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

Bristol Myers CAR-T sales rise despite production problems

Demand has increased faster than Bristol Myers can make Abecma, although the company said supply is improving. A manufacturing issue for Breyanzi, meanwhile, impacted sales. 

By Ned Pagliarulo • July 27, 2022

California to manufacture its own insulin, governor says

Gov. Gavin Newsom announced a $100 million budget to create a production facility and to develop affordable insulin products, saying the medicines’ high cost “epitomizes market failures.”

By Susan Kelly • July 11, 2022

Resilience, a well-funded manufacturing startup, joins with the Parker Institute to make cancer drugs

The unusual biotech, which just raised $625 million earlier this week, will work with the immunotherapy center under a five-year agreement to create and spin off new companies.

By Kristin Jensen • June 9, 2022

Astellas, despite recent setbacks, opens $100M gene therapy plant

The opening of the plant, which could create more than 200 new jobs, comes on the heels of several significant issues with the company’s most advanced gene therapy program.

By Jacob Bell • June 8, 2022

Pfizer to invest $120M, add jobs in Paxlovid production push

After initially struggling to meet demand for Paxlovid, Pfizer is putting significant resources toward expanding an important manufacturing plant in Michigan.

By Delilah Alvarado • June 7, 2022

Why choosing the right primary container is crucial

New mRNA technology: identifying the right drug containment solution is more important than ever.

May 16, 2022

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.  

By Ned Pagliarulo • May 6, 2022

Seagen to expand, add jobs with new cancer drug factory

While some biotechs are restructuring amid a market downturn, SeaGen plans to add 200 positions through a large manufacturing plant that should be operational in 2024.

By Jacob Bell • April 21, 2022

Gilead gets cell therapy boost with FDA clearance of Maryland factory

The new site in Maryland will be used to produce Yescarta, which this month won an expanded approval that substantially widens its market.

By Ned Pagliarulo • April 19, 2022

Sanofi API spinout takes step toward market listing

French regulators have approved plans by Sanofi to list the new EUROAPI business on Euronext Paris beginning May 6.

By Ned Pagliarulo • April 1, 2022

Novartis turns cell therapy skill into contract manufacturing deal

In an unusual arrangement, the Swiss pharma will make Carisma Therapeutics' experimental cell therapy at its Morris Plains factory, part of its plans to build up a CMO business.

By Ned Pagliarulo • March 10, 2022

Novo sees fast growth ahead of obesity drugs despite production hurdles

The Danish drugmaker aims to triple sales of its weight loss treatments Wegovy and Saxenda by 2025. But first, Novo needs to resolve manufacturing constraints that have slowed the former drug's launch. 

By Ned Pagliarulo • March 4, 2022

Atara sells cell therapy plant to Fujifilm for $100M

The site, which specializes in manufacturing off-the-shelf immunotherapies, was once a key asset for Atara. New owner Fujifilm will still supply the biotech under a long-term agreement.

By Ned Pagliarulo • Jan. 27, 2022

3 ways an IWMS can help streamline your manufacturing operations

Manage, maintain and optimize all the tasks, duties and goals that fall under the umbrella of your workplace.

Jan. 24, 2022