Apricus Biosciences, Inc a biopharmaceutical company advancing innovative medicines in urology and rheumatology, announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.
Perrigo Company plc and its partner Dexcel Pharma Technologies, Ltd., announced the launch of store brand Omeprazole Delayed Release Orally Disintegrating Tablets 20mg (Omeprazole ODT), an over-the-counter (OTC) medication to treat frequent heartburn. Omeprazole ODT is an FDA-approved medication, featuring MelTech™ melt-in-your-mouth technology, that dissolves in the mouth without water. This product is packaged and marketed as a store brand or retailer 'own label' brand and will provide consumers with a high-quality option for treating frequent heartburn.
Talent demand in India grew by 8% in March 2018. This is the highest growth registered by the recruitment index in the last four months. Compared to last year (from March 2017- March 2018) this year has registered a 9% increase in overall talent demand. RecruiteX – a monthly hiring trend report by recruitment portal TimesJobs - noted that key industries and functional areas posted a significant rise in talent demand and contributed to this phenomenal rise of 8% in hiring activities in March 2018. Talent demand was highest for professionals with 10-20 years of experience.
Generic developers looking to apply the recently proposed draft US Pharmacopoeia (USP) monograph for Albuterol Inhalation Aerosols will find relevant new testing equipment at the Copley Scientific stand at Respiratory Drug Delivery 2018 (April 22nd to 26th, Tucson, Arizona). The new TPK™ 2100 Critical Flow Controller, a highly automated unit for reproducible, cost-efficient dry powder inhaler (DPI) testing, will also make its US debut. Copley Scientific is proud to be sponsoring this key event in the inhalation calendar and experts from the company will be in attendance throughout to discuss any aspect of inhaler testing.
Eisai Co., Ltd. has announced that it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application (sNDA) for Eisai’s antiepileptic drug (AED) Fycompa® (perampanel) seeking approval for an indication expansion to cover pediatric patients with epilepsy.
Biogen Inc and its partner Samsung Bioepis announced today an agreement with AbbVie for the commercialization of IMRALDI, a biosimilar referencing HUMIRA® (adalimumab). Under terms of the agreement, AbbVie will grant patent licenses for the use and sale of IMRALDI in Europe, on a country-by-country basis, and Biogen and Samsung Bioepis will make royalty payments to AbbVie. The companies have agreed to dismiss all pending patent litigation.
This week, the first commercially available freeze-free vaccine carrier will begin introductory field trials in Nepal. This follows the World Health Organization (WHO) announcement that the Indian-made carrier using PATHs Freeze-Safe reference design passed WHO Performance, Quality, and Safety (PQS) laboratory tests for User Independent Freeze Prevention, which prequalifies it for use in global immunization programs. This is the first low-cost carrier innovation available to address the widespread and long-standing problem of vaccines freezing in the cold chain during the last mile of outreach to infants and children
Currently in low- and middle-income countries, health workers carry millions of temperature-sensitive vaccines next to ice packs inside vaccine carriers to reduce heat exposure, but this risks freezing the vaccines if ice packs are not conditioned (carefully warmed to around 0°C). Freezing can irreversibly compromise vaccine potency, resulting in inadequate protection from disease for people receiving vaccines. When health workers suspect temperature damage, the vaccine or medication is often discarded—at great cost to health care programs.
PATH’s breakthrough solution mitigates the risk of vaccines being damaged by freezing or heat in carriers and eliminates the step of conditioning ice packs, reducing health worker burden. Frozen ice packs can be inserted immediately into the carrier thanks to a built-in barrier that shields the vaccines from reaching negative temperatures and excessive heat.
Many of the newer vaccines that protect children and infants from life-threatening diseases and infections, such as for human papillomavirus, pneumonia, and rotavirus, are freeze sensitive and cost far more than other vaccines. In 2015, the United Nations Children’s Fund (UNICEF) procured approximately USD 1.7 billion worth of vaccines for immunization programs, of which more than USD 1.2 billion were freeze sensitive.
“Our priority is maintaining vaccine potency for the millions of people living in remote communities,” says Pat Lennon, who leads the cold chain team at PATH. “In the future, vaccine carriers that prevent freezing will become the new standard for immunization programs.”
In order to rapidly accelerate introduction of this innovation, PATH put the Freeze-Safe reference design into the public domain for any manufacturer to use in their vaccine carrier products. PATH staff in Seattle and New Delhi, India, have provided technical advice to three product manufacturers who have adopted the technology. India-based AOV International’s product AFVC46 is the first carrier to receive WHO-PQS approval and will be available for purchase through the UNICEF Supply Division catalog.
“The Freeze-Safe vaccine carrier is a great example of Indian industry helping solve a global public health challenge,” says Neeraj Jain, Country Director of PATH’s India country program. “This ‘Made in India’ freeze-preventive vaccine carrier can help health workers in India and globally to administer lifesaving vaccines that do not freeze and could help save millions of lives.”
PATH estimates that more than 2 million new and replacement carriers will be needed by 2020 for the 73 Gavi-member countries. To accelerate scale-up of the Freeze-Safe innovation, PATH is conducting field trials, supporting efforts to integrate the carriers into existing health systems, and working with manufacturers as well as adapting the innovation for use in other cold chain equipment.
“Vaccine carriers that prevent vaccines from freezing while in transit and yet are low cost and easy to use can save millions of children’s lives,” says Dr. Benjamin Schreiber, Deputy Immunization at UNICEF. “These are exactly the type of cutting-edge solutions we need to immunize every child.”
PATH has worked to advance technologies, policies, and programs to address vaccine freezing issues across the supply chain from formulation to the last mile since 1996, and on the Freeze-Safe innovation since 2012. This work aligns with UNICEF; Gavi, the Vaccine Alliance; and WHO strategies to maintain vaccine potency and improve immunization cost efficiencies and coverage.
The European Medicines Agency has published its annual bulletin on the veterinary pharmacovigilance activities carried out to monitor medicines in practice and to ensure their safe and effective use. In 2017, the monitoring of centrally authorised veterinary medicinal products was further strengthened thanks to an overall increase in the electronic reporting of adverse events to EudraVigilance Veterinary (EVVet), the European Economic Area database of suspected adverse reaction reports.
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Sun Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration (FDA) has approved ILUMYA™ (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ILUMYA™ selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro-inflammatory cytokines and chemokines.
The U.S. Food and Drug Administration issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.
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