Biotech: Page 80
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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 -
Explore the Trendline➔
Spencer Platt via Getty Images
TrendlineEmerging biotech
New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.
By BioPharma Dive staff -
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
Chinese biotech partnered with GSK gets funding boost for coronavirus vaccine
Clover Biopharmaceuticals, one of several China-based groups advancing a coronavirus shot, has now received one of the largest investments to date from the vaccine development alliance group CEPI.
By Kristin Jensen • Nov. 3, 2020 -
Regeneron pauses study of rare disease drug following patient deaths
The company hasn't determined whether its drug played a role in the deaths, but concerns over the treatment's safety could dim its chances for approval.
By Jacob Bell • Nov. 2, 2020 -
Courtesy of Regeneron Pharmaceuticals
Safety concerns lead Regeneron to halt testing of COVID-19 drug in some patients
A study monitoring board flagged a "potential safety signal" in some hospitalized COVID-19 patients who require breathing support, telling the biotech to modify its study protocol.
By Ben Fidler • Oct. 30, 2020 -
Atea, riding interest in COVID-19 drugs, pulls off one of 2020's top biotech IPOs
The Boston startup's initial public offering is the fourth-largest in biotech this year, according to data compiled by BioPharma Dive.
By Ben Fidler • Oct. 30, 2020 -
Permission granted by Gilead Sciences
Gilead lifted by fast sales of COVID-19 drug Veklury. Will they last?
Veklury, which was approved by the FDA last week, earned Gilead nearly $900 million in the third quarter, although U.S. sales could slow in the months ahead.
By Ned Pagliarulo • Oct. 29, 2020 -
Adeline Kon/BioPharma Dive
Deep Dive // Emerging biotechBiotech IPOs are the industry’s lifeblood. Track how they’re performing.
Evommune intends to follow a similar playbook as MapLight Therapeutics, using a workaround to raise about $150 million in an IPO during the federal government shutdown.
By Ben Fidler, Gwendolyn Wu • Updated 19 hours ago -
Retrieved from National Cancer Institute on September 27, 2019
Mirati cancer drug results spark hopes of outperforming Amgen's
The biotech's KRAS-blocking pill trails Amgen's sotorasib in development, but early data suggest it might match the bar set by Amgen.
By Jonathan Gardner • Oct. 26, 2020
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