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Adherium receives OTC clearance for AstraZeneca’s Symbicort inhaler

Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.
- Source: MobiHealthNews
- 802
- April 7, 2018
COPD FDA New Approvals
Rumours Allergan is looking to offload $5bn women’s health unit

According to a piece by Bloomberg, Allergan is looking at options to divest its women’s health unit in a move that could potentially reap about $5 billion.
- Source: pharmafile
- 615
- April 6, 2018
Allergan biosimilar Company Insight
FDA refuses to review Alkermes’ depression drug, demands additional clinical trials

The FDA has told Alkermes it needs to see data from “additional well-controlled clinical trials” before it will review a filing for approval of depression drug ALKS 5461. Alkermes plans to appeal the ruling, but at this stage it looks like the biotech’s attempt to get a mixed set of data past the FDA has failed.
- Source: fiercebiotech
- 702
- April 6, 2018
ALKS 5461 Depression New Approvals
Overriding EHR Alerts May Up Adverse Drug Events

Such alerts remind clinicians about everything from a patient's drug allergies, to possible drug interactions, to dosing guidelines, to lab testing guidance. Clinicians can either follow the alerts' recommendations, override them, or ignore them.
- Source: MedPageToday
- 678
- April 6, 2018
digital health EHR Researches
Singapore’s Aslan stalks $86M IPO to fund cancer pipeline

Aslan wants to list on the U.S. exchange under the ASLN symbol.
- Source: fiercebiotech
- 547
- April 5, 2018
Aslan Market Views varlitinib
Apple’s PHR health system partnerships up threefold

Health Records is based on the interoperability standard FHIR and collects encrypted medical data on allergies, immunizations, lab results, medications, procedures, vital signs and conditions. Users will receive notifications when their data are updated.
- Source: HealthCareDive
- 943
- April 5, 2018
Company Insights mHealth PHR
Using CRISPR to introduce beneficial but rare gene mutations in sickle cell

People who suffer from the inherited disease sickle cell disease have defects in their hemoglobin, the blood molecule that transports vital oxygen throughout the body. But a small percentage of patients with the disease have beneficial gene mutations that lessen their symptoms. The mutations switch on a gene that produces fetal hemoglobin—a type of the blood molecule that the body normally stops producing in infancy. The lifelong production of fetal hemoglobin helps shield those sickle cell patients from the worst effects of the disease.
- Source: fiercebiotech
- 478
- April 5, 2018
Researches sickle cell disease
EU reviews for Sanofi’s Dupixent, cemiplimab

European regulators have agreed to review Sanofi and Regeneron’s Dupixent for asthma and cemiplimab for advanced cutaneous squamous cell carcinoma.
- Source: pharmatimes
- 953
- April 4, 2018
asthma FDA New Approvals Sanofi
Partner Therapeutics (PTx) Acquires Leukine® from Sanofi

Purchase includes Lynnwood, WA Biologics Manufacturing Facility
- Source: finance.yahoo
- 640
- April 4, 2018
acute myelogenous leukemia FDA Leukine Sanofi
Martin Pharmaceuticals Receives FDA Orphan Drug Designation For LIVANTRA™

MARTIN PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR LIVANTRA™
- Source: martinpharma
- 619
- April 4, 2018
FDA LIVANTRA™ rare (orphan) diseases

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