Regeneron, Sanofi immunotherapy extends survival in previously untreated lung cancer

In a boost to the companies' come-from-behind immunotherapy bid, their drug Libtayo helped patients live longer than did chemotherapy. Improving on Keytruda, however, will be more challenging.

By Ned Pagliarulo • April 27, 2020

Axsome, beating the odds, finds success treating Alzheimer's agitation

The biotech's drug, which has shown promise in treating depression, pulled off an unusual feat in hitting the main goal of a late-stage Alzheimer's study.

By Jacob Bell • April 27, 2020

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Launch for Neurocrine Parkinson's drug put on hold because of coronavirus

CEO Kevin Gorman told BioPharma Dive it's an inappropriate time to be pitching the drug to neurology doctors, many of who are devoting time to hospitals grappling with COVID-19 cases.

By Jacob Bell • Updated April 27, 2020

Why $120M for Affinivax may reflect a new view of vaccine makers

Secured amid the global pandemic, the sizable Series B round bucks historical trends. One backer sees an "explosion" of similar investments coming.

By Ben Fidler • April 23, 2020

Immunomedics wins long-sought FDA approval for breast cancer drug

Trodelvy, the first approved drug of Immunomedics' 38-year corporate history, was cleared by the FDA roughly five weeks ahead of schedule. 

By Ned Pagliarulo • April 22, 2020

Biogen hammered with questions as Alzheimer's drug moves slower than expected

An application for aducanumab was supposed to be filed with the FDA early this year. Now, the biotech says it will finish doing so by the third quarter.

By Jacob Bell • April 22, 2020

Malaria drug's potential against coronavirus dims as data mounts

Hydroxychloroquine drew praise from President Donald Trump and TV doctors, but recent NIH guidelines and preliminary data build a case against its use.

By Jonathan Gardner • April 22, 2020

Coronavirus vaccine from BioNTech, Pfizer set to enter testing in Germany

The study will test four versions of BioNTech's mRNA vaccine in 200 healthy volunteers, and is the first to be cleared to begin in Germany. 

By Ned Pagliarulo • April 22, 2020

Trial data help small biotech ready its anti-itch drug for approval

Korsuva, a drug from Cara Therapeutics, has now succeeded in two Phase 3 trials in chronic kidney disease patients, setting the stage for potential approval filings in the U.S. and Europe.

By Jonathan Gardner • 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

Seattle Genetics wins another speedy approval as FDA clears breast cancer drug

The FDA OK for Tukysa comes four months early and gives the biotech, which has seen its share price hit record highs, its third marketed cancer drug.

By Ben Fidler • April 17, 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

US government to back Moderna's coronavirus vaccine with up to $483M

The BARDA grant will allow Moderna to hire 150 more staff and accelerate testing of its vaccine, which entered a Phase 1 study in March and could soon move to a mid-stage trial. 

By Ned Pagliarulo • Updated April 17, 2020

After 'superspreading' event, Biogen to build hub for COVID-19 patient data

The biotech's employees, who were some of the first people in Massachusetts diagnosed with COVID-19, can offer blood samples to a new biobank aimed at better understanding the disease.

By Jacob Bell • April 16, 2020

Vir reminds biopharma its original aim is hepatitis B

Vir, which has a closely watched coronavirus program, is also working on what it hopes can be a hepatitis B cure. New Phase 2 data gives it a boost.

By Jonathan Gardner • April 16, 2020

Moderna's coronavirus vaccine plan may be possible, but a lot has to go in its favor

While Moderna has advanced rapidly in the month since this story was published, the biotech still faces many of the same challenges in the path to proving its vaccine.

By Ben Fidler • April 14, 2020

Blackstone backs Alnylam with up to $2B investment

The deal, which hands Blackstone royalty rights to an as-yet unapproved heart drug, is "one of the largest ever private financings of a biotech company," according to the firm.

By Jacob Bell • April 13, 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

Myokardia at inflection point as heart drug readout nears

Results are due soon from EXPLORER, Myokardia's first-ever Phase 3 study and a major test of the company's heart disease treatment mavacamten.

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

Sage to lay off half of workforce in cost-cutting retrenchment

The once high-flying biotech will significantly pare back spending, channeling resources toward recently redrawn plans for its lead antidepressant drug.

By Ned Pagliarulo • April 7, 2020

Inovio begins first human test of experimental coronavirus vaccine

The biotech follows Moderna and China-based CanSino Biologics into the clinic with a vaccine, some three months after designing it. 

By Ned Pagliarulo • April 7, 2020

Alnylam and Dicerna are pals now, which could spell trouble for Arrowhead

All three biotechs are developing drugs for patients with a genetic condition called A1AT deficiency. A new collaboration between the first two puts pressure on Arrowhead.

By Jacob Bell • April 6, 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