Icon to buy contract researcher PRA Health for $12B

The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.

By Kristin Jensen • Feb. 24, 2021

FDA review supports safety, efficacy of J&J coronavirus vaccine

In their review, agency scientists provided new details on the shot's protection against severe COVID-19 and different virus variants as well as its potential to reduce transmission.

By Ned Pagliarulo , Jonathan Gardner • Updated Feb. 24, 2021

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

FDA lays out shortened path for testing vaccines against new coronavirus variants

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.

By Ned Pagliarulo • Feb. 22, 2021

Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints

The companies think a new formulation will yield better results than their first attempt. But with several vaccines available, testing may be more challenging.

By Ben Fidler • Feb. 22, 2021

Accelerating virtual clinical trials

Leveraging the guidance and support of trial virtualization professionals with experience in key areas of a trial's lifecycle will undoubtedly impact overall success.

Feb. 22, 2021

Why this week's FDA meeting on J&J's coronavirus vaccine will be important

The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues.

By Ben Fidler , Ned Pagliarulo • Updated Feb. 23, 2021

10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model

The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.

By Ned Pagliarulo • Feb. 16, 2021

eReconciliation tool: A new software to facilitate Safety Data Reconciliation between clinical and safety databases

Simplify serious adverse events reconciliation operations with a customizable and GxP validated platform solution.

By Eleanor S. Segal, Luca Morbelli, Simone Suriano & Beat Widler • Feb. 16, 2021

AstraZeneca plans for adapting vaccine to coronavirus variants, but offers longer timeline than rivals

The drugmaker says between six to nine months are needed to ramp up production of an adapted shot. South Africa recently stopped using the vaccine due to its reduced potency against a common strain there.

By Jonathan Gardner • Feb. 11, 2021

Gilead, Galapagos halt development of experimental drug, denting research alliance

Independent reviewers found the benefits of the lung disease drug didn't outweigh its risks, marking a second major setback in six months for the companies' partnership.

By Kristin Jensen • Feb. 11, 2021

In surprise finding, Roche arthritis drug cuts risk of COVID-19 death in large UK study

U.K. researchers running the sprawling RECOVERY trial showed that adding Actemra to standard treatment can save lives, a powerfully positive result in a long-running debate about the drug's utility in COVID-19.

By Ben Fidler • Feb. 11, 2021

Small biotech gets big win on treatment for rare swelling disorder

An oral hereditary angioedema treatment from KalVista Pharmaceuticals looks similarly effective to standard injectables, which could threaten big-selling drugs from Takeda and others.

By Jonathan Gardner • Feb. 9, 2021

New data on AstraZeneca vaccine add to worries over coronavirus variant from South Africa

South Africa will use other shots in its immunization campaign after AstraZeneca's offered "minimal protection" against the variant that's spread throughout the country.

By Ben Fidler • Feb. 8, 2021

On target, on-time enrollment, even in a global pandemic

Completing enrollment of a phase 3 trial on-time, even through the height of COVID-19  

Feb. 8, 2021

PTC aims again for FDA review of Duchenne drug despite latest miss

The FDA has rejected PTC's treatment three times, but the biotech's CEO hopes the "totality" of the results it's now accrued will finally lead to a different outcome.   

By Jonathan Gardner • Feb. 5, 2021

UK to start study testing Pfizer, AstraZeneca vaccines together

The government-funded trial will evaluate the effects of mixing vaccines and varying timing between shots.

By Kristin Jensen • Feb. 4, 2021

Breaking down the barriers to decentralized trials

Decentralized trials are here to stay. Here's how technology has and will continue to pave the way.

By Henry McNamara, Senior Vice President and General Manager of Oracle Health Sciences • Feb. 1, 2021

Amgen study data bolster prospects of KRAS-blocking cancer drug

Results from a mid-stage study showed Amgen's drug, sotorasib, shrank tumors in over a third of lung cancer patients, affirming earlier findings. 

By Ned Pagliarulo • Updated Jan. 29, 2021

Lilly allies with Vir, GSK as coronavirus variants raise worries about antibody drugs

The emergence of new variants has made antibody drug combinations, which are harder for the virus to evade, more important and led to a unique partnership between a trio of drugmakers.

By Ben Fidler • Jan. 27, 2021

Can new Regeneron, Lilly data move the needle for COVID-19 antibody drugs?

The results show that drugs from both companies can help prevent or treat COVID-19 when given at the right time. But that won't mean much if barriers to use remain high.

By Ben Fidler • Jan. 26, 2021

J&J says study data on coronavirus vaccine due 'early next week'

Results from the large Phase 3 trial are highly anticipated. If proven effective, J&J's shot could provide much-needed reinforcements to a constrained immunization effort.

By Ned Pagliarulo • Jan. 26, 2021

AstraZeneca, with new data, claims its leukemia drug is safer than Imbruvica

A head-to-head study showed Calquence and Imbruvica benefited patients similarly, but AstraZeneca's drug had fewer heart-related side effects.

By Jonathan Gardner • Jan. 25, 2021

Moderna to study vaccine booster aimed at coronavirus variant

Laboratory tests indicated the biotech's shot would still protect against virus variants detected in the U.K. and South Africa, although the latter appeared to result in a weaker immune response. 

By Ned Pagliarulo • Jan. 25, 2021

Merck stops coronavirus vaccine development in surprise setback

The drugmaker, one of the largest vaccine developers, won't move forward with two candidates it's been testing after disappointing data in early trials.

By Ben Fidler • Jan. 25, 2021

Lilly's antibody drug prevents COVID-19 in study, but hurdles to use remain

Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19

By Ned Pagliarulo • Jan. 20, 2021