Biotech: Page 69
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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 -
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 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 -
Phill Magakoe via 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 -
Kena Betancur via Getty Images
Gilead, Foresite back biotech developer of COVID-19 pill in latest SPAC deal
A merger with Foresite Capital's blank-check company makes Pardes Biosciences the latest well-funded drugmaker pursuing development of an oral coronavirus antiviral.
By Ned Pagliarulo • June 29, 2021 -
Permission granted by Biogen
Congress pressures FDA and Biogen on Alzheimer's drug approval, price
The agency's decision-making process as well as Biogen's pricing of Aduhelm at $56,000 per year are both under the microscope as the repercussions of the controversial OK continue to be felt.
By Jonathan Gardner • June 28, 2021 -
Courtesy of Gilead Sciences
Gilead matches Bristol Myers in showing benefit to earlier CAR-T treatment
A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug.
By Ned Pagliarulo • June 28, 2021 -
Arcus claims positive study results for lung cancer drug, but shares no details
The lack of specific data frustrated analysts, but shares in Arcus rose by double digits Thursday. Partner Gilead is expected to make a decision on whether to license the drug later this year.
By Kristin Jensen • June 24, 2021
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