The study will evaluate how critical biomarkers and cell-therapy cancer vaccines are impacted by temperature and transport packaging at deep frozen temperatures.
Impax Laboratories has issued a voluntary recall for one lot of its Lamotrigine Orally Disintegrating Tablet due to incorrect labeling of its blister packs.
A device that isolates and sprays a patient’s own stem cells onto serious burns could have significant implications in the organ regeneration industry, says developer RenovaCare.
The Society for Clinical Research Sites (SCRS) has announced the finalists for the 2016 SCRS Eagle Award - an award recognizing the clinical research profession.
The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.
Hikma invested over $25m in its US facilities in the first half 2016, and plans to use excess capacity at a former Boehringer Ingelheim plant for contract manufacturing.
Currently, the top ten CROs represent more than half the market, and as the industry continues to grow analysts suggest companies expand revenue streams through “nontraditional” services offerings.
Metrion Biosciences (Metrion), an ion-channel and drug discovery CRO, has joined a network of partners to evaluate the use of primary human dorsal root ganglion (hDRG) neurons in pain research.
Grunenthal has reiterated the benefits of its anti-crush intac tech after licensee Endo withdrew its request to have Opana ER labelled as “abuse deterrent."
AMRI and the University at Albany’s RNA Institute are partnering to speed the development of new RNA-based therapeutics in an “ideal and first of its kind” collaboration.
Marken’s Moscow-based depot has been granted a new pharmaceutical license from the Russian Federation, further extending the company’s capabilities in the area.
Biomedical Systems and Foundry Health of Chicago will collaborate to develop the proprietary cloud-based data management system, which will cover all study phases.
Pfizer will buy most of AstraZeneca’s antibiotics business in a $1.5bn (€1.32bn) deal that will see the Anglo-Swedish drug firm continue to package Merrem at its Macclesfield, UK plant for at least the next 18 months.
Scientists in Switzerland have developed a simple and cheap way to synthesise amines - compounds that form the backbone of many active pharmaceutical ingredients.
Frenova Renal Research has opened a new office in Durham, NC and has added several new staff members to its US field offices in in New York, Illinois, North Carolina, Florida and Louisiana.
The Eagle is MHI’s Americanized version of its PF-D1S – a compact, servo-driven blister machine, and the company’s first entrance into the North American marketplace.
Phyton Biotech has developed a cell based way of making thapsigargin, a cytotoxic plant extract that is being developed for the treatment of cancer by Inspyr Therapeutics.
The international private equity firm, Cinven, is set to purchase Bioclinica, marking the company’s latest in a series of purchases as industry consolidation continues.
As clinical trials “continue to shift to emerging markets,” the translation company Welocalize has acquired Global Language Solutions (GLS) to further support its clients’ linguistic validation processes.
BioPharma Services has acquired intellectual property and human resource assets from Bioanalytical Laboratory Services (BLS), including a list of validated assays.
Siegfried Holding AG has attributed a surge in API sales to the drug ingredients business it bought from BASF last year, but says that integration costs hurt profits.
An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.
Roche is updating instructions for its Accu-Chek insulin pump after patients who failed to load the device correctly experienced hyperglycemic symptoms as a result of under dosing.
The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.
Fresenius Kabi has said it will increase manufacturing capacity and create jobs at a site in Illinois in a move that will earn the German firm US tax breaks.
As regulators push the industry to adopt adaptive studies to reduce risk to both patients and manufacturers, the FDA has finalized a guidance outlining key issues and recommendations.
Biomanufacturing demand will drive revenues for Patheon according to an Evercore ISI analyst, who has predicted the newly-listed CDMO will strengthen its capabilities through M&A.
An issue at a GSK API manufacturing site will limit supplies of the superbug busting antibiotic Avycaz for the next six months according to drug manufacturer Allergan.
Pfizer supplier Zhejiang Medicine Co. should quiz staff to determine the extent of data integrity deficiencies at its API plant in Xinchang, China according to the US FDA.
Alcami has announced plans to expand its facilities in Germantown, Wisconsin, in order to increase its Active Pharmaceutical Ingredient (API) production.
Drug manufacturers that change hard gelatin capsule suppliers do not need to seek approval beforehand under a policy introduced by the US FDA this week.
German regulators want statin APIs made by Artemis Biotech to be banned after finding deviations good manufacturing practice (GMP) at the firm’s facility in Hyderabad, India.
WuXi AppTec has announced that its Jinshan Shanghai-based small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility has passed its third US FDA inspection.
Lonza has announced its plans to acquire Benicia, CA-based InterHealth Nutraceuticals, a nutritional ingredient research, development, and manufacture company.
Purdue Pharma has joined the National Pharmaceutical Council (NPC), a health policy research organization working to advance good evidence and science.
World Courier is set to open a new Moscow, Russia-based investigational drug depot in August – and it will be nearly six times larger than the current depot.
