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

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

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

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

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

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

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

Germany's CureVac, the subject of a reported US overture, thrust into coronavirus spotlight

The U.S. government reportedly sought to access CureVac's vaccine research, deepening the intrigue surrounding the biotech, which just ousted its CEO.

By Ned Pagliarulo • March 16, 2020

As coronavirus spreads, a biotech IPO squeaks through. Others may 'wait and see'

Public offerings could be put on ice as the economic impact of the coronavirus outbreak in the U.S. widens, potentially cooling biotech's momentum.

By Ben Fidler • March 12, 2020

Rubius scraps lead candidate as it exits rare disease drugmaking

The once richly valued biotech cited manufacturing challenges at a contractor as a factor behind delays to its red blood cell therapy for PKU disease. 

By Jacob Bell • March 12, 2020

CureVac CEO replaced in midst of biotech's coronavirus push

Board chairman Ingmar Hoerr will take over for Daniel Menichella, who just last week was meeting with President Trump to discuss CureVac's coronavirus vaccine development.

By Ned Pagliarulo • March 12, 2020

Facing coronavirus risk, a top cancer group postpones annual meeting

AACR, which expected to draw 24,000 attendees to its conference in April, said it plans to reschedule the meeting sometime later this year.

By Ned Pagliarulo • March 11, 2020

Coronavirus spread prompts FDA to postpone nearly all overseas inspections

The agency's decision was based on U.S. government travel restrictions, but it said "alternative tools and methods" will help it maintain oversight.

By Jonathan Gardner • March 10, 2020

Tracking biopharma's response to the new coronavirus

The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.

By Jacob Bell • Updated July 7, 2020

Federal prosecutors make another claim against Mallinckrodt over Acthar prices

A quirk in the FDA approval for the multi-use drug allowed first Questcor and then Mallinckrodt to understate rebates owed to Medicaid, the lawsuit claims.

By Jonathan Gardner • March 4, 2020

In a CRISPR first, Editas therapy used to fix genes in the body

A patient with a severe type of inherited blindness was recently treated with Editas and Allergan's CRISPR medicine, marking the first in vivo use of the gene-editing technology in adults. 

By Ned Pagliarulo • March 4, 2020

New estimate puts cost to develop a new drug at $1B, adding to long-running debate

Pharma companies spend $300 million to $400 million bringing a new medicine to market, but per-product R&D costs are much higher after accounting for the many drugs that fail in testing.

By Jonathan Gardner • March 3, 2020

Gilead breaks M&A lull with $5B immuno-oncology deal

The bid for Forty Seven, a California biotech with a mid-stage cancer agent, comes at a high double-digit premium. Analysts expect it's the first of several near-term buyouts for Gilead.

By Jacob Bell • March 2, 2020

Cell therapy developer Unum restructures, cutting staff in pivot

A preclinical cell therapy will be Unum's focus moving forward, while two early-stage studies will be discontinued.

By Ned Pagliarulo • March 2, 2020

Karyopharm shares jump on positive study data for multiple myeloma drug

The cancer biotech now plans to ask the FDA to expand Xpovio's approval into earlier lines of treatment for the blood cancer.

By Ned Pagliarulo • March 2, 2020

Sangamo sees vindication in Biogen gene-editing deal

Delivering products nearly ready for clinical testing has sparked greater dealmaking interest from big pharma, Sangamo's CEO told BioPharma Dive.

By Jonathan Gardner • Feb. 28, 2020

Biogen, Sangamo look to tackle Alzheimer's, Parkinson's through gene regulation

A new collaboration between the biotechs hands Sangamo $350 million upfront and potentially billions more in milestones in exchange for a license to a dozen neurological disease targets.

By Jacob Bell • Feb. 27, 2020

FDA pushes back decision on Zogenix epilepsy drug

Shares sank on concerns about the future of the drug designed to treat Dravet syndrome, a rare form of epilepsy.

By Kristin Jensen • Feb. 27, 2020