• Novartis gets second trial win for blockbuster hopeful

    The company plans to seek broad approval of the oral medication, iptacopan, next year after it met its primary endpoint in a new pool of patients with the rare blood disease PNH.

    By Kristin Jensen • Dec. 8, 2022
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    Sarah Silbiger via Getty Images

    MEI, Kyowa stop lymphoma drug trials after FDA meeting

    The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

    By Dec. 6, 2022
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Explore the Trendline
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    COVID-19 vaccines and the pandemic's third year

    The urgency of the pandemic’s first two years is giving way to questions of how to sustain public health responses and prepare for what could come next. In the U.S., health officials are urging booster shots and preparing for private sector distribution of vaccines.

    By BioPharma Dive staff
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    Elizabeth Regan / Industry Dive

    J&J drops out of hunt for Horizon, leaving Sanofi and Amgen to bid

    The two remaining suitors said they would make cash bids if they move forward with offers, for which they must declare “firm intent” by Jan. 10 under Irish takeover rules.

    By Dec. 5, 2022
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    J&J’s Duato to replace departing Gorsky as board chair

    The board reshuffling will consolidate Duato’s leadership of J&J as the company absorbs a big medtech acquisition and nears a planned spin out of its consumer health division.

    By Dec. 2, 2022
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    Brian Tucker / BioPharma Dive

    Large pharmas probe takeover of Horizon Therapeutics

    The Dublin-headquartered drugmaker confirmed it is in "highly preliminary" talks with Amgen, J&J and Sanofi, although it cautioned no offer may ever materialize.

    By Updated Nov. 30, 2022
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    iStock via Getty Images

    Roche pulls Tecentriq in bladder cancer, completing sweep of ‘dangling’ accelerated approvals

    The pharma will no longer market the immunotherapy in the U.S. for urothelial carcinoma, the indication for which the drug was first approved six years ago.

    By Nov. 29, 2022
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    Sponsored by Cognizant

    Is your gross-to-net strategy ready for uncertainty?

    Whether economic times are good, bad or somewhere in between, life science companies benefit from a holistic, centralized approach, including technological, financial, operational and regulatory considerations for GtN management and predictability of GtN rates.

    Nov. 28, 2022
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    Md Ariful Islam via Getty Images

    Novartis, research group to advance new kind of malaria drug into late-stage test

    The Swiss pharma and the Medicines for Malaria Venture plan to start a Phase 3 trial of a non-artemisinin combination treatment next year.

    By Nov. 23, 2022
  • A wall showing a Merck & Co. logo in Kenilworth, New Jersey
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    Courtesy of Merck & Co.

    Merck to buy blood cancer biotech Imago for $1.35B

    The deal is Merck’s second notable acquisition in the past year and a half, part of a strategy to diversify its pipeline beyond the top-selling Keytruda.

    By Nov. 21, 2022
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    Courtesy of Merck KGaA

    Merck KGaA outlines plan to rev up drug R&D

    The German company aims to, on average, launch a new medicine or major treatment indication every 18 months in a bid to boost its pharma business.

    By Nov. 21, 2022
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    Courtesy of Teva Pharmaceutical

    Teva taps Sandoz veteran to take over CEO post from Schultz

    Richard Francis will take over for the retiring Kåre Schultz on Jan. 1. He’ll face major challenges at Teva, including opioid settlements, biosimilar launches and reducing the company’s debt.

    By Nov. 21, 2022
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    Pfizer, BioNTech start study testing next COVID-19 vaccine

    The new candidate is meant to provide broader immunity over a longer period of time and is part of the companies’ strategy to stay ahead of a shifting coronavirus threat.

    By Nov. 17, 2022
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    Regeneron teams up with CytomX to develop dual-targeting cancer drugs

    Regeneron will pay CytomX $30 million to try to create bispecific antibody drugs that are safer and have a wider reach than existing treatments.  

    By Nov. 17, 2022
  • Q&A // Emerging biotech

    Eli Lilly’s Julie Gilmore on finding up-and-coming companies and backing small biotechs

    Only a small fraction of the companies Lilly evaluates get into its incubator, according to Gilmore. Here’s how the big pharma selects them.

    By Nov. 15, 2022
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.

    Trial failures end latest hope for Roche’s Alzheimer’s drug

    Eight years after gantenerumab failed a Phase 3 study, the drug came up short in late-stage testing again, proving unable to meaningfully slow cognitive decline in two closely watched trials. 

    By , Nov. 14, 2022
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    Sponsored by Lumanity

    Crossing the new real world data landscape

    Learn about key factors and trends in RWE and why a data luminary is crucial to your success.

    Nov. 14, 2022
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    Courtesy of GSK Flickr page

    Under FDA pressure, GSK limits use of ovarian cancer drug

    The drugmaker’s decision is the latest fallout from safety concerns that have emerged in testing of so-called PARP inhibitors, resulting in withdrawals by Merck & Co., AstraZeneca and Clovis Oncology. 

    By Nov. 11, 2022
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    EMA backs restrictions on certain immune-regulating drugs

    Once the European Commission signs off, use of several so-called JAK inhibitors sold by Eli Lilly, Pfizer and other drugmakers will be limited among smokers and patients who are at high risk of certain health complications. 

    By Nov. 11, 2022
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    zorazhuang via Getty Images

    Pharma earnings outline drug law’s looming impact on sales, development

    While many companies are still unsure of the Inflation Reduction Act's effects, some have begun to warn investors about the likelihood of lower sales and reduced profitability.

    By Nov. 9, 2022
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    National Cancer Institute \ USC Norris Comprehensive Cancer Center

    Ipsen drug shows benefit in pancreatic cancer, lifting shares of ghost company

    Adding Onivyde to chemotherapy helped patients live longer, a finding that could result in increased payouts to shareholders in the drug’s developer, Merrimack, which laid off all of its employees in 2019. 

    By Nov. 9, 2022
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    Amgen Inc.

    Early data hint at benefit for Amgen’s obesity drug

    Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.

    By Nov. 8, 2022
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    Courtesy of Novavax

    Novavax details trial results for omicron-targeting booster shots

    A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.

    By Nov. 8, 2022
  • A corporate building is seen with a sign for the company Viatris
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    Courtesy of Viatris

    Viatris to buy two eye drug developers in deals worth up to $750M

    The generics company is acquiring Oyster Point Pharma and the privately held Famy Life Sciences in a move aimed at creating an ophthalmology business.

    By Updated Nov. 7, 2022
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    Courtesy of GSK

    GSK myeloma drug comes up short in confirmatory test

    The drug, Blenrep, did not outperform a standard treatment in relapsed or refractory multiple myeloma, setting back GSK's plans to confirm the conditional approval it received in 2020.  

    By Nov. 7, 2022
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    Sponsored by flipMD from GoodRx

    flipMD by GoodRx helps physicians create hybrid careers to reduce burnout

    Using flipMD, organizations can find, vet, connect with and source practicing board-certified physicians from all specialties for contract, project-based or full-time assignments.

    Nov. 7, 2022