Regulatory Filings and Submissions

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.

The regulatory agency rejected the medication, citing various issues related to device use.

FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.

Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

The agency has published its refuse-to-receive standards guidance for abbreviated new drug applications.

The agency announces that 81 medicines overall were recommended in 2016.

NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

The guidance assists applicants in preparing prior approval supplements for abbreviated new drug applications.

The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.

The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.

NICE estimates asfotase alfa will cost £367,000 per patient per year.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

On Sept. 19, 2016, FDA announced that it has granted accelerated approval to Exondys 51 (eteplirsen), an injection for the treatment of Duchenne muscular dystrophy (DMD). The drug is marketed by Sarepta Therapeutics in the United States and is currently the only approved treatment for DMD. In light of the approval, Sarepta shares catapulted 76%, Seeking Alpha reported.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

The agency has recommended marketing authorization for Ibrance in the European Union.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?

The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.

Sandoz won FDA approval for its biosimilar version of Enbrel.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.