Travere set back by study failure of kidney disease drug

Shares in the biotech, formerly Retrophin, sank after the company disclosed its newly approved drug sparsentan failed a study meant to expand its use.

By Ned Pagliarulo • May 2, 2023

Alnylam’s early Alzheimer’s results encourage, but company discloses new hurdle

Partner Regeneron said the data, which showed substantial reduction of a key protein, suggests hope for the “bold dream” of silencing genes in the brain.

By Kristin Jensen • April 27, 2023

Explore the Trendline➔

Cell therapy

Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.

By BioPharma Dive staff

Lilly drug Mounjaro succeeds in second weight loss study

Trial participants nearly 16% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

By Jonathan Gardner • April 27, 2023

Novartis trims 10% of drug pipeline in research cutback

The company cut about 20 early-stage projects, including nine solid tumor programs, after reviewing their strategic fit and commercial potential.

By Christopher Newman • April 25, 2023

Morphic shares swing on study data for drug viewed as ‘oral Entyvio’

Results from a small trial suggested Morphic's pill could be effective in treating inflammatory bowel disease, briefly lifting the company’s valuation by hundreds of millions of dollars. 

By Ned Pagliarulo • Updated April 25, 2023

Ionis, AstraZeneca detail data backing rare disease rival to Alnylam drugs

A second-generation treatment called eplontersen halted nerve damage and improved quality of life in a late-stage study the companies are using to seek U.S. approval.

By Ned Pagliarulo • April 24, 2023

Apellis’ immune system drug hits a setback in ALS

The company has chosen to stop an extension portion of a key study after an external group of advisers reviewed the data available and concluded further treatment with the drug was unwarranted.

By Jacob Bell • April 21, 2023

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

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

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

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