Wiping its slate ahead of BMS buy, Celgene to pay 117M Dollars in Revlimid antitrust settlements

Fiercepharma | August 01, 2019

With Celgene making the big move under Bristol-Myers Squibbs umbrella, the drugmaker is looking to clear its books before the merger. Two antitrust settlements totaling more than 100 million dollars could help soothe BMS mind. Celgene will pay Mylan 62 million dollars to settle claims that it intentionally stifled generic competition for its blockbuster multiple myeloma med Revlimid and predecessor Thalomid. The Big Biotech refused to sell samples of the two drugs to generics makers, the lawsuit said—and those samples are necessary for copycats to win FDA approval. Without the samples, Mylan couldn't perform the bioequivalence testing necessary to formulate a generic and submit it to the FDA for approval. Mylan’s suit, filed in 2014, was scheduled for trial in October, according to an SEC filing. Celgene chose not to comment on the settlement. The Mylan settlement follows a separate $55 million payout to close a class-action lawsuit from the International Union of Bricklayers and Allied Craft Workers Local 1 Health Fund. In that case, the union claimed Celgene not only refused to sell Revlimid and Thalomid samples, but also filed superfluous patent challenges to protect its drugs and agreed to exclusive supply agreements to stem the flow of Thalomid’s active ingredient from other suppliers. Celgene approved that settlement a week ago.

Spotlight

Dwight Koeberl, MD, at Duke University describes the studies he is doing to test albuterol and clenbuterol as a means to improve enzyme replacement therapy efficacy in patients with Pompe disease.

Spotlight

Dwight Koeberl, MD, at Duke University describes the studies he is doing to test albuterol and clenbuterol as a means to improve enzyme replacement therapy efficacy in patients with Pompe disease.

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PHARMA TECH

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization. In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market? Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that. The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times. A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government. "We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them." Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

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RESEARCH

MindMed Signs Partnership with Swiss Psychedelic Drug Discovery Startup MindShift Compounds AG

MindMed | February 15, 2021

MindMed, a leading psychedelic medicine biotech company announced another partnership with Swiss startup MindShift Compounds AG to develop and patent next-gen psychedelic compounds with psychedelic or empathogenic properties. As a component of this partnership, MindMed and MindShift Compounds AG have agreed to develop next-gen psychedelic and empathogenic substances together. The first initial compounds have just been combined by MindShift Compounds AG and related patent applications were documented by MindMed. MindMed plans to begin first-in-human Phase 1 clinical trials as ahead of schedule as Q1 2022 through its existing clinical preliminary stage for psychedelic and empathogenic compounds in Switzerland. The partnership on these initial targets will expand MindMed's current, grounded clinical pipeline with extra reinforcement and expansion compounds with comparative and possibly improved restorative properties. The connected combination intellectual property and drug technology will be possessed through and through by MindMed, and MindShift Compounds AG will give all intellectual property identified with the new psychedelic compounds only to MindMed. This partnership adds to MindMed's existing IP portfolio development endeavors in progress in collaboration with the University Hospital Basel's Liechti Lab for exemplary psychedelic compounds including LSD, MDMA, Psilocybin, MDMA-LSD combinations, personalized dosing technologies and a LSD Neutralizer technology, which depend on multiple clinical trials and long stretches of exploration led by the Liechti Lab. MindMed plans to work with the accomplished drug discovery group at MindShift Compounds AG to encourage extensively cover preclinical psychedelics investigation into novel compounds and hopes to continue to record a substantial number of licenses on countless novel substance matters, production innovations, and later clinical applications, allowing MindMed to additionally unite its leading situation in the in general psychedelic-medicine market as it moves these next-gen compounds into the clinic through advanced patient clinical trials. MindShift CEO, Dr. Felix Lustenberger, said "Our innovative psychedelic drug-discovery platform based in Switzerland is pioneering next-gen psychedelic compounds that complement in a synergistic pipeline approach the later-stage development work underway at MindMed. The compounds we are working on are typically derivatives or analogues of known substances with psychedelic properties, such as phenethylamines, tryptamines, and ergolines, and are therefore enhanced versions of both the established and classic psychedelic compounds such as mescaline, psilocybin, DMT, and LSD, as well as compounds with expected combined psychedelic-empathogenic effect profiles. These novel chemical structures, for example MDMA and LSD-like compounds, are designed and synthesized with expected ameliorated psychoactive properties and duration-of-effect profiles with potential added therapeutic benefits." About MindMed MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic-inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company's groundbreaking approach to developing the next generation of psychedelic-inspired medicines and therapies.

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PHARMA TECH

LEO Pharma and Veeva Systems Partner for Digital Patient-Centered Trials

LEO Pharma | September 30, 2021

LEO Pharma , a global leader in medical dermatology, and Veeva Systems announced a strategic technology partnership to enable scalable digital trials, paperless and patient-centered. Building on its success with the Veeva Clinical Operations suite, LEO Pharma will complete its standardization on existing Veeva clinical technology, be an early adopter of future Veeva solutions, and help shape the Veeva digital trials roadmap. By adopting technology and optimized business processes, LEO Pharma plans to achieve the following goals while maintaining the highest standards in data accuracy, regulatory compliance and patient safety: Significant improvement in the patient experience Increased patient diversity through decentralized trials Greater precision of clinical data 25% reduction in the cost of clinical trials 25% reduction in clinical trial time LEO Pharma will use the integrated suite of Veeva clinical products, including eTMF, CTMS, CDMS, Site Connect, eConsent, ePRO, Virtual Visits and eSource. We were exploring ways to transform clinical trials, but COVID-19 has accelerated this process. By responding quickly to changing market dynamics, we allowed our testing to continue without delay. The partnership with Veeva supports our 2030 strategy because it will help us deliver innovative treatments to patients faster while supporting a more sustainable business. Veeva's results in terms of product excellence make it the ideal long-term partner to help us achieve this goal, which allows us to help patients better and faster. - Jörg Möller, Executive Vice President and Head of R&D at LEO Pharma. We are excited and honored to extend our long-standing partnership with LEO Pharma to be an early adopter of our comprehensive digital testing platform, We intend to help the industry move forward with a scalable digital trials platform that dramatically improves the clinical trial process for patients, sites and sponsors. - Peter Gassner , Founder and CEO of Veeva About Veeva Systems Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence and customer success, Veeva has more than 1,000 customers, from the world's largest pharmaceutical companies to emerging biotechnology companies. As a public benefit company, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders and the industries it serves. About LEO Pharma LEO Pharma helps people achieve healthy skin. The company is a leader in the field of medical dermatology, with a strong R&D portfolio, a wide range of therapies and a pioneering spirit. Founded in 1908 and majority-owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advancing the science of dermatology, setting new standards of care for people with skin diseases. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company achieved net sales of 1,359 million euros.

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