The Latest
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Brian Tucker/BioPharma Dive
Deep DiveThe coronavirus vaccine frontrunners are advancing quickly. Here's where they stand.
Taken together, results from Pfizer, Moderna and AstraZeneca show a way out of the pandemic, and boost confidence other shots might work as well.
UPDATED: Nov. 24, 2020 at 10:26 a.m. -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Regeneron COVID-19 drug, used to treat Trump, cleared for emergency use
The drug is the second antibody-based treatment to win FDA emergency authorization this month, though supplies of both are very limited.
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Craighead, Shealah. (2020). "White House Update on Coronavirus Testing" [Photograph]. Retrieved from Flickr.
Trump administration pushes last-ditch plans to lower drug prices
The White House advanced a new plan to tie Medicare drug payments to prices paid abroad, and revived a once-abandoned proposal to end certain rebates.
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Pfizer, BioNTech ask FDA for emergency approval of coronavirus vaccine
The companies expect immunizations with their shot, if approved, could begin in high-risk groups by the middle to end of December.
UPDATED: Nov. 20, 2020 at 6:11 p.m. -
Getty / Edited by BioPharma Dive
Lilly dives into gene editing
Through a deal with Precision Biosciences, the pharma aims to develop therapies for genetic disorders, including Duchenne muscular dystrophy.
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UniQure's gene therapy for hemophilia B meets first goal in key study
The results are first to emerge from a late-stage test of a hemophilia B gene therapy, and show UniQure's treatment can restore clotting protein levels to mild or even near normal levels.
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Permission granted by Gilead Sciences
WHO recommends against Gilead's Veklury, in break with US guidelines
The organization argues there's no evidence the antiviral saves lives or improves outcomes for COVID-19 patients, despite positive data on the latter point from a key U.S. study.
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Permission granted by BioNTech SE
Deep DiveHospitals scramble to get ready for coronavirus vaccines
Facilities are preparing ultra-cold storage capabilities and reviewing secruity plans as they brace for their role in distributing potentially multiple shots.
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Pfizer strikes a deal with newly formed China biotech
The deal, which has Pfizer paying as much as $70 million, is the latest in a series of moves by big pharma companies to forge a stronger position in the world's second-largest drug market.
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New AstraZeneca data offer latest hint coronavirus vaccines may protect elderly
Results published Thursday add to hopes the experimental shots now in testing won't only work for young, healthy people. More details are needed, though.
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Samsung Bioepis
Copycat to top-selling eye drug takes a step toward market
The FDA is reviewing Samsung Bioepis and Biogen's biosimilar of Lucentis. If approved, it would be the first biosimilar for an eye disease drug.
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Permission granted by University of Maryland School of Medicine
New coronavirus vaccine data bolster Pfizer, BioNTech claims of strongly effective shot
Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just eight for those who were vaccinated.
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Fotolia
Stem cell therapy for ALS fails a large clinical trial
The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Trial success for 2 coronavirus vaccines backs up early research bets
Positive results from Pfizer and Moderna offer the strongest validation yet of researchers' approach to coronavirus vaccines, but critical questions remain.
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Permission granted by Bristol-Myers Squibb
FDA delays decision on Bristol Myers cell therapy, putting Celgene deal payouts in jeopardy
Travel restrictions have made it difficult for the regulator to inspect a plant used to make the treatment, meaning the drugmaker could miss a deadline critical to former Celgene shareholders.
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FDA unexpectedly rejects Alkermes schizophrenia drug, citing manufacturing concerns
Though Alkermes believes it can quickly resolve the issues cited by the agency, the complete response letter nonetheless delays approval of a drug that's critical to the company's hopes of a turnaround.
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Moderna
Moderna's vaccine can last for weeks in a refrigerator, expanding an edge on rivals
Pharmacies and doctor's offices should be able to store Moderna's shot on site, a crucial advantage for the mass immunization challenge that lies ahead.
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Elizabeth Regan / Industry Dive
Japanese drugmaker takes full control of a Roivant biotech
With competition looming over one of its top drugs, Sumitomo Dainippon Pharma has been looking for new portfolio additions. It thinks it found one in Urovant Sciences.
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Moderna
Moderna says vaccine prevents COVID-19 in large study, adding to hopes for several protective shots
Multiple effective vaccines will likely be needed to end the pandemic. Moderna's study results, which are equally strong as those reported by Pfizer and BioNTech last week, make that outcome more likely.
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Lilly backs a biotech's spinout and places a small bet on protein degradation
An alliance with BeyondSpring spinout Seed Therapeutics makes Eli Lilly the latest pharma company to dive into the fast-emerging drug research field.
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Getty / Edited by BioPharma Dive
UCB strikes 2 gene therapy deals to build its pipeline
With patent expirations nearing for a top-selling drug, the Belgian pharma will buy one company and partner with another to add several early-stage projects in neurological diseases.
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AstraZeneca cancer drug found ineffective for COVID-19
The setback follows disappointing results from companies like Novartis and Sanofi, which have also sought to repurpose existing drugs for COVID-19.
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Moderna
Moderna close to having results from key coronavirus vaccine trial
The fast-accelerating spread of coronavirus in the U.S. has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results.
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Courtesy of Intellia Therapeutics
Intellia, beginning treatment in CRISPR study, secures Gates Foundation backing
The biotech won a grant from the foundation two days after dosing the first patient in a study of an in vivo CRISPR medicine, a milestone for the company and the technology.
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Permission granted by BioNTech SE
Pfizer, with vaccine results positive, readies plans to ship coronavirus shot
Twelve trucks and 20 planes would be used each day to distribute the vaccine, should approvals follow Pfizer and partner BioNTech's positive study results.
