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FDA classifies Abbott’s blood pumping system recall as most serious

The U.S. Food and Drug Administration classified the recall of Abbott Laboratories’ CentriMag blood pumping system, following the death of a patient, as Class 1 or the most serious type of recall.

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Stryker boosts bone implants with $4 billion Wright Medical buyout

Medical device maker Stryker Corp. will buy smaller rival Wright Medical Group for about $4 billion in cash, expanding into the fast-growing business of implants for shoulders and wrists.

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EVERSANA to acquire Cornerstone Research Group

EVERSANA, a leading independent provider of commercial services to the life science industry, announced an agreement to acquire Canada-based Cornerstone Research Group Inc.

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Johnson & Johnson agrees to pay about $117 million to settle vaginal mesh litigation

U.S. state attorneys general said Johnson & Johnson and a company unit agreed to pay nearly $117 million to settle litigation over deceptive marketing of transvaginal surgical mesh devices.

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QIAGEN and Illumina Partner to Deliver Sequencing-Based IVD Tests

Illumina Inc. and Qiagen N.V. announced a 15-year partnership intended to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.

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Accelmed seeks to raise $100 million for fourth health tech fund

Accelmed, a U.S.-Israel group of funds investing in medical device and digital health companies, is establishing a new fund with the aim of raising and managing $100 million.

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Favorable court ruling for Vectura and Sandoz vs. GSK

A British court ruled in favor of Vectura Group and the company’s partner Sandoz over the packaging of a generic version of an inhaler made by bigger rival GlaxoSmithKline.

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FDA green lights AstraZeneca’s asthma drug Fasenra for self-administration

The U.S. Food and Drug Administration approved self-administration of AstraZeneca’s asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen.

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Abbott Announces European Approval of Two Life-saving Heart Devices for Babies and Children

Abbott announced approvals in Europe for two life-saving pediatric devices, the Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder.

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Orchestra BioMed Announces FDA Breakthrough Device Designation for Virtue Sirolimus-Eluting Balloon

Orchestra BioMed Inc., in partnership with Terumo Corporation, announced Breakthrough Device Designation was granted by the U.S. Food and Drug Administration for the biomedical innovation company’s Virtue Sirolimus-Eluting Balloon in the treatment of below-the-knee peripheral artery disease.

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