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Medlab Clinical - Novel drug delivery and synthetic cannabinoids


Medlab Clinical - Novel drug delivery and synthetic cannabinoids
Medlab is a drug delivery biotechnology company with a proprietary platform, NanoCelle, which is a patented nanomicellar formulation that can improve the delivery of drugs. With the growing appreciation of the medicinal properties of cannabis, Medlab-s lead product became NanaBis, a THC:CBD (1:1) cannabis extract encapsulated in NanoCelle particles, which enable a convenient buccal spray delivery. The most recent breakthrough was Medlab-s announcement that it had successfully produced a synthetic version of NanaBis, thus significantly streamlining the regulatory pathway. Once the product reformulation is done (current guidance is eight to 10 months), NanaBis will re-enter clinical development (potentially Phase III) as a fully synthetic, non-opioid pain relief drug optimised with proprietary delivery technology aimed at a vast market. ....

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Novo Nordisk resubmits once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes for US regulatory approval | Proteins and Peptides


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BAGSVAERD, Denmark I May 28, 2021 I Novo Nordisk today announced the resubmission of a label expansion application to the US Food and Drug Administration (FDA) for the existing marketing authorisation for Ozempic
®, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. The resubmission follows the Refusal to File letter received by the FDA on 22 March 2021. The standard review time by the FDA is 10 months.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk s ....

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Merck KGaA Launches Synthetic Cholesterol Product For MRNA-based Vaccines


Merck KGaA Launches Synthetic Cholesterol Product For MRNA-based Vaccines
BERLIN (dpa-AFX) - German science and technology firm Merck KGaA (MKGAY.PK) announced Wednesday the launch of a new, high-purity synthetic cholesterol product, nine months ahead of schedule, to meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics.
The introduction of the new SAFC synthetic cholesterol product has increased the capacity by 50 times to help bio-manufacturers bring lifesaving therapies to patients faster.
Merck manufactures lipids in Schaffhausen, Switzerland; Darmstadt, Germany; and St. Louis, Missouri, USA. This neutral lipid, used in commercially marketed products, is more than 99 percent pure, offers high batch-to-batch consistency and is scalable under commercial GMP. ....

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Soligenix, Inc.: Soligenix Receives Japanese Patent for Improved Production of Synthetic Hypericin Composition


Soligenix, Inc.: Soligenix Receives Japanese Patent for Improved Production of Synthetic Hypericin Composition
PRINCETON, N.J., May 20, 2021 /PRNewswire/  Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Japan Patent Office has allowed the patent application titled Systems and Methods for Producing Synthetic Hypericin .  The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin, and are similar to those previously allowed in the United States (U.S.). Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™ (SGX301), the Company s photodynamic therapy, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) were recently announced.  This ....

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