Pharma News

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).

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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.

The U.S. Food and Drug Administration announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).

Ionis Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to IONIS-HTTRx for the treatment of patients with Huntington's disease (HD). IONIS-HTTRx is the first therapy to enter clinical development that is designed to directly target the cause of the disease by reducing the production of the protein responsible for HD. IONIS-HTTRx has also been granted orphan drug designation by the European Medicines Agency for the treatment of patients with HD.

United-Guardian, Inc.  announced  that it has received FDA approval of its Supplemental New Drug Application to market a new single-dose form of Renacidin® (Citric Acid, Glucono delta-Lactone, and Magnesium Carbonate), the company’s proprietary irrigating solution that is used to prevent and dissolve calcifications in indwelling catheters.

A small molecule drug combined with chemotherapy may effectively treat colorectal cancer patients, says a new study.

GlenmarK Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), has announced the discovery and initiation of IND-enabling studies for a novel clinical development candidate, GBR 1342. GBR 1342 is a CD38xCD3 bi-specific antibody based on Glenmark’s proprietary BEAT® platform. GBR 1342 is the second clinical development candidate (following GBR 1302 a HER2xCD3 bi-specific antibody) based on the BEAT® technology. It is also Glenmark’s second clinical candidate targeting oncology indications.

Blocking a receptor in the brain responsible for regulating immune cells could protect against the memory and behaviour changes seen in the progression of Alzheimer's disease, says a new study.