Biotech: Page 73
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Permission granted by Biogen
Congress pressures FDA and Biogen on Alzheimer's drug approval, price
The agency's decision-making process as well as Biogen's pricing of Aduhelm at $56,000 per year are both under the microscope as the repercussions of the controversial OK continue to be felt.
By Jonathan Gardner • June 28, 2021 -
Courtesy of Gilead Sciences
Gilead matches Bristol Myers in showing benefit to earlier CAR-T treatment
A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug.
By Ned Pagliarulo • June 28, 2021 -
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 -
Arcus claims positive study results for lung cancer drug, but shares no details
The lack of specific data frustrated analysts, but shares in Arcus rose by double digits Thursday. Partner Gilead is expected to make a decision on whether to license the drug later this year.
By Kristin Jensen • June 24, 2021 -
NIAID. (2019). "T Regulatory Cells" [Microscope image]. Retrieved from Flickr.
Third Rock-backed startup launches to develop cell therapies for MS, diabetes
Led by CEO Samantha Singer, Abata Therapeutics has $95 million to advance its plans to engineer regulatory T cells for treating autoimmune diseases.
By Ned Pagliarulo • June 23, 2021 -
Blackstone to invest $250M in cell therapy startup backed by Intellia, Cellex
The new company aims to pair Intellia's CRISPR gene editing technology with a CAR-T cell therapy platform built by Cellex subsidiary GEMoaB.
By Ned Pagliarulo • June 22, 2021 -
Getty Images
Sponsored by Millipore-Sigma®Incorporating automation and digitalization into the industrial microbiology workflow
A closer look at the impact of automated and digitalized technologies on the industrial microbiology workflow.
By Brad Grobler, Director of Strategic Initiatives, Biomonitoring Solutions at MilliporeSigma • June 21, 2021 -
Trial failure dashes Biogen hopes for next Alzheimer's drug
Days after Aduhelm's approval, Biogen said an experimental drug that works in a different way didn't help patients, leading the company to stop research.
By Jonathan Gardner • June 17, 2021 -
FDA approves Blueprint cancer drug for use in rare blood disease
The agency's decision makes available a new treatment option for patients with advanced systemic mastocytosis, boosting the biotech in the process.
By Kristin Jensen • June 17, 2021 -
Gene editing biotech Verve to raise $267M in large IPO
Capitalizing on investor interest in gene editing, the high-profile startup has secured one of the richest biotech initial public offerings priced this year.
By Ned Pagliarulo • June 17, 2021 -
Courtesy of CureVac
CureVac vaccine disappoints in key study amid 'unprecedented' spread of variants
The German biotech’s shot appeared less effective than other mRNA vaccines at preventing COVID-19. But it's unclear whether differences between the shots, or exposure to more elusive variants in testing, are the cause.
By Ben Fidler • Updated June 17, 2021 -
Biogen gene therapy deal has yet to bear fruit
Another gene therapy from Nightstar Therapeutics, which Biogen bought for $800 million in 2019, has failed in a key clinical study.
By Jacob Bell • June 15, 2021 -
Chip Somodevilla via Getty Images
Former FDA chief Hahn joins venture firm that launched Moderna
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
By Jonathan Gardner • June 15, 2021 -
Sage antidepressant succeeds in key study, but data raise questions
Zuranolone, a drug that's crucial for Sage's future and the focus of a multi-billion dollar bet by Biogen, could be headed for a regulatory review. But new trial results are more mixed than the overall outcome suggests.
By Ben Fidler , Ned Pagliarulo • Updated June 15, 2021 -
Brian Tucker / BioPharma Dive/BioPharma Dive
Moderna founder raises another $2B to fuel new startups
Flagship Pioneering reopened one of its funds in April, quickly raising fresh cash for new biotech investments.
By Jacob Bell • June 14, 2021 -
Getty / Edited by BioPharma Dive
Blood disease treatment from CRISPR, Vertex shows promise in more patients
The latest results from the companies' trials give support to hopes that CRISPR gene editing could functionally cure sickle cell disease and beta thalassemia.
By Ned Pagliarulo • June 11, 2021 -
Vertex stops work on second rare disease drug after study results disappoint
The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.
By Jacob Bell • Updated June 11, 2021 -
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
Beigene expands into cancer cell therapy with Shoreline pact
The fast-growing biotech will work with Shoreline to develop cancer treatments using natural killer cells, an emerging alternative to T-cell based therapies.
By Ned Pagliarulo • June 9, 2021 -
Permission granted by Biogen
Deep Dive // New Alzheimer's drugsA first-of-its-kind Alzheimer's drug raises heavy questions around who will and won't get it
Biogen priced its newly approved medicine Aduhelm at an average cost of $56,000 a year, adding affordability to other barriers patients may face.
By Jacob Bell • June 8, 2021 -
Permission granted by Biogen
The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.
Officially, Biogen has until 2029 to complete a study confirming Aduhelm's benefit. But the agency says it hopes to push the drugmaker to finish faster.
By Ned Pagliarulo • Updated June 9, 2021 -
Permission granted by Biogen
Deep Dive // New Alzheimer's drugsIn historic move, FDA approves a closely watched and controversial Alzheimer's drug
The decision cleared the way for what many predicted would become a lucrative treatment. But a high price and controversy over whether Biogen's Aduhelm benefits patients weighed heavily on the drug's launch.
By Jacob Bell • Updated June 7, 2021 -
Sarah Silbiger via Getty Images
Bluebird cleared by FDA to resume studies of sickle cell gene therapy
An investigation by the company determined the treatment was "very unlikely" to be the cause of a case of leukemia reported in one of the trials.
By Ned Pagliarulo • June 7, 2021 -
Orchard abandons promising gene therapy for rare immune disorder
The U.K. biotech deprioritized the therapy last year, despite positive results in clinical testing that were recently published in a top medical journal.
By Kristin Jensen • June 3, 2021 -
Biotech venture capital still booming as venBio raises another $550M
VenBio has previously invested in a range of treatment areas and technologies, including cell and gene editing companies like Precision Bio and Artiva.
By Jacob Bell • June 3, 2021 -
Bayer buys a biotech and its offshoot in bet on radiopharmaceuticals
The German pharma will add an experimental prostate cancer medicine to its pipeline through the deal, which reflects growing industry interest in the field.
By Ned Pagliarulo • June 3, 2021 -
Elizabeth Regan/BioPharma Dive
MorphoSys to buy Constellation in $1.7B deal, aided by unusual funding
Royalty Pharma will effectively fund MorphoSys' acquisition of the cancer biotech through a separate agreement to buy MorphoSys' shares of royalties on several marketed and experimental medicines.
By Ned Pagliarulo • June 2, 2021
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