Regions

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.

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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.

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Elizabeth Iorns elected to the Board of Directors DCAT

Wednesday, November 15, 2017

Science Exchange, a secure enterprise platform for outsourced research and development (R&D) services, announced that Elizabeth Iorns, Ph.D., CEO of Science Exchange, has been elected to serve her first term on the Board of Directors of the Drug, Chemical & Associated Technologies Association (DCAT) beginning November 1, 2017. Members of DCAT’s Board of Directors are charged with the important work of guiding the organization’s strategic initiatives and activities.

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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.

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Quotient Sciences acquires U.K CDMO Pharmaterials

Wednesday, November 15, 2017

Quotient Sciences, a drug development services organization, announces it has acquired Pharmaterials, a contract development and manufacturing organization (CDMO) based in Reading, U.K. The acquisition strengthens and expands Quotient’s formulation and manufacturing services footprint in the U.K., and further supports the growth of Quotient’s Translational Pharmaceutics platform, following the acquisitions of SeaView Research and QS Pharma in February 2017.

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Purdue Pharma invests in oncology R&D

Wednesday, November 15, 2017

Purdue Pharma announced completion of significant oncology related investments as part of its ongoing efforts to diversify its scientific research into areas of high unmet medical need. Through these investments, executed over a multi-year period and capped recently in 2017, Purdue is establishing a portfolio of drug candidates with the potential to deliver new cancer therapies to patients within the next five years.

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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.

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Sage’s postpartum depression drug Brexanolone hits primary endpoints

Tuesday, November 14, 2017

Sage Therapeutics, a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, announced positive top-line results from two phase III clinical trials with its proprietary i.v. formulation of brexanolone (USAN; formerly SAGE-547); Study 202B in severe postpartum depression (PPD) and Study 202C in moderate PPD. Brexanolone achieved the primary endpoint in both trials, a mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score compared to placebo at 60 hours (Study 202B: p=0.0242 for 90 µg/kg/h dose and p=0.0011 for 60 µg/kg/h dose; Study 202C: p=0.0160 for 90 µg/kg/h dose). Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials. Brexanolone was generally well tolerated and showed a similar safety profile as seen in earlier studies.

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