HHS

FDA approves first biosimilar for certain breast and stomach cancers

Friday, December 8, 2017

The FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

[Read More]

New patient adherence tech tests the limits

Monday, November 27, 2017

With the FDA’s recent approval of Abilify MyCite, a “digital pill” that can indicate whether a patient has taken his or her medication, physicians may finally have an effective way of attacking the problem of medication nonadherence. Abilify MyCite is a drug-device combina-tion product that consists of Otsuka Pharmaceutical’s oral Abilify (aripiprazole) tablets that have been embedded with an ingestible biosensor developed by Proteus Digital Health.

[Read More]

Rethinking the Investigator’s brochure

Wednesday, November 1, 2017

The investigator’s brochure (IB) has long functioned as the main reference document for clinical trials, providing investigators with information needed to understand possible risks or adverse events (AEs) related to the investigational product and keep sites up-to-date on the study. Yet IBs are invariably lengthy, complex documents that are seldom read cover-to-cover or consulted when questions arise. While new technology has impacted many clinical research domains to improve the usability and efficiency of documents or processes, IBs remain a relic of another era.

[Read More]

NIH partners with 11 biopharmaceutical companies on cancer immunotherapy strategies

Friday, October 13, 2017

The NIH and 11 biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role. 

[Read More]

FDA approves Idhifa for relapsed or refractory acute myeloid leukemia

Wednesday, August 2, 2017

The FDA approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

[Read More]

OHRP/FDA offer final guidance on electronic informed consent

Saturday, April 1, 2017

On December 15, 2016, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) and the FDA published final guidance aimed at providing answers to commonly asked questions about using electronic informed consent (eConsent)in clinical investigations. The guidance applies to “electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.”1 This guidance finalizes the draft guidance Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers that was issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance.

[Read More]