Biotech: Page 73
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Akebia to lay off 42% of workforce, suspend trials after FDA drug rejection
The layoffs come after safety concerns led the FDA to rebuff its anemia pill, similar to the agency's spurning of FibroGen's rival drug last year.
By Ben Fidler • April 7, 2022 -
Jacob Bell/BioPharma Dive
Alnylam to wait longer for FDA verdict on latest RNA drug
The FDA has yet to sign off on a third-party packaging and labeling facility that Alnylam planned to help launch its drug, called vutrisiran, meaning an approval decision could come as late as mid-July.
By Jacob Bell • April 4, 2022 -
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 -
Courtesy of Vertex Pharmaceuticals
Vertex gets positive trial results for non-opioid painkiller in boost to pipeline
After several attempts at designing a drug for acute pain, Vertex has a candidate it's ready to take into late-stage testing following two successful Phase 2 studies.
By Ned Pagliarulo • March 31, 2022 -
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FDA rejects Akebia drug, dealing another blow to anemia pills
The biotech's experimental medicine, meant to be a convenient alternative to widely used injectable drugs like Aranesp, is the second of its kind to be knocked back by the agency due to safety concerns.
By Jonathan Gardner • March 30, 2022 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Adagio plans comeback for COVID drug, but is it too late?
The biotech said it will ask the FDA for approval of its antibody treatment after positive results from two trials. But relatively few participants were exposed to omicron, potentially raising questions about its utility.
By Jonathan Gardner • March 30, 2022 -
Jonathan Gardner/BioPharma Dive
Orchard turns to layoffs in cutting gene therapy research
The biotech company plans to reduce its workforce by 30%, or by about 65 employees, in the latest example of a gene therapy developer restructuring.
By Ned Pagliarulo • March 30, 2022 -
Permission granted by Biogen
Biogen shelves ALS drug after early-stage trial failure
The study setback raises questions over how well a type of genetic medicine can work in adults with central nervous system disorders like ALS.
By Jonathan Gardner • March 28, 2022 -
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As biotech retreats, gene therapy companies retrench and redraw plans
At least nine biotechs working in cell or gene therapy have announced layoffs, cost cuts or restructured their research since December — restructurings that have coincided with a stock market downturn.
By Ned Pagliarulo • March 24, 2022 -
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GSK partners with LifeMine as startups advance plans to make drugs from fungi
The deal, announced alongside a $175 million round, makes biotech entrepreneur Greg Verdine's startup the most well-funded among an emerging group of companies searching for drugs in fungal DNA.
By Ben Fidler • March 23, 2022 -
Courtesy of Business Wire
Al Sandrock takes on CEO role at gene therapy developer
The well-known researcher and Biogen alumnus has agreed to take the top spot at Voyager Therapeutics, which, last spring, underwent a "strategic shift" that saw its then-CEO and research head depart.
By Jacob Bell • March 22, 2022 -
Elizabeth Regan/BioPharma Dive
Argenx boosted by positive trial results for new shot
An easier-to-take version of Vyvgart could help Argenx expand the drug's use in autoimmune disease, potentially adding to the biotech's appeal as an acquisition target.
By Jonathan Gardner • March 22, 2022 -
Vertex plans path to FDA for top drug prospect
After observing promising results in a small study, Vertex is moving ahead with a pivotal trial for a kidney disease drug that's become a key part of the company's efforts to grow beyond cystic fibrosis.
By Ned Pagliarulo • Updated March 22, 2022 -
Jacob Bell/BioPharma Dive
FDA approves new epilepsy drug, handing Marinus a long-awaited victory
Nearly 20 years since its founding, Marinus Pharmaceuticals will make the leap to a commercial-stage biotechnology company with the approval of Ztalmy.
By Jacob Bell • March 21, 2022 -
Permission granted by Stevanato Group
Sponsored by Stevanato GroupHow to eliminate design verification failure for your next device
The role of analytical services in preventing the cost and disruption of design verification failure.
March 21, 2022 -
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Moderna, citing need for 'flexibility,' seeks broad clearance of fourth COVID shot
Days after Pfizer asked U.S. regulators to authorize another booster for older adults, Moderna has followed with a similar request for all adults, arguing a green light would "provide flexibility" to public health officials and doctors.
By Ben Fidler • March 18, 2022 -
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Alnylam sues Pfizer, Moderna over technology used in COVID vaccines
The biotech claims the lipid nanoparticles used by Pfizer and Moderna for delivery of their coronavirus shots infringe on a key patent it holds. In response, Moderna called Alnylam's suit "blatant opportunism."
By Ned Pagliarulo • Updated March 17, 2022 -
Passage Bio to cut jobs in latest biotech restructuring
Stung by a stock market downturn, a number of biotechs are trimming spending and reprioritizing research to save cash. Passage's layoffs will reduce its workforce by 13%.
By Ned Pagliarulo • March 15, 2022 -
Elizabeth Regan/BioPharma Dive
BridgeBio looks for comeback with trial results for muscular dystrophy drug
Positive signs for the experimental treatment could help shore up investor confidence in BridgeBio after the December study failure of a drug for a rare heart condition.
By Jonathan Gardner • March 14, 2022 -
Nektar, Bristol Myers drug combination fails in late-stage melanoma trial
The trial results were the most significant setback for the companies' four-year-old partnership and will likely force Nektar to cut costs.
By Ned Pagliarulo • March 14, 2022 -
Photo illustration by Maura Sadovi/BioPharma Dive; photograph by Carl Court via Getty Images
Moderna extends patent waiver for COVID vaccine, but only for lower-income countries
Health advocates say Moderna is narrowing its pledge not to enforce patents worldwide for the duration of the pandemic, while the company argues that, in higher-income countries, vaccine supply isn't a barrier to access anymore.
By Jonathan Gardner • March 8, 2022 -
Bluebird's CFO resigns as cash woes raise doubts about its future
The gene therapy developer's top financial executive, Gina Consylman, is stepping down amid concerns the company needs to raise additional cash to survive for more than a year.
By Jonathan Gardner • March 7, 2022 -
Permission granted by Biogen
Biogen, struggling to sell Alzheimer's drug, begins layoffs to save money
Biogen confirmed that some of its U.S. employees have been informed their roles are being eliminated. The magnitude of the layoffs and which departments are most affected is unclear, however.
By Jacob Bell • March 3, 2022 -
Amid biotech downturn, Atlas raises $450M to build new drug startups
While a stock market slide has made IPOs difficult for young biotech companies, venture capital firms like Atlas are still reloading with new cash to create and invest in new drugmakers.
By Ned Pagliarulo • March 3, 2022 -
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'We have to make a stand': Biotech leaders vow to break ties with Russia over Ukraine war
Biotech CEOs Paul Hastings and Jeremy Levin explained the goals behind a letter supported by more than 400 executives and investors that calls for drugmakers to stop working with Russian companies.
By Ben Fidler , Ned Pagliarulo • Updated March 1, 2022 -
Permission granted by Gilead Sciences
FDA rejects Gilead's closely watched HIV drug
According to Gilead, the agency has concerns about the interaction between an injectable solution of the drug, called lenacapavir, and the vials in which it's contained.
By Jacob Bell • March 1, 2022
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