Quality/GMPs

Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

An FDA panel unanimously recommended the agency approve EP2006, Sandoz’s biosimilar for filgrastim.

The FDA center released a list of the guidance documents it plans to publish in 2015.

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

Switching grades of raw material late in the development cycle can be costly. Best practice says get it right at the beginning.

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

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

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.

Approval of anti-PD-1 antibody Opdivo represents a major milestone for patients who no longer respond to existing treatments for melanoma.

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

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

NICE OKs biologics for the treatment of ulcerative colitis, changing its preliminary guidance that recommended against their use.

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

Operational changes at FDA and CDER aim to improve global market monitoring.

The author proposes a quality management system that uses the power of executive management to promote a positive quality culture.

Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.