price target reduced from USD 887 to USD 799.
https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/
Monday, August 11, 2025
GSK: a priority review in US for gonorrhea
GSK (NYSE:GSK) (LON:GSK) said on Monday that the U.S. Food and Drug Administration has accepted its priority review application for gepotidacin, an oral antibiotic aimed at treating sexually transmitted uncomplicated gonorrhoea.
The drugmaker’s shares climbed 1% in London on the news.
The company is looking to new infectious disease products, including its recently launched respiratory syncytial virus vaccine, to offset expected revenue declines from top-selling medicines and looming patent expirations in its HIV portfolio.
Gepotidacin is already approved in the U.S. under the brand name Blujepa for treating a common urinary tract infection in women and adolescent girls.
The FDA is expected to decide in December on its use for uncomplicated urogenital gonorrhoea, which could offer patients an oral alternative to existing injectable treatments.
Separately, GSK and Germany’s CureVac last week resolved a long-running patent dispute with Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) over mRNA vaccine technology used during the COVID-19 pandemic.
The settlement follows BioNTech’s June agreement to acquire CureVac in an all-stock deal worth $1.25 billion to advance work on mRNA-based cancer therapies.
Under the settlement, CureVac and GSK will receive $740 million and single-digit percentage royalties on future U.S. sales of COVID-19 vaccines, CureVac said. GSK’s share amounts to $370 million, including $50 million to adjust terms from a 2024 licence agreement that expanded their pandemic-era partnership.
If BioNTech’s takeover of CureVac is completed, related mRNA litigation outside the U.S. will also be resolved, with GSK receiving an additional $130 million and royalties extended to non-U.S. sales. CureVac said the acquisition remains on track under the agreed terms.
GSK said it still has separate patent cases against Pfizer and BioNTech in the U.S. and Europe, which are unaffected by this settlement.
https://uk.finance.yahoo.com/news/gsk-climbs-winning-fda-priority-082408011.html
As Novo Nordisk ramps up lawsuits over Wegovy copies, investors ask where is Hims?
In Novo Nordisk’s legal fight against dozens of U.S. pharmacies and companies selling cheaper copies of its weight-loss drug Wegovy, one name remains conspicuously absent: Hims & Hers. The high-profile telehealth company continues to sell compounded versions of Wegovy at lower prices, testing the limits of federal restrictions on such copies and contributing to weaker sales growth for Novo.
In June, Novo accused Hims of violating its intellectual property and endangering patients, scrapping a brief arrangement enabling them to sell Wegovy directly to consumers and raising expectations of litigation.
A Novo spokesperson said the Danish drugmaker was not ruling out further legal action after announcing new lawsuits against 14 small pharmacies, telehealth providers and weight-loss clinics this week, but declined to comment on Hims. The drugmaker has filed more than 130 cases in 40 U.S. states.
A spokesperson for Hims defended personalization of medicines as the future of healthcare, saying patients and providers use their platform to make clinical decisions.
"Investors are happy to see Novo getting more aggressive on the litigation front, but remain puzzled as to why they haven’t confirmed that they are filing or have filed litigation against Hims yet," said Barclays analyst Emily Field.
Legal experts say Novo’s expanding litigation against smaller telehealth players could add pressure on a company like Hims to negotiate a settlement or help the drugmaker test out strategies.
At the same time, the fact that Novo and Hims had a prior collaboration may complicate legal action. "Business happens in the shadow of the law," said Robin Feldman, a professor at UC Law San Francisco who has written books on the pharmaceutical industry and its intellectual property battles. "Sometimes companies file against smaller players as a shot across the bow, a way to rattle the larger players."
The U.S. Food and Drug Administration set a May 22 deadline for compounding pharmacies to cease mass-producing copies of Wegovy, a practice allowed only when a drug is in shortage.
Hims says it still offers personalized versions of Wegovy, in doses not manufactured by Novo, that better suit individual patient needs. The telehealth provider argues that individualized dosing remains legal under compounding rules.
Compounding laws “are just vague enough to allow for different interpretations, and the interpretation that matters – that of the courts – has not been provided to our knowledge,” said TD Cowen analyst Michael Nedelcovych.
Novo’s cases against smaller compounders could shape how courts interpret those boundaries, said Gaston Kroub, a partner at patent litigation firm Kroub, Silbersher & Kolmykov.
“This is an untested set of affairs,” said Kroub. “If you want to train for a heavyweight championship fight, you start sparring with lighter opponents.”
In addition to trademark infringement, Novo has accused pharmacies of steering people toward compounded Wegovy by interfering with the relationship between clinicians and patients.
