The Danish Medicines Agency (DKMA) has banned Europharma from performing manufacturing activities citing a general lack of will and ability to adhere to GMP.
As the industry continues to externalize components of the supply chain, global regulatory authorities are requiring a “quality-by-design” (QbD) approach to help mitigate risk across the drug development process.
The industry has reached an inflection point with 200 new health-related apps added daily – the use of which could lead to potential annual savings of $46bn, says IQVIA.
Recipharm says it will cease manufacturing at sites in Stockholm and Höganäs, citing ‘underperforming operations’ at its package filling and manufacturing-focused sites.
Evoke Pharma has selected Patheon to commercially manufacture its nasal delivery formulation of metoclopramide Gimoti ahead of a planned US FDA submission next year.
QuintilesIMS next week will officially be rebranded as IQVIA – the newest name in the “Mega-CRO” category created by the rapid and ubiquitous consolidation of the industry.
Devana Solutions has released a new platform to help align top performing sites with sponsors and contract research organizations (CROs) as consolidation will make it important to stand out amongst the competition, says CEO.
Takeda has partnered with Portal Instruments to develop a needle-free drug delivery device for biologic medicines, starting with the former’s Entyvio (vedolizumab).
Cambrex Corporation has completed the expansion of its small scale active pharmaceutical ingredient (API) capacity at its Charles City, Iowa, US-based plant.
The Tri-Institutional Therapeutics Discovery Institute, Inc. will use ChemDiv's proprietary discovery chemistry platform to advance its research and development (R&D) pipeline.
Marken’s new online tool enables patients to track home deliveries of clinical trial materials, which the company said will improve the direct to patient experience.
Guangdong Zhanjiang Jimin Pharmaceutical Co. has received a warning letter from the US FDA citing cGMP violations as well as unapproved new drug and misbranding charges.
Oracle Health Sciences has launched its safety-reporting management software in China to monitor adverse events as the country’s clinical trials industry continues to grow.
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.
Sotera Health – the recently rebranded Sterigenics International – will add extractables and leachables testing services to its Nelson Labs business with the acquisition of Toxikon Europe NV.
Servier recently announced $7.5m for new technology, is doubling capacity at its Chinese facility, and is investing $58m to support biologics – a few projects among the company's effort to increase productivity as the industry demands a faster time-to-market.
“Small molecule products should be packaged at the location where they are produced,” says Roche, which is laying-off 235 jobs at a packaging plant in Switzerland.
Teva has lowered its 2017 guidance on the back of higher-than-expected generic price erosion and lower-than-expected Copaxone sales due to competition.
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.
Advanced imaging in drug discovery aims to improve the success rate of drug development as the industry continues to tackle devastating diseases such as Alzheimer’s – but no research lab can do it alone, says Charles River managing director.
Citoxlab Group has acquired Xenometrics, a non-clinical contract research organization (CRO), as client requests continue to increase, says company president.
BioClinica has acquired MDDX Research and Informatics to provide sponsors and CROs access to medical imaging technology, which can determine patient clinical trial eligibility in under an hour, says founder.
Almac Group’s acquisition of BioClin Laboratories expands the company’s analytical services – a growing area of business due to increasing global client requirements, says CDMO.
Generic injectables are a solution to rising healthcare costs says Fresenius, which is expanding its US manufacturing network to benefit from the long-term growth prospects.
ICON and the International Consortium for Health Outcomes Measurement's (ICHOM) pilot patient outcomes platform – known as ‘Globe’ – aims to improve drug development procedures.
AMRI’s SSCI has announced the availability of in vitro bioequivalence testing services, as more products entering the market require laboratory-based testing.
Quintiles IMS’ Alan Shephard says manufacturing cost transparency will reduce criticism surrounding generics pricing, but one association believes this will lead to anti-competitive behaviour among drugmakers.
Clinical trials conducted outside of India – which test drugs for the Indian market – must include Indian subjects, according to a ruling in India last month.
Parexel has augmented its active tracking service with in-pack wireless sensors to monitor temperature-sensitive medications from packaging to patient dispensation.
Pfizer has attributed a 12% operational decline from its sterile injectable products on “capacity constraints and technical issues” stemming from former Hospira facilities.
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.
A proposed regulation in New Jersey demonstrates a lack of understanding regarding the clinical trial process and has clear collateral damage to research conduct in the state, ACRO testifies.
Horizon Discovery and The Michael J. Fox Foundation have introduced two new preclinical models for Parkinson’s Disease research – including a first-of-its-kind model that will help researchers understand the biology behind a mutation linked to the disease.
Charles River is extending its preclinical services through a partnership with InSphero AG – “further affirmation” of its commitment to the in vitro oncology space, says executive director.
EDASA Scientific has partnered with Namiki Shoji Co., a Japanese company distributing drug discovery compounds and intermediates to the pharmaceutical industry.
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.
The National Institute of Health (NIH) has awarded Pharmaceutical Product Development, LLC (PPD) a seven-year contract for clinical research support services.
