Pharma
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Eli Lilly starts first-ever trial of a COVID-19 antibody drug, speeding past rivals
The Indianapolis drugmaker has quickly moved to human tests of an antibody it has developed with privately held biotech AbCellera, with results expected before July.
By Ben Fidler • June 01, 2020 -
Regeneron expands Intellia gene editing deal as its post-Sanofi future emerges
Regeneron and Intellia will grow their alliance and work on hemophilia, an already competitive space that includes several experimental gene therapies.
By Jonathan Gardner • June 01, 2020 -
Getty Images
Q&AHow Merck seeks to catch up in the coronavirus drug race
The pharmaceutical giant just became a major player in the global push to develop medicines against COVID-19. Daria Hazuda, vice president of infectious disease discovery, spoke with BioPharma Dive about its plans.
By Ben Fidler • June 01, 2020 -
AstraZeneca
AstraZeneca bid to expand lung cancer drug's use boosted by trial data
The ADAURA trial — stopped two years ahead of schedule — showed Tagrisso kept early-stage lung cancer patients from relapsing longer than did placebo.
By Jonathan Gardner • UPDATED: May 29, 2020 at 1:11 p.m. -
Permission granted by BioNTech SE
Facing vial shortage, pharmas explore workarounds for coronavirus vaccines
"There's not enough vials in the world," said AstraZeneca's CEO on Thursday. Procuring enough to hold the billions of vaccine doses needed is yet another headache for coronavirus drugmakers to solve.
By Ned Pagliarulo • May 28, 2020 -
Permission granted by University of Maryland School of Medicine
Coronavirus vaccine developers plan to enroll tens of thousands in late-stage tests
As initial studies get underway in small groups of volunteers, companies like Pfizer, AstraZeneca and J&J are preparing for large Phase 3 trials.
By Ned Pagliarulo • May 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/.
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 -
skynesher via Getty Images
Sponsored by West Monroe Partners & rMark BioHow AI meets medical affairs teams' evolving need for KPIs
Deploying real-time analytics can help pharmaceutical companies define targeted engagement plans and develop insights from field interactions.
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With $11B stock sale, Sanofi loosens ties with Regeneron
The French pharma will get a cash windfall by selling most of its 20% stake in Regeneron, spurring speculation as to how it'll spend the money.
By Jonathan Gardner • UPDATED: May 27, 2020 at 7 p.m. -
Getty Images
Merck makes COVID-19 drug plans clear with flurry of deals
The drugmaker, which for months appeared to be watching the pandemic from the sidelines, will advance two coronavirus vaccine candidates, as well as an oral antiviral drug.
By Ned Pagliarulo , Ben Fidler • May 26, 2020 -
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 -
Permission granted by Gilead Sciences
Bangladesh pharma claims to be first to launch generic remdesivir
Beximco, which wasn't one of five drugmakers to license the coronavirus treatment from Gilead, says it can make a copycat version under World Trade Organization rules.
By Jonathan Gardner • May 21, 2020 -
US secures supply of AstraZeneca, Oxford coronavirus vaccine, pledging more than $1B
The deal, brokered through BARDA, will make available to the U.S. "at least" 300 million doses of the vaccine, should testing prove it safe and effective.
By Ben Fidler • May 21, 2020 -
Novartis
Novartis gene therapy Zolgensma cleared for use in Europe
The Swiss pharma estimates 550 to 600 infants are born in Europe each year with spinal muscular atrophy, the hereditary disease Zolgensma treats.
By Kristin Jensen • May 20, 2020 -
AstraZeneca
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 -
Courtesy of Bristol-Myers Squibb
Bristol Myers, trailing Merck in lung cancer, finally wins FDA OK for immunotherapy combo
The long-sought approval of Opdivo and Yervoy gives Bristol Myers an entry into the competitive first-line lung cancer drug market after years of setbacks.
By Ben Fidler • May 18, 2020 -
Craighead, Shealah. (2020). "President Trump Delivers an Update on Vaccine Development" [Photograph]. Retrieved from Flickr.
'Operation Warp Speed,' unveiled by Trump, aims for coronavirus vaccine by year's end
Speeding the development and production of vaccines will be the project's principal aim, but it will also involve readying cold chain storage as well as supplies of needed vials and syringes.
By Ned Pagliarulo • May 15, 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 -
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 -
Alex Ritter, Jennifer Lippincott Schwartz and Gillian Griffiths, National Institutes of Health. (2015). "Killer T cells surround a cancer cell" [Image]. Retrieved from Flickr.
J&J myeloma data heat up cell therapy battle
Bristol Myers' regulatory stumble opens the door for other companies developing CAR-T therapies for multiple myeloma to catch up. ASCO data released Wednesday show J&J could be closing the gap.
By Jonathan Gardner • May 13, 2020 -
Cassi Josh, edited by BioPharma Dive
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 -
Kendall Davis / BioPharma Dive
GenFit delivers latest NASH drug failure
The negative results for GenFit's elafibranor deal another another blow to the NASH field, which has seen only one drug make it through late-stage testing.
By Jacob Bell • May 11, 2020 -
MyoKardia pops as heart drug passes most important test
A late-stage study found patients with a condition similar to heart failure fared better when given MyoKardia's drug. The results sent company shares soaring.
By Jacob Bell • May 11, 2020 -
Lilly's Loxo buyout bears fruit as FDA clears cancer drug Retevmo
The pharma will launch Retevmo at a time when hospitals and academic centers are stretched thin by the COVID-19 pandemic.
By Ned Pagliarulo • May 09, 2020 -
Novartis
Novartis wins approval for niche lung cancer drug
Jumping ahead of competition, the Swiss pharma secured FDA clearance for Tabrecta, the first therapy targeted to certain mutations in a gene called MET.
By Jonathan Gardner • May 07, 2020
