Biotech: Page 86
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Rubius scraps lead candidate as it exits rare disease drugmaking
The once richly valued biotech cited manufacturing challenges at a contractor as a factor behind delays to its red blood cell therapy for PKU disease.
By Jacob Bell • March 12, 2020 -
Official White House Photo by Andrea Hanks. (2020). "President Trump meets with the Coronavirus Task Force" [Photograph]. Retrieved from https://www.flickr.com/photos/whitehouse/49613832638/in/photostream/.
CureVac CEO replaced in midst of biotech's coronavirus push
Board chairman Ingmar Hoerr will take over for Daniel Menichella, who just last week was meeting with President Trump to discuss CureVac's coronavirus vaccine development.
By Ned Pagliarulo • March 12, 2020 -
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.
By BioPharma Dive staff -
Facing coronavirus risk, a top cancer group postpones annual meeting
AACR, which expected to draw 24,000 attendees to its conference in April, said it plans to reschedule the meeting sometime later this year.
By Ned Pagliarulo • March 11, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Coronavirus spread prompts FDA to postpone nearly all overseas inspections
The agency's decision was based on U.S. government travel restrictions, but it said "alternative tools and methods" will help it maintain oversight.
By Jonathan Gardner • March 10, 2020 -
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/.
Tracking biopharma's response to the new coronavirus
The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.
By Jacob Bell • Updated July 7, 2020 -
Federal prosecutors make another claim against Mallinckrodt over Acthar prices
A quirk in the FDA approval for the multi-use drug allowed first Questcor and then Mallinckrodt to understate rebates owed to Medicaid, the lawsuit claims.
By Jonathan Gardner • March 4, 2020 -
Getty / Edited by BioPharma Dive
In a CRISPR first, Editas therapy used to fix genes in the body
A patient with a severe type of inherited blindness was recently treated with Editas and Allergan's CRISPR medicine, marking the first in vivo use of the gene-editing technology in adults.
By Ned Pagliarulo • March 4, 2020 -
New estimate puts cost to develop a new drug at $1B, adding to long-running debate
Pharma companies spend $300 million to $400 million bringing a new medicine to market, but per-product R&D costs are much higher after accounting for the many drugs that fail in testing.
By Jonathan Gardner • March 3, 2020 -
Elizabeth Regan/BioPharma Dive
Gilead breaks M&A lull with $5B immuno-oncology deal
The bid for Forty Seven, a California biotech with a mid-stage cancer agent, comes at a high double-digit premium. Analysts expect it's the first of several near-term buyouts for Gilead.
By Jacob Bell • March 2, 2020 -
Cell therapy developer Unum restructures, cutting staff in pivot
A preclinical cell therapy will be Unum's focus moving forward, while two early-stage studies will be discontinued.
By Ned Pagliarulo • March 2, 2020 -
Elizabeth Regan/BioPharma Dive
Karyopharm shares jump on positive study data for multiple myeloma drug
The cancer biotech now plans to ask the FDA to expand Xpovio's approval into earlier lines of treatment for the blood cancer.
By Ned Pagliarulo • March 2, 2020 -
Getty / Edited by BioPharma Dive
Sangamo sees vindication in Biogen gene-editing deal
Delivering products nearly ready for clinical testing has sparked greater dealmaking interest from big pharma, Sangamo's CEO told BioPharma Dive.
By Jonathan Gardner • Feb. 28, 2020 -
Biogen, Sangamo look to tackle Alzheimer's, Parkinson's through gene regulation
A new collaboration between the biotechs hands Sangamo $350 million upfront and potentially billions more in milestones in exchange for a license to a dozen neurological disease targets.
By Jacob Bell • Feb. 27, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA pushes back decision on Zogenix epilepsy drug
Shares sank on concerns about the future of the drug designed to treat Dravet syndrome, a rare form of epilepsy.
By Kristin Jensen • Feb. 27, 2020 -
Gilead commits to in-house development of coronavirus treatment hopeful
The biotech launched two global, Phase 3 studies of remdesivir, an experimental antiviral already being studied in trials run by Chinese researchers and the NIH.
By Ned Pagliarulo • Feb. 27, 2020 -
Elizabeth Regan/BioPharma Dive
Takeda's small celiac disease bet turns into acquisition
Phase 1 data triggered a takeout of PvP Biologics worth up to $330 million, giving Takeda access to a drug invented by a University of Washington team.
By Jonathan Gardner • Feb. 26, 2020 -
BioMarin inches closer to a gene therapy first
A decision by the FDA on whether to approve valrox, potentially the first gene therapy for hemophilia, should come by late August.
By Jacob Bell • Feb. 21, 2020 -
GSK taps Immatics' cell therapy science in research deal
For $50 million upfront, the British pharma will gain access to two T cell therapies Immatics is developing to treat solid tumors.
By Ned Pagliarulo • Feb. 20, 2020 -
Tocagen restructuring leads to reverse merger with Forte
After a Phase 3 brain cancer study missed its goal last fall, Tocagen laid off two-thirds of its workforce and began evaluating its options.
By Ned Pagliarulo • Feb. 20, 2020 -
Getty / Edited by BioPharma Dive
Bluebird's gene therapy hits another delay, this time in the US
The disclosure of a longer timeline until the biotech fully submits LentiGlobin for U.S. approval sent shares sliding and spurred one analyst to downgrade the stock.
By Jacob Bell • Feb. 19, 2020 -
Retrieved from National Cancer Institute on September 27, 2019
The cancer genes Wall Street is flooding with cash
Revolution Medicines, a biotech working on cancer drugs that target what are known as RAS genes, announced Wednesday it's raising $238 million through a public offering — more than double its initial goal.
By Jacob Bell • Feb. 13, 2020 -
Exelixis prostate cancer data could help stave off competitive threats
As Pfizer makes inroads against Cabometyx in kidney cancer, Exelixis said it will ask the FDA next year for approval in prostate disease.
By Jonathan Gardner • Feb. 11, 2020 -
Moderna, raising cash, quickly advances coronavirus candidate
A initial batch of the biotech's mRNA vaccine could soon be sent to the NIH for use in a Phase 1 study, which would mark a rapid scale-up to clinical testing.
By Ned Pagliarulo • Feb. 11, 2020 -
Biogen dips as Alzheimer's drugs from Lilly, Roche fail again
Analysts have said that, should the DIAN-TU study miss, it may further paint Biogen's aducanumab and the positive Phase 3 data it generated as an "artifact of luck" within a series of failed amyloid-targeting drugs.
By Jacob Bell • Feb. 10, 2020 -
Biohaven misses a chance to prove it's more than migraine
One of Biohaven's late-stage drugs proved no better than placebo in a type of severe anxiety — a lost opportunity for the company to showcase a pipeline beyond its lead migraine therapy.
By Ned Pagliarulo • Feb. 10, 2020
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