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

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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

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

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

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