Biotech: Page 91
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With new Allogene data, same promise, questions surround 'off the shelf' CAR-T
Updated results from Allogene at ASCO's virtual meeting are encouraging, but still don't show whether its allogeneic approach can match autologous CAR-T.
By Ben Fidler • May 29, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
Novartis teams with Mass. Eye & Ear to join coronavirus vaccine chase
The Swiss pharma has become the latest large drugmaker to enter the worldwide race to develop a vaccine for COVID-19, tapping a project developed by gene therapy experts at the Massachusetts Eye and Ear Hospital.
By Jonathan Gardner • May 28, 2020 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
Permission granted by Gilead Sciences
U.K. grants early access to Gilead's remdesivir for COVID-19 patients
Supplies of the antiviral drug are tight, however, with many of the doses donated by Gilead reserved for use in the U.S.
By Kristin Jensen • May 27, 2020 -
Permission granted by Gilead Sciences
Gilead puts $375M into Arcus in latest push to broaden cancer business
The alliance, inked two months after a $5 billion buyout of cancer biotech Forty Seven, extends Gilead's effort to establish itself as a major player in oncology.
By Ben Fidler • May 27, 2020 -
Yujin Kim/BioPharma Dive
Deep DiveVenture capital found its footing in biotech. Then came the virus.
There's been no better time for venture firms to invest in drug startups than the past few years. But when a virus upended the world, it raised new questions about what types of investors and investments would succeed moving forward.
By Jacob Bell • May 26, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Intercept shares fall as FDA again delays closely watched NASH drug
The FDA has asked for more data on obeticholic acid, which could be the first-ever marketed medicine for non-alcoholic steatohepatitis. The latest delay means the drug likely won’t be approved by the agency's June 26 deadline.
By Jonathan Gardner • May 22, 2020 -
Sunovion crowds a new group of Parkinson's drugs, with uncertain sales prospects
Kynmobi has become the fourth drug the FDA has approved since late 2018 for the "off" episodes Parkinson's disease patients experience. The coronavirus pandemic may complicate an already challenging launch.
By Ben Fidler • May 22, 2020 -
AstraZeneca, Merck race past Clovis as PARPs break into prostate cancer
The approvals of Lynparza and Rubraca within days of one another mark the arrival of PARP inhibitors as treatments for prostate cancer — a role that could grow in the coming years.
By Ben Fidler • May 20, 2020 -
More questions than answers as Moderna's coronavirus vaccine speeds ahead
Preliminary results from a Phase 1 study were enough to add $5 billion to Moderna's market capitalization. But they don't answer key questions about the vaccine's safety and effectiveness.
By Jonathan Gardner • May 19, 2020 -
Biotech companies raise cash as coronavirus updates lift stocks
Eight publicly traded drugmakers, including Moderna, announced plans Monday to raise nearly $3 billion via offerings of new stock and debt.
By Ned Pagliarulo • May 19, 2020 -
Moderna delivers first human data for a coronavirus vaccine
The first volunteers who received low or medium doses of Moderna's vaccine produced what look to be meaningful immune responses, but it's unclear whether that will lead to disease prevention.
By Ben Fidler • May 18, 2020 -
Safety questions linger as Pfizer preps Duchenne gene therapy for final test
New data presented at the American Society of Gene & Cell Therapy's yearly meeting show promise, but also side effects that haven't been seen with a rival treatment from Sarepta.
By Ben Fidler • May 15, 2020 -
Alex Wong via Getty Images
Ousted BARDA director: Hydroxychloroquine push distracted government scientists
Safety concerns led to a clash over how widely to distribute the malaria pill for use against COVID-19, Rick Bright testified to Congress Thursday.
By Jonathan Gardner • May 14, 2020 -
Cancer biotech stocks shift on glimpse of ASCO data
Data from Allogene was well received by investors, but several other biotechs saw their market value erode following release of ASCO study abstracts.
By Ned Pagliarulo • May 14, 2020 -
Allogene gives first look at an 'off the shelf' cell therapy for lymphoma
Donor-derived cell therapy has been a goal for drugmakers since CAR-T arrived several years ago. New data from Allogene could offer "proof of concept."
By Ben Fidler • May 13, 2020 -
Activist investor pushes Alexion to sell after Portola deal
Elliot Advisors cited Alexion's buyout of Portola, which triggered a sell-off last week, as reason to ask the biotech's board to solicit bids from larger pharmas.
By Jonathan Gardner • May 12, 2020 -
Getty / Edited by BioPharma Dive
Dyno spins out of Harvard's laboratories with an aim to make gene therapy better
The startup announced collaborations with Novartis and Sarepta, both leading gene therapy makers, that could be worth $2 billion in total.
By Jonathan Gardner • May 11, 2020 -
After trial failure, Enanta narrows its focus to NASH
The biotech's main drug missed its goal in a mid-stage study of patients with a liver disease known as PBC.
By Jacob Bell • May 7, 2020 -
Getty / Edited by BioPharma Dive
Orchard lays off a quarter of its staff amid major shift
The gene therapy developer has given up on plans to build a new manufacturing facility and is adjusting its clinical resources to focus on more common diseases.
By Kristin Jensen • Updated May 8, 2020 -
Moderna plans earlier start to late-stage test of coronavirus vaccine
A Phase 3 trial of Moderna's experimental vaccine could begin in early summer, several months sooner than what was already an ambitious target for starting this fall.
By Ned Pagliarulo • May 7, 2020 -
Permission granted by Gilead Sciences
After donation to the U.S., Gilead outlines plans to distribute COVID-19 drug worldwide
Gilead is negotiating licenses for remdesivir with overseas manufacturers and charities, which parallels past efforts with its hepatitis C and HIV drugs.
By Jonathan Gardner • May 6, 2020 -
Alex Wong via Getty Images
Ousted BARDA director claims retaliation for pushing back on unproven coronavirus drugs
In a newly filed whistleblower complaint, Rick Bright alleged his criticism of the Trump administration's response to the coronavirus pandemic led to his removal last month as head of BARDA.
By Ned Pagliarulo • May 5, 2020 -
Permission granted by BioNTech SE
Pfizer, BioNTech launch U.S. trial of coronavirus vaccine
Initial vaccine data are expected within weeks as biotech and pharma companies intensify their search for a way to prevent the spread of COVID-19.
By Jonathan Gardner • May 5, 2020 -
Alexion, seeking to broaden business, to buy Portola for $1.4B
The acquisition is a bet by Alexion that its commercial strength will help it broaden the market for Portola's top drug, the blood thinning antidote Andexxa.
By Ned Pagliarulo • May 5, 2020 -
Akebia, chasing FibroGen, nears FDA review with new anemia pill data
The company is one of several aiming to upend the market for injectable anemia biologics, which generate billions of dollars in yearly sales.
By Ben Fidler • May 5, 2020
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