Upadhye Cwik LLP Guides About Innovative Legal Practices On Pharmaceutical and FDA Issues in COVID-19 World

Upadhye Cwik LLP | July 02, 2020

The COVID-19 pandemic continues to turn the world upside down. And when upside down, the legal issues surrounding pharmaceuticals and the FDA become apparent. We identify a few areas that our law firm is working on for clients.

Our patent work remains busy helping clients with rationalizing patent portfolios, conducting infringement-mapping exercises to find potential licensing revenues, and patent litigation to enforce patent rights. Interestingly we see some clients not cutting the pipeline and thus increasing their patent activities to be ready with new products once the economy returns. Other companies are using the 505(b)(2) platform to come up with new products in less costly ways.

The COVID-19 crisis has caused a serious disruption on contracts, from supplying raw materials to end producers, up to the inability to pay for product received due to cash-flow problems. We are seeing clients invoking the Force Majeure clause to get out of contracts and similarly helping clients to force the other party to stay in the contract. The failure to supply may also cause consequential problems such as stock-out penalties, product recalls, or mitigation. We are also drafting new contracts to account for pandemics and other viral/bacterial outbreaks. Nevertheless, business is business and we are helping clients in commercial litigation in order to enforce contracts. Other clients are using commercial litigation to protect market share.

Spotlight

Population pharmacokinetic (PopPK) analysis has become a key tool for clinical pharmacology experts when working with data from human subjects. In the recent past, new drug registrations utilized pharmacokinetic (PK) information from healthy volunteers, in whom intensive PK sampling could be performed. In an effort to examine possible dosage adjustments for patients or other subgroups (eg, elderly, children, individuals with compromised liver function, etc) PopPK techniques were developed.

Spotlight

Population pharmacokinetic (PopPK) analysis has become a key tool for clinical pharmacology experts when working with data from human subjects. In the recent past, new drug registrations utilized pharmacokinetic (PK) information from healthy volunteers, in whom intensive PK sampling could be performed. In an effort to examine possible dosage adjustments for patients or other subgroups (eg, elderly, children, individuals with compromised liver function, etc) PopPK techniques were developed.

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RESEARCH

IDBS Launches Polar™ in a New Product Category That Aims to Streamline and Speed up Biopharmaceutical Development

IDBS | December 07, 2020

IDBS, a product informatics arrangement supplier for biotech and pharma, today reported the dispatch of Polar™, building up another item classification, BioPharma Lifecycle Management (BPLM), pointed toward smoothing out medication advancement and assembling in biopharma research. The advancement of biologics is a unique cycle and the individuals who are best should have the option to adjust to changes in cycle or innovation quickly. IDBS information has discovered that without compelling BPLM, the advancement of a biologic can take as long as three years longer than it should, which impacts the two patients and an organization's primary concern. Despite the fact that biopharma organizations perceive the requirement for proficiency, quality and information honesty, most are as yet losing time to paper records, Excel and other specially appointed frameworks that defer results and endanger measure understanding and quality. Without more productive frameworks, organizations will keep on creating irreproducible outcomes, which prompts rehashed work, inability to separate experiences and postpones development. "Putting up a medication for sale to the public is an unpredictable cycle which proceeds with post-commercialization," said Umay Saplakoglu, Chief Digital Officer at Cytiva. "A significant test today is that information that is created all through the periods of disclosure doesn't generally get moved and rather exists in storehouses – in hardware, in somebody's scratch pad or in an information base. There are no communitarian stages where you can dissect the information and draw experiences from it. This remaining parts probably the greatest test confronting industry today." Polar™ is intended to be quickly sent to explain work process, measure quality, joint effort and information investigation challenges that have pained presently accessible programming arrangements including LIMS and ELN. It will decrease manual information preparing and record, prompting less human mistakes and improved generally speaking precision, and incorporates complete pursuit capacities that help clients find what they are searching for, diminishing the need to pointlessly copy measures. Besides, by making a profoundly contextualized information spine that underpins the entire improvement lifecycle, Polar™ offers out-of-the-crate understanding and investigation, assisting organizations with understanding the advantages of demonstrating and reproduction, helping drive development and decrease time-to-showcase. Polar™, will empower organizations to all the more viably explore the complexities and failures of the medication advancement lifecycle, while receiving the groundbreaking rewards that come from a well curated cycle and quality information spine.

