Tuesday, May 13, 2025

Trump's Drug Price Cuts Hit Teva at a Tough Time

(5/13, Sophie Shulman, Ynetnews) ...Teva operates in multiple global markets, but its most profitable sales come from the U.S. Currently, experts believe the reference countries will likely be limited to OECD members, not the entire globe. Despite the share price drop, Sabina Levy, head of research at Leader Capital Markets, believes Teva’s direct exposure to the new policy may be relatively limited. Generic drug prices are already low and may fall further only if the MFN rule includes developing nations... Full

Teva To Slash Thousands Of Jobs And Shut More Sites Under $700M Savings Plan

(5/12, Dean Rudge, Generics Bulletin) ...Responding to Generics Bulletin queries, a Teva spokesperson insisted that “like all companies, we evaluate our business on a regular basis and will continue to prioritize and invest in strategic growth areas for our future. Organizational and workforce adjustments are a necessary part of managing our business.”... Global Sub. Full

‘I'll Be Happy When We Have 40-Plus Assets' – Sandoz Builds Up Biosimilars

(5/12, Dave Wallace, Generics Bulletin) ..."The quarter-one sales performance was in line with our expectations," commented CEO Richard Saynor. "We've now delivered 14 consecutive quarters of top-line growth. This reconfirms our growing track record of execution and performance." In particular, he noted, "we again delivered double-digit growth in biosimilars in the quarter, ahead of more launches later this year, putting us in an excellent position to produce good results in 2025." Meanwhile, he noted, "the new confirmed US tariffs have been absorbed within our full-year guidance," with the chief executive stating that the firm was "confident in our plan for this year and beyond" and "extremely well-positioned to deliver on our reiterated full-year guidance."... Global Sub. Full

Indian Drugmaker Cipla Beats Quarterly Profit View On Strong Demand

(5/13, Rishika Sadam and Kashish Tandon, Reuters) ...Cipla, India's third-biggest drugmaker by sales, reported a fourth-quarter profit that beat estimates on Tuesday, helped by strong demand for its drugs used to treat chronic conditions, especially respiratory illnesses...Cipla's U.S. sales are usually driven by its tumour drug Lanreotide, its second-biggest revenue generator. However, the company had warned in October that certain supply chain issues related to the drug would last until the fourth quarter... Full

Lupin's New Drug Launch Could Contribute Over 25% of its FY26 Earnings, Analyst Says

(5/13, Ekta Batra, CNBC TV-18) ...Axis Capital said Lupin is expected to be the only generic player for the most of the financial year 2026. The company's revenue opportunity for the ongoing fiscal is estimated at $150 million to $200 million. The gTolvaptan drug can contribute over 25% to Lupin's FY26 earnings and can be a major driver for its performance in this fiscal, Axis Capital said... Full

Bayer Shares Jump After Results Beat Expectations On Pharma Strength

(5/13, Helena Smolak, The Wall Street Journal) ...Bayer shares jumped after the company reported better-than-expected sales and adjusted earnings for the first quarter, with cost-cutting and demand for kidney and cancer drugs boosting its pharmaceutical business. The German pharmaceutical and agricultural company said Tuesday that it expects to be able to manage the impact of tariffs and doesn't see a need to revise its guidance. A strong pharma performance in the first quarter means that the division's full-year results are likely to hit the upper end of its full-year guidance, it said... Sub. Req’d

Amneal Proud To Be ‘Made In America' And Ready To Scale Up Its US Manufacturing

(5/12, Urte Fultinaviciute, Generics Bulletin) ...The majority of Amneal's products and revenues already come from US-based manufacturing, with another idle plant waiting to be reopened, if economically viable. Despite mass disruption at the US FDA and its Office of Generic Drugs, Amneal has not experienced any delays to its applications. The company affirmed its full year guidance for 2025, reiterating previously announced plans on building biosimilars presence and GLP-1 offerings... Global Sub. Full

Roche Gets to Work On US Investment Plan with Reveal of $700M Obesity Drug Plant in North Carolina

(5/12, Fraiser Kansteiner, Fierce Pharma) ...Roche has earmarked more than $700 million to construct a sprawling new plant for its Genentech unit in Holly Springs, North Carolina, where myriad large drugmakers have set up production operations in recent years...Roche also firmed up plans on its diagnostics facility on Monday, announcing that it will spend up to $550 million by 2030 to establish a "major hub" for manufacturing of continuous glucose monitoring systems in the state capital of Indianapolis. Indianapolis is already the North American home base for Roche's diagnostics arm. Roche will also chart expansions at its existing U.S. sites... Full

