Another delay for Bristol Myers cell therapy as FDA extends review

Bristol Myers now expects an approval decision on liso-cel by mid-November, some six weeks before a deadline set by the pharma in its buyout of Celgene.

By Kristin Jensen • May 6, 2020

Pfizer, BioNTech launch U.S. trial of coronavirus vaccine

Initial vaccine data are expected within weeks as biotech and pharma companies intensify their search for a way to prevent the spread of COVID-19.

By Jonathan Gardner • May 5, 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

Using AI to align field engagements with strategy in medical affairs

Advanced AI technology can help pharmaceutical companies optimize the medical engagement process. 

May 5, 2020

A coronavirus vaccine may arrive next year. 'Herd immunity' will take longer.

Experimental vaccines for COVID-19 are moving at an unprecedented pace. But that could mean researchers won't definitively know whether they're safe and effective when they do arrive.

By Jonathan Gardner • May 4, 2020

Roche gets emergency OK for coronavirus antibody test as FDA tightens oversight

The Swiss pharma said its product may be less likely to deliver false positives than some earlier-to-market serology tests, a concern regulators attempted to address with a key policy update Monday.

By Nick Paul Taylor • Updated May 4, 2020

J&J contracts with Catalent to boost coronavirus vaccine production

The partnership is the second J&J has inked in recent weeks as it prepares sufficient capacity to supply 1 billion doses of its experimental vaccine.

By Kristin Jensen • April 30, 2020

AstraZeneca, racing past rivals, throws its weight behind Oxford's COVID-19 vaccine

The British drugmaker will take over development of an experimental vaccine that could produce its first clinical results next month.

By Ben Fidler • April 30, 2020

Pfizer resumes trial recruitment suspended by coronavirus

After pausing enrollment into many studies in March, Pfizer is beginning to resume clinical activities at sites that are currently operational.

By Jonathan Gardner • April 28, 2020

Merck starts to feel COVID-19's effects

The pharma giant lowered its 2020 revenue expectations by $2.5 billion as its vaccines, cancer drugs and animal health business face coronavirus-related pressures.

By Jacob Bell • April 28, 2020

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

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