Biotech: Page 76
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Moderna watches for 'waning immunity' as new data show durable vaccine protection
Updated study results show Moderna's coronavirus vaccine was strongly protective against COVID-19 through six months. But executives outlined contingency plans in case those effects fade.
By Ben Fidler • April 14, 2021 -
Permission granted by Gilead Sciences
Gilead stops Veklury study, citing enrollment challenges, changing treatment
The company said a multi-day infusion treatment that must be administered in healthcare settings no longer addresses an unmet need of non-hospitalized COVID-19 patients.
By Jacob Bell • April 13, 2021 -
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 -
Lilly, Arch join Deerfield in backing new gene therapy biotech Jaguar
Just two months after launching, Jaguar Gene Therapy has raised another $139 million for a preclinical pipeline aimed at gene-linked autism and diabetes.
By Ned Pagliarulo • Updated April 13, 2021 -
Jacob Bell/BioPharma Dive
Provention Bio latest drugmaker flagged for 'deficiencies' in FDA approval application
While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response.
By Jacob Bell • April 9, 2021 -
Biogen adds a late-stage prospect to its growing biosimilar business
A deal with Bio-Thera Solutions hands Biogen rights to a late-stage copycat of Actemra, Roche's blockbuster treatment for inflammatory diseases.
By Jacob Bell • April 8, 2021 -
Permission granted by Tessera Therapeutics
Bluebird executive joins Flagship startup Tessera as CMO
David Davidson is leaving Bluebird bio after nearly a decade as the gene therapy developer's top doctor. His new home, Tessera, just raised $230 million to advance its "gene writing" research.
By Ned Pagliarulo • April 7, 2021 -
FibroGen admits misleading safety data for anemia drug, dimming prospects
In a surprise announcement, the company said data used to tout the safety of the anemia pill roxadustat included "post hoc changes" that executives only became aware of during regulatory review.
By Ben Fidler • April 7, 2021 -
New data push a biotech's muscle disease drug closer to a key test
An experimental medicine from Scholar Rock could complement a gene therapy from Novartis and other treatments for the disease, though its benefit needs to be proven in further study.
By Jacob Bell • April 6, 2021 -
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 -
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 -
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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
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