FDA scientists appear supportive of Pfizer, BioNTech's coronavirus vaccine

Agency staff didn't raise any red flags in their review of the companies' study results, documents released ahead of a key advisory committee meeting Thursday show.

By Ned Pagliarulo • Updated Dec. 8, 2020

Altasciences' comprehensive, integrated solution for clinical supply manufacture

Integrated CRO/CDMO solutions for accelerated and more efficient early drug development programs.

Dec. 7, 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

J&J study finds multiple myeloma cell therapy to be strongly effective

Safety issues that have dogged the CAR-T field remain, however, with the drugmaker reporting some severe side effects, including several that led to patient deaths.

By Jonathan Gardner • Dec. 5, 2020

A CRISPR gene editing treatment continues to show promise for two blood diseases

Results from 10 patients with beta thalassemia or sickle cell disease show CRISPR Therapeutics and Vertex's pioneering treatment to be effective, building on earlier study data.

By Ben Fidler • Dec. 5, 2020

Ovid's plan to prove a shelved sleeping pill for a rare disease ends in disappointment

A quest by former Teva and Bristol Myers executive Jeremy Levin to develop an old drug for Angelman's syndrome fell short in a late-stage clinical trial.

By Ben Fidler • Dec. 2, 2020

With anemia data, Agios blood disease drug takes a crucial step forward

Phase 3 results announced Tuesday boost chances that Agios' drug might not just win approval for a rare type of anemia, but also be useful in treating other blood diseases.

By Ben Fidler • Dec. 1, 2020

Moderna, finishing key study, to ask FDA for emergency approval of coronavirus vaccine

New results confirm the shot's strong efficacy against COVID-19 and should raise confidence vaccination can prevent against severe symptoms as well. 

By Ben Fidler • Nov. 30, 2020

AstraZeneca, Oxford vaccine prevents COVID-19, though study results raise questions

Data from two late-stage trials showed the shot to be, on average, 70% effective against COVID-19 — an encouraging finding. The lower dose tested, however, unexpectedly outperformed a higher dose.

By Ben Fidler • Updated Nov. 23, 2020

WHO recommends against Gilead's Veklury, in break with US guidelines

The organization argues there's no evidence the antiviral saves lives or improves outcomes for COVID-19 patients, despite positive data on the latter point from a key U.S. study.

By Jonathan Gardner • Nov. 20, 2020

UniQure's gene therapy for hemophilia B meets goal in key study

The results are first to emerge from a late-stage test of a hemophilia B gene therapy, and show UniQure's treatment can restore clotting protein levels to mild or even near normal levels.

By Ned Pagliarulo • Nov. 19, 2020

New AstraZeneca data offer latest hint coronavirus vaccines may protect elderly

Results published Thursday add to hopes the experimental shots now in testing won't only work for young, healthy people. More details are needed, though.

By Ben Fidler • Nov. 19, 2020

New coronavirus vaccine data bolster Pfizer, BioNTech claims of strongly effective shot

Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just eight for those who were vaccinated. 

By Ned Pagliarulo • Nov. 18, 2020

Trial success for 2 coronavirus vaccines backs up early research bets

Positive data from Pfizer and Moderna offer the strongest validation yet of researchers' approach to coronavirus vaccines, but leave several questions still unanswered.

By Ned Pagliarulo , Ben Fidler • Nov. 17, 2020

Stem cell therapy for ALS fails a large clinical trial

The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.

By Jacob Bell • Nov. 17, 2020

Moderna says vaccine prevents COVID-19 in large study, adding to hopes for several protective shots

Multiple effective vaccines will likely be needed to end the pandemic. Moderna's study results, which are equally strong as those reported by Pfizer and BioNTech last week, make that outcome more likely.

By Ben Fidler • Nov. 16, 2020

Ligand binding program considerations – the value of preclinical to clinical bioanalytical expertise

Careful selection of a partner CRO can deliver advantages and accelerate your drug development program. 

Nov. 16, 2020

5 reasons life sciences needs better clinical trial supply management

A new industry consortium is lining up stakeholders to work together to address long-standing pain points that disrupt clinical trials.

Nov. 16, 2020

AstraZeneca cancer drug found ineffective for COVID-19

The setback follows disappointing results from companies like Novartis and Sanofi, which have also sought to repurpose existing drugs for COVID-19.

By Kristin Jensen • Nov. 12, 2020

Moderna close to having results from key coronavirus vaccine trial

The fast-accelerating spread of coronavirus in the U.S. has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results.

By Ned Pagliarulo • Nov. 12, 2020

Pfizer, BioNTech's strong results give lift to other coronavirus vaccines

The companies' early success helps validate an industry-wide bet to target the coronavirus' spike protein. But differences between each vaccine could still prove crucial.

By Jonathan Gardner • Nov. 11, 2020

Pfizer and BioNTech's coronavirus vaccine works. Here's what we still don't know.

An early analysis found the companies' shot more than 90% effective in preventing COVID-19. Beyond that highly encouraging number, however, there were few other details.

By Ned Pagliarulo , Ben Fidler • Nov. 10, 2020

Amgen's asthma drug delivers a needed win

A late-stage study found Amgen's tezepelumab benefited a variety of patients with severe asthma, results that one analyst called a "best-case outcome."

By Jacob Bell • Nov. 10, 2020

Coronavirus vaccine from Pfizer, BioNTech prevents COVID-19, early results show

An early look at Pfizer and BioNTech's large coronavirus vaccine study found the companies' experimental shot more than 90% effective, an encouraging result that bodes well for others in development.

By Jonathan Gardner • Updated Nov. 9, 2020

Novartis rare disease drug, repurposed for COVID-19, fails in late-stage study

The Swiss drugmaker's COVID-19 research efforts now largely rest on the outcome of a recent alliance to develop oral medicines for the new coronavirus.

By Ben Fidler • Nov. 6, 2020

Gene therapy for Duchenne muscular dystrophy: nearing final tests

Sarepta and Pfizer are advancing their experimental treatments into late-stage trials, while others are accelerating research in what's become one of gene therapy's most active fields.

By Ben Fidler • Nov. 5, 2020