Food and Drug Administration (FDA)

Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated...

Following further successful GMP inspections by FDA and MHRA, Melbourn Scientific has been awarded a Manufacturer’s/Importer’s Authorisation (MIA) and is to be named as the EU testing and release site for an aseptically prepared medicinal product...

Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly...

Vetter’s new Center for Visual Inspection and Logistics passed its first GMP inspection by the FDA. The inspection was conducted on 11–14 March 2013 to ensure the facility is in compliance with good manufacturing practices.

Wickham Laboratories — a specialist GMP contract analytical services provider, based in Hampshire, UK — has reported a successful conclusion to its recent FDA inspection at its Hoeford Point facility in Gosport.

Sensors, fixings and accessories can be the weakest link in stringent hygienic food and beverage processing or pharmaceutical production. SICK has extended its range with new Inox and Hygienic sensors and mountings to deliver seamless protection...

The India Brand Equity Foundation (IBEF) has compiled its findings and released an overview of the current generics market in India. It predicts that the Indian pharmaceutical market is now at the precipice of the next stage in its development...

Eliminating areas in process systems which may increase the potential for bacteria growth, such as traps and crevices, is an important requirement for control valves used in aseptic applications. Samson Controls offers a range of products...

Novasep has announced that the FDA successfully audited two of its European custom manufacturing sites in Le Mans, France and Leverkusen, Germany. FDA investigators audited the two facilities in June and July 2013.

LGC Standards has launched a new range of pharmaceutical primary reference standards. These reference materials are designed to be used in pharmaceutical quality control if no official pharmacopoeia standard exists for a given purpose.

SCM Pharma’s UK-based clinical development and manufacturing facility has been approved at the first attempt by the FDA. The inspection at the CDMO was triggered by the company supporting British specialist healthcare company BTG in preparation...

UK-based chemistry specialist Onyx Scientific has unveiled a huge increase in demand for its solid-state chemistry services versus last year. The contract research and manufacturing organisation has reported a 45% uplift in solid formulation...

UK-based sterile manufacturing specialist SCM Pharma has bolstered its North American profile with the appointment of a US-based Business Development Manager. Derek Richards will oversee the CDMO’s business development activities across the...

Supplier in chemical development and manufacturing Lonza has established an agreement with Pharmacyclics, Inc. to support the commercial and clinical production of its oral oncology drug IMBRUVICA (Ibrutinib). This agreement follows a successful...

Invest & protect: Almac has invested in ICP-MS equipment at its European headquarters to future-proof clients’ drug development programs

Over the last 60 years, FDA approved 20 medications for ADHD based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events,

The reference product is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant.

Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed).

Despite some positive development, novel treatments for multidrug-resistant (MDR) gram-negative bacteria in particularly high demand.

FDA has approved Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of metastatic carcinoma of the cervix.

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