Pharma

Contamination concerns spur FDA call for nationwide withdrawal of heartburn drug

Some pharmacies and manufacturers had already discontinued distribution of Zantac due to impurities involving a probable human carcinogen. 

By Jonathan Gardner • April 01, 2020

Under pressure, FDA touts speedy coronavirus drug development

By redeploying staff and request "triaging," the agency says it has streamlined its process for approving use of experimental drugs for COVID-19.

By Jonathan Gardner • April 01, 2020

Drugmakers await reckoning as doctors, patients make tough choices during pandemic

Decisions to delay medical visits and treatment could have a ripple effect on the businesses of biotech and pharma companies, which begin reporting earnings this month.

By Ben Fidler , Jonathan Gardner • April 01, 2020

With latest FDA submission, Bristol Myers keeps pace with Celgene milestones

Bristol Myers' second cancer cell therapy is now on track to be approved before the deadline set in its $74 billion acquisition of Celgene last year. 

By Jonathan Gardner • March 31, 2020

Merck's search for growth outside Keytruda may not end in heart disease

A study of vericiguat, which Merck is developing with Bayer, found the drug kept patients with declining heart function out of the hospital, but couldn't delay death.

By Jonathan Gardner • March 30, 2020

J&J picks top coronavirus vaccine candidate; human tests to start in September

Together with BARDA, the pharma has agreed to spend $1 billion co-funding vaccine research, development and testing.

By Jacob Bell • March 30, 2020

Sanofi adds mRNA to coronavirus vaccine push

A deal with Translate Bio to develop an mRNA-based vaccine adds the newer technology to the French pharma’s pandemic response.

By Jonathan Gardner • March 27, 2020

Bristol Myers investors breathe easier as multiple sclerosis drug approved by FDA

Regulatory clearance for Zeposia is the first of three drug approval milestones that must be met for former Celgene shareholders to see the full value of the 2019 acquisition.

By Jonathan Gardner • March 26, 2020

In rare move, Gilead gives up 'orphan' status for experimental coronavirus drug

After sparking controversy, the biotech asked the FDA to rescind a designation designed to encourage research into therapies for rare diseases.

By Jonathan Gardner • March 25, 2020

AstraZeneca turns again to UK's Silence in renewed RNAi push

AstraZeneca and Silence Therapeutics, which first partnered in 2007, will team up to develop RNA interference drug candidates for diseases of the liver, heart, kidney and lung.

By Ned Pagliarulo • UPDATED: March 25, 2020 at 2:35 p.m.

Sponsored by ZS

COVID-19 and pharma's in-person sales model

Once the pharma industry and its customers learn to function in a world without face-to-face detailing, we may see the digital flip switch with physicians preferring to engage via digital channels.

By Pratap Khedkar Co-author: Daniel Brox • March 24, 2020

Leukemia drug from Roche, AbbVie extends survival, study finds

Paired with chemotherapy, Venclexta succeeded in a Phase 3 acute myeloid leukemia trial just weeks after falling short in another combination study.

By Jonathan Gardner • March 23, 2020

Lilly, Galapagos halt trials as coronavirus deepens impact on drug research

The moves likely herald similar announcements by other large drugmakers as medical centers focus resources on treating patients with COVID-19.

By Ben Fidler • UPDATED: March 23, 2020 at 4:45 p.m.

Sponsored by Covance

Addressing the challenges of data management for pharmaceutical and biotechnology companies

The need for timely availability of clean data based on unique sponsor format/industry requirements has become extremely complex.

No White House offer for coronavirus vaccine access, CureVac says

An abrupt exit by CEO Daniel Menichella following a meeting with President Donald Trump, and the medical leave taken this week by his successor, were "pure coincidence," a board member said.

By Jonathan Gardner • March 17, 2020

Pharma salesforces brought to a halt as coronavirus shutters economy

Coronavirus' spread, and the measures taken by states and cities to contain it, are forcing drugmakers like Amarin, Pfizer and Merck & Co. to pull back their sales teams from hospitals and doctors' offices.

By Ned Pagliarulo • March 17, 2020

Deep Dive

Big pharma shied away from gene therapy for years. Academia picked up the slack

The byproduct was richer licensing fees for universities and a throng of startups, but also questions on fair prices and research priorities.

By Jonathan Gardner • March 17, 2020

Regeneron and Sanofi speed Kevzara into coronavirus trials

Positive signs from a Chinese test of Roche's Actemra support the companies' decision to start studying their anti-inflammatory drug against COVID-19.

By Jonathan Gardner • March 16, 2020

With AbCellera deal, Lilly becomes latest pharma to start coronavirus program

Lilly hopes to begin human testing of a therapeutic antibody within four months, the company's top scientist said. 

By Ned Pagliarulo • March 13, 2020

AstraZeneca and Merck's string of Lynparza successes ends in ovarian cancer

Results from a Phase 3 combination study in the tumor type read out negative, marking a rare miss for the pharmas' fast-growing cancer drug. 

By Jonathan Gardner • March 12, 2020

Sponsored by ZS

The future of data in pharma

The world is becoming more and more data dependent while slow, tectonic shifts are under way across healthcare. 

Coronavirus spread prompts FDA to postpone nearly all overseas inspections

The agency's decision was based on U.S. government travel restrictions, but it said "alternative tools and methods" will help it maintain oversight.

By Jonathan Gardner • March 10, 2020

Acceleron shelves drug after disappointing readout

Despite hitting the main goal of a mid-stage neuromuscular study, Acceleron isn't convinced its drug offers meaningful improvement to muscle function or quality of life.​

By Jacob Bell • March 10, 2020

Tracking biopharma's response to the new coronavirus

The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.

By Jacob Bell • UPDATED: March 26, 2020 at noon

As US coronavirus cases mount, top drugmakers tell employees to work from home

Eli Lilly and Takeda are asking thousands of their U.S.-based employees to practice "social distancing," while Biogen tries to contain an outbreak among staff who attended a Boston meeting earlier this month.

By Ned Pagliarulo • March 09, 2020