Fiercepharma | June 09, 2020
Consumers are on edge as the COVID-19 pandemic casts doubts on the quality of drugs reaching shelves around the world. On U.S. shores, experts say those issues are warranted—and a wave of Pfizer recalls for menopause drug Duavee won't help build confidence. Pfizer voluntarily recalled two batches of Duavee––marketed as Duavive abroad––from U.K. shelves after identifying faulty packaging that may have reduced the drug's efficacy, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) said Monday. Pfizer launched the recall after manufacturers identified a flaw in the drug's foil laminate pouch that introduced oxygen and lowered the dissolution rate of active pharmaceutical ingredient bazedoxifene acetate, the MHRA said.
Spotlite360 | July 07, 2021
SPOTLITE360 TECHNOLOGIES, INC. is happy to announce that it has started an initiative to provide tailored supply chain tracing and tracking solutions for pharmaceutical companies, for which it is now in contract discussions with pharmaceutical firms. This effort coincides with an impending regulatory shift in the USD 1.3 trillion pharmaceutical industry1 that will require companies to comply with the Drug Supply Chain Security Act (“DSCSA”), which requires the deployment of electronic tracing systems. The Company has recognized an opportunity to offer solutions to DSCSA compliance by combining RFID and IoT sensors with blockchain, machine learning, and enterprise tracking software licensed from TrackX Holdings Inc.
In addition to the cost of complying with new and upcoming laws such as the DSCSA, pharmaceutical sector participants confront the following persistent difficulties in their supply chains:
• Every year, about USD 200 billion in counterfeit medicines are sold worldwide.
• Pharmaceutical cargo theft costs more than USD 1 billion per year, with a median stolen value of USD 100,000 being more than the industry average.
• Inadequate storage and transportation practices (e.g., unrefrigerated trucks, shipment periods that exceed a drug’s shelf life) can cause pharmaceutical damage, which has been highlighted as a multibillion-dollar issue in 2018.
The Company’s existing SaaS solution, powered by Spotlite360 technologies tailored to clients in the pharmaceutical industry, will capture real-time and event-driven data that can identify inefficiencies and potential hazards for pharmaceutical firms, potentially mitigating issues such as those listed above. Furthermore, potential benefits to clients in the pharmaceutical industry include accountability of global suppliers, as well as validation of claims relating to environmental, social, and corporate governance (“ESG”) matters by providing proof of origin, reliably authenticating goods, and allowing visibility into the chain of custody.
Blockchain technology has already shown to be effective in various pharmaceutical supply chain functions, including DSCSA compliance. In 2020, a major technology company released a study of its blockchain pilot program in collaboration with pharmaceutical behemoth Merck & Co. and the United States Food and Drug Administration (“FDA”), which was judged initially viable as stated in its final report filed to the FDA5. Spotlite360’s newest effort for the pharmaceutical sector aims to set new industry standards by providing an improved value proposition through full visibility and tracking capabilities.
About Spotlite360 Technologies Inc.
Spotlite360 is a logistics technology solutions provider that unlocks value, opportunities, and efficiency for all supply chain participants. Spotlite360 aims to establish new standards of transparency, integrity, and sustainability in the pharmaceutical, healthcare, and agriculture industries by building on existing applications of IoT technology, distributed ledgers, and machine learning. As authorities worldwide continue to enforce additional tracing and accountability requirements for consumer protection, the need for dependable, cost-effective, and flexible monitoring technology is anticipated to grow. Spotlite360’s flagship SaaS solution has been designed to monitor the movement of a product in real-time by connecting with the systems of all major stakeholders in the supply chain, from raw materials to the hands of the end customer.
Dicerna Pharmaceuticals, Inc. | December 27, 2021
Dicerna Pharmaceuticals, Inc. announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended in connection with Novo Nordisk’s cash tender offer for Dicerna expired at 11:59 p.m., Eastern Time, on December 24, 2021.
As previously announced on November 18, 2021, Novo Nordisk commenced a cash tender offer to purchase all outstanding shares of Dicerna common stock for $38.25 per share in cash, without interest and subject to any withholding of taxes. The expiration of the HSR waiting period satisfies one of the conditions necessary for the consummation of the tender offer. Other conditions remain to be satisfied, including, among others, a minimum tender of shares representing one more share than 50% of the sum of the total number of Dicerna shares outstanding at the time of the expiration of the offer. Unless the tender offer is extended, the offer and withdrawal rights will expire at 5:00 p.m., Eastern Time, on December 27, 2021.
Dicerna Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference to silence selectively genes that cause or contribute to disease. Using our proprietary GalXC™ and GalXC-Plus™ RNAi technologies, Dicerna is committed to developing RNAi-based therapies with the potential to treat both rare and more prevalent diseases. By silencing disease-causing genes, Dicerna’s GalXC platform has the potential to address conditions that are difficult to treat with other modalities. Initially focused on disease-causing genes in the liver, Dicerna has continued to innovate and is exploring new applications of its RNAi technology with GalXC-Plus, which expands on the functionality and application of our flagship liver-targeted GalXC technology to tissues and cell types outside the liver, and has the potential to treat diseases across multiple therapeutic areas. In addition to our own pipeline of core discovery and clinical candidates, Dicerna has established collaborative relationships with some of the world’s leading pharmaceutical companies, including Novo Nordisk A/S, Roche, Eli Lilly and Company, Alexion Pharmaceuticals, Inc.