Almac Group has invested £30m ($41.65) to expand its clinical and commercial drug supplies capabilities at its European Campus in Ireland as it prepares for the UK’s exit from the EU.
Ipca Laboratories, a fully-integrated Indian pharmaceutical company, has purchased an NC-based CMO in a $9.65m deal that will enable it to manufacture small volume APIs for the US market.
Massachusetts biopharma companies received $2.9bn in venture capital investment in 2016 – and as pressure continues to accelerate the drug development process, manufacturers will continue to turn to CROs and CMOs, says MassBio.
Frontida BioPharm has made an equity investment in Oncoceutics as part of a product development and commercialization agreement to advance the company's lead compound.
The European Commission has publish a draft revision of its GMP guidelines on the production of sterile drugs with tweaks to recommendations on clean rooms, sealing technologies and single-use systems.
Recipham has agreed to pay the founders of Nitin Lifescience Limited INR2.8bn ($44m) for the remaining 26% stake they own in the India-based drug manufacturer.
Outsourcing models examined, market shifts scrutinized, and trial tribulations analyzed – take a look back at some of the top reports published in 2017.
TxCell SA has developed the production process for it range of CAR-Treg based therapies and is preparing to transfer it to its CMO ahead of first-in-human trials.
Merck KGaA says it will provide technology and training to a local team in Sub-Saharan Africa, to help establish a dedicated human vaccine manufacturing facility.
Harpoon Therapeutics has selected CMC Biologics to develop and manufacture three molecules for cancer treatments at the CDMO’s facilities in California and Washington State, US.
Augmented reality has unlimited potential and will address the pharmaceutical industry’s need for greater control over efficiency, safety, and reliability, says Apprentice CEO.
Three-dimensional printing technology is attracting increased attention from the US FDA say Aprecia and Cycle, which have announced a partnership to develop 3D-printed orphan drugs.
Only eight of the top 40 CROs are Privacy Shield Framework-certified, says Science Exchange CEO as the company continues to rack up partnerships with pharma companies looking to streamline outsourcing efforts and mitigate risk.
By Sudip S. Parikh, PhD, senior vice president & managing director, DIA Americas
The healthcare product development ecosystem is undergoing massive changes. Significant transformations are underway in how drugs and medical devices are researched, developed, manufactured, and approved.
The US FDA made one observation at the finished dose formulation in Chantilly, Virginia bought by Indian drugmaker Granules from Valeant Pharmaceuticals in 2014.
Regulatory changes and promising starts ups are fueling demand for outsourced services in China – and as venture capital flows into the country, the pace of innovation is expected to accelerate, says STA Pharmaceutical.
Apprentice has raised $2.5m in venture funding for its augmented reality solution, Affinity, which is designed to improve productivity, audit readiness quality, and safety within pharmaceutical lab and research environments, says CEO.
Wasdell Group will invest €30m in a packaging, testing and distribution facility in Ireland, which it says could help UK and US customers serve European clients post-Brexit.
Tjoapack has tripled its bottle packing capacity as increased legislative complexity, ageing populations and pricing pressures drive demand for outsourced packaging solutions.
AMRI has more than doubled its bulk Active Pharmaceutical Ingredient (API) aseptic manufacturing capacity in response to an increasing need for sterile API and an evolving pharma pipeline, says CCO.
Corning says it is planning to increase manufacturing capacity for its Valor Glass packaging technology to take advantage of a multi-billion dollar industry.
Brammer Bio has completed renovations at its gene therapy manufacturing facility in Cambridge, MA amid industrywide capacity concerns as more biologics enter late-stage clinical trials.
Recipharm says three more of its facilities are equipped and ready for US Drug Supply Chain Security Act (DSCSA) serialisation demands, the deadline for which passes today.
Encouraged by a North Carolina state grant, Fresenius Kabi will expand its prefilled syringes business acquired from Becton, Dickinson and Company in 2016.
The US Food and Drug Administration (FDA) has approved Emergent BioSolutions’ supplemental Biologics License Application (sBLA) for the manufacture of ACAM2000, the only FDA-licensed smallpox vaccine, as the company looks to expand its CMO services.
Peregrine Pharmaceuticals was a biotech company – now, the company is transitioning to a pure-play contract development and manufacturing organization (CDMO) as it sells off its R&D assets.
Pfizer has sold its share of a joint venture with Zhejiang Hisun Pharmaceuticals but will continue supporting the local production of generic drugs in China.
Quotient Clinical unveiled its new identity at AAPS – and today, has announced another acquisition as the company looks to represent “a new class of business,” says CEO.
Recipharm says it will cease manufacturing at sites in Stockholm and Höganäs, citing ‘underperforming operations’ at its package filling and manufacturing-focused sites.
Servier recently announced $7.5m for new technology, is doubling capacity at its Chinese facility, and is investing $58m to support biologics – a few projects among the company's effort to increase productivity as the industry demands a faster time-to-market.
“Small molecule products should be packaged at the location where they are produced,” says Roche, which is laying-off 235 jobs at a packaging plant in Switzerland.
Heavy investment in quality control, quality assurance and dedicated equipment is likely to keep CAR T-cell manufacturing in-house, says Juno Therapeutics.