Josh Gerben, an intellectual property attorney, said the fact that Hims and Novo had a prior business relationship will complicate any claim Novo could bring.
https://www.yahoo.com/news/articles/novo-nordisk-ramps-lawsuits-over-100931813.html
The Price Of Being Half A Superpower
by Tamuz Itai via The Epoch Times,
In July 2025, the European Union signed a landmark trade agreement with the United States. President Donald Trump described it as “the biggest deal ever made.” On paper, it looked like a win-win. But in policy circles across Europe, it landed more like a warning shot than a celebration.
The core terms were stark: The EU agreed to impose a flat 15 percent tariff on all goods it exports to the U.S.—more than the 10 percent the UK deal got—including autos, auto parts, pharmaceuticals, and semiconductors. Crucially, steel, aluminum, and copper exports will remain subject to punitive 50 percent tariffs. In return, the United States will pay zero tariffs on all American exports to Europe, covering industrial goods, agricultural products, and digital services.
Perhaps more striking were the European purchase commitments. Under the deal, the EU pledged to import $750 billion of U.S. energy products—liquefied natural gas (LNG), crude oil, and refined fuels—by 2028, along with substantial volumes of semiconductors and industrial inputs. Brussels also committed to facilitating $600 billion in new European investment into the United States over the course of President Trump’s second term.
European Commission President Ursula von der Leyen framed the agreement as necessary pragmatism. “You’re known as a tough negotiator and dealmaker,” she told Trump, adding that the deal “delivers stability and predictability.” But her tone was notably defensive. When pressed on the 15 percent tariff for European carmakers, she conceded it was ”the best we could get.”
German Chancellor Friedrich Merz struck a similar note: relief over avoiding a full trade rupture, but no illusion about the pain to come. “More simply wasn’t achievable,” he said of a better outcome.
Across the continent, the reaction was muted. Belgium’s Prime Minister called it a “moment of relief but not of celebration.” France’s Minister for European Affairs described the deal as “unbalanced.” Hungary’s Viktor Orbán offered perhaps the most vivid summation: “Trump ate Ursula von der Leyen for breakfast.”
Veteran British journalist Andrew Neil, with a dash of post-Brexit schadenfreude, pointed out that the UK had negotiated a “far better deal”—unshackled, as it were, from Brussels.
But this wasn’t just a debate over tariffs. For many observers, the real question was structural: How did a bloc of 27 nations, with 450 million people and immense economic weight, end up looking like a junior partner in negotiations?
The answer lies in the long, unfinished story of European integration—and the strategic costs of building power without consolidating it.
The Stealth Path to Unity
The European project was never just about economics. From its earliest postwar visionaries like Jean Monnet and Robert Schuman, the idea was that lasting peace and prosperity in Europe required deeper political union.
But the path chosen was gradual and elite-driven. Instead of launching a public constitutional process like the United States in 1787, which demanded buy-in from the citizenry, Europe’s leaders opted for incremental integration through treaties and bureaucratic layering. Monetary union was introduced without full political union. Institutions like the European Commission and the European Central Bank were empowered without always being directly accountable to European citizens.
In the words of former German Chancellor Helmut Kohl: “We decided to go ahead with monetary union because we could not achieve political union.” Jacques Delors, architect of the Maastricht Treaty, put it more bluntly: “Political union will be the consequence of economic integration.”
This approach worked—until it didn’t. When French and Dutch voters rejected the proposed EU Constitution in 2005, leaders responded not with a public rethinking, but with a workaround: the Lisbon Treaty. Same substance, different packaging. As Valéry Giscard d’Estaing, who helped draft the original constitution, admitted: “The proposals remain practically unchanged.”
What emerged was what scholars came to call “integration by stealth.” Not a conspiracy, but a methodology—one that produced a powerful administrative apparatus, but a weaker sense of civic ownership. Today’s EU sits somewhere between a federation and a confederation. Authority is divided. Responsibilities overlap. This process—of layering authority without fortifying accountability—helped build impressive institutions, but left Europe ill-prepared to act decisively when it matters most.
It’s not unlike what we see in business. Think of a large conglomerate owning many subsidiaries. In theory, each subsidiary should have the best of both worlds: the resources and stability of a corporate giant, and the nimbleness of a local operator. Some Berkshire Hathaway companies manage to strike that balance. But in many other cases, it becomes the worst of both worlds—corporate headquarters micromanages what it doesn’t understand, while local managers feel disempowered to lead. The result isn’t immediate catastrophe. It’s drift. Underperformance. Missed opportunity. And when a crisis hits, nobody is quite sure who’s in charge—or how quickly they’re allowed to act.
A System That Blinks in a Crisis
In stable times, the EU functions. Its institutions regulate markets, coordinate standards, and pool technical expertise.
