Stockholm, Sweden
Stockholm, Sweden

Pharmalink Consulting is a Global regulatory affairs consultancy based in UK, US, India, Singapore and Latin America which provides regulatory expertise and resource to the healthcare industry. Wikipedia.


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STOCKHOLM, November 29, 2016 /PRNewswire/ -- Pharmalink AB, a specialty pharma company, announces that the European Commission (EC) has granted Orphan Medicinal Product (OMP) designation in the European Union (EU) to Nefecon® (budesonide), the Company's treatment for patients with...


Pharmalink AB, a specialty pharma company, announces that the European Commission (EC) has granted Orphan Medicinal Product (OMP) designation in the European Union (EU) to Nefecon® (budesonide), the Company's treatment for patients with primary IgA nephropathy (IgAN). Nefecon, which already has orphan designation for IgAN in the US, has successfully completed a randomized, placebo-controlled Phase 2 study (the NEFIGAN trial) in more than 150 IgAN patients at risk of developing end stage renal disease (ESRD), under standardized rigorous blood pressure control. Full data and analysis of the trial is expected to be published in a peer-review journal. A Phase 3 registration trial is currently being planned. Johan Häggblad, Pharmalink CEO, commented: "Receiving orphan drug designation from the EC, in addition to the previous orphan drug designation granted by the US FDA, is an important event for Pharmalink. It highlights the need for new products for the treatment of primary IgAN as well as our commitment to developing Nefecon for these patients." Orphan drug designation is granted to drugs that are intended for the treatment of life threatening or chronically debilitating rare diseases where no therapeutic options either exist or are satisfactory. Rare diseases are those defined as having a prevalence of less than five in 10,000 in the European Union. The designation provides sponsors with development and commercial incentives, including 10 years of market exclusivity, prioritized consultation by the European Medicines Agency (EMA) on the development of the drug, including clinical studies, and certain exemptions from or reductions in regulatory fees. Click here for more information. IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage. IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with IgAN progress to renal failure, often referred to as end-stage renal disease (ESRD) within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets. Patients suffering renal failure require dialysis or kidney transplantation. IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs. Nefecon is a treatment for patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD). Nefecon has successfully completed a randomized, placebo-controlled Phase 2b study in more than 150 IgAN patients at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB). Full data and analysis of the NEFIGAN trial is expected to be published in a peer-review journal. A Phase 3 registration trial is currently being planned. Nefecon is an oral formulation of a locally-acting and potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Promising results indicate that treatment with Nefecon may provide clinical benefits to IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon has received orphan drug designation by the US Food and Drug Administration (FDA). Pharmalink is a specialty pharma company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products. For further information, please contact: Pharmalink AB: Johan Häggblad,


A method for manufacturing a hyaluronan conjugate comprises providing hyaluronan in solution or gel form, reacting the hyaluronan in solution or gel form with anhydride reagent to provide a hyaluronan hemi-ester with a chain of length L between the hyaluronan and the ester group, and subsequently binding the hyaluronan hemi-ester to a pharmaceutically active compound. A hyaluronan conjugate comprises hyaluronan having free hemi-ester-groups and a pharmaceutically active compound bound to the hyaluronan via hemi-ester groups, wherein the hemi-ester groups have a chain length of 2-9 atoms. The hyaluronan conjugate is suitable for use in various methods of treatment in human or veterinary medicine and for preparation of a medicament for use in human or veterinary medicine.


Trademark
Pharmalink | Date: 2013-05-21

Veterinary preparations and products and natural medicine for animals for the treatment of inflammatory conditions in the nature of arthritis, arthritic pain and various skin disorders; natural medicines for animals containing extracts from shellfish for the treatment of inflammatory conditions in the nature of arthritis, arthritic pain and various skin disorders; dietetic substances based on extracts from shellfish, namely, powder, paste, tablets and solutions adapted for veterinary use also as an anti-inflammatory; dietary and nutritional supplements for animals. Foodstuffs for animals based on extracts from shellfish.


Trademark
Pharmalink | Date: 2014-04-30

Pharmaceutical preparations; sea water for pharmaceutical purposes and veterinary. Nasal inhalers for medical purposes.


