Sun’s factory is under Import Alert until it becomes compliant with FDA and cGMP standards, while Hikal was hit with a warning letter due to repeated metal contamination.
Sept. 12, 2025
Despite industry setbacks with adeno associated virus-based gene therapy programs, the issue is “largely overblown” for Repligen, contend Leerink Partners analysts.
Sept. 11, 2025
Software platforms can seamlessly integrate with emerging technologies to unlock efficiencies, strengthen sustainability and enable proactive prevention of disruptions.
Sept. 10, 2025
William Blair analysts contend the Swiss-headquartered CDMO has a leading position in the attractive, but often underappreciated, small-molecule drug manufacturing space.
Sept. 9, 2025
The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.
Sept. 8, 2025
Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&D facilities. What if it’s not accurate?
Sept. 5, 2025
The India-based CDMO’s 80,000 square-foot facility in Hopewell, New Jersey includes drug substance manufacturing suites, laboratories, storage, dispensing and warehousing.
Sept. 4, 2025
The family-owned business is expanding capacity for handling complex injectables, while positioning for growth in drug product development, device assembly and packaging.
Sept. 3, 2025
Having an effective strategy so products remain free from contaminants is essential to pharmaceutical manufacturing to prevent delays, product recalls, and patient harm.
Sept. 2, 2025
A second report in as many weeks makes the case that Indian CRDMOs are positioned to take advantage of a global supply chain shakeup and Chinese firms stand to lose.
Aug. 29, 2025
In a cabinet meeting, President Trump ratcheted up pressure on drugmakers as HHS Secretary Robert F. Kennedy Jr. said his department is “deep” into MFN negotiations.
Aug. 28, 2025
Of about $350 billion in U.S. investments announced in 2025, approximately half of the capital expenditures were previously planned or have already occurred, finds CBRE.
Aug. 27, 2025
While Jefferies analysts predict Cohance Lifesciences is poised to achieve the highest growth rate among Indian firms, Sai Life Sciences is their top pick in the sector.
Aug. 26, 2025
The CDMO acquired the 128,000-square-foot cell and gene therapy facility in Hopewell last year, which is now ProBio’s North American hub.
Aug. 25, 2025
This week, J&J pledged $2 billion to establish a 160,000-square-foot facility at contract manufacturer Fujifilm Biotechnologies’ new biomanufacturing site in North Carolina.
Aug. 22, 2025
Climate change-driven extreme weather events threaten the pharmaceutical supply chain in the U.S., with 62.8% of facilities in disaster-prone counties, finds new research.
Aug. 21, 2025
William Blair analysts have initiated coverage of Thermo Fisher and expect the company to build on its status as the “partner of choice” for the biopharma industry.
Aug. 20, 2025
Outsourced R&D and manufacturing offers substantial cost efficiency, driven by specialized expertise, economies of scale, and access to skilled talent, finds Ind-Ra.
Aug. 19, 2025
Co-CEO Minzhang Chen says the increasing size and complexity of drug molecules require greater knowledge and a sophisticated approach.
Aug. 18, 2025
Stockpiling active pharmaceutical ingredients for critical drugs is prudent. However, domestic production of prioritized auxiliary chemicals must be part of strategy.
Aug. 15, 2025
The Assistant Secretary for Preparedness and Response must come up with a list of approximately 26 drugs, secure a six-month supply, and prioritize domestic sourcing.
Aug. 14, 2025
The industry’s robotics market showed the strongest sector growth in the second quarter of 2025, according to new data from the Association for Advancing Automation.
Aug. 13, 2025
While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.
Aug. 12, 2025
The contract manufacturer has 11 late-stage projects with commercial approval potential within the next few years, including a developer of GLP-1 therapeutics for obesity.
Aug. 11, 2025
President Donald Trump’s playbook is to threaten outrageously high industry-specific tariffs in the hope of pressuring drugmakers to come running back to this country.
Aug. 8, 2025
The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.
Aug. 7, 2025
President Trump told CNBC his administration would initially levy a “small” pharma-specific tariff, followed by an increase to 150% in a year or so and then as high as 250%.
Aug. 6, 2025
While the facility has had several run-ins in recent years with U.S. regulators, selling the site is part of Lilly’s broader global manufacturing strategy.
Aug. 5, 2025
The Bloomington, Indiana facility is a fill-finish site for Regeneron’s Eylea HD and odronextamab and handles the final stages of drug preparation and packaging.
Aug. 4, 2025
The agreement includes a 15% tariff on branded pharmaceutical products imported from the European Union to the United States, elevating costs across the pharma value chain.
Aug. 1, 2025