But when the world gets messy—when pandemics hit, energy supplies are weaponized, or trade conflicts erupt—the EU’s slow, multi-speed machinery struggles to respond.
Take the COVID-19 crisis. The EU struggled to coordinate vaccine procurement, while national interests quickly reasserted themselves, national borders re-erected. Energy policy offered another: the bloc’s decades-long reliance on Russian gas was well known, yet efforts at diversification remained piecemeal until after Moscow’s 2022 invasion of Ukraine.
On foreign policy, the picture is even starker. While the EU has long aspired to “strategic autonomy,” it continues to rely heavily on U.S. defense guarantees through NATO. Joint military procurement is limited. Diplomacy is often divided. And even where Brussels speaks for the bloc—on trade or sanctions—individual member states can undercut consensus.
R. Daniel Kelemen, McCourt Chair at the McCourt School of Public Policy at Georgetown University, once summarized this imbalance clearly: “The EU can regulate Google, but it cannot stop Putin. That says everything about the imbalance.” Princeton’s Andrew Moravcsik has also elucidated, “The EU’s intergovernmental system may function well in stable times, but in moments of crisis, its slowness and fragmentation can undermine decisive action.”
This isn’t just theory. It’s happened repeatedly. From the Eurozone debt crisis to the migrant crisis, from Syria to Libya to Ukraine, the EU has often arrived late—or not at all. And its credibility as a geopolitical actor has suffered accordingly.
How Others Exploit the Gaps
External actors have noticed. Over the past two decades, powers like the United States, China, and Russia have learned to navigate the EU’s divided structure—and have strategically exploited those gaps.
The United States has frequently bypassed Brussels to negotiate directly with key capitals. During the Iraq War, the Bush administration built a “coalition of the willing” by engaging newer EU members like Poland and the Czech Republic, sidelining France and Germany. In trade talks, often Washington preferred dealing with the nations that matter most to its interests at the time.
Russia has played a long game of energy diplomacy—cutting bilateral gas deals with Germany while using supply disruptions to pressure Eastern states. The Nord Stream 1, signed in 2005, was a bilateral pipeline deal between Russia and Germany—negotiated without Brussels. It deepened divisions within the EU just as Eastern states warned that dependency on Russian gas was a strategic mistake. And during crises, such as the 2021 migrant standoff engineered by Belarus, the EU’s disjointed response only confirmed Moscow’s strategic calculations.
The Chinese Communist Party, too, has worked the EU’s seams. Its 17+1 initiative engaged Central and Eastern European countries directly, offering infrastructure deals outside of EU frameworks. In 2017, Greece—after Chinese investment in its port—blocked an EU statement criticizing Beijing’s human rights record. Italy’s 2019 decision to join the Belt and Road Initiative further exposed Brussels’ lack of cohesion. Then Italy was hit hardest during the pandemic, and has in recent times done an about-face.
Even Middle Eastern powers like Qatar and the United Arab Emirates have learned to deal bilaterally—through energy contracts, arms deals, or cultural diplomacy—with France, Germany, or Italy, bypassing collective EU positions.
Even internally, countries like Hungary and Poland have repeatedly vetoed or delayed joint EU positions on rule of law, migration, and Ukraine sanctions—further weakening the bloc’s external credibility.
And that gap hasn’t just cost Europe. It’s cost the world.
Would China’s strategic rise over the past three decades have gone so uncontested if the EU had been a global actor with real geopolitical weight? Would Russia have deepened its military alignment with Beijing if Europe had projected more than regulation? Would the first Iran nuclear deal—crafted with heavy EU involvement—have been so easily circumvented?
When Europe doesn’t show up as a pillar of power, others shape the order without it. And sometimes, against it.
The Shift Toward Sovereignty—and the Importance of Timing
The global mood has changed. The 1990s and early 2000s were characterized by optimism about globalism, supranational governance, and borderless integration—a window of opportunity for the “European project.” Today’s world is more fragmented, more adversarial, and more focused on national sovereignty.
From Brexit to Trump, from Eastern Europe to Asia, citizens and leaders are asserting national autonomy. Integration, once assumed to be the future, is now questioned—even by former advocates. More than ever, bold reform requires not just treaties, but persuasion—of citizens, not just elites. And in this climate, systems that can’t move with clarity risk getting sidelined.
That’s the deeper story behind the 2025 trade deal. It’s not just about tariffs. It’s about the difference between having weight and having force.
The EU still has enormous assets: population, capital, technological capability, and cultural reach. Yet without institutions that combine legitimacy with the capacity to act, those assets remain relatively inert.
