Pharma


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    Novartis

    Novartis pays $150M for access to UCB's Parkinson's drug

    UCB's experimental pill is one of the most advanced projects that's aimed at blocking accumulation of an abnormal protein in patients' brains.

    By Dec. 2, 2021
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    Courtesy of Merck & Co.

    FDA panel, after debate, narrowly backs Merck COVID pill

    While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.

    By Updated Nov. 30, 2021
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
    Trendline

    Inside the race to bring coronavirus vaccines to the world

    More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

    By BioPharma Dive staff
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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 Nov. 30, 2021
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    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 Nov. 29, 2021
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    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 Nov. 26, 2021
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    Dr_microbe via Getty Images

    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
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    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 Nov. 23, 2021
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    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 Nov. 22, 2021
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    XH4D via Getty Images
    Sponsored by Altasciences

    Nanomilling: 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 Nov. 19, 2021
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    Sarah Silbiger via Getty Images

    FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

    Soon after the FDA's authorization, a panel of CDC advisers followed with similar recommendations for third doses in adults over 18 years old. 

    By Updated Nov. 20, 2021
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    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 Nov. 18, 2021
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    Getty Images

    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 , Nov. 18, 2021
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    Courtesy of 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
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    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 Nov. 16, 2021
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    Win McNamee via Getty Images

    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 Nov. 16, 2021
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    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 Nov. 16, 2021
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    Permission granted by IQVIA

    Sponsored by IQVIA

    Establishing 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
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    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 , Updated Nov. 12, 2021
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    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 Nov. 9, 2021
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    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 Nov. 9, 2021
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    Permission for use granted by IQVIA

    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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    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
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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/.

    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
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    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