Industry News

The U.S. Food and Drug Administration approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.

Sanofi and Innate Pharma announced that they have entered into a research collaboration and licensing agreement to apply Innate Pharma's new proprietary technology to the development of innovative bispecific antibody formats engaging natural killer (NK) cells to kill tumor cells through the activating receptor NKp46.

The U.S. Food and Drug Administration announced that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.

Advinus Therapeutics  has reached the third milestone in its research and development collaboration with Takeda Pharmaceutical Company Limited. The achievement of this milestone highlights the success of the collaboration.

LivaNova PLC received a Warning Letter dated December 29, 2015, from the United States Food and Drug Administration (“FDA”) alleging certain violations of FDA regulations applicable to medical device manufacturers at its Munich, Germany and Arvada, Colorado facilities.

MiMedx Group, Inc., the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced that it has recently posted an updated "Certificate to Foreign Government" on its website that describes all of the MiMedx  sheet form allografts and the Food and Drug Administration FDA's certification that the listed products are HCT/P's.

NeuroMetrix, Inc.  announced that it received a 510(k) clearance (K152954) from the U.S. Food and Drug Administration (FDA) for an upgraded version of Quell, the company's over-the-counter, 100% drug free chronic pain relief wearable. Under this 510(k), the Quell device can be controlled directly via the Quell Relief smartphone app. This provides an unprecedented level of convenience and comfort when using Quell to treat chronic pain.

Takeda Pharmaceutical Company Ltd.  and Enterome Bioscience SA (“Enterome”) announced they have entered into a strategic drug discovery collaboration to research and develop potential new therapeutics directed at microbiome targets thought to play crucial roles in gastrointestinal disorders, including inflammatory bowel diseases (e.g. ulcerative colitis) and motility disorders (e.g. irritable bowel syndrome).

BOCA Cleartronic, Inc., through its subsidiary ReadyOp Communications, Inc., announces that the US Food and Drug Administration (FDA) has expanded its use of ReadyOp as an integral part of their communications and incident response planning.