Biotech: Page 72
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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 -
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 -
Explore the Trendline➔
Spencer Platt via Getty Images
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 -
Elizabeth Regan/BioPharma 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 -
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 -
Permission granted by Biogen
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 -
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 -
Permission granted by Biohaven Pharmaceutical
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 -
Getty Images
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, 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 9, 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 8, 2021 -
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 7, 2021 -
Maddie Meyer via Getty Images
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 7, 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 6, 2021 -
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 6, 2021 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 2, 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 1, 2021 -
Getty / Edited by BioPharma Dive
Beam, Apellis partner in deal to expand gene editing's reach
The companies aim to develop therapies for complement-driven diseases, a specialty of Apellis and relatively new research ground for gene editing.
By Ned Pagliarulo • Updated June 30, 2021 -
Deals surge, returns slip: takeaways from a record half for biotech IPOs
Biotech initial public offerings could break records set just last year. But their average size and performance are declining, which some say might reflect an overdue correction.
By Ben Fidler • June 30, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Roche partner sees promise for anti-COVID 19 pill in early study
A pill from Atea Pharmaceuticals rapidly reduced the amount of virus in the blood of patients with COVID-19, a step forward in drugmaker efforts to develop easier-to-take treatments for the disease.
By Kristin Jensen • June 30, 2021 -
Pfizer's neuroscience spinout scores in schizophrenia
Cerevel Therapeutics on Tuesday revealed positive results from an early-stage study of one of its drugs, doubling the price of the company's stock.
By Jacob Bell • June 29, 2021
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