House Republican investigators have asked the National Archives to hand over any unredacted records in which then-VP Joe Biden used a pseudonym.
Previously released emails retrieved from Hunter's abandoned laptop reveal that Biden used a "Robert.L.Peters@pci.gov" email address while he was serving as Vice President of the United States. What's more, that Biden aide John Flynn cc'd Hunter on 10 emails which contained Joe's daily schedule between May 19 and June 15, 2016.
Moderna Inc. said Thursday that preliminary clinical trial data show that its updated COVID-19 vaccine is effective against newer variants that are starting to circulate widely. The shot significantly boosted neutralizing antibodies against the Eris, or EG.5, variant, as well as the Fornax FL 1.5.1 variant that is starting to surge in parts of the U.S., the company said in a release. Pending approval, the updated vaccine is expected to be available in the coming weeks for fall vaccinations, Moderna said. The EG.5 variant has shown increased prevalence and immune escape properties, and may cause a rise in cases and potentially become dominant globally, the World Health Organization said in a report last week. Shares of COVID vaccine makers rose Thursday amid an uptick in COVID hospitalizations. Moderna (MRNA) shares jumped 7.4%, while BioNTech's ADR (BNTX) climbed 4.9%, Novavax Inc. (NVAX) shares gained 3.4%, and Pfizer Inc. (PFE) stock rose 2.9%.
Blue Shield of California plans to stop using most of CVS Health's pharmacy benefit management services and work with others, including Amazon.com and Mark Cuban's drug firm, in a bid to reduce drug costs for its insurance plan members.
The non-profit insurer, which serves roughly 4.8 million members, said on Thursday it now plans to tap five different partners for services typically provided by pharmacy benefits managers (PBMs), which negotiate drug prices with manufacturers.
The regional health insurance provider will still retain CVS Caremark for managing specialty drugs, costly medications used to treat complex conditions like cancer and rheumatoid arthritis.
Still, it expects to save $500 million annually in drugs costs once the program is fully launched in January 2025.
Paul Markovich, Blue Shield of California's CEO, said in an interview that the move had been in the works for some time but was spurred by CVS's reluctance to cover a much cheaper version of Johnson & Johnson's cancer drug Zytiga this year.
"We managed to get to the same drug for about $160 a month (from around $3,000) and went to CVS and said we'd like them to sell it, but they told us 'no' for about five months until they would," he said.
Lawmakers and the Federal Trade Commission have been investigating the role of PBMs in rising healthcare costs this year, which Markovich said is needed alongside further scrutiny from employers to mold a fairer pharmacy system for patients.
CVS shares slid over 9%, while rivals that also have PBMs also fell. Cigna Group shares fell 6% and UnitedHealth Group dipped almost 2%, in early trade over investor concerns that other insurers may adopt a similar model.
"Many in the industry will likely be watching this situation closely as managing the five partnerships could prove tricky, but if it (Blue Shield) is successful, we could see additional regionals move more in a similar direction," said Elizabeth Anderson, analyst at Evercore ISI.
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement to increase the principal amount of its existing $100 million senior secured debt financing agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed. The add-on loan facility provides Valneva with immediate access to $50 million, with an additional $50 million available at the Company’s discretion until December 31, 2023. The increased funding will be used to further invest in R&D, as well as continued market access preparations and potential commercialization of Valneva’s chikungunya vaccine candidate.
https://www.biospace.com/article/releases/valneva-announces-extension-of-existing-loan-agreement/
April 1 - June 30, 2023
January 1 - June 30, 2023
Significant Events in Q2 2023, in Summary
Key Takeaways:
Updated 2023 Outlook
For 2023, Calliditas expects revenue growth in the US where: Net sales from TARPEYO are estimated to be USD 100-120 million for the year ending December 31, 2023.
Investor Presentation August 17, 2023, 14:30 CET
Audio cast with teleconference, Q2 2023
Webcast: https://ir.financialhearings.com/calliditas-therapeutics-q2-2023
Teleconference: SWE +46 (8) 525 07 003, US +1 774 450 99 00, UK +44 7073 5048
by Dave DeCamp via AntiWar.com,
A NATO official has suggested Ukraine could cede some territory to Russia in exchange for joining the Western military alliance.
