Biotech: Page 83
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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 -
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 -
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 -
Courtesy of Centers for Disease Control and Prevention
Deep DiveA coronavirus vaccine may arrive next year. 'Herd immunity' will take longer.
Experimental vaccines for COVID-19 are moving at an unprecedented pace. But that could mean researchers won't definitively know whether they're safe and effective when they do arrive.
By Jonathan Gardner • May 4, 2020 -
Permission granted by Gilead Sciences
With new estimate, ICER sets terms of debate on pricing Gilead's COVID-19 drug
The influential watchdog group judged Gilead's remdesivir would be cost effective at $4,500 per treatment course, setting the stage for what's likely to be a controversial decision by the company.
By Ned Pagliarulo • May 4, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
After 2 months of work, Alnylam has its top pick for a COVID-19 drug
The company and its partner, Vir Biotechnology, are now trying to speed their inhaled RNA interference drug into human testing.
By Jacob Bell • May 4, 2020 -
Permission granted by Gilead Sciences
Gilead may have a drug for COVID-19. Wall Street asks whether it will profit
The biotech is donating its current supply of remdesivir. Afterwards, will it make money on the drug, or continue to take losses for the greater good?
By Ned Pagliarulo • May 1, 2020 -
Moderna, with government cash, taps Lonza to make 1 billion doses of COVID-19 vaccine
The deal gives Moderna more manufacturing might to make sufficient supplies of its experimental coronavirus vaccine, which it's advancing quickly.
By Ben Fidler • May 1, 2020 -
Vertex's drug launch hits new heights, but further growth could be harder to find
Though Trikafta blew by Wall Street estimates with almost $900 million in first quarter sales, Vertex cautioned that patient compliance and the coronavirus pandemic could dampen the drug's growth in the coming months.
By Jacob Bell • April 30, 2020 -
Permission granted by Gilead Sciences
'We really did need a win.' Gilead drug no knockout in COVID-19, but results spur optimism
Doctors interviewed by BioPharma Dive said results from an important clinical trial of remdesivir were encouraging, even if its benefit seemed only modest.
By Ned Pagliarulo • April 30, 2020 -
Texas university spins out Taysha, a gene therapy startup with 15 programs
The university uses a gene therapy delivery tool that Taysha says can be scaled for both small and large manufacturing needs.
By Jonathan Gardner • April 29, 2020 -
Permission granted by Gilead Sciences
Gilead drug for COVID-19 clears crucial clinical test
Data from an NIH-led study showed the antiviral therapy helped to speed recovery in patients hospitalized with coronavirus disease.
By Ned Pagliarulo • Updated April 29, 2020 -
Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women
A first-of-its-kind trial of 10,000 women supported the test's potential to catch some cancers early. Whether it can truly help people, however, is not yet clear.
By Ben Fidler • April 28, 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/.
Repurposed arthritis drug disappoints in closely watched COVID-19 trial
A study of Regeneron and Sanofi's Kevzara will continue, but only for patients in the most critical condition after an early look suggested less-severe patients did worse than those taking placebo.
By Jonathan Gardner • April 27, 2020
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