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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.

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    Permission granted by Biogen
    Biogen's new Alzheimer's drug

    European drugs regulator signals rejection likely for Biogen's Aduhelm

    A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month.

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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.

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    Permission granted by Biogen
    Biogen's new Alzheimer's drug

    Al Sandrock, Biogen's top scientist and Aduhelm defender, to retire in surprise exit

    Sandrock championed the controversial Alzheimer's drug, and was integral to the development of several other of Biogen's most important medicines during his 24 years at the biotech. 

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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.

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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.

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    Permission granted by Chroma Medicine

    A startup emerges with $125M and plans to edit the epigenome

    Chroma Medicine's launch is the latest step in a decadeslong quest by drugmakers to capitalize on research into epigenetics, a way of controlling gene expression without altering DNA.

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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.

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    Permission granted by Ed Shipman for Mass Eye and Ear
    Deep Dive

    Years later, a first-of-its-kind treatment shows the power, and limits, of gene therapy

    Luxturna, approved four years ago as the first gene therapy for an inherited disease in the U.S., is improving sight and quality of life for several of the patients who received it.

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    Permission granted by Biogen
    Biogen's new Alzheimer's drug

    Anticipating Aduhelm's costs, Medicare plans big jump in premiums

    While CMS is still weighing whether to authorize wide coverage of Biogen's pricey Alzheimer's drug, administrators are planning to build reserves in case costs skyrocket.

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    Win McNamee via Getty Images

    Biden nominates Robert Califf to return as FDA head

    If confirmed by Congress, the cardiologist would return to lead an agency facing weighty questions on COVID-19, a new user fee agreement and department staffing. 

    Updated Nov. 12, 2021
    FDA
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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. 

    Updated Nov. 12, 2021
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    Permission granted by Cortexyme

    Cortexyme plans path forward for Alzheimer's drug that failed study

    Detailed trial results presented last week are "interesting," one Alzheimer's expert said, but there are still "many challenges and uncertainties" with Cortexyme's unorthodox approach to treating the disease.

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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.

    Detailed Roche study results muddy another Alzheimer's hypothesis

    Data presented at an Alzheimer's meeting raised more questions about the seeming benefit of Roche and AC Immune's drug semorinemab, which they claim is the first of its kind to slow deterioration of memory.

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    Maddie Meyer via Getty Images

    Moderna, escalating dispute with NIH, claims government had no role in key vaccine patent

    The biotech claimed its NIH partners were involved only after a key discovery was made "by Moderna scientists using Moderna technology." The dispute could end up in court.

  • FibroGen cuts jobs as it weighs anemia drug's future in US

    The company, which had its treatment rejected by the FDA in August, eliminated 30 jobs and 70 open positions. An upcoming meeting with the agency looms as a key event.

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    Courtesy of Alltrna

    Moderna founder unveils new drug company focused on a different kind of RNA

    Encouraged by Moderna's success, Flagship Pioneering has been busy creating startups like Alltrna, which launched Tuesday. The biotech is researching how to make medicines from transfer RNA molecules.

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    Permission granted by Biohaven Pharmaceuticals

    Pfizer buys into Biohaven's fast-selling migraine medicine

    The pharmaceutical giant will pay Biohaven $500 million for ex-U.S. rights to rimegepant — a sizable licensing deal, though not the buyout that some of the biotech's investors appeared to be hoping for.

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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. 

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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.

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    National Cancer Institute, NIH

    Mirati gives first look at KRAS drug combination in lung cancer

    Study results for Mirati's drug combined with Keytruda have been much anticipated, as the San Diego biotech aims to challenge Amgen and its rival KRAS-blocking drug Lumakras.

    Updated Nov. 8, 2021
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    Artur Plawgo via Getty Images

    Beam gets green light to begin first clinical test of base editing

    Alongside the milestone, the gene editing biotech also announced John Maraganore, who will soon step down as Alnylam's CEO, will join its board.

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    Courtesy of Sanofi

    Eye-focused gene therapy startup gets $60M cash infusion from Sanofi

    Shortly after postponing a $135 million IPO, Gyroscope has found another way to back a treatment for a disease that's become a top target of multiple drugmakers.  

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    Kena Betancur via Getty Images

    Blackstone continues biotech push with up to $250M cell therapy investment

    The investment in CAR-T maker Autolus Therapeutics adds to a string of biotech deals the private equity firm has made since 2018.

  • Image attribution tooltip
    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.