Regulatory Authority Actions

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

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.

FDA will delay its decision regarding the new drug application for panobinostat.

USP and ChP jointly host two-day meeting to strengthen cooperation.

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

FDA opens public docket on proposed criteria for “first generic” ANDAs.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.

USP releases compendium of quality standards for compounded medicines.

Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.