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 Nov. 9, 2021
  • A photo of Merck & Co. and Ridgeback Biotherapeutics' molnupiravir being manufactured.
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    Courtesy of Merck & Co.
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    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 Nov. 9, 2021
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    Brian Tucker / BioPharma Dive/BioPharma Dive
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    Trendline

    Top 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
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    Permission for use granted by IQVIA

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    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
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    Gorodenkoff/Shutterstock.com

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    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
  • Electron microscope image of SARS-CoV-2, isolated from a patient in the U.S.
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    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/.
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    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 Nov. 5, 2021
  • A photo of Merck & Co. and Ridgeback Biotherapeutics' molnupiravir being manufactured.
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    Courtesy of Merck & Co.
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    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
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    Megan Quinn/BioPharma Dive
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    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 Nov. 4, 2021
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    Novartis
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    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 Nov. 4, 2021
  • Glass vials of Moderna COVID-19 vaccine.
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    Gabriel Kuchta via Getty Images
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    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
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    Jens Schlueter via Getty Images
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    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
  • A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England.
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    Dan Kitwood via Getty Images
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    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
  • A stylized illustration of a "patent thicket" for Jonathan Gardner's Nov. 1 story on Amgen's Enbrel.
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    Adeline Kon / BioPharma Dive/BioPharma Dive
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    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 Nov. 1, 2021
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    Alex Wong via Getty Images
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    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 Oct. 29, 2021
  • A photo of Merck & Co. and Ridgeback's molnupiravir being manufactured.
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    Courtesy of Merck & Co.
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    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 Oct. 28, 2021
  • A technician at a Takeda Pharmaceutical laboratory works on cancer cell therapies
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    Courtesy of Takeda Pharmaceutical
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    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
  • A photo of Merck & Co. and Ridgeback's molnupiravir being manufactured.
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    Courtesy of Merck & Co.
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    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
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    Courtesy of Eli Lilly
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    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 Oct. 26, 2021
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    Novartis
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    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
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    Sergio Flores via Getty Images
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    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 Oct. 25, 2021
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    Permission granted by Novartis
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    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
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    Permission granted by Roche
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    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 Updated Oct. 25, 2021
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    Lisa Maree Williams via Getty Images
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    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 , Ned Pagliarulo • Updated Oct. 24, 2021
  • A podium showing the logo for the Centers for Disease Control and Prevention is seen.
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    Kevin C. Cox via Getty Images
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    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
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    Jens Schlueter via Getty Images
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    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 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