Bristol Myers boosts cell therapy production with Novartis plant

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

By Kristin Jensen • April 26, 2023

Novartis plant cleared to produce in-demand cancer drug

The FDA has approved the pharma, which has had difficulty producing radiopharmaceutical drugs, to make its treatment Pluvicto at a New Jersey site.

By Delilah Alvarado • April 24, 2023

FDA again knocks back Alvotech’s Humira biosimilar

The agency rejected the partners’ copycat version of AbbVie’s blockbuster drug for a second time, citing problems spotted during the inspection of a manufacturing facility.

By Jonathan Gardner • April 14, 2023

Pharma partner Sartorius eyes gene therapy market with $2.6B deal

The biotech tools supplier is acquiring Polyplus, a French company that makes components essential to the viral vector backbones of gene therapies.

By Ned Pagliarulo • March 31, 2023

Early decisions to de-risk the transition to combination products

Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing. 

March 20, 2023

Addressing manufacturing challenges in gene therapy development

As new gene therapies are developed to treat a growing number of indications, patients may soon have access to novel treatment options and potential cures.

By Kate Silver • March 20, 2023

Sandoz, betting on biosimilar sales, to build new production plant

The Novartis division will invest at least $400 million in a new manufacturing facility in Slovenia amid expectations that demand for copycat biologics will surge in the coming years.

By Delilah Alvarado • March 9, 2023

Novartis takes step toward expanding supply of in-demand cancer drug

The company has struggled to maintain supply of its prostate cancer drug Pluvicto, hampered by production issues and higher-than-expected demand.

By Delilah Alvarado • March 3, 2023

A startup launches with plans to open up a gene and cell therapy bottleneck

The pipeline of CAR-T therapies and ex vivo gene therapies has swelled in recent years, but manufacturing hasn’t been able to keep up with demand.

By Gwendolyn Wu • Jan. 31, 2023

Lilly to boost diabetes drug production with $450M factory investment

The pharma aims to double its manufacturing capacity for drugs like Mounjaro and Trulicity as competition with rival Novo Nordisk heats up.

By Jonathan Gardner • Jan. 24, 2023

The inspection challenges posed by the self-administration trend

Automatic visual inspection: rising to the challenges of syringe inspection. 

Dec. 19, 2022

Novo Nordisk to boost drug manufacturing in Denmark

The Danish drugmaker has invested heavily in expanding its production capacity for oral and injectable drugs. A new $744 million project is the latest investment.

By Christopher Newman • Nov. 22, 2022

Integrating lab data into your physician engagement strategy: 5 key benefits

Normalized lab data can help pharma companies promote their therapies to a targeted audience. 

By Ritupriya Yamujala • Nov. 14, 2022

Modular plug-and-produce facilities for cell therapies

Commercial-scale production is pivotal for the success of cell therapy. Is modularity the solution?

Nov. 7, 2022

FDA again delays review of Amicus rare disease drug

For the second time this year, the agency has put off a decision on Amicus' therapy for Pompe disease. European regulators are also reviewing the treatment and could soon issue an opinion.

By Christopher Newman • Oct. 31, 2022

The demand for nanoparticles in drug formulation is rising

Collaborating with an experienced partner, such as a Contract Development & Manufacturing Organization (CDMO), could prove to be invaluable in developing nano-based systems.

By Kate Silver • Oct. 17, 2022

Expediting IND applications with drug master files

By taking advantage of pre-filed DMFs, researchers benefit from the value, time savings and reduced complexities of having someone else do the heavy lifting for key components of the final drug product.

Oct. 10, 2022

Merck expands Singapore hub to support Keytruda, Gardasil

The company opened a packaging facility for its two top-selling products and began work on a plant that will produce next-generation inhalers.

By Christopher Newman • Oct. 6, 2022

BioNTech to build an mRNA hub in Australia

A new agreement with the Australian government will bring messenger RNA research and manufacturing capabilities to the country, adding to the COVID-19 vaccine developer’s global expansion efforts. 

By Delilah Alvarado • Oct. 6, 2022

Takeda to stop making parathyroid drug Natpara in 2024 after production challenges

The Japanese drugmaker said it was unable to resolve manufacturing problems that led to a 2019 recall of the drug, which treats hypoparathyroidism.

By Christopher Newman • Oct. 4, 2022

Standardized materials: Meeting the demand for gene therapies

With supply and labor constraints creating backlogged custom-manufacturing schedules, developers have felt the pain in cost and speed to market.

Sept. 26, 2022

Novartis funnels $300M into early biologic drug manufacturing

The investment is meant to improve Novartis’ capacity for developing and manufacturing biologic medicines that make up a larger share of its pipeline. 

By Christopher Newman • Sept. 12, 2022

FDA holds back Alvotech’s Humira biosimilar over manufacturing issues

The company received a complete response letter, but still expects to win approval of the copycat drug in time to launch it in the U.S. next year.

By Jonathan Gardner • Sept. 6, 2022

‘Treg’ startup Sonoma expands with plans for manufacturing plant

The biotech, launched by immunologist Jeffrey Bluestone, is developing regulatory T cell therapies for autoimmune and inflammatory diseases.

By Ned Pagliarulo • Aug. 24, 2022

US speeds rollout of monkeypox vaccine, treatment

The Biden administration next week will provide 1.8 million doses of the Jynneos vaccine and 50,000 courses of antiviral Tpoxx to states and local governments.

By Christopher Newman • Aug. 19, 2022