AstraZeneca says its hyperkalaemia candidate ZS-9 is back on track for approval after manufacturing issues at its Texas facility resulted in regulatory delays.
Kadam Exports Private has received a statement of non-compliance with GMP after the Danish Medicines Agency found manufacturing deficiencies at its facility in Gujarat.
Rephine says its online Quality Assurance database transforms the lengthy active pharmaceutical ingredient (API) pre-selection process to just a couple of clicks.
Scientists say a modified plant extract traditionally used as an arrow poison in eastern Africa could inhibit sperm cells’ ability to swim, and lead to the development of a male contraceptive pill.
Radiopharmaceuticals firm Telix Pharmaceuticals Limited has established a subsidiary in Japan to support clinical development and manufacturing activities.
A natural substance found in stinging nettles and ants repeatedly attacks cancer within cells, say scientists developing low-dose alternatives to current chemotherapy drugs.
Investment firm LeBaronBrown Llc has acquired American International Chemical Inc (AIC), a distributor of ingredients for the pharmaceutical sector and other industries.
Fresenius Kabi says drug ingredients made at an Indian plant hit with a US FDA warning letter meet quality specifications and has reiterated that tests were halted for technical reasons.
Aurobindo Pharma Limited has denied rumours it is interested in Orchid Pharma after a report suggested it is vying with Dr Reddy’s to acquire the bankrupt API firm.
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.
update - CEO: ideal model is two to four API plants and six to eight drug facilities
Teva Pharmaceutical Industries will reduce its workforce by 14,000, rejig its generics portfolio and speed up optimization of its plant network as part of a $3bn (€2.5bn) cost saving plan.
Compass Pathways has selected Worldwide Clinical Trials to conduct studies of its investigational psychoactive therapy, designed for patients with treatment-resistant depression.
Rumours fumes from Pfizer’s Viagra API facility are ‘arousing’ locals have been quashed by the drugmaker, which said emissions from manufacturing sites have no effect on human health.
Seaweed extracts can reduce tumour growth and improve the effectiveness of chemotherapy says Marinova, which is developing the compounds for pharmaceutical applications.
Cannabinoid firm GW Pharmaceuticals says it is “inspection ready” as it prepares for potential US approval of its epilepsy candidate Epidiolex (cannabidiol or CBD).
The International Pharmaceutical Excipient Council (IPEC) has updated its Quality Agreement guidelines to reflect changing regulatory expectations and global nature of supply chains.
Cambrex Corporation has completed the expansion of its small scale active pharmaceutical ingredient (API) capacity at its Charles City, Iowa, US-based plant.
Emerging countries face significant barriers to becoming API manufacturing hubs, keeping India and China the dominant suppliers to regulated pharma markets, says a Clarivate Analytics analyst.
The acquisition of FMC Corporation's health and nutrition business gives DowDuPont “one of the broadest pharma offerings to serve the growing excipients industry,” the firm says.
Fleming Laboratories has been banned from shipping APIs to the US by the FDA which says its manufacturing plant in Nawabpet, Telangana in India is not up to code.
InMed Pharmaceuticals is developing a gel-based cannabinoid drug for eye diseases such as glaucoma, which it says could be cheaper and more accessible than cannabinoid-based products on the market.
Generics industry group Medicines for Europe says proposed supplementary protection certificate (SPC) waiver will help European API manufacturers compete.
The pharma world has converged in Frankfurt, Germany for this year’s CPhI Worldwide. In-Pharmatechnologist is here too to report the latest trends affecting the industry.
The New Jersey Innovation Institute and Rutgers University have teamed up to establish an institute to promote the development of continuous manufacturing technologies for drug production.
