From no drugs to 3: Patients with spinal muscular atrophy now face hard choices

The availability of three vastly different, cutting-edge medicines for the rare disease has put patients, families and doctors in an unfamiliar position.

By Jonathan Gardner • Oct. 5, 2020

AstraZeneca restarts another coronavirus vaccine trial, but US delay lingers

The company is now cleared to resume testing of its experimental shot in multiple countries, but a Phase 3 trial in the U.S. remains halted as an FDA investigation reportedly widens.

By Ben Fidler • Oct. 2, 2020

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

Solid gets all-clear from FDA to restart gene therapy trial

Worrisome immune responses had led the FDA to halt Solid's study. Now, the agency will permit Solid to continue after the biotech made adjustments to its manufacturing and patient enrollment procedures.

By Jonathan Gardner • Oct. 1, 2020

Regeneron says antibody drug may speed recovery of patients with mild COVID-19

Early data suggested the therapy could help people whose bodies aren't already fighting infection, a finding that led to emergency clearance in the U.S.

By Ben Fidler • Updated Sept. 30, 2020

Ironwood lays off one-third of staff after heartburn drug falls short in study

The company will halt further work on its only fully owned drug and focus instead on expanding sales of its marketed product Linzess.

By Jonathan Gardner • Updated Sept. 29, 2020

FDA delays testing of Inovio's coronavirus vaccine

The FDA has suspended the planned start of a late-stage trial of Inovio's experimental shot, dealing another setback to one of the most advanced DNA-based vaccine programs in development.  

By Jonathan Gardner • Sept. 28, 2020

J&J, beginning final test, shares first data on coronavirus vaccine

The early study results were used to support the drugmaker's recent decision to start a large Phase 3 study that, unlike other large tests underway, will evaluate a one-shot regimen.  

By Ned Pagliarulo • Sept. 25, 2020

Novavax starts large-scale coronavirus vaccine trial in UK, as cases surge

The Maryland-based biotech is the first developer to advance a more traditional protein-based vaccine into the final stages of clinical testing.

By Ben Fidler • Sept. 25, 2020

J&J begins largest Phase 3 study of a coronavirus vaccine

The trial, which launched Wednesday in the U.S., South Africa and several South American countries, will enroll as many as 60,000 participants.

By Ned Pagliarulo • Sept. 23, 2020

AC Immune drug fails in blow to another Alzheimer's hypothesis

Negative results for the experimental drug semorinemab dents a theory that Alzheimer's disease may be caused by tangles of the protein tau in the brain.

By Jonathan Gardner • Sept. 23, 2020

FDA sets back Novartis plans to expand use of SMA gene therapy

The agency has asked the company to run a new study of the Zolgensma formulation that it aims to bring to older patients with spinal muscular atrophy.

By Ben Fidler • Sept. 23, 2020

Regeneron forges ahead in lung cancer, but will need more to unseat Merck

The biotech's immunotherapy Libtayo looks headed for approval in lung cancer, but surpassing the bar set by Merck's Keytruda remains a challenge.

By Ben Fidler • Sept. 22, 2020

Blueprint's bet on itself pays off with rare disease drug data

Study data show Blueprint's first approved cancer drug, Ayvakit, could also work to treat a rare disease, a result that sent the company's shares higher.

By Ned Pagliarulo • Sept. 22, 2020

Merck matches Roche in search for next cancer immunotherapy

The maker of Keytruda unveiled data for three experimental cancer drugs, including results for an anti-TIGIT therapy that compare favorably to those for a similar medicine being developed by Roche.

By Ned Pagliarulo • Sept. 21, 2020

With Eli Lilly data, another drug emerges to stop breast cancers from returning

The highly anticipated results could change how some patients with the most common form of breast cancer are treated — and drive up the costs of care. 

By Ben Fidler • Sept. 20, 2020

Amgen's KRAS drug can shrink tumors for months, but new data leave room for improvement

Study results unveiled Sunday, if replicated later this year, could be strong enough to garner an approval for Amgen's sotorasib, the first KRAS-blocking drug to get this far.

By Ned Pagliarulo • Sept. 20, 2020

Seattle Genetics stays step ahead of rivals with bladder cancer data

Data confirming the company's drug Padcev can extend the lives of bladder cancer patients should strengthen its position with regulators, although Immunomedics is close behind with a competing treatment.

By Jonathan Gardner • Sept. 18, 2020

In unexpected finding, Roche claims arthritis drug may have role in treating COVID-19

Previous study findings from Roche and others had indicated the Swiss drugmaker's Actemra, and other drugs like it, weren't helping patients hospitalized with coronavirus disease. 

By Ben Fidler • Sept. 18, 2020

What to watch as the first late-stage coronavirus vaccine trials near potential readouts

Predictions of results by the end of October look ambitious, as the number of COVID-19 cases needed to generate definitive data could still take months.

By Jonathan Gardner • Updated Sept. 17, 2020

Vaccine makers, in bid for transparency, disclose detailed plans of coronavirus vaccine trials

Moderna was the first to share the so-called study protocol of its Phase 3 trial, spurring Pfizer and AstraZeneca to quickly do the same.

By Ned Pagliarulo • Updated Sept. 19, 2020

Arrowhead shares soar on liver disease data from four patients

Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

By Jonathan Gardner • Sept. 16, 2020

Lilly offers first evidence that its antibody drug may help treat COVID-19

The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear. 

By Ben Fidler • Sept. 16, 2020

Pfizer says coronavirus vaccine study still on track for October readout

Unusually, the drugmaker also shared blinded safety results from its ongoing Phase 3 trial, showing participants' side effects were generally mild to moderate.

By Ned Pagliarulo • Sept. 15, 2020

Lilly says its arthritis drug helps speed COVID-19 recovery

The benefit of adding Lilly's Olumiant to Gilead's antiviral Veklury appeared modest, reducing time to recovery by one day in a study of hospitalized patients.

By Ned Pagliarulo • Sept. 14, 2020

AstraZeneca, Oxford vaccine study allowed to restart in UK

Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume.

By Ben Fidler • Sept. 12, 2020