Dom

Trademark
Pharmalink | Date: 2013-10-28

Mineral raw materials processed or derived from deep ocean sea water for use in the manufacture of personal care products, namely soaps, perfumery, essential oils, cosmetics, hair lotions, pharmaceutical and veterinary preparations, sanitary preparations, dietetic food and substances, food for babies, dietary supplements for humans and animals, as well as in the manufacture of foodstuffs and beverages for human or animal consumption; aqueous dispersions of inorganic minerals; mineral substances (raw materials). Dietetic food and substances adapted for medical or veterinary use, food for babies, dietary supplements for humans and animals, all the aforesaid goods based on deep ocean sea water ingredients; deep ocean sea water for medicinal or therapeutic use; salts for mineral water baths; mineral salts for medical purposes; health food supplements made principally of minerals, drinks and mineral water for medical purposes; foodstuff and food supplements containing minerals and vitamins for medical purposes; water containing mineral salts for medical purposes. Beers; mineral and aerated waters and other non-alcoholic beverages; fruit beverages and fruit juices; syrups and other preparation for making beverages; all of the aforesaid goods also enriched with minerals and with deep ocean sea water ingredients; deep ocean sea water (beverages) with added minerals, for the manufacture of bottled drinking water, beer, carbonated and non-carbonated soft drink beverages and juices.


Trademark
Pharmalink | Date: 2013-04-30

Pharmaceutical preparations for nasal hygiene; pharmaceutical preparations, namely nasal rinses, nasal spray preparations, decongestant nasal sprays; sea water for pharmaceutical purposes and veterinary purposes. Nasal inhalers for medical purposes.


Trademark
Pharmalink | Date: 2013-01-01

Cardboard shipping containers for use in processing and disposing of pharmaceutical returns. Pharmaceutical resource business management services, namely, supply chain logistics and reverse logistics for managing and controlling inventory and processing and disposing of pharmaceutical returns; providing a website that manages and controls inventory and processing returns of pharmaceuticals.


News Article | December 5, 2016
Site: www.prweb.com

PharmaLink is proud to partner with Miami-Luken, Inc., a leading regional wholesaler servicing independent pharmacies across multiple Midwestern states, on an innovative new solution to handle Unsaleable Pharmaceutical Returns for Pharmacy customers. The System OneSM returns program from PharmaLink provides Pharmacy customers with a simple, compliant, outlet to handle returns processing and reporting of unsaleable products with the ultimate convenience. Miami-Luken selected PharmaLink to work on this initiative because of their vast experience working with various Pharmacy classes of trade and their robust relationships throughout the pharmaceutical supply chain. Thierry Beckers (President/COO, PharmaLink) was noted saying, “We are excited about this new program because we will be providing independent pharmacy customers with services and reporting that delivers a new level of visibility to the returns process.” PharmaLink is known for their industry leading technology platform and boutique style services to handle pharmaceutical returns. Michael Faul (CEO, Miami-Luken) said, “We are always looking for innovative ways to provide our pharmacy customers with better solutions to their common problems. PharmaLink shares in a similar set of values to our organization and we are confident this new partnership will add significantly to our service offering.” The System One Returns program offers a robust suite of on-site and mail-in return services with no out of pocket expense to customers. Contact your Miami-Luken representative for details. Based in the Tampa Bay Area of Florida, PharmaLink, Inc. is the nation's premier Pharmaceutical Reverse Logistics and Disposal provider. With services spanning the complete spectrum of the pharmaceutical supply chain, they have a 360 degree view of the needs of all businesses involved in the delivery of healthcare. From a reverse logistics perspective, they deliver impactful solutions that trim cycle time while safely removing unwanted product from the marketplace. PharmaLink’s simple user interfaces are backed by a powerful enterprise infrastructure, producing accurate processing and quality analytics that optimize business decision and increase bottom line. This is all achieved while adhering to stringent regulatory guidelines at the state and federal level. PharmaLink has customizable solutions available for any size client. Centrally located in Ohio’s Miami Valley, Miami-Luken has been providing personal service and outstanding value to their customers since 1962. Miami-Luken offers full-line service of branded and generic pharmaceuticals, OTC items, private label products, home healthcare, health and beauty products, retail candy, and related items. These items are shipped daily to customers throughout Ohio, Indiana, Kentucky, Tennessee, West Virginia, western Pennsylvania and southern Michigan. Maintaining a variety of Industry Partnerships allows Miami-Luken to leverage the benefits of numerous programs and affiliations to meet the unique needs of their customers. Recently, Miami-Luken has been striving to provide innovative solutions to the challenges of the evolving healthcare industry, while expanding into new geographic territories. For additional information, visit http://www.miamiluken.com

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