Boston Biomedical starts phase III study of Napabucasin
Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, announced dosing of the first patient in CanStem303C, a new global phase III study investigating napabucasin in combination with standard of care (Folfiri) in patients with previously treated metastatic colorectal carcinoma (mCRC). Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.
Martindale Pharma’s clobazam oral suspension receives approval from seven European countries
Martindale Pharma, UK-based international specialty pharmaceutical company, announced the regulatory approval of its clobazam oral suspension product, Epaclob. The suspension has received approval in France, Ireland, Germany and Italy and Silocalm in Denmark, Spain and Iceland following the successful completion of a decentralised procedure (DCP). Epaclob/Silocalm are based on Tapclob, and are approved in two strengths, 5mg/5ml and 10mg/5ml. They will be supplied in packs containing dosing syringes and dosage cups to facilitate accurate dosing and aid adherence to treatment.
Merck snagged a green light for Zinplava
The anti-infectives field is heating up–and Merck’s the latest Big Pharma player to win approval for a new entrant. The medicine meant to reduce resistance of Clostridium difficile infection in adults. Zinplava will join a Merck anti-infectives portfolio that took shape with its early 2015 purchase of Cubist Pharmaceuticals. Zinplava also faces the prospect of competition not only from other drugs, but also from vaccines that might prevent C. Diff altogether. Pfizer and Sanofi are each working on versions, and smaller vaccine makers are in the mix, too.
Nanotechnology to improve HIV drug therapies
Researchers at the University of Liverpool, UK, are exploring the use of nanotechnology to improve administration and availability of drug therapies to HIV patients. A recent investigation conducted by Pharmacologist professor Andrew Owen and Materials Chemist professor Steve Rannard, has discovered that HIV patient groups have shown their desire to switch to nanomedicine alternatives. They are working on the development of new oral therapies, by using solid drug nanoparticle (SDN) technology. The SDN technology is anticipated to reduce both the dose and the cost per dose.
Biocon’s Malaysia insulin plant will be ready for commercial production in H2
India’s Biocon has been working for six years on a massive, $250 million facility to manufacture insulin in Malaysia and says it will soon produce commercial product there. The company’s plant is in Nusajaya, which was certified by authorities this year, and has 400 employees and represents the largest foreign investment made in Malaysia’s biotech sector to date. It also is Biocon’s first overseas biopharma manufacturing and research facility.
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.