Merck launches Biosimilars, ABITEC announces extension, First human clinical trial, FDA awards 2grants, Corden Pharma Expands, Juniper Pharma Services Offers

Merck launches Biosimilars Clarified, a new online educational resource about biosimilar medicines for patients and the healthcare community

Merck has announced the launch of Biosimilars Clarified, a new educational website for patients, caregivers and the healthcare community that is designed to provide clear, concise and straightforward information about biosimilar medicines. Biosimilars Clarified is designed to help answer questions about biosimilars to the patients to help improve knowledge about the use of biosimilars in the treatment of different diseases.

ABITEC announces extension of product portfolio and enters new market

ABITEC’s R&D continues to develop innovative products that meet the ever evolving demands of the pharmaceutical market. The expansion of their non-ionic High HLB surfactant line, ACCONON®, offers a product that can be used in solid formulation as a high melt emulsifier and bioavailability enhancer.  ABITEC is also introducing to market their first line of functional lipid excipients for parenteral applications, INJECTA™.

First human clinical trial for nicotinamide riboside

In the first controlled clinical trial of nicotinamide riboside (NR), a newly discovered form of Vitamin B3, researchers have shown that the compound is safe for humans and increases levels of a cell metabolite that is critical for cellular energy production and protection against stress and DNA damage. The trial showed that the NR vitamin increased NAD+ metabolism by amounts directly related to the dose, and there were no serious side effects with any of the doses. The next step will be to study the effect of longer duration NR supplementation on NAD+ metabolism in healthy adults.

FDA awards 21 grants to stimulate product development for rare diseases

The USFDA Announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international clinical sites. The FDA awards the grants through the Orphan Products Clinical Trials Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases.

Corden Pharma Expands Highly Potent API Capabilities

Corden Pharma has completed a new highly potent API process bay for category 4 compounds. This new investment comes after the completion in early 2016 of a new CTD2 facility for the handling (development/manufacturing) of oral solid dosage drug product manufacturing of highly potent and oncology compounds in its Plankstadt (Germany) facility, along with further expansion of capabilities in handling sterile oncology drug products at Latina (Italy).

Juniper Pharma Services Offers Granulation Capabilities

UK-based contract development and manufacturing organization (CDMO) Juniper Pharma Services has added a roller compactor to its enabling technologies platform. The company has purchased a Gerteis Mini-Pactor to expand its granulation capabilities and support recent capability. The Mini-Pactor offers the latest in dry granulation technology, which improves the material handling and processing characteristics of poor-flowing materials, such as amorphous solid dispersions and low dose compounds including potent materials.