From fiercebiotech.com
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Eli Lilly has dropped (PDF) the lead candidate from its $2.4 billion takeover of Dice Thera | Eli Lilly has dropped the lead candidate from its $2.4 billion takeover of Dice Therapeutics, shifting the focus of its oral IL-17 psoriasis program to a follow-up molecule. Lilly kicked DC-806 to the...
on Nov 1
From fiercebiotech.com
MeiraGTx's gene therapy improves motor function and quality of life in phase 2 Parkinson's trial
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MeiraGTx is looking to march its Parkinson’s disease treatment forward into phase 3 after the gene therapy improved motor ability and quality of life in a small midphase trial. | MeiraGTx is looking to march their Parkinson’s treatment forward after the gene therapy improved motor ability and...
on Oct 18
From fiercebiotech.com
MARAbio raises $19M to develop an antibody blood test for autoimmune-related autism
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A startup that aims to deliver a blood test to identify a biomarker linked with a specific subtype of autism—and then potentially develop early behavioral interventions and treatments—has | MARAbio Systems derived its name from a particular pattern of antibodies carried by the child’s mother,...
on Oct 8
From fiercebiotech.com
Embecta secures FDA clearance for insulin patch pump in Type 1 and Type 2 diabetes
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Embecta has secured an FDA clearance for its first wearable insulin delivery system, with a patch pump designed for people with either Type 1 or Type 2 diabetes. | The fully disposable device includes a 300-unit insulin reservoir, which embecta said could last most users with Type 2 diabetes...
on Sep 4
From fiercebiotech.com
FDA's drug center to consolidate AI efforts under single council
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The FDA’s Center for Drug Evaluation and Research (CDER) is consolidating its artificial-intelligence-related activities under a single AI Council, in part in response to efforts from the | In an email to staff, CDER Director Patrizia Cavazzoni, M.D., said the council would replace its...
on Sep 3
From fiercebiotech.com
Dexcom's Stelo, its first over-the-counter glucose monitor, hits the market
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After getting the green light from the FDA back in March, Dexcom today launched its first over-the-counter wearable continuous glucose biosensor, Stelo, in the U.S. market. | After getting the green light from the FDA back in March, Dexcom today launched its first over-the-counter wearable...
on Aug 31
From fiercebiotech.com
J&J files for FDA approval of $6.5B autoimmune drug, teeing up showdown with argenx and UCB
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Johnson & Johnson has taken another step toward realizing a return on its $6.5 billion nipocalimab bet,
on Aug 30
From fiercebiotech.com
Merck advances lung cancer attack, pocketing $170M from Daiichi and plotting ADC-trispecific combo
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Merck & Co. | Merck & Co. has quickly recouped some of the costs of its Harpoon Therapeutics buyout, pulling in $170 million upfront by incorporating the lead candidate into a co-development deal with Daiichi Sankyo.
on Aug 9
From fiercebiotech.com
Synchron links brain-computer interface with Apple Vision Pro headset
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As brain-computer interface developer Synchron has tried to expand how its tech links with the brain, it’s now trying to do the same with the computers. | Describing the technology as a way to reconnect people with paralysis to fast-moving consumer tech, Synchron is pitching a Bluetooth standard...
on Aug 4
From fiercebiotech.com
IRA drug price reductions won't hurt biotech innovation, analyses find
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Since its passage in August 2022, the Inflation Reduction Act (IRA) has attracted criticism and even derision from biopharma leaders because it gives Medicare the ability to negotiate drug prices. | Since its passage in August 2022, the Inflation Reduction Act has attracted criticism and even...
on Aug 1
From fiercebiotech.com
Roche pumps brakes in Pompe disease, axing gene therapy after assessing competition
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Roche has punted a Pompe disease gene therapy from its pipeline after weighing up the competitive landscape. | Roche has punted a Pompe disease gene therapy from its pipeline after weighing up the competitive landscape. The Swiss drugmaker made the change in a second-quarter update that also...
on Jul 26
From fiercebiotech.com
With seventh person seemingly cured of HIV, signs of hope for a broader cure
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Though his real name isn’t known, there’s no doubt that he’ll go down in history. | Though his real name isn’t known, there’s no doubt that he’ll go down in history. An adult man dubbed “The Next Berlin Patient” has been declared the seventh person to be cured of HIV, and his case provides...
