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FDA issues Complete Response Letter for AcelRx's NDA for Zalviso System

FDA issues Complete Response Letter for AcelRx's NDA for Zalviso System

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso (sufentanil sublingual tablet system). [More]
IDEXX revenues increase 11% to $390M in second quarter 2014

IDEXX revenues increase 11% to $390M in second quarter 2014

IDEXX Laboratories, Inc. today reported that revenues for the second quarter of 2014 increased 11% versus the prior year period to $390 million. [More]
Butterfly Health campaign provides common language education on accidental bowel leakage

Butterfly Health campaign provides common language education on accidental bowel leakage

Butterfly Health launches an accidental bowel leakage (ABL) educational initiative with NAFC called "Let's Talk about Bowel Health." The campaign is designed to increase dialogue and care for ABL – a little discussed bowel health condition. [More]
Cardiovascular Research Foundation to co-sponsor 2014 VEINS conference

Cardiovascular Research Foundation to co-sponsor 2014 VEINS conference

VEINS is an established Venous Endovascular Interventional Strategies group comprised of experts in the field whose primary aim is to provide a "How To" meeting for cardiologists and other healthcare providers who are interested in advancing their knowledge and skills in venous interventions and whose ultimate goal is developing their own comprehensive venous interventional program. [More]
Malvern acquires MicroCal business and Affinity Biosensors' Archimedes product

Malvern acquires MicroCal business and Affinity Biosensors' Archimedes product

Malvern Instruments Ltd (Malvern, UK) has today announced that it has completed the acquisition of MicroCal from GE Healthcare Life Sciences and has also purchased the Archimedes particle characterization system from Affinity Biosensors LLC (Santa Barbara, CA). [More]
Viewpoints: Looking to the supremes for answer on subsidies; 'personhood' laws

Viewpoints: Looking to the supremes for answer on subsidies; 'personhood' laws

Liberals are telling themselves that the latest ObamaCare legal challenge won't amount to much, although more nervously after the D.C. Circuit Court of Appeals ruled Tuesday that the White House is defying the law's plain text by allotting insurance subsidies through the federal exchanges. Allow us to increase their anxiety by speeding things along to the Supreme Court (7/23). [More]
Cedars-Sinai launches applied research center to improve value of patient care

Cedars-Sinai launches applied research center to improve value of patient care

Cedars-Sinai has launched an applied research center to improve the value of patient care inside the medical center and beyond its walls by strengthening patient-doctor bonds and bringing greater efficiency to the delivery of clinical services. [More]

GAO official: Report intended to identify trouble spots in health law fraud controls

It's too early to draw conclusions about fraud in the Obamacare marketplaces, a congressional investigator said at a hearing focused on a report finding 11 out of 12 fake applicants were able to obtain subsidized health insurance. Republicans jumped on the report as proof that the health care law invites fraud, but the Government Accountability Office official said the sample is too small and investigators "can't draw any conclusions" until their work is complete. [More]
Study: Dementia carers may require more support with medication management

Study: Dementia carers may require more support with medication management

Family carers of people with dementia may need more support with medication management, according to a recent study. [More]
Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS). [More]
Senate could vote on VA nominee's confirmation before the August break

Senate could vote on VA nominee's confirmation before the August break

Meanwhile, Health and Human Services Secretary Sylvia Burwell named Leslie Dach, a former Wal-Mart vice president, to be a senior adviser as part of Burwell's effort to head off difficulties in the upcoming health law enrollment period. [More]

Parsing the health law court decisions: What does it all mean?

News outlets analyze this week's conflicting appeals courts' decisions regarding a key part of the health law, including the impact the ultimate outcome of the cases could have on coverage, politics and the marketplace. [More]

Healthcare.gov active with special enrollments

ProPublica reports that the once problem-plagued federal exchange handled an estimated 960,000 "834" forms between April 19 and July 15. [More]

10 million newly insured because of health law, study says

The study, done by Harvard researchers and published by the New England Journal of Medicine, was based on Gallup polling and data from the Department of Health and Human Services. [More]

Medicaid residents sue Tennessee on Medicaid enrollment delays

The suit claims that the state's decision to require residents to apply through the health law marketplace slowed down enrollment. In other Medicaid news, The Associated Press examines problems in Oregon caused by the rush of enrollment. [More]
Asia's first genetic test developed for identifying patients with corneal stromal dystrophy

Asia's first genetic test developed for identifying patients with corneal stromal dystrophy

A team of eye doctors and scientists from Singapore have developed Asia's first genetic test for identifying patients with a type of eye disease that affects the cornea called corneal stromal dystrophy which can lead to blurring and loss of vision. [More]

Health insurers to refund consumers $330 million

The refunds are required under the health law when insurers spend less than 80 to 85 percent of health care premiums for medical care. Florida consumers will receive the biggest rebates, with $41.7 million returned, according to government data. [More]
WIRB-Copernicus Group acquires Alliance Biosciences

WIRB-Copernicus Group acquires Alliance Biosciences

WIRB-Copernicus Group, the world's largest provider of regulatory and ethical review services for clinical research, announced today that it has acquired Alliance Biosciences. Formerly a division of Richmond, VA-based Alliance Engineering, Alliance Biosciences was the leading biosafety and biosecurity consulting firm in the United States. [More]
TransCelerate selects Cognizant to develop first-of-its-kind, subscription-based platform

TransCelerate selects Cognizant to develop first-of-its-kind, subscription-based platform

Cognizant today announced that it has been selected by TransCelerate BioPharma Inc., a non-profit organization with membership representation from 19 major pharmaceutical companies, to develop a first-of-its-kind, subscription-based platform that will transform the way clinical sites collaborate with pharmaceutical companies on clinical trials. [More]
First Edition: July 24, 2014

First Edition: July 24, 2014

Today's headlines include more analysis of this week's conflicting appeals courts' decisions regarding a key part of the health law. [More]