Industry News

The U.S. Food and Drug Administration approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient’s life.

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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

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.