Biotech: Page 76
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Permission granted by Biogen
European regulators say no to Aduhelm, but Biogen is pushing back
The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks."
By Jacob Bell • Dec. 17, 2021 -
Spark expands in Philadelphia, with new facility meant to be Roche's gene therapy hub
The Luxturna developer, now owned by Roche, will invest $575 million to build a huge research and development center on Drexel University's campus.
By Ned Pagliarulo • Dec. 17, 2021 -
Explore the Trendline➔
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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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565662436/in/album-72157713108522106/.
Adagio, after bold promises, says antibody drug won't work well against omicron
Shares in the biotech, which raised nearly $500 million to develop a treatment able to neutralize a wide range of coronavirus variants, plummeted on news of the disappointing laboratory test results.
By Kristin Jensen • Dec. 15, 2021 -
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Moderna reveals first study results for seasonal flu vaccine
Data from a small Phase 1 trial showed the biotech's vaccine spurred immune responses to four common strains, although they didn't appear significantly greater than an already available shot from Sanofi.
By Ned Pagliarulo • Dec. 10, 2021 -
Courtesy of Eli Lilly
Lilly deepens research ties in China with biotech deal
The collaboration with Regor Therapeutics is another example of large pharma companies' interest in partnering with emerging biotechs from China.
By Ned Pagliarulo • Dec. 10, 2021 -
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FDA panel turns down Reata kidney disease drug in unanimous vote
The company said it will keep working with the FDA ahead of a Feb. 25 decision date, but the committee's verdict greatly diminishes the drug's chances of an approval.
By Kristin Jensen • Dec. 9, 2021 -
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Intercept, awaiting needed trial data, pulls its NASH drug application in Europe
The biotech has lost much of its market value amid delays and regulatory questions for obeticholic acid. But the failures of other drugmakers still leave the company with a chance to rebound.
By Ben Fidler • Dec. 9, 2021 -
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Omicron cuts Pfizer vaccine's potency, but data show booster may restore protection
Preliminary laboratory testing by Pfizer and partner BioNTech indicated three doses may protect against omicron as well as two doses versus the original coronavirus strain.
By Ned Pagliarulo , Ben Fidler • Dec. 8, 2021 -
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Acadia shares rise on study success for Rett syndrome drug
The biotech claims the results are enough to pursue an approval, but high rates of side effects and modest efficacy could raise questions about the treatment.
By Ned Pagliarulo • Dec. 7, 2021 -
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AstraZeneca wagers $200M on Ionis' next chance at a rare disease drug
The alliance follows AstraZeneca's buyout of Alexion last year and puts the British drugmaker in competition with Alnylam, Bridgebio and several others.
By Ben Fidler • Dec. 7, 2021 -
Permission granted by Odyssey Therapeutics
A serial biotech entrepreneur launches his next startup with high-dollar backing
Founded and led by Gary Glick, Odyssey Therapeutics has raised $218 million in Series A funding for its cancer and inflammatory disease drug research.
By Ned Pagliarulo • Dec. 7, 2021 -
Permission granted by Biohaven Pharmaceuticals
Biohaven to seek FDA approval for second migraine drug after study success
The biotech's drug, called zavegepant, is delivered intranasally and could offer a similar convenience advantage as its first, the fast-selling Nurtec ODT.
By Ned Pagliarulo • Dec. 6, 2021 -
Former Immunomedics executive charged with insider trading around trial data
Usama Malik, chief financial officer of Immunomedics from 2017 to late 2020, is charged with tipping his partner and several relatives of positive study results for the biotech's breast cancer drug.
By Ned Pagliarulo • Dec. 3, 2021 -
Getty / Edited by BioPharma Dive
A startup led by Novartis veteran raises $80M to develop gene therapies for the brain
AviadoBio, which was built around research from the lab of Christopher Shaw at King's College London, is backed by venture firms NEA and Monograph Capital.
By Kristin Jensen • Dec. 2, 2021 -
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Facing challenges, Deciphera cuts workforce by a third
The Massachusetts biotech is eliminating 140 positions as it looks to cut costs following disappointing study results for its sole commercial product.
By Kristin Jensen • Dec. 1, 2021 -
Courtesy of Vertex Pharmaceuticals
Vertex, needing research spark, finds promising results in small study of kidney disease drug
The biotech, which has been stung by recent clinical setbacks, plans to soon advance the medicine into late-stage testing.
By Ned Pagliarulo • Dec. 1, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Regeneron warns its antibody drug may be less potent versus omicron
While Regeneron is still testing its treatment against the variant, the biotech is readying contingency plans, including second-generation versions of its drug.
By Ben Fidler • Nov. 30, 2021 -
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Blueprint, taking aim at larger drugmakers, becomes a biotech buyer
A $250 million acquisition of startup Lengo Therapeutics has given Blueprint a lung cancer drug that could compete with medicines from Takeda and J&J.
By Jonathan Gardner • Nov. 29, 2021 -
Seth Babin/BioPharma Dive
Deep Dive // Gene editingHeart attacks struck Sek Kathiresan’s family. He’s devoted his life to stopping them.
After several family members had early heart attacks, Kathiresan vowed to understand why they happen. His research journey has changed medical practice and led to a new biotech startup, Verve Therapeutics, that seeks to prevent them.
By Ben Fidler • Nov. 29, 2021 -
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Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy
The regulator will decide whether to approve Bluebird's treatment by next May, but its evaluation is beginning more than a year later than the biotech hoped.
By Ned Pagliarulo • Nov. 22, 2021 -
Permission granted by Gilead Sciences
Gilead pays up to retain rights to Arcus cancer drugs
The biotech will pay $725 million to opt into rights on four experimental medicines developed by Arcus, including ones that could challenge Merck's Keytruda in lung cancer.
By Jonathan Gardner • Nov. 18, 2021 -
Permission granted by Chroma Medicine
A startup emerges with $125M and plans to edit the epigenome
Chroma Medicine's launch is the latest step in a decadeslong quest by drugmakers to capitalize on research into epigenetics, a way of controlling gene expression without altering DNA.
By Ben Fidler • Nov. 17, 2021 -
Permission granted by Roche
Roche cuts ties with Atea after COVID-19 pill's trial failure
The Boston biotech, shares of which soared last year on hopes for the antiviral drug, said it has plenty of money to advance development on its own.
By Kristin Jensen • Nov. 17, 2021 -
Permission granted by Biogen
European drugs regulator signals rejection likely for Biogen's Aduhelm
A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month.
By Ned Pagliarulo , Jonathan Gardner • Nov. 17, 2021 -
Permission granted by Biogen
Al Sandrock, Biogen's top scientist and Aduhelm defender, to retire in surprise exit
Sandrock championed the controversial Alzheimer's drug, and was integral to the development of several other of Biogen's most important medicines during his 24 years at the biotech.
By Jacob Bell • Nov. 16, 2021
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