The comments were made on Tuesday by Stian Jenssen, chief of staff for NATO Secretary-General Jens Stoltenberg, and reported by the Norwegian newspaper VG. "I think that a solution could be for Ukraine to give up territory, and get NATO membership in return," he said, adding that it should be up to Ukraine when and on what terms to negotiate.
Jenssen said the issue of Ukraine’s status after the war is being discussed within the alliance and that some countries have raised the possibility of Kyiv ceding some territory. The comments come as the Ukrainian counteroffensive is stalling, and Western officials are admitting it’s very unlikely to succeed.
The comments mark the first time that a high-level NATO official suggested Ukraine might have to cede territory to Russia.
The US and NATO have backed Ukraine’s demands for peace, which include Russia withdrawing from all the territory it has captured since invading, as well as giving up Crimea, which has been Russian-controlled since 2014.
Jenssen’s suggestion drew a sharp rebuke from Ukraine:
"Trading territory for a NATO umbrella? It is ridiculous," Mykhailo Podolyak, an aide to Ukrainian President Volodymyr Zelensky, wrote on X. "That means deliberately choosing the defeat of democracy, encouraging a global criminal, preserving the Russian regime, destroying international law, and passing the war on to other generations."
Podolyak said the war could only end if Russian President Vladimir Putin is defeated. "Obviously, if Putin does not suffer a crushing defeat, the political regime in Russia does not change, and war criminals are not punished, the war will definitely return with Russia’s appetite for more," he said.
Russia would likely not go for any post-war settlement that involves Ukraine joining NATO as long as it can keep fueling the war since one of its main motives for invading was Kyiv’s alignment with NATO.
https://www.zerohedge.com/geopolitical/nato-suggests-first-time-ukraine-could-cede-territory
Matthew Foehr : Thanks, Kurt. Good afternoon, everyone, and thanks for joining our second quarter conference call. I'll start today with an overview of our business here on Slide number 4 of the deck. At the core of OmniAb's business model is our proprietary discovery technology platform that's designed to help partners discover innovative therapeutics quickly and efficiently. In a simple sense, it's a model based on licensing innovative technologies to partners. OmniAb is differentiated in the marketplace by having the most diverse host systems for fully human bispecific -- fully human and bispecific antibody discovery with the industry's only 4-species platform. That includes transgenic mice, rats, chickens and cow-based technologies.
Our partners have an increasing number of antibodies in clinical trials that are from our technology and the versatility of our platform continues to be demonstrated in the number of modalities and formats being employed by our partners, both preclinically and clinically. We offer flexibility to meet our partners' evolving scientific needs as we believe generating large and diverse repertoires of high-quality antibodies increases the likelihood of success in optimizing desired therapeutic characteristics. Our technology and our core capabilities are driven by, what we call, the biological intelligence of our transgenic animals and are further strengthened by our innovative, high throughput screening and other technologies. There are 74 partners with access to our technology or to OmniAb antibodies with over 300 programs in various stages of research and development.
The antibody space is one of the fastest-growing parts of the drug industry with a market size expected to be larger than $250 billion within a couple of years. We believe we're in a great position to capitalize on this opportunity with our unique and expanding technology offerings. We're constantly innovating our technology stack, and this past May, we introduced our newly branded OmniDeep offering, which is a suite of in silico capabilities, including structural modeling, large, multi-species antibody databases, molecular dynamic simulations, artificial intelligence and machine and deep learning sequence models that are applicable across our technology platforms to further enhance our partners' discovery process. In addition, we plan to introduce our novel heavy-chain-only OmniChicken that we will be branding as OmnidAb in the fourth quarter of this year.
