Biotech: Page 73
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Ionis cuts jobs at a former spinout and inks new deal with Sobi
Some seven months after acquiring the rest of Akcea Therapeutics, Ionis is laying off most of the subsidiary's staff and turning to Sobi to sell its drugs.
By Ben Fidler • April 6, 2021 -
Jacob Bell/BioPharma Dive
Acadia, with drug application rejected, calls out FDA for backtracking
According to Acadia, the FDA took issue with the main study used in its drug approval submission. That surprised the company, since regulators had never seemed concerned with the study's design.
By Jacob Bell • April 5, 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 -
Brian Tucker/BioPharma Dive
US spent millions funding research on COVID-19 drug, but doesn't hold patents: GAO
Government contributions failed to generate patent-worthy inventions on Gilead's remdesivir, a drug now worth billions of dollars.
By Kristin Jensen • April 1, 2021 -
Audentes CEO exits as Astellas rebrands a gene therapy buyout
Natalie Holles, who was appointed CEO of Audentes soon after Astellas acquired the gene therapy developer in 2019, has departed amid the company's integration.
By Ned Pagliarulo • April 1, 2021 -
Jacob Bell/BioPharma Dive
FDA advisers reassert case against approval of Biogen's Alzheimer's drug
In a new editorial, three of the agency's advisers reiterated that they see "no persuasive evidence to support approval of aducanumab at this time."
By Jacob Bell • March 31, 2021 -
A biotech shelves its Huntington's drugs after trial failures
Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.
By Jacob Bell • March 30, 2021 -
Jacob Bell/BioPharma Dive
Akebia tries for FDA approval of anemia drug after mixed data
The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain.
By Ned Pagliarulo • March 30, 2021 -
Westend61 / Rainer Berg via Getty Images
Sponsored by Parexel BiotechHow RWE can help Biotechs optimize the value of their asset
No matter the exit strategy, the use of Real-World Evidence (RWE) can provide a framework for Biotech companies to develop insights needed for the various stakeholders.
March 29, 2021 -
Dufour, Tia. (2020). "White House Coronavirus Update Briefing" [Photograph]. Retrieved from Flickr.
Slaoui steps down from two more biotechs after harassment claim
The former Warp Speed leader resigned from leadership roles at VaxCyte and Centessa Pharmaceuticals after being fired by GlaxoSmithKline over harassment allegations.
By Ned Pagliarulo • March 25, 2021 -
Crunching the numbers on a busy first quarter for biotech IPOs
Seven gene or cell therapy developers have now gone public in the first quarter, outpacing each of the past three years. Biopharma Dive examined the class of 2021's performance.
By Ben Fidler • March 19, 2021 -
Yujin Kim/BioPharma Dive
With new results, Sarepta's 2nd gene therapy holds steady
Stung by a clinical trial miss in Duchenne muscular dystrophy, the biotech now has promising, if early, data to back a gene therapy for a different rare neuromuscular disease.
By Jonathan Gardner • March 19, 2021 -
A first-of-its-kind mRNA drug falls short in cystic fibrosis
A treatment that sprays synthetic messenger RNA into the lungs failed to help cystic fibrosis patients, a blow to efforts to use the technology for more than vaccines.
By Ben Fidler • March 18, 2021 -
Kendall Davis/BioPharma Dive
Gilead, still aiming at NASH, broadens an alliance with Novo
With positive safety data in hand, the partners will advance work pairing the diabetes medicine Ozempic with two experimental treatments to see if they can reverse the liver disease, which has proven a tough target for drugmakers.
By Jonathan Gardner • March 18, 2021 -
Bluebird's top doctor to depart as company grapples with safety review
David Davidson has served as Bluebird's chief medical officer since 2012. He'll leave in one month, per a separation agreement with the company.
By Ned Pagliarulo • March 17, 2021 -
Global Blood takes on more sickle cell drugs through Sanofi deal
Global Blood says the two acquired programs could complement Oxbryta, its marketed sickle cell drug that gained approval in late 2019.
By Jacob Bell • March 16, 2021 -
Elevate Bio raises half a billion dollars to fuel cell, gene therapy expansion
Softbank and Fidelity joined a large group of investors in a $525 million Series C investment into Elevate, a high-powered genetic medicine startup with an unusual business model.
By Ned Pagliarulo • March 15, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
Vir breaks through with study success for COVID-19 antibody
A data monitoring board said a study testing Vir's drug should be stopped early because of an overwhelming benefit from treatment.
By Kristin Jensen • March 11, 2021 -
Vertex begins human testing for diabetes cell therapy
While Vertex is confident in the therapy, which came via the $1 billion acquisition of Semma Therapeutics, it will still be a few years before the company has a good read on its effects in Type 1 diabetes patients.
By Jacob Bell • March 10, 2021 -
Acadia shares plunge after unexpected FDA feedback
According to Acadia, the FDA had said multiple times that there were no problems with its drug approval application. But last week, the agency surprisingly reversed course.
By Jacob Bell • March 9, 2021 -
Galapagos reports long-awaited safety data for inflammation drug
The data show similar declines in sperm counts among patients on the Belgian biotech's drug, filgotinib, or a placebo. But it's unclear whether that finding will appease the FDA, which surprisingly rejected filgotinib last year.
By Jacob Bell • March 4, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
Vir shares tumble after apparent setback for COVID-19 drug
The NIH stopped enrolling patients hospitalized with coronavirus disease into a study of Vir's antibody drug after data monitors questioned its effectiveness.
By Jonathan Gardner • March 3, 2021 -
Takeda takes full control of drug for rare epilepsies
A new agreement with Ovid Therapeutics has Takeda paying almost $200 million to secure global rights to soticlestat, an experimental treatment for certain brain diseases.
By Jacob Bell • March 3, 2021 -
FibroGen shares sink as FDA meeting decision suggests another delay for top drug
The biotech expected the FDA to rule on approval of its anemia drug by March 20. But a newly announced advisory committee meeting seems to make a decision by then unlikely.
By Ned Pagliarulo • March 2, 2021 -
A closely watched schizophrenia drug fails key test
Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.
By Jacob Bell • March 2, 2021 -
Courtesy of Sarepta
Sarepta wins FDA approval of another drug for rare muscular dystrophy
Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed.
By Jacob Bell • Feb. 25, 2021
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