The two most popular injectables used to transition are disappearing from shelves as one awaits re-approval by the FDA, but other factors remain murky
Lupin Ltd, India’s third largest drug maker, will buy a portfolio of 21 generic brands from Osaka-based Shionogi & Co. Ltd at the cost of US $150 million. August 3, 2016: The move will help the company to strengthen
Pfizer is the latest addition to an expanding list of drug makers found deviating from good manufacturing practices in India.In the last week of June,a high profile team drawn from world's four leading regulators identified a number of deficiencies at the company's Irungattukottai facility, near Chennai.
KalVista Pharmaceuticals announced the dosing of the first subject in a first-in-human clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally delivered KVD818 in healthy volunteers.
Inovio Pharmaceuticals, Inc announced the dosing of the first subject in its multi-center phase I trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700). In addition to the previously announced US FDA approval for the conduct of the study, Health Canada’s Health Products and Food Branch has also approved this study, which will be conducted at clinical sites in Miami, Philadelphia, and Quebec City.
AstraZeneca announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC).
In yet another expansion of its manufacturing operations, Pfizer ($PFE) plans to lay out nearly $150 million to build a sterile manufacturing facility and warehouse at its site near Kalamazoo, MI. It is the third manufacturing project the drug giant has unveiled in the last couple of months.
Aurobindo is starting to build on its pledge to expand operations in New Jersey, literally. The Indian drugmaker this week broke ground on the 567,000-square-foot facility that is slated to include a manufacturing and distribution center and warehouse, according to NJ.com.
Agilent Technologies reports that it acquired 20 acres in Weld County in northern Colorado, on which it plans to build a pharmaceutical manufacturing facility.
Nelipak Corp. has acquired thermoforming company Tegrant Alloyd Brands of Puerto Rico Inc. (TABPR), a subsidiary of Sonoco Products Co. Located in Juncos, the business will now operate under the name of Nelipak Healthcare Packaging.
Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announces its plans to expand capabilities for development and manufacturing of Active Pharmaceutical Ingredients (APIs) at its Germantown, WI facility.
At PACK EXPO International 2016, Bosch Packaging Technology will showcase its testing equipment for jelly production, including medicated and functional gummies, such as cough lozenges, omega-3 and mineral-enriched products, as well as other supplemented jellies.