2023

Sanofi, Regeneron surge as Dupixent scores in COPD trial

The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.

By Ben Fidler • March 23, 2023

Karuna’s schizophrenia drug succeeds in a second late-stage trial

The results add to a growing body of evidence that Karuna’s drug, known as KarXT, could be a valuable new option for patients living with the brain disorder.

By Jacob Bell • Updated March 20, 2023

Early decisions to de-risk the transition to combination products

Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing. 

March 20, 2023

Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data

"This is why we did the deal," said Takeda R&D chief Andy Plump, referring to his company's $4 billion acquisition of the medicine from startup Nimbus Therapeutics.

By Ben Fidler • March 18, 2023

Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.

By Jonathan Gardner • March 17, 2023

Clinical trial researchers are burned out too. Automated data capture is helping.

Manual data transcription increases clinical research coordinator burnout. There is a better way.

By Ben Baumann, OpenClinica Co-Founder and COO • March 13, 2023

FDA advisers back earlier use of Roche lymphoma drug

The positive vote comes despite doubts from FDA scientists and increases the chance that Polivy could soon be approved as a first-line treatment alongside a drug regimen called R-CHOP.    

By Jonathan Gardner • March 10, 2023

Lilly reaches end of the road with long-studied Alzheimer’s drug

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.

By Jonathan Gardner • March 9, 2023

AstraZeneca builds on study successes in early lung cancer

The pharma’s drug Tagrisso extended survival in a trial that stirred debate at ASCO three years ago, while its immunotherapy Imfinzi reduced the risk of relapse in a different study.

By Ben Fidler • March 9, 2023

With PCSK9 pill, Merck aims to succeed where others failed

The company is planning an ambitious Phase 3 program testing its oral cholesterol-lowering drug, which in a mid-stage trial appeared to match the effects of approved injectable competitors.

By Christopher Newman • March 7, 2023

Merck drug data suggest ‘new direction’ for rare blood vessel disease

Treatment with Merck’s sotatercept helped improve the exercise capacity of patients with pulmonary arterial hypertension, anticipated results from a Phase 3 study showed.

By Christopher Newman • March 6, 2023