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

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

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

Gilead to lean on Second Genome's microbiome work in $38M research pact

The four-year collaboration aims to unearth biomarkers that can help Gilead predict the benefit of drugs for diseases involving inflammation and fibrosis. 

By Ben Fidler • April 6, 2020

Gilead working to quickly boost production of experimental coronavirus drug

CEO Daniel O'Day said Gilead would provide at no charge its current supply of remdesivir, enough to treat some 140,000 patients with severe COVID-19. 

By Ned Pagliarulo • 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

Commercial and regulatory strategy considerations for biotech

Discover ideas and insights for getting innovations in the biotech pipeline to patients sooner. 

By Alberto Grignolo, Corporate Vice President, Parexel; Sheela Hegde, Partner and Managing Director in Parexel’s Health Advances subsidiary; and Leslie DeVos, VP, Regulatory Consulting, Parexel • April 3, 2020

Amgen, partnering with Seattle's Adaptive, begins coronavirus drug search

Like other drugmakers, the companies will screen antibodies from recovered COVID-19 patients to identify ones capable of neutralizing SARS-CoV-2. 

By Ned Pagliarulo • April 2, 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

A small NASH drugmaker finds positive data, but coronavirus makes for a 'tricky' path forward

Results from a mid-stage study showed Akero Therapeutics' experimental drug could reduce liver fat in NASH patients, sending shares higher. 

By Jacob Bell • March 31, 2020

Amarin shares slump as surprising court defeat puts Vascepa at risk

In what one analyst called a "serious blow," a federal court ruled patents held by Amarin on its heart drug Vascepa were obvious and therefore invalid. 

By Ned Pagliarulo • March 31, 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