Roche Could Rethink $50B US Expansion Plan if New Policies 'Harm' Operations

(5/12, Anna Brown, Endpoints News) ...Earlier in the day, Roche said that it had budgeted $700 million to build a new weight loss drug factory in Holly Springs, NC. The site is envisioned to span 700,000 square feet and would employ 400 staffers once it is open. While details are limited on which drugs would be affected by Trump's executive order, White House officials mentioned that GLP-1s are likely to be targeted since these drugs have the "largest disparities and the largest expenditures."... Sub. Req’d

World-First Approval Supports AstraZeneca's Sustainability Goals

(5/12, Catherine Eckford, European Pharmaceutical Review) ...Approval of the novel tool marks progress for both respiratory disease patients in the UK and reducing the global environmental impact of inhaled medicines...Authorised for use in the UK, the treatment is delivered via the Aerosphere pressurised metered-dose inhaler (pMDI). It is the first medicine delivered by a pMDI approved with the propellant that has 99.9 percent lower global warming potential (GWP) compared to propellants used in currently available pMDIs, AstraZeneca explained... Full

Trump Says He'll Set 30-Day Deadline for Drugmakers to Lower the Cost of Prescription Drugs

(5/12, Amanda Seitz, Will Weissert and Seung Min Kim, Associated Press) ...Trump repeatedly defended pharmaceutical companies, instead blaming other countries for the high price Americans pay for drugs, during a wide-ranging speech at the White House on Monday...He did, however, threaten the companies with federal investigations into their practices and opening up the U.S. drug market to bring in more imported medications from other countries. "The pharmaceutical companies make most of their profits from America," Trump said. "That's not a good thing."...White House offered no specifics for how much money the administration anticipates it could save... Full

Trump Executive Order Demands Pharma Industry Price Cuts

(5/13, Steve Holland, Michael Erman and Patrick Wingrove, Reuters) ...Trump said his order on drug prices was partly a result of a conversation with an unnamed friend who told the president he got a weight-loss injection for $88 in London and that the same medicine in the U.S. cost $1,300. If drugmakers do not meet the government's expectations, it will use rulemaking to bring drug prices to international levels and consider a range of other measures, including importing medicines from other developed nations and implementing export restrictions, a copy of the order showed... Full

Kiran Mazumdar-Shaw On How Trump's Order Aims to Fix US Drug Price Gap

(5/13, Ekta Batra, CNBC TV-18) ...Mazumdar-Shaw explained that President Trump's focus is primarily on reducing the cost of high-value drugs. " If you know how the market is split, 80% of prescription drugs by volume only account for 20% of the value and it's 20% of prescription drugs by volume, account for 80% of value and that's the 80% he wants to shrink." When asked about the potential increase in prices of patented drugs imported or licensed from branded pharma in India, Mazumdar-Shaw explained that President Trump does not plan to raise prices in developing countries... Full

Celltrion Anticipates Growth from U.S. Executive Order On Drug Price Reduction

(5/13, Heo Ji-yoon, ChosunBiz) ...U.S. President Donald Trump signed an executive order aimed at lowering drug prices in the United States to match those in other countries, and local biotechnology corporation Celltrion noted, "This executive order could provide a better business environment." According to the company, this executive order is expected to weaken the distribution dominance that high-priced original drug manufacturers have held in the U.S. market, while biosimilars may benefit from improved distribution structures and increase prescriptions in the United States... Full

PhRMA Statement On Most Favored Nation Executive Order

(5/12, PhRMA) ..."Importing foreign prices from socialist countries would be a bad deal for American patients and workers. It would mean less treatments and cures and would jeopardize the hundreds of billions our member companies are planning to invest in America – threatening jobs, hurting our economy and making us more reliant on China for innovative medicines."... Full

Trump Drug Price Order Puts New Pressure On Pharma

(5/12, Maya Goldman, Axios) ...The administration expects the U.S., as the largest purchaser of pharmaceuticals, to get the best deal across the world, the official said. But cracking down on other countries' "unfair and discriminatory practices" will have the effect of increasing prices abroad and provide additional revenues for pharmaceutical companies, the official added... Full

Pharma is Facing its Nightmare Scenario

(5/13, Caitlin Owens, Axios) ...But the predicament drugmakers find themselves in marks a fall from grace for an industry that was recently considered among the most powerful in Washington..."This is a 10-year screwup; they've been targeting the PBMs and they've done nothing but lose ground," said one source close to both the drug industry and the White House. "I think they have totally misplayed their hand."... Full