on Jul 19
From fiercebiotech.com
Drug prevents COVID symptoms in mice by protecting mitochondria, without resistance risk
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New findings in mice suggest it’s possible to prevent organ damage from COVID-19 with an antioxidant enzyme that protects a cell’s mitochondria without the risk of resistance. | New findings in mice suggest it’s possible to prevent organ damage from COVID-19 with an antioxidant enzyme that...
on Jul 18
From fiercebiotech.com
Caribou cuts NK cell therapy program, lays off 12% of staff to fund CAR-T priorities
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A year ago, Caribou Biotherapeutics’ CEO was telling Fierce Biotech that the company’s natural killer (NK) cell therapy program was the “tip of the spear” for its solid tumor strategy and didn | Eyeing up ways to keep the money flowing into 2026, the CRISPR-focused company has decided that the...
on Jul 17
From fiercebiotech.com
CytoDyn's legal fight against CRO Amarex ends in $12M settlement
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CytoDyn’s legal fight with Amarex Clinical Research appears to be coming to an end. | CytoDyn’s legal fight with Amarex Clinical Research appears to be coming to a close. The biotech said it reached a settlement in which its former CRO will pay CytoDyn $12 million on top of eliminating a $14...
on Jul 11
From fiercebiotech.com
Roche stops pivotal TIGIT trial after Keytruda lands knockout blow at first attempt
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Keytruda has beaten Roche’s TIGIT drug candidate at the first interim analysis of a phase 2/3 lung cancer trial, prompting the Swiss drugmaker to
on Jul 10
From fiercebiotech.com
Ginkgo Bioworks 'a hoax for the ages,' says activist short seller firm
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Calling its business model “hocus-pocus” and “a colossal scam,” activist short seller firm Scorpion Capital has stung Ginkgo Bioworks. | Calling its business model “hocus-pocus” and “a colossal scam,” activist short seller firm Scorpion Capital has stung Ginkgo Bioworks—the synthetic biology...
on Jul 2
From fiercebiotech.com
Study shows generative AI can speed up clinical trial enrollment for pennies per patient
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Researchers at Mass General Brigham found that artificial intelligence software like ChatGPT could help speed up the screening process to find patients eligible for clinical trials—though they caut | Using a version of OpenAI’s GPT-4 program, the AI quickly combed through doctors' notes and...
on Jun 26
From fiercebiotech.com
'Unprecedented' CAR-T results for lupus net Insight prize for researchers
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Two scientists whose work sparked industry excitement about the prospect of using chimeric antigen receptor T cell (CAR-T) therapy for autoimmune disease are the recipients of the Lupus Research Al | Two scientists whose work sparked industry excitement about the prospect of using chimeric...
on Jun 26
From fiercebiotech.com
‘We’re flying blind’: CDC has 1M bird flu tests ready, but experts see repeat of COVID missteps
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It’s been nearly three months since the U.S. government announced an outbreak of the bird flu virus on dairy farms. | As the outbreak grows—with at least 114 herds infected in 12 states as of June 18—researchers said the CDC and FDA are not moving fast enough to remove barriers that block...
on Jun 26
From fiercebiotech.com
Lilly's donanemab sails through FDA meeting with 2 unanimous votes in favor
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Eli Lilly’s Alzheimer’s disease treatment sailed through an FDA advisory committee meeting Monday, with panelists praising the therapy as innovative—while also cautioning about a lack of data on sp | Eli Lilly’s Alzheimer’s treatment sailed through an FDA advisory committee meeting Monday, with...
on Jun 24
From fiercebiotech.com
Moderna flu/COVID combo beats immune responses for approved shots in phase 3 after speedy season
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Moderna’s combo flu and COVID-19 vaccine zipped through a late-stage trial this winter, and the results are showing a higher immune response than licensed comparators—including the famed biotech’s | Moderna’s combo flu and COVID-19 vaccine zipped through a late-stage trial this winter, and the...
on Jun 24
From fiercebiotech.com
Cell therapy reckoning: How to get cell therapies flying off-the-shelf
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This story is the final part of a four-part series about cell therapy created by the Fierce Biotech team. | A Special Report from the Fierce Biotech team on the state of cell therapy.
on Jun 9
From fiercebiotech.com
Takeda gets crafty with $1.2B biobucks deal to create molecular glues with Degron
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Takeda has taken a trip all the way to Shanghai to find just the right kind of glue to stick together a $1.2 billion biobucks deal for new candidates in oncology, neuroscience and inflammation. | Takeda has taken a trip all the way to Shanghai to find just the right kind of glue to stick...
