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.
Emergent BioSolutions says it is looking to expand auto-injector manufacturing capacity due to growing demand for its nerve agent antidote product Trobigard.
Tjoapack has tripled its bottle packing capacity as increased legislative complexity, ageing populations and pricing pressures drive demand for outsourced packaging solutions.
There are several opportunities for the industry to introduce connectivity into the pharmaceutical supply chain, but a one size fits all solution will likely not be the answer, says Novartis head.
This month’s roundup includes new CEOs at Bioclinica and Comprehend Systems, several hires at Parexel's consulting division, and new roles – and new offices – for two service providers.
Corning says it is planning to increase manufacturing capacity for its Valor Glass packaging technology to take advantage of a multi-billion dollar industry.
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.
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.
The Danish Medicines Agency (DKMA) has banned Europharma from performing manufacturing activities citing a general lack of will and ability to adhere to GMP.
Recipharm says it will cease manufacturing at sites in Stockholm and Höganäs, citing ‘underperforming operations’ at its package filling and manufacturing-focused sites.
This month’s round up includes Adent’s new product management director who joins the company from Eli Lily and a new CEO at Clinipace, as the CRO’s co-founder steps down after 14 years.
Sponsors using a single-source outsourcing partner could potentially save up to $45m through reduced time to market, according to a recent Tufts study.
Pharmaceutical companies are more likely than their suppliers to cite cost improvement over time as the most effective metric for measuring supplier performance, according to a recent report.
Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.
AmerisourceBergen (ABSG) has pleaded guilty to distributing misbranded injectable cancer drugs processed at an unregistered facility in Alabama and agreed to pay $260m (€220m).
Implementing ‘aggregation’ – the term used to describe pharmaceutical product unit-to-case hierarchy – is not mandatory in Europe, however industry delegates say there is incentive to push its adoption.
Ajinomoto Althea, Inc. has added a new aseptic fill/finish line in response to client's concerns regarding active pharmaceutical ingredient (API) manufacturing costs.
Hikma has ramped up capacity at manufacturing facilities in the US and Portugal manufacturing to meet the growing demand for its lyophilised and oncology products.
Corning has penned separate collaboration agreements with Italy-based Stevanato Group and Germany-headquartered Gerresheimer to supply glass packaging for injectable drugs.
PCI Pharma Services continues to expand its serialization capabilities following an extended regulatory deadline that will provide much-needed “breathing room” for the industry.
Merck KGaA has announced a plan to close some EU production sites and invest in others, citing the centralization strategy employed by Sigma-Aldrich as inspiration.
German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission
Avista Pharma Solutions, Inc. has been contracted to manufacture an opioid-derived small molecule, which is a component of a conjugate vaccine being developed to treat opioid addiction.
Corning says it is on the brink of capturing an increased share of the $12bn glass quality and packaging markets through material advancements in the space.
3D printing, augmented reality and deep learning algorithms will shape the future of the pharmaceutical supply chain says Dr Bertalan Mesko, the Medical Futurist.
India's largest polyester-based packaging film company Jindal Poly Films Ltd (JPFL) is allegedly in talks to buy the European production assets of DuPont Teijin Films (DTF) for an estimated $300m.
This month’s roundup includes new executive leadership teams, hires on both sides of the Atlantic for CRO Smithers Viscient, a new VP and medical director at Clinipace, among others.
LSNE Contract Manufacturing has signed a manufacturing supply agreement with Selecta Biosciences, Inc. through which the CDMO will advance Selecta’s lead candidate, SEL-212.
With almost 40% of attendees coming from outside the US, the political climate has had no effect on the latest CPhI franchise which starts today in Philadelphia.