Drugmakers Spared Worst-Case Drug Pricing Scenario for Now

(5/12, Jared S. Hopkins and Peter Loftus, The Wall Street Journal) ...A spokesperson for Novo Nordisk, which makes drugs that have become popular for weight loss including Ozempic and Wegovy, said, "We agree that Americans need more access to affordable medication, and we will continue to engage with policymakers to develop and implement more effective solutions. We look forward to learning more about the measures discussed by the administration today and how they will work within the current U.S. healthcare system."... Sub. Req’d

Lack of Detail in Trump's Drug Price Plan Raises More Questions Than Answers

(5/12, Zachary Brennan, Endpoints News) ...But the order has few, if any, details about how that process would play out. For example, it doesn't spell out which countries would be included, or how the administration will get pharma companies to come to the negotiating table. And it doesn't make clear how patients — the vast majority of whom are covered by insurance — would actually access the lower prices that would be "directly" offered by drug companies. "It's a voluntary ask with the threat of a series of clubs," John Shakow, partner at the law firm King & Spalding who co-chairs the firm's life sciences group, told Endpoints News. "What's going to go on in the next 30 days is expectation setting, not negotiations."... Sub. Req’d

Trump's Plan to Lower U.S. Drug Prices Contains Threats But Few Teeth

(5/12, Daniel Gilbert, The Washington Post) ...The issue of drug prices is bipartisan, with Sen. Bernie Sanders (I-Vermont) also voicing outrage that prices are so much higher in the United States than in other countries. Sanders said Monday that he agreed with Trump that the situation is "beyond unacceptable," but said the problem isn't that prices are too low in Europe and Canada. "The problem is that the extraordinarily greedy pharmaceutical industry made over $100 billion in profits last year by ripping off the American people," he said in a statement. Pharmaceutical companies make more than half of their revenue, on average, in the United States, according to TD Securities... Full

Prescription Drug Prices Still Surging Despite Efforts by Federal Government

(5/13, Daniella Genovese, FOX Business) ...Association for Accessible Medicines CEO John Murphy said the high prices for brand-name drugs are to blame as they are the reason the U.S. pays more for prescription drugs. These brand drug pricing increases are a "significant problem" that lead "to a host of costs beyond just patients and employers paying more," according to Murphy. Murphy said the U.S. needs to do a better job at using generic and biosimilar medicines, which he said "should have always been the case under the law."... Full

Astellas CEO On Outlook Ahead of Trump's Pharma Tariffs

(5/12, Bloomberg) ...The global pharmaceutical industry is grappling with an uncertain outlook, amid President Donald Trump's plans to cut US prescription drug prices and impose tariffs on pharma imports. Astellas Pharma is among the Japanese drug makers that depends on the US for a large chunk of sales. CEO Naoki Okamura spoke to Bloomberg TV in Tokyo on May 7th about the impact of Trump's tariffs, and the firm's engagement with activist investor Farallon Capital Management... Full

Pharmacists Stockpile Most Common Drugs On Chance of Targeted Trump Tariffs

(5/13, Jackie Fortiér and Arthur Allen, NPR) ...Independent pharmacist Benjamin Jolley...bought six months' worth of the most expensive large bottles, hoping to shield his business from the 10% across-the-board tariffs on imported goods that President Trump announced April 2. Now with threats of additional tariffs targeting pharmaceuticals, Jolley worries that costs will soar for the medications that will fill those bottles. In principle, Jolley said, using tariffs to push manufacturing from China and India to the U.S. makes sense. In the event of war, China could quickly stop all exports to the United States... Full

Independent Pharmacists Warn of Higher Prices and Shortages From Proposed Tariffs

(5/12, Jackie Fortiér, NPR: Morning Edition) ...FORTIER: Generics make up a whopping 90% of prescriptions in the U.S. John Murphy is president of the Association of Accessible Medicines, a trade group that represents generic manufacturers. He says if the tariffs happen, shortages will follow. JOHN MURPHY: If you increase the cost of goods via tariff on a medicine that has, in some cases, less than a 5% margin, they just may not sell them in the United States...MURPHY: We don't pay enough for generic drugs in the United States for anyone to make the kind of investment that would be necessary to build new facilities in the US... Full

