FDA

Fasenra (Benralizumab) receives FDA approval for severe eosinophilic asthma

Friday, November 17, 2017

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the FDA has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

[Read More]

FDA gives clearance for opioid addiction withdrawal treatment

Friday, November 17, 2017

The FDA gave clearance  for a neurological device with an indication to aid in the reduction of opioid withdrawal symptoms. The NSS-2 BRIDGE device, pioneered by Indiana-based medical technology firm Innovative Health Solutions (IHS), is placed behind the ear with micro-needle arrays that percutaneously implant in and around the ear. Research study results of the technology show an 84.6% reduction of withdrawal symptoms in as little as 60 minutes. The NSS-2 BRIDGE device is a patented technology and is Rx (prescription) only.

[Read More]

PAREXEL adds senior executives from FDA and oncology industry

Wednesday, November 15, 2017

PAREXEL, a global biopharmaceutical services provider, announced the appointment of three former senior regulatory consulting executives from the FDA and Oncology industry positions. The new hires are part of PAREXEL’s Global Integrated Product Development and Compliance team and will be focused on helping PAREXEL clients deliver commercially viable, reimbursable products to market faster and more cost-effectively.

[Read More]

FDA approves pill with sensor to track patients adherence

Tuesday, November 14, 2017

The FDA approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

[Read More]

Diversity in clinical trials critical to refining medicines and therapies

Tuesday, November 14, 2017

Leaders from Northwell Health’s Feinstein Institute for Medical Research, the FDA and Boehringer Ingelheim recently led a symposium on the barriers and opportunities to increase patient diversity in clinical trials. Because medicines may affect people differently based on age, sex and race, the diversity of clinical trial participants is important to better anticipate differences in treatment effects once the medicines are on the market.

[Read More]

FDA approves Bydureon BCise for type 2 diabetes

Thursday, October 26, 2017

AstraZeneca announced that the FDA has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control.

[Read More]

Shire’s SHP654 receives Orphan Designation for hemophilia A

Thursday, October 26, 2017

Shire, a global biotechnology leader in rare diseases, announced the FDA awarded Orphan Drug Designation to Shire’s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.

[Read More]