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Warren Little via Getty Images
GSK hires away top Pfizer vaccine scientist
Philip Dormitzer, who helped Pfizer develop shots for COVID-19, RSV and influenza, will become the British pharma's head of vaccine R&D next month.
By Ned Pagliarulo • Nov. 30, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Vaccine makers move quickly to confront omicron threat
Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.
By Ned Pagliarulo • Nov. 29, 2021 -
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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 -
Courtesy of Merck & Co.
New Merck study results raise questions about its COVID pill
Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.
By Ben Fidler • Nov. 26, 2021 -
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Takeda wins US approval for new CMV treatment
The antiviral drug, which has been a top research focus of Takeda for years, is the first to be cleared by the FDA for post-transplant CMV infections that are resistant to other treatments.
By Kristin Jensen • Nov. 24, 2021 -
Courtesy of AstraZeneca
AstraZeneca, after years of delays, opens UK hub meant to recharge drug research
Formally unveiled five years after originally planned, the $1 billion headquarters will become the British drugmaker's second-largest R&D center by headcount.
By Jonathan Gardner • Nov. 23, 2021 -
Antonio Masiello via Getty Images
Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens
Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.
By Ben Fidler • Nov. 22, 2021 -
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Sponsored by AltasciencesNanomilling: an optimal solution for poorly soluble, challenging APIs
A versatile technique to ensure your drug is ready on time for your first-in-human clinical trial.
Nov. 22, 2021 -
A worrisome safety signal slows Merck's HIV ambitions
After a study raised safety concerns, Merck has paused development of one of its experimental drugs and will keep a close eye on another that's critical to its plans in HIV.
By Jacob Bell • Nov. 19, 2021 -
Sarah Silbiger via Getty Images
FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults
A monthslong process of authorizing booster shots for vulnerable Americans culminated in the FDA's Nov. 19 decision to open eligibility for all adults, now all the more critical with omicron's spread.
By Ben Fidler • Updated Nov. 20, 2021 -
Permission granted by Gilead Sciences
Gilead pays up to retain rights to Arcus cancer drugs
The biotech will pay $725 million to opt into rights on four experimental medicines developed by Arcus, including ones that could challenge Merck's Keytruda in lung cancer.
By Jonathan Gardner • Nov. 18, 2021 -
FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer
Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely.
By Ben Fidler , Ned Pagliarulo • Nov. 18, 2021 -
Permission granted by Roche
Roche cuts ties with Atea after COVID-19 pill's trial failure
The Boston biotech, shares of which soared last year on hopes for the antiviral drug, said it has plenty of money to advance development on its own.
By Kristin Jensen • Nov. 17, 2021 -
Jeenah Moon via Getty Images
Pfizer asks FDA to authorize COVID-19 pill
Study results released this month showed the pill, when given soon after symptoms start, sharply reduced the risk of COVID-19 hospitalization or death.
By Ned Pagliarulo • Nov. 16, 2021 -
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As Congress weighs drug price restraints, ICER calls out 'unsupported' increases
In a new report, ICER highlighted AbbVie's price hikes on Humira, which the group said resulted in more than $1 billion in U.S. spending last year without any new evidence of health benefits.
By Jonathan Gardner • Nov. 16, 2021 -
Spencer Platt via Getty Images
Pfizer will allow generic drugmakers to produce promising COVID-19 pill
A licensing deal with a U.N.-backed patent group could expand supply of Pfizer's experimental drug Paxlovid in lower- and middle-income countries.
By Ned Pagliarulo • Nov. 16, 2021 -
Permission granted by IQVIA
Sponsored by IQVIAEstablishing an integrated evidence plan for medical affairs and beyond
Over the life of a biopharmaceutical product, there are many situations when data from randomized controlled trials (RCTs) may not be sufficient to address stakeholder questions of value, safety and effectiveness.
Nov. 15, 2021 -
Mario Tama via Getty Images
J&J, world's largest drugmaker, plans to split in two
The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand.
By Ben Fidler , Ned Pagliarulo • Updated Nov. 12, 2021 -
Mario Tama via Getty Images
Pfizer again asks FDA to authorize COVID-19 boosters for all adults
Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk of COVID-19.
By Jonathan Gardner • Nov. 9, 2021 -
Courtesy of Merck & Co.
US pays $1B to nearly double supply of Merck's COVID-19 pill
The new agreement raises the financial upside of molnupiravir, which Merck believes could be a $7 billion product in 2022. But Pfizer's rival drug, which is seemingly more effective, could affect those projections.
By Ben Fidler • Nov. 9, 2021 -
Permission for use granted by IQVIA
Sponsored by IQVIAIQVIA Omnichannel Navigator: A platform for informing smarter marketing decisions
This year, the pharmaceutical industry will spend more on its promotional activities than any year before. It’s estimated that the total U.S. promotional spend for 2021 will be around $30 billion.
By Kathryn Grimshaw • Nov. 8, 2021 -
Gorodenkoff/Shutterstock.com
Sponsored by NuvoloHow to support successful audits and inspections
Set yourself up for successful audits and inspections with the Connected Workplace.
Nov. 8, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158908/in/album-72157713108522106/.
Pfizer pill for COVID-19 shows dramatic benefit in major study finding
The drugmaker, which on Oct. 29 won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.
By Jonathan Gardner • Nov. 5, 2021 -
Courtesy of Merck & Co.
Merck wins UK authorization to sell first COVID-19 pill
Molnupiravir, as the drug is known, is also under review by the FDA and other regulators. Merck expects billions in sales as countries seek to stockpile the oral treatment.
By Kristin Jensen • Nov. 4, 2021 -
Megan Quinn/BioPharma Dive
Democrats’ drug pricing plan, while scaled back, could still squeeze pharma top-sellers
Legislation backed by President Joe Biden and top Democratic lawmakers would allow for price negotiation on 20 older drugs, potentially impacting blockbusters from Pfizer, Bristol Myers Squibb and others.
By Jonathan Gardner • Nov. 4, 2021 -
Novartis to sell long-held stake in Roche for nearly $21B
Novartis, which paid around $5 billion for its shares two decades ago, says it will gain about $14 billion from its sale and use the proceeds to further its current strategy.
By Jacob Bell • Nov. 4, 2021
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