Biotech: Page
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Jacob Bell/BioPharma Dive
PTC aims again for FDA review of Duchenne drug despite latest miss
The FDA has rejected PTC's treatment three times, but the biotech's CEO hopes the "totality" of the results it's now accrued will finally lead to a different outcome.
By Jonathan Gardner • Feb. 5, 2021 -
Permission granted by Gilead Sciences
Gilead sales propped up by COVID-19 drug Veklury
Sales of the antiviral drug accounted for a quarter of the biotech's product revenue in the fourth quarter, disguising hits to its business elsewhere.
By Ned Pagliarulo • Feb. 5, 2021 -
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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 -
With $588M IPO, Sana leads wave of new biotechs going public
Nine other drug developers are set to price initial public offerings this week, extending a record run of financing activity from last year. Sana's is one of the largest in recent history.
By Ben Fidler • Feb. 3, 2021 -
Permission granted by Biogen
Biogen laser-focused on Alzheimer's drug as rest of business falters
While the biotech prepares to launch aducanumab, its latest earnings report shows significant hits to top-selling drugs, plus another pipeline failure.
By Jacob Bell • Feb. 3, 2021 -
Jacob Bell/BioPharma Dive
Jazz Pharma to buy GW Pharma, maker of CBD-based epilepsy drug, for $7.2B
The deal gives Jazz, best known for its sleep disorder drugs, access to Epidiolex, the first prescription cannabidiol medicine approved by the FDA.
By Ned Pagliarulo • Feb. 3, 2021 -
Vertex comes to a crossroads
The biotech's cystic fibrosis business is booming. But with a pipeline of risky, disjointed assets, some on Wall Street aren't sure what Vertex's next move is, or why it hasn't been spending its massive amounts of cash.
By Jacob Bell • Feb. 2, 2021 -
Shifting strategy, Coherus buys rights to experimental cancer drug
The biosimilar maker will develop an immunotherapy rival to Merck's Keytruda via a deal with China's Junshi Biosciences.
By Jonathan Gardner • Feb. 1, 2021 -
Permission granted by Gilead Sciences
Gilead partners with a cancer biotech, seeking to develop an HIV immunotherapy
Gritstone Oncology, known for its cancer research, is drawing attention in infectious disease, signing a deal with Gilead two weeks after announcing plans to develop a coronavirus vaccine.
By Ned Pagliarulo • Feb. 1, 2021 -
Permission granted by Vetter Pharma
Sponsored by Vetter PharmaNavigating the challenges of proper fill and finish in clinical development
Given all the uncertainties of fill and finish in clinical development, one thing is certain – there is little room for failure, and rarely a second chance.
By Claus Feussner, Ph.D., Senior Vice President Vetter Development Service, Vetter Pharma-Fertigung GmbH & Co. KG • Feb. 1, 2021 -
Jacob Bell/BioPharma Dive
FDA delays verdict for Biogen's closely watched Alzheimer's drug, raising investor optimism
Investors feared an outright rejection for aducanumab. But the FDA moving its approval deadline back three months is a signal to some that the agency wants to approve Biogen's drug.
By Jacob Bell • Jan. 29, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
Amgen study data bolster prospects of KRAS-blocking cancer drug
Results from a mid-stage study showed Amgen's drug, sotorasib, shrank tumors in over a third of lung cancer patients, affirming earlier findings.
By Ned Pagliarulo • Updated Jan. 29, 2021 -
FDA approves first-of-its-kind lupus drug
Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.
By Jacob Bell • Jan. 25, 2021 -
Getty / Edited by BioPharma Dive
Beam, Verve stockpile cash as investors bank on gene editing progress
Beam expects to receive $260 million through a private stock placement, while Verve raised $94 million to support initial studies of its heart disease treatment.
By Ned Pagliarulo • Jan. 19, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
Cancer-focused biotech turns its tools to building a 2nd-generation coronavirus vaccine
As worries about coronavirus mutations grow, Gritstone Oncology will work with the NIH to develop a shot capable of stimulating a broad immune response.
By Jonathan Gardner • Jan. 19, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
US pushes for wider use of 'underutilized' COVID-19 antibody drugs as pandemic worsens
A $2.6 billion deal with Regeneron is part of a renewed effort by government officials to bolster uptake of the treatments, which haven't gained traction.
By Ben Fidler • Jan. 15, 2021 -
US to pay up to $2.6B for more doses of Regeneron's COVID-19 antibody drug
The deal expands an earlier agreement between Regeneron and the U.S., though many of the issues limiting the drug's use haven't been solved.
By Kristin Jensen • Jan. 13, 2021 -
Danielle Ternes/BioPharma Dive
JPM21: Gene editing for heart disease, a new date to watch in Alzheimer's research and Pfizer's deep pockets
Verve, a buzzy gene editing startup, unveiled its first drug candidate, which is designed to treat hereditary high cholesterol by changing a single letter in the DNA sequence of a key gene.
By Ned Pagliarulo • Jan. 12, 2021 -
Danielle Ternes/BioPharma Dive
JPM21: Vaccines soar, antibodies struggle as COVID-19 drugs become a business
Moderna and Gilead reported billions in sales for their coronavirus treatments, but Regeneron's antibody drug cocktail hasn't gained traction. BioNTech, meanwhile, could report critical new vaccine results in days.
By Jonathan Gardner , Ben Fidler • Jan. 12, 2021 -
Danielle Ternes/BioPharma Dive
JPM21: Biogen faces make-or-break year, Vertex mulls deals and Sarepta pitches a silver lining
After disappointing results from a key study, Sarepta's CEO shared new data on its treatment for Duchenne muscular dystrophy.
By Ben Fidler , Jonathan Gardner • Jan. 11, 2021 -
Bluebird to split company, spin off cancer drug business
The high-profile biotech will separate into two independent, publicly traded companies in an attempt to revive its fortunes after several setbacks.
By Ned Pagliarulo , Ben Fidler • Updated Jan. 11, 2021 -
Lilly rockets up on mixed Alzheimer's results
Analysts cautioned that results for Lilly's drug, donanemab, weren't a total home run. Even so, investors sent the company's market value higher by roughly $18 billion.
By Jacob Bell • Jan. 11, 2021 -
Alnylam, with positive data in hand, prepares to submit 4th drug for approval
Late-stage results for vutrisiran look as though they'll help Alnylam deliver on the promise that RNAi technology can be a repeatable drug platform.
By Jacob Bell • Jan. 7, 2021 -
Courtesy of CureVac
Bayer partners with CureVac on coronavirus vaccine development
The German companies will work together to push a shot using similar technology as Moderna's and BioNTech's over the finish line.
By Kristin Jensen • Jan. 7, 2021 -
Dewpoint forges another big pharma partnership — and a potential rivalry
The biotech, which works in the emerging research field of biomolecular condensates, is teaming up with Pfizer to find new treatments for a rare type of muscular dystrophy.
By Jacob Bell • Jan. 6, 2021 -
A new, well-connected biotech aims to fight cancer with viruses
Founded by industry veteran Arie Belldegrun's venture capital firm, IconOVir Bio raised $77 million to push its lead drug — derived from the common cold — into clinical testing.
By Jacob Bell • Jan. 5, 2021
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