Pharma: Page 60
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Moderna planning to add doses to coronavirus vaccine vials
The biotech aims to add five more vaccine doses to each vial — currently labeled to hold 10 each — but needs to secure FDA sign-off on the change.
By Ben Fidler • Feb. 2, 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 -
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 -
Novartis joins Sanofi in aiding manufacture of coronavirus vaccines
A deal to fill vials of Pfizer and BioNTech's vaccine could be the first of several Novartis signs to help others make COVID-19 treatments.
By Ben Fidler • Jan. 29, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
J&J says single dose of coronavirus vaccine 66% effective in large trial
The vaccine's efficacy was higher in the U.S., but lower in Latin America and South Africa, where new, more infectious virus variants are circulating.
By Ned Pagliarulo • Updated Jan. 29, 2021 -
Courtesy of Novavax
Novavax vaccine prevents COVID-19 in studies, but less effective against new variants
The drugmaker is already discussing an authorization with health authorities in the U.K., and plans to begin talks with the FDA and other regulators, too.
By Jonathan Gardner • Jan. 28, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Vaccine makers prepare response as coronavirus mutations raise alarms
So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.
By Jonathan Gardner • Jan. 28, 2021 -
Safety finding weighs on Pfizer's inflammation drug, and could spell trouble for others
A large safety study found that patients given Pfizer's Xeljanz had health issues like major heart complications and cancer at a higher rate than those who got a different kind of anti-inflammation drug.
By Jacob Bell • Jan. 27, 2021 -
Sanofi, in unusual move, to help Pfizer, BioNTech make coronavirus vaccine doses
The French drugmaker, having hit delays with its own coronavirus shot, agreed to manufacture over 125 million doses of Pfizer and BioNTech's vaccine for supply in Europe.
By Ned Pagliarulo • Updated Jan. 27, 2021 -
Jacob Bell/BioPharma Dive
AstraZeneca, with new data, claims its leukemia drug is safer than Imbruvica
A head-to-head study showed Calquence and Imbruvica benefited patients similarly, but AstraZeneca's drug had fewer heart-related side effects.
By Jonathan Gardner • Jan. 25, 2021 -
Shutterstock.com/totojang1977
Sponsored by Medidata, a Dassault Systèmes companyCOVID-19 study builds at pandemic speed
How to accelerate time-to-market, gain greater control of study data and execution, and optimize the entire trial lifecycle.
Jan. 25, 2021 -
Long-acting HIV drug secures FDA approval, giving GSK a competitive boost
Rather than a once-a-day pill, Cabenuva comes as a once-a-month injection. That convenience could become a valuable tool for GSK as it tries to broaden adoption of two-drug treatments.
By Jacob Bell • Jan. 22, 2021 -
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/.
Pfizer, BioNTech say vaccine effective against fast-spreading UK coronavirus variant
BioNTech's CEO has also promised data will soon be available on the shot's protection against a South African variant that's worried public health experts.
By Jonathan Gardner • Jan. 20, 2021 -
Merck, Bayer win FDA approval for heart failure drug
The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study.
By Kristin Jensen • Jan. 20, 2021 -
Kendall Davis/Industry Dive/BioPharma Dive, data from Marc Nozell
Former FDA chief Kessler tapped as top Biden adviser for COVID-19 response
David Kessler, who served in both the first Bush and Clinton administrations, will be joined by former acting Medicare head Andy Slavitt in a revamped effort from the new administration.
By Jonathan Gardner • Jan. 15, 2021 -
Permission granted by PQE Group
Sponsored by PQE GroupPQE Group creates an internal research task force to fight the spread of misinformation in relation to COVID-19
PQE Group creates internal task force to fight the biggest side effect of the Covid-19 pandemic: the infodemic. A common vocabulary to reinforce knowledge, security and safety.
Jan. 11, 2021 -
Permission granted by Roche
Roche adds to RNA drug deal streak with Ribometrix partnership
The companies' pact is the latest addition to a growing list of deals involving startups developing chemical drugs to target RNA molecules.
By Ben Fidler • Jan. 6, 2021 -
AbbVie, Biogen lead pharma in new year's drug price hikes
Average list price increases across the drug industry, however, appear lower than last year, according to one analysis.
By Jonathan Gardner • Jan. 4, 2021 -
Permission granted by Bristol-Myers Squibb
How an all-or-nothing bet on 3 Bristol Myers drugs came undone
With no decision from the FDA on approval of an experimental cancer cell therapy, an agreement by Bristol Myers to pay out more money as part of its Celgene acquisition fell apart.
By Ned Pagliarulo • Jan. 4, 2021 -
Getty Images
Sponsored by SGSSurface plasmon resonance in biopharmaceutical industry: Real-time and label-free characterization
Surface Plasmon Resonance (SPR) is a robust, but complex analytical tool that provides paramount value to the development and understanding biopharmaceutical products.
By Dr. Sasmit S. Deshmukh and Dr. Alex Perieteanu • Jan. 4, 2021 -
Courtesy of AstraZeneca
UK authorizes AstraZeneca, Oxford coronavirus vaccine, but questions linger
The first public vaccinations with AstraZeneca and Oxford’s shot are now underway. But it’s still unclear how effective the vaccine is, or the best way to use it.
By Ben Fidler • Dec. 30, 2020 -
Merck signs $356M deal to supply US with experimental coronavirus drug
The drugmaker spent $425 million a month ago to acquire the biotech developer of the treatment, which tamps down on the body's inflammatory response to viral infections.
By Jonathan Gardner • Dec. 23, 2020 -
Courtesy of BioNTech
US pays another $2B to buy more doses of Pfizer, BioNTech coronavirus vaccine
The new deal will provide the U.S. with 100 million additional doses of Pfizer and BioNTech's shot, but the much-needed supply won't be available for several months.
By Ben Fidler • Dec. 23, 2020 -
Permission granted by University of Maryland School of Medicine
Rollout of Pfizer's coronavirus vaccine hits some speed bumps amid confusion over shipments
Several thousand doses were returned and replaced after getting too cold. Pfizer and the federal government, meanwhile, don't appear to be on the same page for the next wave of shipments.
By Matt Leonard • Dec. 18, 2020 -
Novartis acquires a small biotech and its trio of brain drugs
More active in neuroscience than most pharmaceutical firms, Novartis would gain three experimental drugs for depression, schizophrenia and movement disorders through the deal.
By Jacob Bell • Dec. 17, 2020 -
With trial plans, Novo wagers its diabetes drug can help treat Alzheimer's
Similar diabetes drugs from Novo have shown signs of promise in treating dementia. The Danish biotech is now putting that hypothesis to the test.
By Jonathan Gardner • Dec. 16, 2020
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