on May 28
From fiercebiotech.com
Home COVID testmaker Cue Health to shut down operations, lay off staff: report
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Cue Health is taking last week’s FDA warning letter—and the agency’s public missive urging users to throw its central product in the trash—as its cue to leave the diagnostics business. | According to a report from the San Diego Union-Tribune, the company will shutter operations at the end of...
on May 23
From fiercebiotech.com
AstraZeneca prepares fresh COVID push to regulators after antibody's phase 3 success
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While AstraZeneca’s globally used COVID-19 vaccine is leaving the scene, the British Big Pharma is hoping it | While AstraZeneca’s globally used COVID-19 vaccine is leaving the scene, the British Big Pharma is hoping it will be taking a fresh therapeutic option to regulators soon.
on May 18
From fiercebiotech.com
How gut enzymes could make universal donor blood possible
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Finally, some bloody good news: Researchers have identified new enzymes that bring science closer to developing universal donor blood. | Finally, some bloody good news: Researchers have identified new enzymes that bring science closer to developing universal donor blood. In an article in Nature...
on May 1
From fiercebiotech.com
Roche picks up Prenosis' newly cleared sepsis AI tool for distribution
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Following last week’s de novo clearance for the artificial intelligence program, Roche has stepped up to distribute Prenosis’ sepsis risk prediction tool through its diagnostic platforms. | Following last week’s de novo clearance for the AI program, Roche has stepped up to distribute Prenosis’...
on Apr 16
From fiercebiotech.com
Report: Every dollar of NIH research funding doubles in economic returns
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Research funded by the National Institutes of Health (NIH) generated $2.46 in economic activity for every $1 of funding in 2023, a total of $92.9 billion, according to an
on Apr 6
From fiercebiotech.com
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A man with end-stage renal disease is now healthy enough to be discharged from the hospital, after becoming the first in the world to receive a kidney transplant from a genetically engineered pig.< | In a world first, a man with end-stage renal disease is now enjoying "one of the cleanest bills...
on Apr 6
From fiercebiotech.com
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The headlines are, at a minimum, a bit sensational: “Alzheimer’s can be transmitted between people.” “What you need to know about Alzheimer’s spreading between humans.” “First evidence of human-to- | A case series published Jan. 29 in Nature Medicine by scientists at University College London...
on Mar 23
From fiercebiotech.com
Neuralink fined for violating hazardous material transport rules, docs show: Reuters
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Nearly a year after reports first surfaced of the U.S. | The violations were outlined in U.S. Department of Transportation documents obtained in a records request by the Physicians Committee of Responsible Medicine—an animal research advocacy group that has previously claimed that Neuralink...
on Mar 2
From fiercebiotech.com
Novavax's 2nd round of job cuts reached 12% of staff, though execs say that should be it for now
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Novavax says 12% of its workforce was cut as part of a second wave of layoffs announced at the end of 2023, bringing last year’s full-year staff reduction to about 30%. | Novavax says 12% of its workforce was cut as part of a second wave of layoffs announced at the end of 2023, bringing last...
on Mar 2
From fiercebiotech.com
Galapagos halts lupus CAR-T program, confirms 100 layoffs so far this year
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Galapagos has never been afraid of reworking its pipeline or workforce to face the future. | Galapagos used its earnings report to disclose that work has been halted on a CD19 CAR-T candidate for refractory systemic lupus erythematosus.
on Mar 1
From fiercebiotech.com
Novartis calls time on TIM-3, axing cancer candidate after phase 3 flop
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Novartis’ anti-TIM-3 antibody has flunked a phase 3 blood cancer trial, prompting the Swiss drugmaker to pull the drug candidate from its pipeline. | Novartis’ anti-TIM-3 antibody has flunked a phase 3 blood cancer trial, prompting the Swiss drugmaker to pull the drug candidate from its...
on Feb 1
From fiercebiotech.com
Merck & Co. signs $220M macrocyclic peptide deal after hailing ‘next wave of drug discovery’
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Months after hailing macrocyclic peptides as the “next wave of drug discovery,” Merck & Co. | Months after hailing macrocyclic peptides as the “next wave of drug discovery,” Merck & Co. has pushed further into the space by penning a $220 million biobucks deal with Unnatural Products.
