Manufacturing
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PharmaVoice 100
2024 PharmaVoice 100s: Cell and Gene Therapy Pioneers
Leaders molding the cutting-edge cell and gene therapy field into tomorrow's cures.
By Michael Gibney • Oct. 30, 2024 -
Backlash builds against Novo’s Catalent takeover
Roche recently joined naysayers who argue the deal threatens competition in the burgeoning weight loss and diabetes drug market.
By Amy Baxter • Oct. 30, 2024 -
Trendline
Cell and gene therapies
How the industry is overcoming hurdles in cell and gene therapy space and pushing for the next generation of treatments.
By PharmaVoice staff -
Dengue is spreading and Sanofi is pulling the U.S. market’s only vaccine. What’s next?
As Sanofi prepares to halt production on its dengue vaccine in 2026, locally acquired infections in the U.S. are raising the alarm.
By Alexandra Pecci • Oct. 23, 2024 -
Q&A
‘It’s been hard to watch.’ A noted epidemiologist talks H5N1 and the U.S.’s fragmented response.
Katelyn Jetelina, well known for her newsletter “Your Local Epidemiologist,” digs into the H5N1 outbreak, the public health response and what’s next for vaccinations.
By Alexandra Pecci • Oct. 9, 2024 -
Novo plans new plant as it races to meet drug demand
The new factory, which Novo is committing some $220 million to build, will supply raw materials for the company’s chronic disease medicines.
By Ned Pagliarulo • Aug. 19, 2024 -
Can robots break the cell therapy bottleneck?
A partnership between the cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could bring the manufacturing bottleneck under control, the CEOs said.
By Michael Gibney • May 29, 2024 -
FTC request may signal trouble for Novo/Catalent deal
As Novo Nordisk aims to secure its manufacturing foothold for GLP-1s, regulators are digging for clues of anti-competitive behavior.
By Kelly Bilodeau • May 29, 2024 -
3 up-and-coming US biotech hotspots
These three U.S. cities are putting themselves on the biotech map as unsung hubs of the industry.
By Alexandra Pecci • May 21, 2024 -
As Lilly surges, headwinds against its weight loss drugs are growing
After missing analysts’ earnings expectations for Mounjaro sales in the first quarter due to overwhelming demand, Lilly is also dealing with a legal loss and incoming pricing questions from lawmakers.
By Amy Baxter • May 15, 2024 -
As drug shortages reach record highs, regulators float next steps
With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.
By Kelly Bilodeau • May 6, 2024 -
FDA’s new diagnostic rules draw pharma criticism
Tests frequently used in clinical trials will soon be regulated like medical devices — with some exceptions.
By Amy Baxter • May 6, 2024 -
As Lilly and BMS invest in manufacturing, demand for drugs still outweighs supply
From popular weight loss drugs to lifesaving cancer therapies, recent pharma deals show the industry is doubling down on manufacturing capacity to meet demand.
By Michael Gibney • April 25, 2024 -
Q&A
Former U.S. patent head on why federal march-in rights for drugs would be a ‘devastating’ mistake
A Biden administration proposal to seize patents for drugs deemed too pricey would have a ripple effect that cuts into the heart of innovation, says former U.S. PTO head Andrei Iancu.
By Michael Gibney • March 14, 2024 -
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 Amy Baxter • March 1, 2024 -
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 -
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 -
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 Meagan Parrish • Oct. 27, 2023 -
3 recent FDA adcomm rejections — and why they matter
Decisions that could spell doom for drugs in development and already on the shelves.
By Meagan Parrish • Sept. 29, 2023 -
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 Michael Gibney • Aug. 30, 2023 -
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 -
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 Meagan Parrish , Karissa Waddick • Aug. 14, 2023 -
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 -
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 Michael Gibney • July 19, 2023 -
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 -
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