As historian Timothy Garton Ash warned back in the year 2000: “Europe’s drive toward unification threatens just the opposite—disunity.” That paradox remains as yet unresolved.
https://www.zerohedge.com/geopolitical/price-being-half-superpower
Sunday, August 10, 2025
EJ Antoni warns NYC of Mamdani's 'economically illiterate' policies
Heritage Foundation research fellow EJ Antoni analyzes the political landscape of New York City after Democratic Socialist Zohran Mamdani's presumed Democratic nomination in the 2025 mayoral race.
Novartis announces both ianalumab phase III trials met primary endpoint in Sjögren's
Novartis (NYSE:NVS) announced significant breakthrough in Phase III clinical trials for ianalumab in treating Sjögren's disease. Both NEPTUNUS-1 and NEPTUNUS-2 trials met their primary endpoint, demonstrating statistically significant improvements in disease activity measured by EULAR Sjögren's syndrome disease activity index (ESSDAI).
Ianalumab, which features a dual mechanism of action through B-cell depletion and BAFF-R inhibition, could become the first targeted treatment approved for Sjögren's disease. The drug demonstrated a favorable safety profile and was well-tolerated in trials. Having received FDA Fast Track Designation, Novartis plans to present detailed trial data at an upcoming medical meeting and submit to health authorities globally.
'USPS blocks shipping of illicit vapes in boost for Big Tobacco'
The U.S. Postal Service has cracked down on distributors of unregulated vapes using its services for business shipments, letters reviewed by Reuters show, in a blow to a multi-billion dollar industry that has dented Big Tobacco's sales.
The letters, previously unreported, show that USPS wrote to major New York-based distributor Demand Vape, blocking it from using its services after New York City's Law Department, which represents the city's government and officials in legal matters, provided evidence that its shipments broke laws.
USPS' action stands to benefit tobacco giants including Altria and British American Tobacco, which have for years battled against unregulated vapes, mostly from China.
Unregulated vapes lack the authorisation from the U.S. Food and Drug Administration that is required for them to be legally sold in the United States, the world's largest market for smoking alternatives.
USPS revoked Demand Vape's mailing exception last month after it received evidence the company shipped vapes lacking FDA authorisation and that violated a local flavour ban, a letter from USPS to the company, dated July 15, showed.
"Your local Buffalo BME Office will not accept any packages from... Demand Vape that contain ENDS products," the letter read, referring to electronic nicotine delivery systems, another term for vapes.
Demand Vape said it complied with relevant laws and was contesting the revocation, adding the industry operates in a "regulatory grey zone" with only a small number of FDA-authorised products that do not meet consumer demand.
"We reject any characterisation that paints Demand Vape as anything other than a transparent, lawful and reputable business," it said in a statement.
USPS did not respond to a request for comment.
LIMITED EXCEPTIONS
So far, the U.S. Food and Drug Administration has authorised only 39 e-cigarette products.
But unauthorised devices are widely available as authorities struggle to contain them.
Under a 2021 law, USPS is restricted from mailing vapes directly to consumers, internationally and in most other circumstances.
The limited exceptions include domestic shipments between businesses, which need a "mailing exception" and their shipments must comply with relevant laws.
Some other large carriers, including FedEx, refuse to ship vapes. DHL only offers carriage for business shipments with prior approval.
USPS has provided NYC's Law Department with a list of other vape firms it has granted mailing exceptions so it can assess whether they should be challenged, in line with legal requirements, Eric Proshansky, deputy chief of the city's division of affirmative litigation, told Reuters.
This could further limit the number of carriers available to the unauthorised vape industry.
Other options, such as using smaller carriers or handling freight directly, tend to be more costly.
MOUNTING PRESSURE
BAT estimated the unauthorised vape market was worth around 6 billion pounds ($8.05 billion) last year. It is, however, increasingly under pressure. This year's U.S. import tariffs and seizures at ports have reduced unauthorised vape imports.
The FDA also wrote letters to 24 U.S.-based middlemen, including distributors that are crucial to the unauthorised vape market, as part of a crackdown in May.
This has led to empty shelves in vape stores, said Tony Abboud, executive director of the Vapor Technology Association, which represents firms including Demand Vape.
USPS revocations will further damage U.S. vape businesses, he said.
One of the largest U.S. e-cigarette distributors, Demand Vape sells to some 5,000 retailers in 49 states, according to 2024 filings in a NYC lawsuit against the company.
The evidence city attorneys provided to USPS included copies of invoices showing Demand Vape's sales of unauthorised e-cigarettes. Brands the FDA has specifically flagged as illegal to sell were among them, a separate letter reviewed by Reuters showed.
https://www.aol.com/news/exclusive-usps-blocks-shipping-illicit-050255743.html
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