on Jan 24
From fiercebiotech.com
2023's top 10 clinical trial flops
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You can learn as much about how to develop a drug from past failures as you can from success. When you look at the biopharma pipeline, there are plenty of lessons learned to choose from. Companies take on significant risk to bring life-saving medicines to market. According to an estimate from...
on Jan 24
From fiercebiotech.com
JPM24: How Takeda beat 'almost every biopharmaceutical company' to win Nimbus’ TYK2 med
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| Takeda cemented itself as a player in the immunology arena when it bought Nimbus' TYK2 inhibitor a year ago, putting it toe-to-toe against Bristol Myers Squibb. Now, the Japanese pharma has detailed just how the drug landed in its pipeline.
on Jan 22
From fiercebiotech.com
GLP-1 drug hydrogels could reduce shots to once every 4 months
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The GLP-1 receptor agonist drug class became a household na | A single injection secreted therapeutic doses of semaglutide and liraglutide for 42 days in rats. The delivery system could improve adherence not only to GLP-1 drugs, but also other diabetes meds and beyond.
on Dec 3, 2023
From fiercebiotech.com
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Acquisitions are back, biotech. After a stagnant year with pharma sitting on a heap of cash, the fruits of in-person business development meetings are beginning to ripen. | Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe.
on Nov 20, 2023
From fiercebiotech.com
Pencils down for Graphite, as gene editing biotech merges into vision-loss-focused Lenz
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Lenz Therapeutics is absorbing sickle-cell-focused Graphite Bio in a reverse merger that will see the combined company reemerge with a focus on vision loss and $225 million in cash on hand at close | Lenz Therapeutics is absorbing sickle-cell-focused Graphite Bio in a reverse merger that will...
on Nov 20, 2023
From fiercebiotech.com
Months after ending cancer program, Theseus lays off 72% of staff as it considers options
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Four months after a safety signal blew Theseus Pharmaceuticals’ quest to develop a gastrointestinal stromal tumor (GIST) treatment off course, the biotech is
on Nov 20, 2023
From fiercebiotech.com
Merck-backed VectorY Therapeutics raises $138M series A to push forward ALS program
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VectorY Therapeutics has secured 129 million euros ($138 million) in a series A financing that will help the Dutch biotech advance its preclinical lead program in amyotrophic lateral sclerosis (ALS | VectorY Therapeutics has secured €129 million ($138 million) in a series A financing that will...
on Nov 17, 2023
From fiercebiotech.com
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We've launched a new Fierce Biotech Fundraising Tracker for 2023 to track all the venture capital flowing into the industry. | Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.
on Nov 17, 2023
From fiercebiotech.com
Aclaris' stock sinks further as biotech abandons MK2 inhibitor over latest phase 2 fail
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Aclaris Therapeutics has abandoned zunsemetinib after the latest phase 2 fail saw the MK2 inhibitor unable to match placebo on any primary or secondary endpoints in a rheumatoid arthritis (RA) tria | Aclaris Therapeutics has abandoned its immuno-inflammatory plans for zunsemetinib after the...
on Nov 17, 2023
From fiercebiotech.com
2023 Executive Interviews at Fierce Biotech Summit and New Product Planning
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Fierce Biotech sits down with life science executives at Fierce Biotech Summit & Fierce New Product Planning Summit. | Fierce Biotech sits down with digital marketing leaders to discuss this year's most innovative topics at Fierce Biotech Summit and New Product Planning
on Nov 15, 2023
From fiercebiotech.com
Anticipating the disruption of regenerative medicine
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Travis McCready is an individual with immense experience in the biotech arena. | While AI is undoubtedly driving key progress in biotech, Travis McCready sees disruptive opportunity elsewhere. Discover why the Head of Life Sciences for Americas Markets at JLL is excited for regenerative...
on Nov 15, 2023
From fiercebiotech.com
Drug discovery 2.0 fuels the next-generation of life-saving medicines
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“The future of drug discovery in biotechnology is dependent on achieving scale, speed and cost efficiency,” according to Dr. | Dr. Sharon Benzeno, Chief Commercial Officer of Immune Medicine at Adaptive Biotechnologies, shines a spotlight on the key immune-driven medicine advancements that show...
on Nov 15, 2023
From fiercebiotech.com
The future of lab digitalization and automation
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In this interview, Chuck Donnelly, CEO and co-founder of RockStep Solutions, discusses the significance of lab digitalization and future trends in the biotech industry. | Emerging technologies and scientific advancements, specifically, artificial intelligence, robotics, and automation will...
on Nov 15, 2023