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Permission granted by Johnson & Johnson
J&J's 1-dose coronavirus vaccine becomes third available in US
A CDC vaccine panel recommended use of the shot on Sunday following FDA authorization, and McKesson began shipping out doses to states Monday.
By Ned Pagliarulo • Updated March 1, 2021 -
AstraZeneca withdraws immunotherapy in bladder cancer after trial failure
The British drugmaker's decision to pull Imfinzi from what was its first approved treatment setting hints at the limitations of immuno-oncology drugs.
By Jonathan Gardner • Feb. 22, 2021 -
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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 -
Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints
The companies think a new formulation will yield better results than their first attempt. But with several vaccines available, testing may be more challenging.
By Ben Fidler • Feb. 22, 2021 -
Courtesy of BioNTech
Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot
Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution.
By Jonathan Gardner • Feb. 19, 2021 -
Courtesy of Eli Lilly
Lilly wagers almost $1B on Rigel's drugs for immune and nervous systems
For $125 million up front, Lilly secures rights to a drug about to enter mid-stage testing for autoimmune and inflammatory diseases, as well as preclinical assets targeting the central nervous system.
By Jacob Bell • Feb. 18, 2021 -
Gates Foundation backs Novartis' search for a sickle cell cure
An initial grant will support a research team at Novartis' R&D labs whose sole focus will be to develop a single-administration gene therapy for sickle cell disease.
By Jacob Bell • Feb. 17, 2021 -
Novartis expects sales lift from expanded heart drug approval
The Swiss drugmaker's pill Entresto is now cleared in the U.S. for use in patients with stronger hearts, expanding the eligible population by two-thirds.
By Jonathan Gardner • Feb. 17, 2021 -
Courtesy of Regeneron Pharmaceuticals
FDA approves Regeneron drug for rare genetic form of high cholesterol
The biotech set an average annual price of $450,000 for the first-of-its-kind drug, which treats a condition affecting about 1,300 people in the U.S.
By Jonathan Gardner • Feb. 12, 2021 -
Courtesy of AstraZeneca
AstraZeneca plans for adapting vaccine to coronavirus variants, but offers longer timeline than rivals
The drugmaker says between six to nine months are needed to ramp up production of an adapted shot. South Africa recently stopped using the vaccine due to its reduced potency against a common strain there.
By Jonathan Gardner • Feb. 11, 2021 -
Courtesy of Eli Lilly
FDA clears Lilly's COVID-19 antibody cocktail for emergency use
In a late-stage study of people recently diagnosed with COVID-19, the dual-antibody drug sharply reduced the risk of hospitalizations and death.
By Ned Pagliarulo • Feb. 10, 2021 -
Courtesy of Eli Lilly
Lilly CFO steps down after investigation found 'inappropriate' behavior
Josh Smiley had engaged in "consensual though inappropriate" personal communications with certain employees, according to Lilly. He's being replaced by Anat Ashkenazi, chief financial officer of Lilly Research Laboratories.
By Jacob Bell • Feb. 9, 2021 -
As COVID-19 becomes a business, vaccine makers confront thorny pricing questions
Yearly vaccinations could be required after the pandemic ebbs. Will drugmakers change how they approach pricing their shots?
By Jonathan Gardner • Feb. 9, 2021 -
Courtesy of AstraZeneca
New data on AstraZeneca vaccine add to worries over coronavirus variant from South Africa
South Africa will use other shots in its immunization campaign after AstraZeneca's offered "minimal protection" against the variant that's spread throughout the country.
By Ben Fidler • Feb. 8, 2021 -
J&J asks FDA for emergency clearance of coronavirus vaccine
The regulator scheduled an advisory committee meeting for Feb. 26, making an authorization by the end of the month possible.
By Ned Pagliarulo • Updated Feb. 5, 2021 -
Ken Frazier, veteran pharma leader, to step down as Merck CEO
Frazier, who's retiring as CEO after a three-decade career at Merck, will hand the reins to CFO Robert Davis at the end of June. While Frazier's tenure was framed by the success of Keytruda, his leadership extended far beyond Merck's walls.
By Ned Pagliarulo • Updated Feb. 4, 2021 -
UK to start study testing Pfizer, AstraZeneca vaccines together
The government-funded trial will evaluate the effects of mixing vaccines and varying timing between shots.
By Kristin Jensen • Feb. 4, 2021 -
Courtesy of CureVac
GSK expands CureVac vaccine partnership, changing course after setbacks
The U.K. drugmaker will help CureVac make 100 million doses of its coronavirus vaccine and join in developing a multivalent shot for 2022.
By Jonathan Gardner • Feb. 3, 2021 -
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 -
Courtesy of BioNTech
Pfizer forecasts $15B sales boost from coronavirus vaccine orders
The estimate for 2021 sales, which Pfizer splits with partner BioNTech, would make the vaccine one of the highest-selling medicines in the industry.
By Ned Pagliarulo • Updated 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 -
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
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