Manufacturing


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    After ‘tragic’ bacterial outbreak, lawmakers press FDA to step up foreign inspections

    Impatience to fix long-held challenges to overseas drug facility inspections is growing on Capitol Hill.

    By March 1, 2024
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    Courtesy of Kite Pharma, Inc.
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    Kite’s next-gen CAR-T aims include quicker production and more disease targets

    While buzz builds around “off the shelf” CAR-T cell therapies, Kite is staying competitive with a shorter manufacturing turnaround and a focus on broadening applications.

    By Kelly Bilodeau • Feb. 20, 2024
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    Trendline

    Artificial intelligence & machine learning

    After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

    By PharmaVoice staff
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    3 questions hanging over the Novo-Catalent deal

    As backlash builds for the recently announced matchup, critical questions remain over its impact.

    By Kelly Bilodeau • Feb. 13, 2024
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    Q&A // Red Jacket winners 2023

    Red Jacket: Helen Sabzevari, an immunotherapy pioneer

    Precigen’s CEO is pushing for her next therapeutic breakthrough with innovative cell and gene therapy platforms.

    By Oct. 27, 2023
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    3 recent FDA adcomm rejections — and why they matter

    Decisions that could spell doom for drugs in development and already on the shelves.

    By Sept. 29, 2023
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    Finding the right flu vaccine is hard. Getting people to take it is harder.

    Experts have determined the strains of this year’s flu season — now the question is whether people are too fatigued by the pandemic to be immunized.

    By Aug. 30, 2023
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    Drug shortages: The ‘fundamental problem’ that has pharma’s top regulator ‘fired up’

    FDA Commissioner Robert Califf suggested larger reforms are needed to bolster the generic drug industry and prevent future medication shortages. 

    By Karissa Waddick • Aug. 25, 2023
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    Pharma’s rare disease rush

    Biogen’s acquisition of Reata Pharmaceuticals is the latest in a string of high-dollar rare disease deals over the last few months. What does it mean for industry?

    By , Karissa Waddick • Aug. 14, 2023
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    Biosimilar makers split strategies in bid to take on top-selling Humira

    In challenging AbbVie for share of a $19 billion drug market, competitors are testing whether high upfront discounts or behind-the-scenes rebates can win them an advantage.

    By Jonathan Gardner • July 26, 2023
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    Q&A

    As biologics boom, here’s how manufacturers are keeping up

    Stevanato’s focus on biologic-related vials and delivery devices has put it in a unique position amid a quickly growing market.

    By July 19, 2023
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    Boosting the cell and gene therapy workforce with a skilled, localized approach

    Experts provide a roadmap for how the industry can work with academia to ensure a robust talent pipeline for the burgeoning field.

    By Karissa Waddick • June 15, 2023
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    Drugmakers feel the squeeze as cost pressures mount

    Supply chain challenges have eased — but now inflation and manufacturing complexity are triggering a new sense of urgency to bring costs down.

    By Kelly Bilodeau • June 5, 2023
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    Strangers in a strange land: 8 unlikely companies making plays in pharma

    How these consumer and service companies are tapping into major trends in the biopharma industry.

    By Karissa Waddick • May 22, 2023
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    Profile

    A day in the life of a pharma exec: Lyndra’s Patricia Hurter

    How the CEO starts each day with a ride on one of her horses, reduces daily meetings and uses her network to get through crises like the SVB Bank collapse.

    By May 17, 2023
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    Where one unicorn struggled, another biotech is aiming for a diabetes win

    Intarcia looked poised to break into a lucrative diabetes implant market but has been dogged by safety issues — now Vivani thinks it’s found a way to succeed.

    By Kelly Bilodeau • April 10, 2023
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    Staff shortages cause slowdowns in booming cell and gene therapy market

    New reports highlight the need for more targeted biotech education curriculums to shore up a sustainable workforce.

    By Karissa Waddick • April 3, 2023
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    Q&A // Biotech Spotlight

    Gracell Biotechnologies’ quest to unlock the CAR-T bottleneck

    The biotech hopes to upend the CAR-T category by cutting manufacturing from weeks to hours and developing a first-line cell therapy.

    By Jan. 9, 2023
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    Opinion

    The 2023 PharmaVoice Crystal Ball: Peering into the future of life sciences

    A preview of the top trends on the minds of industry and market leaders for the new year.

    By Jan. 3, 2023
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    Q&A

    A historic approval could transform CSL from being ‘the biggest company no one has ever heard of’

    The company’s head of R&D on its profile-raising FDA approval of a gene therapy that’s now the world’s most expensive drug. 

    By Dec. 6, 2022
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    While CAR-T wait times remain ‘heartbreaking,’ researchers push for innovations that could help

    Facing an unprecedented manufacturing bottleneck, a new coalition is aiming to create the next generation of CAR-T therapies.

    By Nov. 8, 2022
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    How Europe’s energy crisis is impacting pharma

    Inflationary pressures and rising energy costs could further expedite the movement of generics manufacturing from Europe to Asia if governments don’t step in.

    By Karissa Waddick • Nov. 2, 2022
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    Sponsored by Phil, Inc.

    Developing a channel strategy that optimizes gross to net

    Today, pharma manufacturers face unprecedented GTN challenges. To unlock sustainable brand growth, a value-aligned channel strategy is pivotal.

    Oct. 31, 2022
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    Backed by celebrity interest, Novo is finding new success in weight loss — while staying true to its roots

    The company's head of U.S. and Canadian operations explains how it’s evolving its game plan after 100 years in the insulin space.

    By Oct. 25, 2022
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    5 impactful drug trial failures from the last year

    Major recent trial flops and what they mean for companies, patients and the industry.

    By Oct. 19, 2022
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    Making Moves

    C-suite shake-ups at 23andMe, Moderna signal new stages of growth

    With their latest personnel moves, these life sciences companies are preparing for major business shifts.

    By Karissa Waddick • Oct. 5, 2022