Biotech: Page 19
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FDA lifts pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
By Delilah Alvarado • Nov. 11, 2024 -
Permission granted by Cullinan Therapeutics
Sponsored by Cullinan TherapeuticsFueling accelerated drug development in autoimmune diseases with a modality-agnostic approach
Innovation-without-borders philosophy seeks to bring forward only the most promising therapies.
By Cullinan Therapeutics • Nov. 11, 2024 -
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 -
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Sponsored by LabConnect7 steps to selecting the right global central lab
Unlock global clinical trial success with seamless sample logistics and standardized testing.
Nov. 11, 2024 -
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Kalaris to go public via reverse merger with AlloVir
After Kalaris and AlloVir combine, the new company will have about $100 million to advance a treatment for age-related macular degeneration.
By Delilah Alvarado • Updated Nov. 8, 2024 -
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Tezspire succeeds in chronic rhinosinusitis; Gilead writes down Trodelvy value
AstraZeneca and Amgen's drug could have a new use after positive Phase 3 study results. Elsewhere, Jazz set new plans for a narcolepsy drug and CDMO Avid Bioservices agreed to be taken private.
By BioPharma Dive staff • Nov. 8, 2024 -
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Athira exploring strategic alternatives after Alzheimer’s failure
On the heels of its most advanced medicine flunking a key study, the drugmaker is looking at the different paths it could take to “maximizing stockholder value.”
By Jacob Bell • Nov. 8, 2024 -
Jacob Bell/BioPharma Dive
Moderna earnings beat forecasts, but analysts question whether sales spike will last
Sales of Moderna’s COVID-19 shot exceeded expectations, but the company’s launch of its new RSV vaccine has started slowly.
By Ned Pagliarulo • Nov. 7, 2024 -
Jacob Bell/BioPharma Dive
Sarepta scraps a Duchenne drug as gene therapy sales rise
Elevidys sales have increased since the FDA made a controversial choice to expand the therapy's use. Meanwhile, Sarepta is abandoning a successor to its drug Exondys 51, citing an “evolving" treatment landscape.
By Kristin Jensen • Nov. 7, 2024 -
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With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change at the FTC could lower M&A scrutiny.
By Ned Pagliarulo , Ben Fidler • Nov. 7, 2024 -
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Moderna said to shuffle sales leadership; Vertex records first Casgevy sale
Stephen Hoge will now oversee vaccine sales at Moderna, per a Bloomberg report. Elsewhere, Intra-Cellular unveiled an ambitious sales target and Syndax inked a lucrative royalty deal.
By BioPharma Dive staff • Nov. 6, 2024 -
Jacob Bell/BioPharma Dive
Emerging biotechAn RNAi renaissance is creating a new generation of startups
Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.
By Gwendolyn Wu • Nov. 6, 2024 -
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Cancer cell therapy from Arcellx, Gilead shows promise in early data
The companies’ CAR-T seemed to cause fewer movement disorders in a multiple myeloma trial than J&J's Carvykti has in other tests, although Wall Street analysts were divided on how the two drugs compare.
By Jonathan Gardner • Nov. 5, 2024 -
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Sickle cell patient dies in Beam study of base editing therapy
The death, which investigators linked to a preparatory chemo treatment rather than Beam's medicine, highlights the risks of using decades-old transplant drugs alongside cutting-edge CRISPR medicines.
By Ned Pagliarulo • Nov. 5, 2024 -
Permission granted by Rallybio
Two former Alexion leaders fight through a tough market to sustain a rare disease biotech
Rallybio is headed into a mid-stage trial with enough cash to last it through 2026, but biotech's down market has made the company's journey difficult.
By Michael Gibney • Nov. 5, 2024 -
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Neurogene secures $200M ahead of anticipated study readout
The news led to a stock surge on expectations that forthcoming data for the company’s experimental gene therapy for Rett syndrome may turn out positive.
By Delilah Alvarado • Nov. 4, 2024 -
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Sponsored by CognizantCenters of excellence or product-centric BizDevOps managed services?
As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.
Nov. 4, 2024 -
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Sponsored by Bio-RadEmpowering versatile applications of digital PCR with standardized, validated assays
Bio-Rad’s extensive ddPCR assay offerings help researchers leverage the full power of digital PCR.
Nov. 4, 2024 -
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Regeneron battles Wall Street uncertainty; Madrigal extends fast launch of MASH drug
Regeneron shares continued to decline on growing concerns about Eylea’s future. Elsewhere, new details emerged about Lundbeck’s Longboard buyout and PTC continued a quixotic quest.
By BioPharma Dive staff • Nov. 1, 2024 -
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Jade, another biotech spinout of Paragon, to merge with Aerovate
The immune disease drug developer expects to raise $300 million in a private financing set to close before its combination with the struggling Aerovate.
By Ned Pagliarulo • Oct. 31, 2024 -
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Compass delays anticipated psilocybin readout, cuts staff
The company’s moves come after the FDA seemed to place a new hurdle in the path of psychedelic treatments for mental disorders.
By Kristin Jensen • Oct. 31, 2024 -
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Evommune raises $115M to accelerate immune drug tests
The biotech expects three Phase 2 readouts in urticaria and eczema over the next two years, and will keep its “options open” regarding an IPO, its CEO said.
By Gwendolyn Wu • Oct. 31, 2024 -
Permission granted by Axonis Therapeutics
Investors put $115M into Axonis amid revived interest in brain drugs
The funding for Axonis, which is developing novel medicines for pain and epilepsy, reflects growing confidence in precision therapies for neurological diseases, one investor told BioPharma Dive.
By Jacob Bell • Oct. 30, 2024 -
Permission granted by Sage Therapeutics
Biogen, Sage admit a defeat in major depression
The partners no longer intend to develop Zurzuvae for one of the most common forms of depression, citing the time and cost of running new studies that would satisfy the FDA.
By Kristin Jensen • Oct. 30, 2024 -
Jacob Bell/BioPharma Dive
Biogen optimistic as new products gain traction
Even though Biogen raised earnings guidance, the company still has “some potentially concerning signals” in its base business, according to one analyst.
By Jacob Bell • Oct. 30, 2024 -
Permission granted by Archon Biosciences
A new biotech, built around protein design, springs from David Baker’s lab
Archon Biosciences, co-founded by the winner of the 2024 Nobel Prize in Chemistry, emerged from stealth Wednesday with $20 million in seed capital.
By Gwendolyn Wu • Oct. 30, 2024
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