Biotech: Page
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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 -
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 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases or in reprogramming cells inside the body.
By BioPharma Dive staff -
Emerging biotech
An 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 -
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 -
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 -
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 -
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 -
Sponsored by Bio-Rad
Empowering 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 -
Sponsored by Cognizant
Centers 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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
Paragon spinout joins hunt for new type of cancer immunotherapy
Crescent Biopharma is advancing a drug its CEO claims is “purpose-built” to be a perfected version of Summit Therapeutics’ ivonescimab, which recently beat Merck’s Keytruda in a Phase 3 trial.
By Ben Fidler • Oct. 29, 2024 -
Biogen refreshes its C-suite; Novartis writes down MorphoSys assets
Daniel Quirk, an immunology and neuroscience executive at Bristol Myers Squibb, will be Biogen’s next chief medical officer. Meanwhile, Robin Kramer will replace retiring CFO Michael McDonnell.
By BioPharma Dive staff • Oct. 29, 2024 -
Monte Rosa joins with Novartis in ‘molecular glue’ drug deal
Novartis follows cross-town rival Roche in partnering with Monte Rosa Therapeutics on so-called molecular glue degraders that can target “undruggable” proteins.
By Ned Pagliarulo • Oct. 28, 2024 -
After Pfizer deal, former Seagen CEO returns to lead oncology startup
David Epstein has joined Ottimo Pharma, which is developing an antibody drug that board member and longtime Roche dealmaker James Sabry claims could “change the face of cancer immunotherapy.”
By Ben Fidler • Oct. 28, 2024 -
With $92M, Kivu sets out to make ‘kinder, gentler’ ADCs
The startup claims its proprietary linker molecules can yield ADCs that are more precise and potent than existing options.
By Gwendolyn Wu • Oct. 27, 2024 -
GSK invests $800M in manufacturing; Amgen sets small discount for Eylea biosimilar
The British pharma is making what it calls its largest U.S. manufacturing investment. Elsewhere, Roche and Dyno expanded their alliance to create better viral vectors for use in gene therapy.
By BioPharma Dive staff • Oct. 25, 2024 -
GPCR drugmaker Septerna amasses $288M in IPO
Septerna upped the size of its offering twice before pricing a stock sale that raised funds for its lead candidate, a treatment for hypoparathyroidism now in Phase 1 testing.
By Gwendolyn Wu • Oct. 24, 2024 -
Q&A // Emerging biotech
J&J’s Asish Xavier on biotech’s rebound in a volatile era
Xavier, who leads biotech venture investing for the big drugmaker, expects an uptick in IPOs as well as renewed interest in the newer crop of gene and cell therapy companies.
By Gwendolyn Wu • Oct. 24, 2024