Pharmas boosted by drug stockpiling, but warn of COVID-19 impact

Patients and wholesalers stocked up on medicines early in 2020, lifting first-quarter sales for many pharmas. But that boost is likely fleeting, disguising the substantial effects the pandemic is having on their businesses.

By Ned Pagliarulo • April 28, 2020

Repurposed arthritis drug disappoints in closely watched COVID-19 trial

A study of Regeneron and Sanofi's Kevzara will continue, but only for patients in the most critical condition after an early look suggested less-severe patients did worse than those taking placebo.

By Jonathan Gardner • April 27, 2020

Explore the Trendline➔

Top 5 stories from BioPharma Dive

Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.

By BioPharma Dive staff

Another step for PARPs as AstraZeneca, Merck drug extends lives in prostate cancer

Lynparza is now the first PARP inhibitor to help prostate cancer patients live longer versus hormone therapy, giving it an edge over rival Rubraca.

By Ben Fidler • April 24, 2020

Pharma's new mission: Bridging the care gap

While public health officials focus on fighting the virus itself, the pharmaceutical industry must look more broadly to continue realizing its purpose of discovering and delivering treatments to a world in need.

By Howard Deutsch, Pratap Khedkar, Peter Manoogian and Ganesh Vedarajan • April 21, 2020

Positive data keep Bristol Myers and Exelixis in the kidney cancer race

A combination of Opdivo with Exelixis' Cabometyx, if cleared for use, would compete against an approved pairing of Merck's Keytruda and Pfizer's Inlyta.

By Jonathan Gardner • April 20, 2020

Novartis, launching COVID-19 trial, seeks to prove hydroxychloroquine's worth

The Swiss pharma, one of hydroxychloroquine's many generic manufacturers, will soon start a randomized, placebo-controlled study of the malaria pill.

By Ned Pagliarulo • April 20, 2020

NIH spearheads broad partnership with drugmakers, regulators to speed COVID-19 therapies

The initiative reflects the urgency for drugmakers to work together, rather than independently, to advance promising treatments for the novel coronavirus.

By Ben Fidler • April 17, 2020

Merck, Samsung join newly crowded market for Herceptin biosimilars

Ontruzant, which will be sold by Merck, is the fifth copycat version of Roche's top-selling breast cancer drug to launch in the U.S.

By Kristin Jensen • April 15, 2020

J&J cuts sales forecast by $7B as coronavirus impact hits

The big pharma lowered its sales guidance Tuesday as it begins to see the effects of delayed treatments, although it expects a recovery later this year.

By Jonathan Gardner • April 14, 2020

In rare move, Sanofi and GSK ally on coronavirus vaccine development

"We believe that if we're successful we'll be able to make hundreds of millions of doses by the end of next year," GSK CEO Emma Walmsley told reporters.

By Ned Pagliarulo • Updated April 14, 2020

AstraZeneca and Merck drug wins approval for rare cancer after failing elsewhere

Koselugo, as the drug will be sold, is now cleared to treat an inherited disorder that affects around one in 3,000 people in the U.S.

By Jonathan Gardner • Updated April 13, 2020

Pfizer accelerates clinical trial plans for coronavirus drug

Pfizer's pursuing several coronavirus therapies in parallel, including an mRNA vaccine for which it's already planning to scale up production. 

By Ned Pagliarulo • April 9, 2020

Eye drug side effects are real, Novartis confirms in new warning

A recent review by the Swiss pharma found Beovu caused potentially serious side effects about once in every 1,000 injections.

By Jonathan Gardner • April 9, 2020

Amid a pandemic, Roche bets $190M on Arrakis and drugging RNA

The deal is one of the largest for a group of companies that aim to use small molecule drugs to block the function of RNA in the body's cells.

By Ben Fidler • April 8, 2020

FDA delays decision on Roche spinal muscular atrophy drug

Roche says the three-month delay is needed for the FDA to review new data for risdiplam, which could become the first oral option for the disabling and often fatal disorder.

By Jonathan Gardner • April 7, 2020

FDA's new Keytruda review is a step for genetic medicine, immunotherapy

A decision on approval, expected by June 16, would be the fourth tissue-agnostic drug approval — and could help to validate an emerging immunotherapy biomarker.

By Ben Fidler • April 7, 2020

Takeda, CSL forge coronavirus alliance, forgoing their own drugs in the process

The companies aim to develop a blood plasma therapy for COVID-19, a task made easier by pooling resources and manufacturing facilities.

By Jacob Bell • April 7, 2020

GSK bets $250M on Vir's antibody approach to treating coronavirus

The companies aim to advance two antibodies developed by Vir directly into Phase 2 testing within the next three to five months, pending regulatory OK.

By Jonathan Gardner • April 6, 2020

Fate inks $100M J&J pact for 'off-the-shelf' cancer cell therapies

Several companies, including Fate, could soon provide meaningful data in support of allogeneic cell therapy, unless COVID-19 disrupts those plans.

By Ben Fidler • April 3, 2020

Novartis gives up on planned $1B generic drug sale to Aurobindo

The companies called off the deal, which was supposed to close last quarter, after failing to secure regulatory sign-off from the FTC.

By Kristin Jensen • April 2, 2020

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 1, 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 1, 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.

By Ben Fidler , Jonathan Gardner • April 1, 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