Bayer has pulled-out of a development and licensing deal for a pseudoephedrine containing product based on Acura Pharmaceuticals’ methamphetamine resistant technology, Impede.
Japanese regulators are investigating allegations API firm Yamamoto Chemical Industry gave inspectors false information and improperly bulked-up batches of acetaminophen and zonisamide.
BrainStorm Cell Therapeutics has contracted Worldwide Clinical Trials (WCT) to conduct its planned Phase III study of NurOwn in the treatment of amyotrophic lateral sclerosis (ALS).
Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.
NGOs have criticised the European Commission’s plan to combat antimicrobial resistance (AMR), saying the policy does not adequately address environment contamination concerns.
The US Food and Drug Administration (FDA) has released draft guidelines offering a reprieve for manufacturers which have not integrated product identifier requirements by the November 26 serialisation deadline.
French technology firm Cellnovo has selected Flex Ltd to build a production line in Romania, to manufacture insulin cartridges for its diabetes management system.
The European Medicines Agency has approved a new tablet formulation of Esbriet (pirfenidone), which Roche says reduces pill-load and increases dosing flexibility for patients with a rare lung disease.
Industry delegates say the US Food and Drug Administration (FDA) is showing increased support for continuous manufacturing, a stance C-SOPS told us is quality control-driven.
Patheon NV has announced it will spend $45m to expand and enhance its manufacturing network citing customer demand for more reliable, flexible and cost-efficient supply chains.
QuintilesIMS is releasing a new pharmaceuticals commercial operations SaaS software called Orchestrated Customer Engagement (OCE) in response to customer demand.
LabCorp has teamed up with Walgreens to open “LabCorp at Walgreens” service centers and will explore additional collaboration opportunities – such as in clinical trial enrollment.
The team behind a microneedle patch designed to administer influenza vaccines say it has increased thermostability compared to needle and syringe immunisation methods.
The Carlyle Group and GTCR LLC are poised to complete the takeover of Albany Molecular Research (AMRI) after the early termination of the mandatory waiting period that covers such deals in the US.
Pfizer says a lack of harmony among regulators made its continuous granulation platform untenable for bulk manufacturing but is positive about using such tech for smaller volumes.
The China Food and Drug Administration (CFDA) has become a member of ICH as it looks to continue advancing regulatory reform to improve the review process.
BASF has said it will build an ibuprofen plant in Ludwigshafen, Germany and increase production capacity for the API at a facility in Bishop, Texas in the US.
Biogen and Accenture Labs have collaborated to develop a quantum-enabled molecular comparison application to accelerate drug discovery and ultimately, time to clinic.
Lonza expects to complete its $5.5bn (€5.2bn) takeover of Capsugel SA in the next few days having secured approval from competition authorities around the world.
QuintilesIMS may potentially divest its contract sales business – which would improve the company’s overall profitability and enable it to focus on growing other aspects of the organization.
Evotec has joined a consortium through which it gains access to a sample biobank in order to perform drug discovery based on unique kidney disease patient cohorts.
CROS NT has announced a new clinical trial solution that enables sponsors to take a risk-based approach to site monitoring – a shift to which is driving company growth, says CEO.
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.
The EMA has cleared Janssen to make the HIV drug Prezista (darunavir) using a continuous manufacturing (CM) process as well as the previously approved batch method.
Helomics Corporation and Pittsburgh Life Sciences Greenhouse (PLSG) have collaborated to form a biotechnology incubator with a precision and diagnostics medicine focus.
Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.
Dutch scientists have developed a microgel chip that is capable of holding single cells for analysis and research for far longer than currently available 3D culturing technologies.
Baxter International has announced an agreement with India-based Dorizoe Lifesciences to develop over 20 generic injectables, a sector it says is growing annually.
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.
Industry professionals at a continuous manufacturing (CM) summit last month said while the approach offers advantages, implementing the method can be challenging.
