Biotech

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 06, 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 06, 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 06, 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 06, 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 03, 2020

Sponsored by Parexel

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 03, 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 02, 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 01, 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, which begin reporting earnings this month.

By Ben Fidler , Jonathan Gardner • April 01, 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

For CAR-T, coronavirus brings uneven impact to studies, treatment

Cancer cell therapy, approved only for the very sick, depends on a complex and precisely timed series of steps, all of which could be disrupted by COVID-19.

By Ned Pagliarulo • March 27, 2020

Despite another delay, Intercept says its NASH drug remains on track

The coronavirus outbreak, though, adds more uncertainty to what will be a closely watched regulatory review of Intercept's therapy.

By Ben Fidler • March 26, 2020

Bluebird says gene therapy application delayed again, citing disagreement with FDA

Discussions between Bluebird and the FDA are hung up on a release assay, data from which would be included in the company's application. 

By Kristin Jensen • March 26, 2020

Q&A

Galapagos CEO talks next steps as coronavirus stalls the biotech's top drug

The Belgian drugmaker announced this week that a series of Phase 2 and Phase 3 studies for filgotinib, an immune system regulator, had paused enrollment because of safety concerns related to COVID-19.

By Jacob Bell • 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 at 2:35 p.m.

Gilead, flooded with requests, suspends access to experimental coronavirus drug

The biotech plans to transition to an expanded access program for remdesivir, which is being tested as a treatment for COVID-19 in five late-stage studies.

By Ned Pagliarulo • March 23, 2020

Lilly, Galapagos halt trials as coronavirus deepens impact on drug research

The moves likely herald similar announcements by other large drugmakers as medical centers focus resources on treating patients with COVID-19.

By Ben Fidler • UPDATED: March 23, 2020 at 4:45 p.m.

In hard-hit Seattle, coronavirus pushes biotechs to a new normal

Local drugmakers are on the frontlines of a pandemic that's affecting travel, clinical research and daily operations. It's forcing them to adapt quickly. 

By Jacob Bell • March 19, 2020

Sage redraws its plans for failed antidepressant drug

Hoping to chart a path forward after a damaging study setback, Sage will start three new trials of zuranolone this year.

By Ned Pagliarulo • March 18, 2020

Q&A

Coronavirus led one biotech to pause a key trial, as more begin to follow

Clinical trial timelines are being threatened amid social distancing and a widening outbreak. Provention Bio's decision to suspend a study on Monday was one of the first publicly disclosed examples.

By Ben Fidler • UPDATED: March 18, 2020 at 10:06 a.m.

No White House offer for coronavirus vaccine access, CureVac says

An abrupt exit by CEO Daniel Menichella following a meeting with President Donald Trump, and the medical leave taken this week by his successor, were "pure coincidence," a board member said.

By Jonathan Gardner • March 17, 2020

Regeneron expects its antibody cocktail for coronavirus to enter human testing in early summer

The biotech is prepping manufacturing facilities so that, once the top antibody contenders are selected, clinical production can quickly begin. By the end of the summer, the aim is to make hundreds of thousands of doses per month.

By Jacob Bell • March 17, 2020

Regeneron and Sanofi speed Kevzara into coronavirus trials

Positive signs from a Chinese test of Roche's Actemra support the companies' decision to start studying their anti-inflammatory drug against COVID-19.

By Jonathan Gardner • March 16, 2020