Pharma: Page 67
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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 -
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 -
Explore the Trendline➔
Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineTop 5 stories from BioPharma Dive
Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.
By BioPharma Dive staff -
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 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, 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 -
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 -
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 -
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 -
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 -
Courtesy of Eli Lilly
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 9, 2020 -
Permission granted by 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 7, 2020 -
Novo's diabetes drug also appears to work in NASH
Results from a Phase 2 study showed three doses of Novo's semaglutide were better than placebo at resolving the liver disease without worsening fibrosis.
By Jacob Bell • May 6, 2020 -
Another delay for Bristol Myers cell therapy as FDA extends review
Bristol Myers now expects an approval decision on liso-cel by mid-November, some six weeks before a deadline set by the pharma in its buyout of Celgene.
By Kristin Jensen • May 6, 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 -
Adobe Stock: KanawatVector
Sponsored by West Monroe Partners & rMark BioUsing AI to align field engagements with strategy in medical affairs
Advanced AI technology can help pharmaceutical companies optimize the medical engagement process.
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 Roche
Roche gets emergency OK for coronavirus antibody test as FDA tightens oversight
The Swiss pharma said its product may be less likely to deliver false positives than some earlier-to-market serology tests, a concern regulators attempted to address with a key policy update Monday.
By Nick Paul Taylor • Updated May 4, 2020 -
J&J contracts with Catalent to boost coronavirus vaccine production
The partnership is the second J&J has inked in recent weeks as it prepares sufficient capacity to supply 1 billion doses of its experimental vaccine.
By Kristin Jensen • April 30, 2020 -
AstraZeneca, racing past rivals, throws its weight behind Oxford's COVID-19 vaccine
The British drugmaker will take over development of an experimental vaccine that could produce its first clinical results next month.
By Ben Fidler • April 30, 2020 -
Pfizer resumes trial recruitment suspended by coronavirus
After pausing enrollment into many studies in March, Pfizer is beginning to resume clinical activities at sites that are currently operational.
By Jonathan Gardner • April 28, 2020 -
Jacob Bell/BioPharma Dive
Merck starts to feel COVID-19's effects
The pharma giant lowered its 2020 revenue expectations by $2.5 billion as its vaccines, cancer drugs and animal health business face coronavirus-related pressures.
By Jacob Bell • April 28, 2020
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