PHARMACY

FDA turns down Advaxis orphan drug request

BY Alaric DeArment

NORTH BRUNSWICK, N.J. The Food and Drug Administration has denied a biotech company’s request for a special designation for a drug it is developing to treat invasive cervical cancer.

Advaxis said Wednesday that it had received a letter from the FDA denying its request for orphan drug designation for ADXS11-001. The FDA grants the designation for drugs that treat diseases affecting fewer than 200,000 people, though the agency told Advaxis that the disease exceeds the 200,000-person cutoff, including people who have been cured.

“When we announced this ODD filing, we said it was historically a 50% probability of getting approved,” Advaxis chairman and CEO Thomas Moore said. “With an annual incidence of only 10,000 patients in the U.S. diagnosed with invasive cervical cancer and a very poor prognosis if standard therapies fail, which they do for about half these patients, this appeared to be just what orphan drug was designed to encourage.”

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Par ships first generic version of J&J drug

BY Alaric DeArment

WOODCLIFF LAKE, N.J. Par Pharmaceutical Cos. has begun shipping its generic version of a drug used to treat schizophrenia and bipolar disorder.

The company announced Tuesday the shipment of risperidone ODT in the 0.25-mg, 3-mg and 4-mg strengths. The drug is used in adults as a stand-alone treatment for schizophrenia and as a combination, with lithium or valproate, for the treatment of manic and mixed episodes in bipolar I disorder.

The drug is a generic version of Johnson & Johnson’s Risperdal M-TAB, which had sales of $89 million last year, according to IMS Health data. As the first company to file an approval application with a paragraph IV certification, Par has six months of market exclusivity, though J&J retains exclusivity for the use of the drug in children.

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FDA creates transparency taskforce

BY Alaric DeArment

ROCKVILLE, Md. After years of criticism, the Food and Drug Administration wants to take the tinting off its windows.

The agency announced Tuesday the creation of an internal transparency taskforce, headed by principal deputy commissioner Joshua Sharfstein, to find ways to make its decision making more transparent for the public while protecting confidentiality.

“Over the years, there have been complaints made about the FDA’s lack of transparency,” commissioner Margaret Hamburg said in a conference call with reporters Tuesday morning.

Hamburg said the taskforce would take comments from the public and stakeholders to find ways to make information about agency operations, recall information, enforcement and other activities more accessible. The agency will convene a public meeting on June 24 and another one in the fall and accept public comment through a docket until Aug. 7.

“The recommendations of the taskforce will allow us to more effectively implement the agency’s public health mission,” Hamburg said.

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