Negotiations with drugmakers to lower pharmaceutical prices in the U.S. have reached an advanced stage, HHS Secretary RFK Jr. says.
https://seekingalpha.com/news/4489276-rfk-jr-says-talks-lower-drug-prices-advanced-stage
Tuesday, August 26, 2025
'Zelensky Boasts No Longer Needs US Permission For Long-Range Missile Strikes On Russia'
This week saw Ukrainian President Volodymyr Zelensky boast for the first time that his military can conduct long-range strikes on Russian territory using weapons made within Ukraine, and this means he doesn't need to coordinate these attacks with the United States.
His remarks came in response to a Wall Street Journal report claiming that the US has quietly established a process requiring the Pentagon's prior approval for Ukrainian long-range strikes using American-supplied weapons. This policy has reportedly blocked such strikes for several months, at a moment President Trump is trying to get the sides to the peace table.
An unnamed official cited by the WSJ said that since late spring this internal Pentagon approval process has effectively blocked Ukraine from using the Army Tactical Missile Systems (ATACMS) to hit targets inside Russia.
While speaking alongside Canadian Prime Minister Mark Carney earlier this week, Zelensky emphasized that no such restrictions were under discussion and declared that Ukraine uses its own weapons for attacks on Russian territory.
"At the moment, we are using our long-range domestically produced weapons, and we haven’t been discussing such matters with the US lately. There was a time when there were different signals regarding our retaliatory strikes after their (Russian) attacks on our energy system," Zelensky said.
This followed Zelensky last Thursday unveiling the 'Flamingo' cruise missile, reported in The Guardian as follows:
Ukraine’s president announced the huge missile, known as Flamingo, could strike targets as far as 3,000km (1,864 miles) away. “The missile has undergone successful tests. It is currently our most successful missile,” Zelenskyy told reporters. Mass production could begin by February, he added.
This kind of range would bring the Moscow area within striking distance. If Kiev decides to target the Russian capital with cruise missiles - this would likely cause Putin order that Kiev get pounded even harder.
Throughout well over three years of grinding war, the Russian military has still not directly targeted top-level government buildings in Kiev, or military and intelligence HQs there. That could all soon change.
Business Insider on test-firing video of the Flamingo: I"n the clip, the Flamingo is seen rail-mounted on a canted platform before it is fired. The missile starts climbing upward almost immediately after launch."
Certainly the White House wants to see some kind of peace deal take effect before things escalate to that point, but neither side appears in the mood for compromise. And given Russia has the clear battlefield momentum, it has little reason to back off Putin's maximal conditions.
Invivyd up on hopes for non-vaccine Covid therapy amid political shift
Invivyd Inc. shares rose 75% premarket Tuesday following commentary from STAT News reporter Adam Feuerstein, whose social media post highlighted the company as a potential COVID-19 vaccine alternative amid growing political skepticism toward traditional immunizations. The biotech firm, which is developing a next-generation monoclonal antibody, has seen renewed momentum after a $58 million financing round backed by RA Capital and Janus Henderson.
“$IVVD garnering attention again as potential alternative to Covid vaccines in the current anti-vaccine political climate,” Feuerstein wrote on X, referring to the broader environment where alternative therapies are gaining traction. The surge in share price marks the latest example of market sensitivity to public health policy commentary and reflects investor interest in treatments positioned outside the traditional vaccine framework.
The rally also comes amid reports of a potential policy shift in the U.S., with the Trump administration reportedly planning to roll back support for COVID-19 vaccines. According to The Daily Beast, Dr. Aseem Malhotra stated that “Health and Human Services Secretary Robert F. Kennedy Jr. and President Donald Trump are allegedly planning to phase out the COVID-19 vaccine ‘within months.’”
These developments have made Invivyd a focal point for both retail traders and institutional backers, as evidenced by the recent capital injection from long-term healthcare investors. The company had already notched a 193% stock increase in February after releasing favorable pharmacokinetic and safety data, igniting hope for non-vaccine preventative options.
With federal support for existing vaccine infrastructure facing uncertainty, market participants are watching Invivyd’s trajectory closely.
Allarity FDA Fast Track Designation for Stenoparib for Advanced Ovarian Cancer
Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian cancer.
The FDA’s Fast Track designation is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. This designation enables more frequent interactions with the FDA throughout the drug development process and potentially provides eligibility for accelerated approval, priority review, and rolling review if relevant criteria are met.
“We are very pleased that the FDA has granted Fast Track designation to stenoparib,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “This recognition underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes. We look forward to engaging closely with the FDA as we advance this program.”
Allarity recently began patient enrollment under a new Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The first patient was enrolled in early June 2025, and several patients have already been dosed. The trial is designed to accelerate clinical development of stenoparib and its DRP® companion diagnostic and builds on prior encouraging Phase 2 data showing durable clinical benefit, including patients who remain on treatment now for over 22 months.
https://finance.yahoo.com/news/allarity-therapeutics-granted-fda-fast-120000019.html
Monday, August 25, 2025
Drugmakers Hail Early Wins in AI-Driven Transformation of Manufacturing
Companies have claimed improvements to yield, batch consistency and output while acknowledging the risks and challenges created by the technology.
