Pharma: Page 51
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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 -
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 -
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 -
Sponsored by IQVIA
IQVIA 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 -
Sponsored by Nuvolo
How 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 -
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 -
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 -
Moderna cuts vaccine sales, delivery targets for 2021
The biotech now expects to deliver between 700 million and 800 million doses this year, down from a previous forecast of 800 million to 1 billion.
By Ned Pagliarulo • Nov. 4, 2021 -
CDC panel unanimously backs use of Pfizer's COVID-19 vaccine in young children
CDC director Rochelle Walensky signed off on the committee's recommendations Tuesday night, allowing kids between ages 5 and 11 to start receiving the vaccine.
By Shoshana Dubnow • Updated Nov. 3, 2021 -
Pfizer sales of COVID-19 vaccine climb, with tens of billions more expected next year
The drugmaker again increased its forecast for 2021 sales, this time to $36 billion, or about 80% of what the rest of Pfizer's business is expected to earn this year.
By Ned Pagliarulo • Nov. 2, 2021 -
Deep Dive // Patent thickets
A three-decade monopoly: how Amgen built a patent thicket around its top-selling drug
Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.
By Jonathan Gardner • Nov. 1, 2021 -
Drug price restraints dropped as Biden prioritizes other measures
Despite majority control of Congress, it appears unlikely the Biden administration will be able to pass meaningful pricing reform, though a slimmed-down bill may still be in the works.
By Jonathan Gardner • Oct. 29, 2021 -
Merck sees up to $7B in coming sales of coronavirus pill
Executives based their projections on contracts already in place for the drug, known as molnupiravir. But sales could climb even higher if it works as a preventive treatment too.
By Jonathan Gardner • Oct. 28, 2021 -
Takeda reels in a cell therapy research partner with 'build-to-buy' deal
The Japanese drugmaker is acquiring GammaDelta Therapeutics, a partner since 2017, and its research on allogeneic cell therapy for cancer.
By Ned Pagliarulo • Oct. 27, 2021 -
Merck agrees to license COVID-19 pill widely through pact with patent group
The deal with the Medicines Patent Pool is meant to increase access in lower-income countries to molnupiravir, an experimental drug that could become the first oral treatment for COVID-19.
By Kristin Jensen • Oct. 27, 2021 -
With approval plans underway, Lilly's next move is to test its Alzheimer's drug against Biogen's
Alongside a new earnings report, Lilly announced plans for a late-stage study to evaluate whether donanemab is better than Aduhelm at clearing amyloid beta plaques.
By Jacob Bell • Oct. 26, 2021 -
Novartis to consider sale or separation of Sandoz business
The generic drug unit has struggled in recent years, while Novartis has moved to focus more narrowly on higher-margin branded medicines.
By Ned Pagliarulo • Oct. 26, 2021 -
Moderna vaccine safe and spurs immune response in kids, company says
The trial results should allow the company to ask the FDA for approval of its vaccine in younger children, just as Pfizer nears a crucial decision for its shot in 5- to 11-year olds.
By Jonathan Gardner • Oct. 25, 2021 -
Novartis hits another setback in plan to repurpose rare disease drug in lung cancer
Canakinumab, which is approved as Ilaris, didn't slow progression or improve survival when used as a lung cancer treatment. Novartis still hopes it might work alongside surgery.
By Ned Pagliarulo • Updated Nov. 8, 2021 -
Roche's refillable eye implant becomes Eylea's latest threat
The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug.
By Ben Fidler • Updated Oct. 25, 2021 -
What to watch at the FDA's high-stakes meeting on COVID-19 vaccines for kids
Documents released by the FDA Friday indicate agency staff are supportive of Pfizer's data, setting up an advisory panel meeting Tuesday that could open the door for an authorization in young children.
By Ben Fidler , Ned Pagliarulo • Updated Oct. 24, 2021 -
CDC panel levels playing field for new Merck, Pfizer pneumonia vaccines
New guidance for the rival shots didn't favor Pfizer's, as analysts had expected, giving Merck a better chance to gain ground in one of the most lucrative market opportunities for vaccines.
By Kristin Jensen • Oct. 21, 2021 -
Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large study
A third dose was 96% effective in preventing COVID-19 compared to a placebo in a Phase 3 trial of previously vaccinated adults. Missing details, however, leave some questions unanswered.
By Ben Fidler • Oct. 21, 2021 -
Boehringer Ingelheim takes next step in development of cystic fibrosis gene therapy
Drugs from Vertex can effectively treat the lung disease in as much as 90% of patients. Gene therapy could be a solution for the remaining 10%, but the path forward is challenging.
By Shoshana Dubnow • Oct. 19, 2021