News

To support women entrepreneurs in biotech, MassNextGen initiative launches

Monday, November 20, 2017

Takeda Pharmaceutical Company and the Massachusetts Life Sciences Center (MLSC) have formed a $1 million initiative aimed at supporting women entrepre­neurs in early-stage biotech with an eye toward addressing gender gaps in the life sciences sector. The five-year program, called the Massachu­setts Next Generation (MassNextGen) Initiative, provides funding and customized support, including mentoring from investors and industry executives, to empower women entrepreneurs and allow them to develop the network and skills necessary to become industry leaders.

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Relationship sustainability—It’s the bigger picture

Monday, November 20, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

In clinical research, we are taught to always move forward—through change to a better process, through error toward the true lesson. Our industry is constantly evolving: risk-based monitoring, ClinicalTrials.gov, social media for patient recruitment. Progress has made us so efficient with accomplishing the short-term goals (interim analysis deadlines and query resolutions) that it can take our sight off of the bigger picture tasks that, though more time-intensive, have a longer-lasting impact. Relationship development is one of these. 

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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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