Biotech: Page 30
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United Therapeutics, in unusual step, sues FDA over rival’s drug application
The biotech alleges the agency is letting rival Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.
By Kristin Jensen • Feb. 21, 2024 -
Permission granted by Iovance Biotherapeutics
Behind the new kind of cell therapy that just won FDA approval
One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.
By Kelly Bilodeau • Feb. 21, 2024 -
Explore the Trendline➔
Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineTop 5 stories from BioPharma Dive
Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.
By BioPharma Dive staff -
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FDA puts hold on Rapt trials of drug for eczema, asthma
Rapt reported one case of liver failure in a study participant who received the biotech’s drug, which is seen by analysts as a possible competitor to Dupixent.
By Delilah Alvarado • Feb. 20, 2024 -
Permission granted by ClinicalMind
Sponsored by ClinicalMindHere are 7 practical ways asynchronous advisory programs can make an impact in 2024
Can asynchronous advisory programs can add distinct value to your strategic mix? Yes! Here's how.
Feb. 20, 2024 -
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ALS drug developmentALS drug from Denali, Sanofi falls short in mid-stage study
The disclosure the experimental therapy missed its trial goal comes after Sanofi had earmarked the drug for advancement into Phase 3.
By Delilah Alvarado • Feb. 16, 2024 -
Courtesy of Sarepta
FDA to review expanded use of Sarepta Duchenne gene therapy
The agency will decide by June 21 whether to broaden eligibility for Elevidys, and won’t convene a group of outside experts beforehand.
By Jonathan Gardner • Feb. 16, 2024 -
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Gilead reviewing drug acquired in $5B buyout after latest setback
The FDA paused enrollment in the only remaining tests of the drug, as Gilead reviews the program it acquired through a buyout of biotech Forty Seven.
By Ben Fidler • Feb. 16, 2024 -
Courtesy of Astellas Pharma
Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies
Kelonia will receive $40 million upfront through the partnership, and could receive $35 million more if Astellas opts into another program.
By Gwendolyn Wu • Feb. 16, 2024 -
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Intellia, ReCode partner on genetic medicines for cystic fibrosis
The partnership will use Intellia's "DNA writing” technology, and focus on people with the lung disease who have limited or no available treatments
By Jacob Bell • Feb. 15, 2024 -
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Aurinia to cut research after sale process fails to find a buyer
The lupus drug developer said it engaged more than 60 parties during its eight-month business review, but only one expressed interest before walking away.
By Kristin Jensen • Feb. 15, 2024 -
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Versant-backed Firefly Bio wants to make the next generation of ADCs
Armed with $94 million in funding, the biotech is marrying antibody-drug conjugates with protein degraders to create a new kind of cancer medicine.
By Gwendolyn Wu • Feb. 15, 2024 -
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Sage offers details on launch of new postpartum depression pill
The company and partner Biogen say signs from payers and doctors suggest the launch of Zurzuvae, the first oral therapy for PPD, is off to a good start.
By Kristin Jensen • Feb. 14, 2024 -
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LianBio to shut down, return cash to investors
The biotech is planning to dissolve less than four years after launching with plans to license drugs and market them in China and other Asian countries.
By Delilah Alvarado • Feb. 14, 2024 -
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Hunting a non-opioid painkiller, a biotech reveals plans to chase Vertex
Latigo Biotherapeutics has raised $135 million to develop drugs that block NaV1.8, the target of a Vertex therapy that just succeeded in Phase 3 trials.
By Ned Pagliarulo • Feb. 14, 2024 -
Dilok Klaisataporn
BioAge raises $170M to back Phase 2-ready obesity drug
BioAge’s Series D will fund a study combining its medicine with Eli Lilly’s Zepbound, a strategy the company hopes could help people lose weight while maintaining muscle mass.
By Jonathan Gardner • Feb. 13, 2024 -
Permission granted by Biogen
New Alzheimer's drugsBiogen has a fuzzy line of sight on prized Alzheimer’s drug
CEO Chris Viehbacher said there are about 3,800 U.S. patients on a registry for Leqembi. But Biogen doesn’t have all the details, as development partner Eisai is leading commercial efforts.
By Jacob Bell • Feb. 13, 2024 -
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ADC startup ProfoundBio, led by Seagen veterans, raises $112M
The Series B round will fund development of antibody-drug conjugates now in clinical testing, among them a rival to AbbVie’s ovarian cancer drug Elahere.
By Gwendolyn Wu • Feb. 13, 2024 -
Permission granted by GV
Q&ATwo GV investors on biotech’s reset and building their next drug startups
Newly named general partner Anthony Philippakis and managing partner Krishna Yeshwant discussed biotech’s newfound optimism and their investing “North Star.”
By Gwendolyn Wu • Feb. 13, 2024 -
Elizabeth Regan/BioPharma Dive
Kalvista pill succeeds in late-stage study for rare swelling disorder
The biotech's drug quickly alleviated symptoms of the swelling attacks associated with hereditary angioedema, supporting the idea it could be an oral alternative to existing medicines.
By Ben Fidler • Updated Feb. 13, 2024 -
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Alys launches with $100M and a pipeline of skin disease drugs
European venture firm Medicxi built the startup by combining six of its portfolio companies, similar to when it merged 10 startups to form Centessa Pharmaceuticals in 2021.
By Delilah Alvarado • Feb. 12, 2024 -
Permission granted by Kyverna Therapeutics
Q&A // Emerging biotechKyverna CEO Peter Maag on courting investors in a ‘volatile’ IPO market
After the CAR-T company priced one of the sector’s largest IPOs in recent years, Maag spoke with BioPharma Dive about what it takes to go public now.
By Ben Fidler • Feb. 9, 2024 -
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Gene editing biotech Metagenomi pulls off nearly $94M IPO
The company is one of just three preclinical biotechs to go public since last summer, but it raised significantly less than others that debuted with more advanced medicines.
By Gwendolyn Wu • Feb. 8, 2024 -
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Neurona raises another $120M for brain disease cell therapies
The company’s haul is the latest sign brain drugs are recapturing the interest of investors after years of being passed over for other areas of research.
By Jacob Bell • Feb. 8, 2024 -
Thomas Lohnes via Getty Images
BioNTech partners with Autolus to boost cell therapy manufacturing
The German biotech will invest $200 million in Autolus — funds that, along with a $50 million fee, give it licensing options and access to supply infrastructure.
By Kristin Jensen • Feb. 8, 2024 -
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Kyverna IPO adds to biotech momentum with $319M fundraise
The company, a leading developer of cell therapies for autoimmune diseases, is the fifth drug startup to go public in 2024. All raised at least $100 million.
By Ben Fidler • Feb. 7, 2024
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