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

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

Explore the 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

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

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 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

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

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

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

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

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

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 Meagan Parrish • May 17, 2023

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

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

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 Taren Grom • Jan. 9, 2023