Manufacturing
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Catalent cuts outlook, delays results as it reveals new hurdles
The pharmaceutical CDMO said it found “significant” issues with its forecasts over the past year, compounding manufacturing problems at three of its plants.
By Ned Pagliarulo • May 8, 2023 -
Baxter to sell biopharma unit to private equity for $4.25B
The deal is the latest in a string of private equity-backed deals for contract development and manufacturing businesses in the pharmaceutical sector.
By Elise Reuter • May 8, 2023 -
Obesity drugs
Novo reveals another setback in obesity drug’s launch
U.S. supply of Novo’s Wegovy will be “reduced temporarily,” while the Danish drugmaker gets a new contract manufacturer up and running, executives said.
By Jonathan Gardner • May 4, 2023 -
Pfizer turns focus to new drugs as COVID vaccine revenue falls
The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.
By Jonathan Gardner • May 2, 2023 -
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 -
Sponsored by MilliporeSigma
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 -
Sponsored by West Pharmaceutical Services
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 -
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 -
Sponsored by Stevanato Group
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 -
Sponsored by MMIT
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 -
Sponsored by Miltenyi Biotec
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 -
Mateusz/Shutterstock.com
Sponsored by Emergent BiosolutionsThe 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 -
Sponsored by Aldevron
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 -
Sponsored by Aldevron
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