And I'll say more detailed [Audio Gap] and our excitement around that technology until later this year when we launch it. On this next slide, I just want to reiterate that as a company and as a team, we're mission-driven to enable the rapid discovery of innovative pharmaceutical products by pushing the frontiers of drug discovery technologies. We're poised for continued growth, as shown here on Slide number 6 by the new license agreements we signed during the second quarter. In Q2, our team closed 4 new platform license agreements, one with Merck, Inc. and one with Neurocrine Biosciences as well as platform deals with Stanford University and Seattle Children's Hospital. Regarding Merck, this is a new agreement and is with the U.S. Merck & Co., not to be confused with the German Merck KGaA with whom we also have an agreement.
We reached a total of 74 active partners at quarter end, up from a partner count of just slightly more than 60 as of a year ago. Our discovery platform continues to garner interest in the industry among a diversified group of leading global pharmaceutical companies, allowing us to leverage our highly scalable business model. Adding partners like Merck Inc., who are global leaders in the industry and who are committed to using the power of leading-edge science to improve lives, bolsters our growing list of partners. We believe this is a testament to our effective and efficient discovery technologies to our in-house expertise for scientific collaboration services, our mindset for developing a deep understanding and also prioritizing the current and the future needs of our partners as well as our commitment to continued innovation.
Here on Slide number 8, our portfolio of active programs increased to 305 with 29 programs in the clinic under regulatory review or approved for commercialization at the end of Q2. During the second quarter, we added a net total of 4 new programs to our portfolio. Importantly, I want to note that when we report program count, we do so net of attrition, as attrition is expected in the pharmaceutical industry. In this quarter, attrition was seen only in the discovery stage of our partner pipeline. The pie chart on the right-hand side of the slide breaks down our 305 programs by stage of development. The discovery phase consists of 261 programs in addition to 15 programs now in the preclinical stage. In the clinic, at the end of June, our partners had 22 programs in Phase I, 2 programs in Phase II, 1 in Phase III as well as 1 program currently under regulatory review.
There are 3 approved drugs utilizing OmniAb-derived antibodies, and we're recognizing royalty revenue from commercial sales of zimberelimab and sugemalimab in China, both of which are also being pursued in other geographies. We saw some nice progression of programs in the quarter as well, with 3 programs transitioning from the discovery stage to the preclinical stage with 2 programs moving from the preclinical stage into their first human clinical trials and with 1 Phase III program moving to a regional filing for approval, shown here on this Slide number 8 pie chart on the right as BLA stage. Our large and growing portfolio features a diversified set of partners utilizing a variety of formats and modalities, as I mentioned earlier. I'd also like to note here that the count of active programs has increased from 270 in the year-ago period, up to 305 programs at the close of the second quarter, noting again that this is net of program attrition.
Despite some of the industry's challenges, including evolving financing environment and funding constraints, especially for some of the smaller players in our industry, our portfolio continues to expand from a combination of new and existing partners. We don't feel that it's entirely unexpected that macro factors can influence the velocity of growth of some of our business metrics. And although we see a slightly lower number of net new program additions compared to last year, OmniAb is in a very solid position for continued growth with an increasing number of both active programs and active partners. Moving now on to Slide number 9. As I mentioned, in the second quarter, 2 new programs entered the clinic with Immunovant who initiated a Phase I clinical trial of IMVT-1402, which is a subcu FcRn inhibitor.
Also, Gloria Pharmaceuticals initiated a Phase I/II study to investigate the safety, tolerability and preliminary efficacy of GLS-012 as a monotherapy in combination with GLS-010 in subjects with advanced solid tumors that have progressed following standard treatment. We've now had 3 new programs entered the clinic in the first half of this year, and we expect a potential 1 to 2 more to enter the clinic before year-end. I want to note that when 2023 began, we indicated that we expected 3 to 5 new programs to enter the clinic this year. By the end of June, we'd already reached 3, and we're now focused on an upward range of 4 to 5 new clinical programs for the year. Our partners made numerous public announcements about their clinical and commercial progress during the second quarter and in recent weeks.
https://finance.yahoo.com/news/omniab-inc-nasdaq-oabi-q2-092026884.html