Pharma’s rush to adopt artificial intelligence is changing manufacturing. Seeking to improve success rates, yields and many other variables, drugmakers are exploring AI across their manufacturing chains, with upstream, downstream and fill-finish uses all under consideration as targets. The technology comes with new risks and challenges, but companies are forging ahead in pursuit of potential efficiency gains.
The term AI is used to refer to a wide range of technologies, from machine learning systems that analyze images to large language models that help companies manage and interpret complex datasets. While older computational technologies excel at logging data and retrospective analyses, AI tools can spot patterns in large datasets and enable predictive analytics and maintenance.
Versions of some of the technologies entered pharma manufacturing plants years ago, with executives at Pfizer and Roche discussing the use of machine learning as early as 2018 and 2019, respectively. More and more companies have outlined their use of the technology since those early examples.
Joe Margarones, head of digital INT at Moderna, told BioSpace that near-term opportunities include the ability to “chat with our data,” enabling employees to “ask questions, explore trends and generate canvases using natural language.” Moderna also anticipates user configurations of prebuilt and custom agents to suit operational and quality needs as a near-term use.
Biogen signaled its intent to invest further in advanced automation and AI when it committed $2 billion to a manufacturing expansion in July. Nicole Murphy, head of pharmaceutical operations and technology at the company, told BioSpace the biggest near-term opportunities include predictive maintenance of equipment and automating investigations of the root causes of deviations (i.e., departures from approved instructions or standards).
Sanofi has identified similar near-term uses for AI. A spokesperson told BioSpace that the company is “reducing downtime, extending equipment life and improving overall operational efficiency” by adopting AI-driven predictive maintenance. Like Biogen, Sanofi is applying AI to deviations management, with the spokesperson saying the technology has “reduced closure time for minor deviations drastically.”
At Biogen, Murphy’s other near-term uses include the application throughout the manufacturing process of digital twins and soft sensors, data-driven models that digitally represent physical processes to provide insights beyond direct measurement. Using the technologies, Murphy said drugmakers can “enable adaptive process control to improve yields and batch-on-batch consistency.”
In 2023, AstraZeneca said digital twins for raw material planning drove a 90% reduction in dispensing planning time. Roche has hailed the impact of digital twins on its ability to predict cell age and growth for production cell lines. The company told investors last year that the technology increased production yields by 10% and quality by 40%.
One of Sanofi’s near-term use cases for AI is yield optimization. The spokesperson said Sanofi has seen substantial benefits from its AI-powered yield analytics platform. The tool enables manufacturing teams “to spend less time on data analysis and more time acting on insights, resulting in consistently higher yields and optimized use of raw materials,” the spokesperson said.
Pam Cheng, EVP of global operations, IT and chief sustainability officer at AstraZeneca, has credited the use of “over 30 digital tools and AI solutions for selected processes and products” with increasing output at a facility in China by 55%. Cheng, who told investors about the improvements in May, added that there was a 44% fall in lead time and a 54% boost to productivity.
Despite the improvements, overall manufacturing costs at at least some companies have continued to rise. Roche reported a 14% increase in manufacturing cost of goods sold and period costs in 2024. Costs rose by a further 7% in the first half of 2025. At AstraZeneca, which bundles manufacturing costs with royalties and other costs of sales, the cost of sales increased 20% over last year and, at the midpoint of the year, was on course to rise again in 2025.
Risks of Action, Risks of Inaction
AI is creating new challenges. Murphy said regulatory compliance and upskilling the workforce are the biggest challenges to deploying AI in good practice environments. Margarones hit on similar points, saying that as AI advances it requires new skills and governance and that regulators expect interpretable outputs for critical decisions. It is unclear what happens within some AI tools to produce outputs, making it hard to interpret and validate their findings.
Margarones added that there are AI data integrity and traceability challenges because models must be version-controlled, audit-trailed and compliant with FDA 21 CFR Part 11 regulations governing electronic records and signatures. An additional challenge, the Moderna digital leader said, is the need for a “continuous validation” framework that marries machine learning operations with standard operating practices for quality assurance.
The cybersecurity implications of AI tools create further challenges. Margarones noted that such tools increase a company’s attack surface. Connected sensors, cloud-based platforms and other technologies that collect and manage data for AI models create potential new entry points for attackers. Drugmakers now routinely list AI in disclosures to investors about the risks they face, including in some cases in relation to the impact of the tools on manufacturing and supply.
Moderna, noting its level of equipment automation and integration of AI systems, told investors in its 2024 annual report that facility digitization exposes it to the risk of process equipment malfunctions. The risks include system failures or shutdowns because of design issues, system compatibility problems or cybersecurity incidents.
While acknowledging the risks, drugmakers have concluded that choosing not to adopt AI would pose a bigger threat to their businesses. AbbVie summed up the risk of inaction in its annual report, telling investors that the “failure to effectively implement these technologies could hinder our ability to compete, as competitors’ advancements in AI may lead to more efficient operations.”
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