Biotech: Page 84
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
On eve of first big coronavirus vaccine study, trial leaders brace for 'unprecedented' task
Researchers will need millions of volunteers to find the roughly 150,000 required for the five Phase 3 trials expected this year. Here's what lies ahead for them.
By Ben Fidler • July 24, 2020 -
Permission granted by BioNTech SE
Coronavirus vaccines speed ahead, but experts fear not everyone will take them
Gaining trust will be a tough task as public health officials gear up for one of the biggest immunization campaigns in decades.
By Jonathan Gardner • July 23, 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 -
Biogen points to COVID-19 for disappointing drug launch
Sales of Vumerity, a key new product in Biogen's plan to bolster its multiple sclerosis drug business, have been slow since it launched in December.
By Jacob Bell • July 22, 2020 -
At a pivotal moment, Biogen loses another top executive
Just weeks after Biogen submitted its closely watched Alzheimer's drug to the FDA, the company announced its CFO Jeff Capello will depart next month.
By Jacob Bell • July 22, 2020 -
Permission granted by Gilead Sciences
Gilead adds to string of cancer drug deals with Tizona stake
An upfront payment of $300 million gives Gilead a nearly 50% stake in Tizona Therapeutics and the exclusive option to acquire it later, depending on how promising the biotech's immunotherapy looks.
By Jacob Bell • July 21, 2020 -
Permission granted by University of Maryland School of Medicine
Pfizer and BioNTech coronavirus vaccine gets boost from German data
As the race to bring a vaccine to market accelerates, the companies unveiled new clinical results and a deal that promises the U.K. 30 million doses of a successful shot.
By Jonathan Gardner • July 20, 2020 -
Getty Images
Sponsored by Parexel BiotechOpportunities for biotechs in precision medicine
Exploring the promise of precision medicine in helping biotechs bring new therapies to patients.
By Angela Qu, MD, PhD, Vice President, and Arlene Hughes, PhD, Senior Director • July 20, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
A startup launches with big plans to develop antibody drugs for coronaviruses
Larger drugmakers like Regeneron have led the way in developing antibody drugs for COVID-19. Adagio Therapeutics aims to prove it can follow suit, with an eye to future coronavirus outbreaks as well.
By Ben Fidler • July 16, 2020 -
Researchers publish long-awaited study data on Moderna coronavirus vaccine
The results support the biotech's earlier claim of positive results, but don't show whether the vaccine protects against infection. Still, "we're so hungry for a vaccine we're trying to read the tea leaves," said vaccine expert Paul Offit.
By Ned Pagliarulo • Updated July 14, 2020 -
Preventive studies for Eisai, Biogen Alzheimer's drug could add years to amyloid debate
Two late-stage trials will assess the companies' experimental drug BAN2401 in people without Alzheimer's symptoms but with biological signs of the disease.
By Jonathan Gardner • July 14, 2020 -
Permission granted by Roche
Blueprint, eyeing an independent future, gets $775M in new Roche alliance
The deal, which gives Roche rights to Blueprint's lead drug pralsetinib, is another bet by the Swiss drugmaker on targeted cancer therapies.
By Ben Fidler • Updated July 14, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565662436/in/album-72157713108522106/.
India clears a psoriasis drug for COVID-19, and a tiny US biotech's shares soar
An emergency approval for Biocon's drug Alzumab in India could lead its U.S. partner, Equillium, to start broader trials in coronavirus disease.
By Ben Fidler • July 13, 2020 -
Jonathan Gardner/BioPharma Dive
Beigene, already flush with cash, raising $2B from investors
Amgen, which last year partnered with the Chinese biotech, will invest another $420 million in the company to maintain its roughly 20% stake.
By Ned Pagliarulo • July 13, 2020 -
Big pharma, battling COVID-19, looks to 'buy time' on another health crisis: superbugs
Facing an alarming scarcity of new antibiotics, about two dozen of the world's largest drugmakers are backing a fund meant to develop two to four by 2030.
By Jacob Bell • July 9, 2020 -
ALS drug development
In the hunt for ALS treatments, researchers find promise in silencing genes
Two studies published in the New England Journal of Medicine, including one that tested a Biogen drug, provide some evidence that a decades-long effort to develop genetic medicines for ALS is starting to pay off.
By Jacob Bell • July 8, 2020 -
Biogen submitted its Alzheimer's drug for approval. Now what?
The later-than-expected filing is just the first of many hurdles Biogen faces in trying to get aducanumab approved. Some analysts on Wall Street don't have high hopes for the drug's chances.
By Jacob Bell • July 8, 2020 -
US buys up early supply of Regeneron's COVID-19 antibody cocktail
A $450 million grant will help Regeneron scale up manufacturing of its drug, which is among the front-running antibody therapies for COVID-19.
By Jonathan Gardner • July 7, 2020 -
Courtesy of Regeneron Pharmaceuticals
Regeneron advances COVID-19 antibody cocktail into late-stage trials
The launch of a Phase 3 prevention study accelerates work on antibody-based drugs, which could offer strained healthcare systems a "bridge" to a vaccine.
By Jonathan Gardner • July 6, 2020 -
Bellus shares plummet as cough drug fails Phase 2 test
While Bellus plans to do more testing, the negative readout now puts it further behind Merck in the race to develop a drug for refractory chronic cough.
By Jacob Bell • July 6, 2020 -
Amgen prevails in high-stakes drug case against Novartis
Novartis, which appealed an earlier court decision upholding two patents on Amgen's Enbrel, indicated it may try to take the case to the Supreme Court.
By Jacob Bell • July 1, 2020 -
Alex Wong via Getty Images
Federal coronavirus contracts dodge pricing oversight, advocacy group says
Contracts with six companies waive "march-in rights" and omit provisions that could be used to object to high drug prices. Moderna's contract, however, includes those clauses.
By Jonathan Gardner • Updated July 1, 2020 -
Ultragenyx wins early approval for rare disease drug
Dojolvi, as Ultrangenyx's drug will be sold, is the first FDA-approved treatment for a group of genetic disorders that affect several thousand people in the U.S.
By Kristin Jensen • July 1, 2020 -
Permission granted by Gilead Sciences
Gilead pricing suggests it will make a business out of COVID-19 drug
Even at the lower end of its price range, remdesivir could earn Gilead a billion dollars. How well the drug's price is received will be an important test for other companies working on coronavirus treatments.
By Jacob Bell • June 30, 2020 -
Jacob Bell/BioPharma Dive
Intercept's NASH drug faces its biggest delay yet
The FDA rejected obeticholic acid, asking for more data. If the agency ends up requiring outcomes results too, it could set Intercept's approval hopes back by two years or more.
By Jacob Bell • June 29, 2020 -
Permission granted by Gilead Sciences
Gilead sets price for COVID-19 drug remdesivir
A typical course of treatment with remdesivir will cost between $2,340 and $3,120 in the U.S., a price range that likely ensures Gilead earns a profit on sales of the drug.
By Ned Pagliarulo • June 29, 2020
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