Biotech: Page 74
-
With Merck blocking its path, a small biotech reroutes, to the dismay of investors
Shares of Agenus fell around 25% Friday, after the company said the FDA has recommended withdrawing an approval application for its cancer immunotherapy balstilimab.
By Jacob Bell • Oct. 22, 2021 -
Permission granted by Biogen
Biogen's Alzheimer's drug is struggling, and a turnaround might not be coming soon
Sales of Aduhelm during the third quarter totaled only $300,000, falling well below expectations amid controversy over its approval and physician reluctance to prescribe it.
By Jacob Bell • Oct. 20, 2021 -
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Atea, Roche change plans for oral COVID-19 drug after trial setback
A closely watched competitor to Merck's molnupiravir failed a Phase 2 study, prompting its makers to change their strategy in a move that could delay an answer on the drug's efficacy until late next year.
By Ben Fidler , Jonathan Gardner • Oct. 19, 2021 -
Permission granted by Biogen
Biogen's closely watched ALS drug comes up short in late-stage study
Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.
By Jacob Bell • Oct. 18, 2021 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
CRISPR touts new results as fresh questions surround 'off-the-shelf' CAR-T
The biotech's lymphoma treatment initially seems as potent as earlier cell therapies, but its effects waned, adding to doubts about off-the-shelf CAR-T.
By Jonathan Gardner • Updated Oct. 13, 2021 -
Courtesy of CureVac AG
CureVac scraps its first COVID-19 vaccine and pivots to a second
The German biotech has abandoned plans to seek approval of the shot in Europe, citing tough competition, waning demand and the progress of a second candidate it's developing with GlaxoSmithKline.
By Ben Fidler • Oct. 12, 2021 -
Permission granted by Relay Therapeutics
Relay’s targeted cancer drug could be safer than its competitors. Is it more effective?
Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too.
By Ned Pagliarulo • Oct. 8, 2021 -
Maddie Meyer via Getty Images
Under pressure to share technology, Moderna to build vaccine factory in Africa
The biotech company expects to make its coronavirus vaccine and mRNA shots for other diseases at the planned plant, into which it will invest $500 million.
By Kristin Jensen • Oct. 7, 2021 -
Permission granted by Intergalactic Therapeutics
Intergalactic Therapeutics launches with $75M to build a new type of gene therapy
Founded by former Biogen executive Michael Ehlers and backed by Apple Tree Partners, Intergalactic aims to create non-viral gene therapies delivered via an advanced form of electroporation.
By Ned Pagliarulo • Oct. 7, 2021 -
Armed with half a billion dollars, a startup aims to change how brain drugs are made
Neumora Therapeutics launched Thursday with $100 million from Amgen and another $400 million from a long list of venture capital firms, including Arch, which is taking another shot at building a neuroscience company.
By Jacob Bell • Oct. 7, 2021 -
Jeenah Moon via Getty Images
Gene therapy developer gets chance at a comeback with Pfizer deal
Voyager Therapeutics recently scrapped much of its pipeline and replaced top executives. Now, a Pfizer deal on new technology gives investors hope.
By Jonathan Gardner • Oct. 6, 2021 -
Permission granted by Biohaven Pharmaceutical
Biohaven migraine drug sales again top Wall Street forecasts
The neuroscience-focused biotech continues to win market share in a battle with some of the industry's largest companies.
By Kristin Jensen • Oct. 6, 2021 -
Courtesy of Sarepta
Sarepta embarks on late-stage clinical trial of Duchenne gene therapy
Initiation of the Phase 3 trial is an important milestone for the biotech after earlier setbacks, as well as for patients with the inherited muscle disease.
By Shoshana Dubnow • Oct. 4, 2021 -
Kena Betancur via Getty Images
How a busy year for biotech IPOs measures up at the three-quarter mark
Drugmaker initial public offerings could break records set just a year ago. But valuations and stock performance have slipped from historic highs.
By Ben Fidler • Oct. 4, 2021 -
Permission granted by Editas Medicine
After long wait, Editas reveals first data for CRISPR gene editing treatment
Early study results offer some hopeful signs but were difficult to interpret. Shares in the biotech slid by nearly 20% in response on Wednesday.
By Ned Pagliarulo • Sept. 29, 2021 -
FDA lifts hold on GeneTx, Ultragenyx study of Angelman therapy
The hold, which was put in place during the fourth quarter last year, came after five patients in an early trial experienced muscle weakness following treatment.
By Shoshana Dubnow • Sept. 27, 2021 -
Permission granted by Biohaven Pharmaceuticals
Biohaven's pipeline takes a hit as drug for rare neurological disease falls short in trial
After success with the migraine drug Nurtec, Biohaven has been looking to prove the rest of its neuroscience research. Negative Phase 3 results in multiple system atrophy could close off one opportunity.
By Ned Pagliarulo • Sept. 27, 2021 -
iStock.com/PeopleImages
Sponsored by SGSCharged aerosol detection: Chromatographer's magical tool to unravel the invisible in biologics
The discovery and development of next generation therapeutics will drive the availability and use of Biologics to meet the unmet medical needs, never imagined before.
By Yena Patel, Sahil Shah and Bart Byczynski • Sept. 27, 2021 -
Getty / Edited by BioPharma Dive
Bluebird officially asks FDA to approve gene therapy for rare blood disorder
After several delays, Bluebird has completed an application to the agency to get beti-cel cleared as a treatment for beta-thalassemia.
By Jacob Bell • Sept. 22, 2021 -
Incyte eczema drug wins FDA OK, but with safety warning
A topical cream formulation of the drug in Incyte's top-selling product could help the company expand. The black box warning, though, might limit use.
By Kristin Jensen • Sept. 22, 2021 -
Permission granted by Vertex Pharmaceuticals
Deep Dive'This is the time to double down': Top Vertex executives defend research plan as pressure builds
A series of setbacks has led to criticism of the storied biotech's bid to diversify. But Vertex intends to stay the course, its CEO and top scientist say.
By Ben Fidler • Sept. 22, 2021 -
ESMO21: Mirati sets new KRAS bar, AstraZeneca's breast cancer data and Keytruda challengers line up
Mirati's KRAS-blocking drug looks to have an edge over Amgen's, while AstraZeneca and Daiichi reported impressive data for their drug Enhertu.
By Ned Pagliarulo • Updated Sept. 21, 2021 -
Martin Vleck/Shutterstock.com
Sponsored by NuvoloCalibrate and connect your equipment in the cloud
Calibration is too important to do on spreadsheets or paper. See how you can improve your calibration activities with a cloud-based solution.
Sept. 20, 2021 -
Permission granted by Biogen
Biogen says experimental pain drug helps neuropathy patients in mid-stage trial
With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug.
By Jonathan Gardner • Sept. 17, 2021 -
Theravance to lay off 75% of employees alongside larger restructuring
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.
By Jacob Bell • Sept. 15, 2021
Previous
