Biotech: Page 89
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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 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
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 -
Explore the Trendline➔
Spencer Platt via Getty Images
TrendlineEmerging 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 -
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 -
Elizabeth Regan/BioPharma Dive
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 -
Courtesy of Gilead Sciences
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
Courtesy of Galapagos
Q&AGalapagos 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 -
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 -
Courtesy of Eli Lilly
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
Q&ACoronavirus 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 -
CDC/Alissa Eckert, MS. "covid-19 coronavirus on black background". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
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 -
Courtesy of Regeneron Pharmaceuticals
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 -
Official White House Photo by Joyce N. Boghosian. (2020). "President Trump meets with the Coronavirus Task Force" [Photograph]. Retrieved from https://www.flickr.com/photos/whitehouse/49614607817/in/photostream/.
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 -
Official White House Photo by Andrea Hanks. (2020). "President Trump meets with the Coronavirus Task Force" [Photograph]. Retrieved from https://www.flickr.com/photos/whitehouse/49613832638/in/photostream/.
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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
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