Pharma: Page 65
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
J&J, on the cusp of starting coronavirus vaccine trials, sets high bar for success
On a second quarter earnings call, J&J's top scientist said he expects the company's vaccine to significantly surpass the effectiveness standard set out by the FDA.
By Ned Pagliarulo • July 16, 2020 -
Novartis says it won't profit from sale of generic COVID-19 drugs to lower-income countries
The Swiss drugmaker plans to supply 15 medicines — among them the steroid dexamethasone — to as many as 79 nations without taking a profit.
By Kristin Jensen • July 16, 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 -
Side effects don't stop FDA panel from backing GSK blood cancer drug
An approval decision on what could be a first-in-class multiple myeloma drug is due this month, but the FDA will need to weigh safety concerns against the panel's unanimous support.
By Jonathan Gardner • July 15, 2020 -
Courtesy of AbbVie
AbbVie's 'drip-feed' of patents shields top cancer drug from competition, group says
More than seven dozen patents have been granted for Imbruvica in the U.S., helping AbbVie create a legal defense that could protect the drug until 2036.
By Kristin Jensen • July 15, 2020 -
FDA documents reveal doubts about GSK blood cancer drug
Eye-related side effects could derail the leading drug that homes in on a new multiple myeloma target, just as rival therapies progress toward FDA review.
By Jonathan Gardner • July 10, 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 -
Jacob Bell/BioPharma Dive
Merck hits rare FDA setback for cancer drug Keytruda
The regulator declined to grant a speedy approval for Keytruda and Lenvima in liver cancer, citing the recent clearance of another regimen.
By Kristin Jensen • 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 -
J&J, with new deal, plans for long-term manufacture of coronavirus vaccine
A five-year agreement with Maryland's Emergent Biosolutions will provide for large-scale production of J&J's candidate, set to begin testing in July.
By Ned Pagliarulo • July 6, 2020 -
Novartis to pay $678M to settle claims over 'sham' doctor events
The Swiss drugmaker admitted to hosting lavish dinners and events that were intended to convince doctors to prescribe Novartis heart and diabetes drugs.
By Ned Pagliarulo • July 2, 2020 -
AdobeStock/stokkete - Fotolia
Sponsored by ComarchHow to improve document management in the pharma business?
In the near future, many companies within the pharma supply chain will make a step towards EDI in the cloud to increase their productivity, reduce costs, strengthen its own position within the supply chain and achieve many other benefits.
By Mateusz Szarek • July 2, 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 -
Permission granted by BioNTech SE
Coronavirus vaccine from Pfizer, BioNTech shows early potential
Initial data from a small study of healthy volunteers show the companies' shot can elicit immune responses against the virus.
By Ned Pagliarulo • July 1, 2020 -
Sponsored by Parexel
COVID-19 and the new pragmatism
What can we learn from the COVID-19 pandemic? What does it mean for the pharmaceutical industry?
By Paul Bridges SVP Worldwide Head Regulatory & Access, Parexel and Sheela Hegde, Partner and Managing Director, Health Advances • June 30, 2020 -
FDA rejects AbbVie's eye drug, citing safety concerns
The drug, abicipar, was supposed to challenge market-leading drugs like Regneron's Eylea. But inner eye inflammation seen in clinical trials appear to have sunk its chances.
By Jacob Bell • June 26, 2020 -
Merck strikes another neuroscience deal, tapping Yumanity for 2 brain drugs
The pharma hasn't invested much in neuroscience since its Alzheimer's drug plans unraveled in 2017. Three deals in the past year, however, should help keep its options open.
By Ben Fidler • June 24, 2020 -
Courtesy of Sanofi
Sanofi's fight for a better research reputation
Competitive markets and questionable deals make it harder for Sanofi to deliver on claims it can lead in its now-favored areas of research.
By Jacob Bell • June 23, 2020 -
Courtesy of Sanofi Pasteur
Trailing leaders, Sanofi speeds coronavirus vaccine plans
The French drugmaker now intends to begin initial testing of its primary vaccine candidate in September. An expanded alliance with Translate Bio gives it rights to a back-up.
By Ned Pagliarulo • June 23, 2020 -
Courtesy of Lonza Ltd.
Deep DiveVaccines can end the coronavirus pandemic. Will every country get them?
Scientists around the world are racing to develop a coronavirus vaccine. But the factories slated to make the leading candidates are concentrated in a handful of countries, raising concerns about global access.
By Jonathan Gardner • June 23, 2020 -
Adobe/BENIS
Sponsored by West Monroe Partners & rMark BioLeveraging data and AI for better results in pharmaceutical development
Medical Affairs teams need to be able to transfer information into well understood, viable data that translates to insights.
By Robert Eubanks, Erik Brown, Jason Smith (rMark Bio), Mike Abbadessa (rMark Bio) • June 23, 2020 -
Merck gives 1st look at Phase 3 results for its Prevnar competitor
Results from two late-stage studies of V114, Merck's experimental pneumococcal conjugate vaccine, could help support a submission for approval later this year.
By Ned Pagliarulo • June 22, 2020 -
With latest Keytruda approval, Merck beats Bristol Myers to a new immunotherapy target
The FDA decision validates a genetic cancer measure known as tumor mutational burden, which has been studied in multiple trials but previously never led to an approval.
By Ben Fidler • June 17, 2020 -
Sanofi's latest investment signals long-term focus on vaccines
The new coronavirus has brought a renewed interest in vaccines. Now, Sanofi plans to spend hundreds of millions of dollars preparing for future pandemics.
By Jacob Bell • June 16, 2020 -
Courtesy of Eli Lilly
Lilly claims success in early breast cancer study, leaping past Pfizer
The results for Lilly's Verzenio come just weeks after Pfizer's drug Ibrance fell short in a similar trial, and sent shares in the Indianapolis drugmaker soaring.
By Ben Fidler • June 16, 2020
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