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PHARMACY MARKET

Lilly Collaborates with Samsung to boost COVID-19 antibody manufacturing amid supply concerns

Lilly | November 18, 2020

Seven days after Eli Lilly won a FDA crisis approval for its COVID-19 counter acting agent, worries over restricted supplies are as of now springing up, and the organization is getting an accomplished assembling accomplice to help with the worldwide scale-up. Under a drawn out arrangement with Samsung Biologics, the organizations are set to "incredibly quicken the worldwide gracefully" for Lilly's COVID-19 antibodies, Samsung Biologics said in a delivery. Lilly would like to make up to 1 million dosages this year and a lot more in 2021, Reuters reports. The accomplices entered an underlying assembling association back in May, and, from that point forward, Samsung created a first clump of dynamic drug fixing in spite of struggling getting crude materials. The organizations took care of the tech move in under a quarter of a year, a consequence of routine collaborations between specialists at both medication creators, Samsung Biologics said. Lilly's bamlanivimab scored a FDA crisis use approval a week ago in gentle to-direct COVID-19 patients who are at a high danger of advancing to extreme illness. The FDA said the medication isn't approved in hospitalized patients, and Lilly is instructing imbuement inside 10 days concerning manifestation beginning. Before the crisis gesture, the organization entered a flexibly manage the U.S. government for 300,000 dosages at $1,250 per portion. All things considered, the stock could last only multi week dependent on current disease patterns, Reuters reports. While the arrangement incorporates a possibility for additional portions, specialists told the news administration they expect the medications will turn into a business drug sooner or later.

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BUSINESS INSIGHTS

Virpax Pharmaceuticals Engages Torreya Capital to Advise on Global Partnering Efforts

Torreya Capital, Virpax Pharmaceuticals | April 23, 2021

Virpax® Pharmaceuticals, Inc. reported today that it has appointed Torreya Capital, LLC as the Company's sole financial adviser for its partnering and licensing activities in strategic global markets. Torreya is a leading investment bank that has supported more than $100 billion in life sciences transactions since its establishment in 2007. “We are thrilled to be collaborating with Torreya to extend our partnerships in key markets,” said Anthony Mack, Chairman, and CEO of Virpax Pharmaceuticals. "There is an increasing worldwide need for non-opioid, non-addictive pain treatments, and we agree that our product candidates, EpoladermTM, ProbudurTM, and EnveltaTM, will provide a competitive advantage in their target markets," Mr. Mack concluded. "We look forward to assisting Virpax Pharmaceuticals in identifying strong regional partners for their innovative acute and chronic pain product candidate pipeline,” said Torreya Partner Tom Bird. "Virpax's product candidates include proprietary technologies that can enable the product candidates to provide enhanced benefits while providing non-addictive pain relief.” About Torreya Torreya is a global investment banking boutique that works with life sciences industries. Since its inception in 2007, the company has closed over $100 billion in transactions spanning branded pharmaceutical, biotechnology, generic pharmaceutical, and life sciences firms in nearly 250 assignments. Their associates are senior bankers and executives with extensive industry expertise, insights, and networks. They are a preferred advisor for businesses seeking secure, conflict-free, and knowledgeable advice on M&A, capital markets, licensing, and asset sale transactions. The breadth of Torreya's global footprint separates it from any other life sciences advisory practices. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management product candidates by optimizing and enhancing drug delivery using its proprietary technologies. Virpax is seeking FDA approval for its three proprietary drug delivery systems. EpoladermTM is a metered-dose topical diclofenac spray film formulation being used to treat acute musculoskeletal pain and osteoarthritis. ProbudurTM is a liposomal bupivacaine formulation for a single injection that is being used to treat post-operative pain. EnveltaTM is an intranasal molecular-envelope enkephalin formulation that is being developed to treat acute and chronic pain, particularly cancer-related pain. Virpax is also developing its PES200 product candidate to treat post-traumatic stress disorder (PTSD) and its MMS019 product candidate to prevent viral replication caused by influenza or SARS-CoV-2 using its intranasal Molecular Envelope Technology (MET).

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