Biotech
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BioNTech, WHO hatch plan to bring mRNA vaccines to Africa
Responding to criticism, the German biotech plans to develop a malaria shot and build manufacturing infrastructure on the continent.
By Jonathan Gardner • July 26, 2021 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
Caribou raises $304M in one of gene editing's most lucrative IPOs
The IPO is several times larger than what CRISPR Therapeutics, Intellia and Editas raised several years ago, and ranks well ahead of a more recent offering from gene editing startup Beam.
By Ned Pagliarulo • July 23, 2021 -
Explore the Trendline➔
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TrendlineThe expanding world of RNA therapies
Vaccines from BioNTech and Moderna proved the power of messenger RNA in medicine. A growing field of RNA-targeting therapies is advancing alongside them.
By BioPharma Dive staff -
Seres, after earlier success, fails a key test for microbiome drugs
A pill made of gut bacteria wasn't effective at treating ulcerative colitis in a closely watched study that was viewed as a proof point for the emerging field.
By Ben Fidler • July 22, 2021 -
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Biogen executives attack Aduhelm criticism, blaming 'extensive misinformation'
The company responded forcefully to controversy roiling around the Alzheimer's drug's approval, defending its data and interactions with the FDA.
By Jonathan Gardner , Ned Pagliarulo • July 22, 2021 -
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Amylyx, faced with longer FDA path for promising ALS drug, gets major cash infusion
A $135 million investment will help the small biotech potentially prepare to launch the treatment in Canada and Europe as well as fund another trial requested by U.S. regulators.
By Ned Pagliarulo • UPDATED: July 20, 2021 at 2:47 p.m. -
Gilead Sciences Inc. / Kite Pharma
BioNTech returns to cancer roots with deal for Gilead cell therapy factory
The German biotech purchased Kite Pharma's Gaithersburg, Maryland-based site, along with related research on T cell receptor-based cancer treatments.
By Shoshana Dubnow • July 19, 2021 -
Elizabeth Regan / Industry Dive
Cytokinetics heart drug succeeds in mid-stage study, boosting shares
Treatment with one of the biotech's drugs improved heart function in a small trial, an outcome that could help the company rebound and potentially challenge a rival medicine from Bristol Myers Squibb.
By Ned Pagliarulo • July 19, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
COVID-19 drug developer Adagio plans IPO to cap fast rise
The offering is the latest step in the rapid emergence of Adagio, which raised $465 million and brought a drug to pivotal testing in less than a year.
By Ben Fidler • July 19, 2021 -
Dollar Photo Club
FDA advisers push back on FibroGen anemia drug
Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to boost red blood cells.
By Jonathan Gardner • July 16, 2021 -
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Major health centers, insurers push back against Aduhelm
The Cleveland Clinic and Mount Sinai won't yet administer the controversial Alzheimer's drug, while UnitedHealth's CEO said the insurer would need more time to iron out coverage.
By Jacob Bell • July 15, 2021 -
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
A cancer drug startup banks new funds for NK cell therapy
Backed by Abingworth, Tybourne Capital and others, Wugen has raised $172 million in a Series B round meant to fuel research of its leukemia treatment.
By Kristin Jensen • July 15, 2021 -
Courtesy of Galapagos
Galapagos shares sink as first data from touted drug program disappoints
The biotech will push forward with other candidates from its "Toledo" research, but investors did not appear encouraged by the mixed data Wednesday.
By Ned Pagliarulo • UPDATED: July 20, 2021 at 2:45 p.m. -
Permission granted by Prime Medicine
Prime Medicine raises $315M to fuel 'search-and-replace' gene editing work
Formed around research from the Broad Institute's David Liu and Andrew Anzalone, Prime has attracted significant funding from a wide range of high-profile biotech backers.
By Shoshana Dubnow • July 14, 2021 -
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Q&ABiohaven CEO on migraine drug's fast launch, TikTok ads and battling big pharma
Sales of Nurtec ODT during the second quarter were double what Wall Street expected. CEO Vlad Coric explained to BioPharma Dive how the biotech did it, despite being far smaller than its chief rival.
By Jacob Bell • July 14, 2021 -
Permission granted by Biogen
Biogen chases rivals with another bet on emerging class of multiple sclerosis drugs
A deal with Innocare gives Biogen a second therapy for MS that targets a protein called BTK, an approach several other competing drugmakers are pursuing, too.
By Ben Fidler • UPDATED: July 14, 2021 at 9:34 a.m. -
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FDA flags rare side effect in new warning on J&J's coronavirus vaccine
The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of an immune-driven condition known as Guillain-Barré.
By Jonathan Gardner • July 12, 2021 -
Novo Nordisk
Novo, in rare deal, buys rights to Prothena amyloidosis treatment
The Danish pharma will pay $100 million in the near term and as much as $1.2 billion overall for an antibody Prothena is developing for ATTR amyloidosis.
By Ned Pagliarulo • July 12, 2021 -
Permission granted by Celldex
Celldex pins its hopes for a comeback on skin disease drug
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.
By Ben Fidler • July 09, 2021 -
Permission granted by Biogen
FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment
Aduhelm's approval last month, already highly controversial, was made more so by the agency's decision to clear the drug for a broad group of patients. New prescribing information more closely matches clinical testing criteria.
By Ned Pagliarulo , Ben Fidler • July 08, 2021 -
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A well-funded cancer drug startup brings on GSK's Axel Hoos as CEO
Hoos, who led cancer R&D at GSK, will take over as head of Scorpion Therapeutics, a new biotech company that's raised $270 million in venture funding since launching last October.
By Ned Pagliarulo • July 07, 2021 -
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Moderna puts seasonal flu vaccine ambitions to the test
Having proved mRNA's might in COVID-19, the biotech company aims to develop similar vaccines for other respiratory illnesses caused by influenza, RSV and metapneumovirus.
By Ned Pagliarulo • July 07, 2021 -
Sarah Silbiger via Getty Images
FDA knocks back diabetes prevention drug, crushing its maker's shares
Provention Bio said it expects to collect data that could address the FDA's concerns before the end of September. In the meantime, though, the company's shares have taken another hit.
By Jacob Bell • July 06, 2021 -
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As Arrowhead falters, lungs remain a tough target for RNA drugs
The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs.
By Ben Fidler • July 06, 2021 -
5 FDA decisions to watch in the third quarter
The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm.
By Ned Pagliarulo , Ben Fidler • July 02, 2021 -
The 'dovetail' partnership meant to turn Boston Children's into a hub for gene therapy startups
A five-year alliance with high-profile biotech ElevateBio is designed to get around a bottleneck that has held back the institution’s gene therapy work.
By Shoshana Dubnow • July 01, 2021