Trump Issues Draft Guidance for Third Cycle of Drug Price Talks

(5/12, Nyah Phengsitthy, Bloomberg Law) ...The agency said it will announce up to 15 additional drugs covered under Medicare Part D or payable under Part B for the third cycle of talks by February 2026. The price that is ultimately negotiated for the third set of drugs will be effective starting Jan. 1, 2028. The draft includes policies that seek to improve the transparency of the negotiation program, a goal the Trump administration shared earlier this year... Sub. Req’d

CMS May Add Part B Drugs to Negotiation Program Under Draft Guidance

(5/12, Paige Minemyer, Fierce Healthcare) ...Under the guidance, drugs administered under Medicare Part B would be potentially included for the first time. The agency is looking for feedback in comments on how to manage access to the maximum fair price negotiated for Part B drugs. The guidance also outlines that CMS may choose to renegotiate the price for certain drugs already set for 2026 or 2027... Full

In Price Negotiations, Medicare Should Reassess How It Determines A ‘Qualifying Single Source Drug'

(5/12, T. Joseph Mattingly II, Health Affairs) ...This article describes the consequences, both intended and unintended, with this aggregating and describes how these actions may impact pharmaceutical manufacturers' ability to invest in future research... Full

Trump's Drug Pricing Order Delivers Blow to Pharmacy Benefit Managers

(5/12, Amina Niasse, Reuters) ..."We're going to cut out the middlemen and facilitate the direct sale of drugs at the most favored nation price, directly to the American citizen," Trump said during a press conference...The pharmaceutical industry has blamed them for high prices, saying the aftermarket discounts and fees add hidden costs to drug prices. Jeff Jonas, portfolio manager at Gabelli Funds, said the executive order would keep that negative pressure on companies like Cigna, CVS, and UnitedHealth. "The system of high list prices and big, hidden rebates makes the system very opaque and hard to navigate," he said... Full

PBM Overhaul and Drug Price Negotiations Make the Cut in Republicans' Tax Bill

(5/12, Zachary Brennan, Endpoints News) ...The bill uses language that mirrors prior bipartisan legislation on pharmacy benefit managers, which has long been a drug industry priority. That includes language to prevent the use of "abusive spread pricing" under Medicaid. Spread pricing occurs when PBMs pocket the difference between the amount they reimburse a pharmacy for a prescription and the amount they charge a health plan for the drug. The text also includes new clarifications on drug rebates and PBM transparency... Sub. Req’d

Analysts Assess the Impact of Trump's Drug Pricing Order On Indian Pharma

(5/13, Prashant Nair and Surabhi Upadhyay, CNBC TV-18) ...Kunal Dhamesha, Pharma and Healthcare Research Analyst at Macquarie Capital, noted that the latest version is "much diluted" compared to Trump's 2020 proposal, which had faced legal hurdles and was ultimately shelved by the Biden administration...Annaswamy Vaidheesh, former MD of GSK Pharmaceuticals, added that generic drugs, especially those sold by Indian companies, are unlikely to be affected. "The comparative pricing for non-branded generics in the US versus other OECD countries isn't significantly different... Full

India's Free Trade Deals with UK and Europe Won't Hamper Domestic Drug Companies, Say Officials

(5/12, Abhimanyu Sharma, CNBC TV-18) ...Officials confirmed that India rejected requests from the UK and Switzerland for data exclusivity clauses, which could have posed challenges for the country's $25 billion generic drugs sector. This decision means British and Swiss pharmaceutical companies such as AstraZeneca, GSK, Novartis and Roche will be unable to block local firms from producing affordable versions of their medicines...The European Union has also pushed for amendments to allow evergreening in the pharmaceutical sector, but India has so far stood firm... Full

Euro Convergence 2025 Focuses On Competing, Adapting Amid Global Change

(5/12, Emily Hayes, Regulatory Focus) ...The Euro Convergence meeting runs from Tuesday, May 13, to Friday, May 16, at the Square Brussels Meeting Centre in Brussels, Belgium. The meeting, held annually, brings together a diverse set of regulatory professionals for a broad program spanning pharmaceuticals, medtech, IVD, artificial intelligence (AI), software and cybersecurity... Full

Big Chinese Pharma Firms Can Withstand Trump's Policies with Cost Advantages: Analysts

(5/13, Eric Ng, South China Morning Post) ...Given that China's role in global drug manufacturing focuses on active pharmaceutical ingredients and generics, L. E. K Consulting's Anderson said it would be less affected by Trump's initiatives in the short term... Full

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