Quality Systems

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to handle staff challenges to regulation requirements

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Valeant voluntarily recalled one lot of Virazole due to sterility problems; no adverse events have been reported to date.

Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.

When used in combination with chlorambucil to treat chronic lymphocytic leukemia, Gazyva was found to be more effective than Rituxan.

Entrectinib has received FDA’s orphan drug and rare pediatric disease designations for the treatment of neuroblastoma.

Teva Pharmaceuticals announced that FDA approved Granix injection for self-administration in patients.

FDA announced that it approved a new antibacterial drug, Zerbaxa, for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.

FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.

Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

Generic drug manufacturing is no longer the only driver for growth in India's pharmaceutical market as more companies start investing in R&D.

Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

CDMO Vetter announced the addition of a new flexible serialization service, introduced in response to stricter packaging regulations calling for drugs to be serialized as a means to fight counterfeits.

The spate of drug scandals may alter the relationship between manufacturers and research institutions, and reshape Japan’s clinical research industry.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.