Biotech: Page 76
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Sarepta shares first results on next-generation Duchenne drug
The biotech claims early results from a Phase 2 study suggest one of its newer therapies may be more powerful at a lower dose than Exondys 51.
By Kristin Jensen • Dec. 8, 2020 -
UniQure offers a closer look at the leading hemophilia B gene therapy
Doctors on Tuesday got a more detailed idea of how the therapy works and who might be eligible to take it, as late-stage results were presented at ASH.
By Jacob Bell • Dec. 8, 2020 -
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 -
Jonathan Gardner/BioPharma Dive
Lilly to pit Loxo cancer drug against top-selling rival after strong study results
Following positive data at ASH, Lilly will test a drug it acquired in last year's buyout of Loxo Oncology against Imbruvica, one of the world's best-selling cancer treatments.
By Ned Pagliarulo • Dec. 7, 2020 -
Getty / Edited by BioPharma Dive
A CRISPR gene editing treatment continues to show promise for two blood diseases
Results from 10 patients with beta thalassemia or sickle cell disease show CRISPR Therapeutics and Vertex's pioneering treatment to be effective, building on earlier study data.
By Ben Fidler • Dec. 5, 2020 -
Jonathan Gardner/BioPharma Dive
4 storylines to track at the year's biggest meeting on blood diseases
A closely watched gene editing therapy, a slate of new multiple myeloma drugs and much more are set to highlight the American Society of Hematology conference this weekend.
By Ben Fidler , Ned Pagliarulo , Jacob Bell • Dec. 3, 2020 -
Ovid's plan to prove a shelved sleeping pill for a rare disease ends in disappointment
A quest by former Teva and Bristol Myers executive Jeremy Levin to develop an old drug for Angelman's syndrome fell short in a late-stage clinical trial.
By Ben Fidler • Dec. 2, 2020 -
With anemia data, Agios blood disease drug takes a crucial step forward
Phase 3 results announced Tuesday boost chances that Agios' drug might not just win approval for a rare type of anemia, but also be useful in treating other blood diseases.
By Ben Fidler • Dec. 1, 2020 -
Moderna, finishing key study, to ask FDA for emergency approval of coronavirus vaccine
New results confirm the shot's strong efficacy against COVID-19 and should raise confidence vaccination can prevent against severe symptoms as well.
By Ben Fidler • Nov. 30, 2020 -
Biogen stocks up on Sage's brain drugs in $3B deal
Biogen and Sage each face challenges. While executives from both companies said the deal could provide a boost, investors don't appear to be sold just yet.
By Jacob Bell • Updated Nov. 30, 2020 -
Alnylam wins US approval for its third rare disease drug
The drug, now known as Oxlumo, is the first approved treatment for patients with a potentially life-threatening condition that can cause kidney failure. Like other Alnylam drugs, it comes at a six-figure list price.
By Kristin Jensen • Nov. 24, 2020 -
Permission granted by Gilead Sciences
Deep DiveHow Gilead finally spent its money
This year, the biotech spent about $27 billion trying to become a leader in cancer research. Executives who spoke to BioPharma Dive said there's still work to be done.
By Jacob Bell • Nov. 24, 2020 -
Amgen cuts Cytokinetics loose after heart drug disappointment
The smaller biotech vowed to push forward, although the pill's inability to prevent heart failure death may complicate its plans to win approval.
By Jonathan Gardner • Nov. 23, 2020 -
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.
By Ben Fidler • Nov. 22, 2020 -
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.
By Jacob Bell • Nov. 17, 2020 -
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.
By Ben Fidler • Nov. 16, 2020 -
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.
By Kristin Jensen • Nov. 11, 2020 -
Getty / Edited by BioPharma Dive
Pfizer invests in Homology, adding to gene therapy ambitions
Along with an equity stake, Pfizer will get right of first refusal on any deal involving Homology's most advanced therapies, which the biotech is developing for a rare metabolic disorder.
By Kristin Jensen • Nov. 10, 2020 -
Amgen's asthma drug delivers a needed win
A late-stage study found Amgen's tezepelumab benefited a variety of patients with severe asthma, results that one analyst called a "best-case outcome."
By Jacob Bell • Nov. 10, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Eli Lilly wins FDA emergency clearance for COVID-19 antibody drug
The regulator approved Lilly's synthetic antibody treatment for emergency use, but short supplies and logistical challenges could limit its initial impact.
By Ben Fidler • Nov. 9, 2020 -
Jacob Bell/BioPharma Dive
5 takeaways from the FDA's high-stakes meeting for Biogen's Alzheimer's drug
The expert panel's decidedly negative vote on aducanumab raised questions about the drug's future, as well as the credibility of the FDA.
By Jacob Bell , Ned Pagliarulo , Ben Fidler • Nov. 9, 2020 -
FDA advisers vote against Biogen's Alzheimer's drug, leaving its future in doubt
In a tense meeting, a group of experts found Biogen and the FDA's case for aducanumab unpersuasive, voting overwhelmingly against the drug.
By Jacob Bell , Jonathan Gardner , Ned Pagliarulo • Updated Nov. 7, 2020 -
Courtesy of BioMarin Pharmaceutical
BioMarin, stung by FDA rejection, pressed on path forward for 2 key drugs
Roctavian, the biotech's hemophilia gene therapy, was turned down by the FDA in August, while an important rare disease drug is now under review.
By Ned Pagliarulo • Nov. 6, 2020 -
Biogen surges as FDA reviewers appear supportive of Alzheimer's drug approval
Documents made public ahead of a key advisory meeting Friday revealed an FDA more willing than expected to accept Biogen's controversial case for approval of aducanumab.
By Ned Pagliarulo , Jacob Bell • Updated Nov. 4, 2020 -
Allogene shares sink on early look at an 'off the shelf' CAR-T for myeloma
Results the company will present at a medical meeting, while early, don't appear to meet the high bar set by rival CAR-T cell therapies from Bristol Myers Squibb and Johnson & Johnson.
By Ben Fidler • Nov. 4, 2020 -
The meeting that could change Alzheimer's treatment
On Friday, a panel of experts and FDA staff will weigh in on a closely watched Alzheimer's drug from Biogen. Their feedback could affect how the disease is treated for years to come.
By Jacob Bell • Nov. 3, 2020
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