Thursday, May 15, 2025

Ajovy Clinical Trial Shows Little Improvement Over Placebo in Migraine and Depression

(5/15, Justin Jackson, Medical Xpress) ...Albert Einstein College of Medicine and Teva Pharmaceuticals, in collaboration with multiple international institutions, report findings on the efficacy of fremanezumab (sold as Ajovy by Teva) in reducing migraine frequency and depressive symptoms among patients with comorbid major depressive disorder. Significant reductions in monthly migraine days and depressive symptoms were observed in both fremanezumab and placebo. Fremanezumab did not demonstrate clinically meaningful effects on depression and headache-related disability when compared to placebo... Full

Celltrion Expects Minimal Impact from Trump's Drug Pricing Order

(5/15, Choi Kyong-ae, Yonhap News) ...Celltrion Inc., a leading South Korean biopharmaceutical company, said Thursday its business will remain largely unaffected by U.S. President Donald Trump's executive order aimed at lowering drug prices to match those in other countries... Full

Viatris Awaits ‘Significant Rebound' At Indore In 2026 After Painful Q1 Bite

(5/14, Dean Rudge, Generics Bulletin) ...The fallout from the Indore import alert wiped $140m from Viatris' top line in the first quarter, in line with the firm's previous estimate of a $500m impact for 2025. Viatris has engaged third-party experts to assist the firm's remediation efforts, and plans to submit a request for an FDA reinspection by mid-2025. Scott Smith, Viatris' CEO, told investors during the firm's Q1 earnings call that it anticipated a "significant rebound" at Indore in 2026. "We don't think it will have a significant impact on our overall financials" next year, he added... Global Sub. Full

Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

(5/15, Urte Fultinaviciute, Generics Bulletin) ...Biocon's generics revenues in Q4 were driven by the limited launch of the generic rival of Revlimid. However, until the market fully opens up in 2026, sales are expected to be lumpy. GLP-1s continue to be a growth driver for Biocon, but the firm does not see a need to increase its capacity for the next several years. Anticipated US approval and launch of generic Copaxone is expected to fill in the revenue gaps... Global Sub. Full

Merck KGaA Strikes More Cautious Tone On 2025 Profit

(5/15, Ludwig Burger, Reuters) ...German pharmaceutical and specialty materials group Merck KGaA on Thursday guided more cautiously for 2025 earnings, citing the macro-economic and geopolitical environment as well as foreign-exchange headwinds. Earnings before interest, tax, depreciation and amortisation (EBITDA), adjusted for one-off items, would likely reach between 5.8 billion euros ($6.5 billion) and 6.4 billion this year, compared with 6.07 billion euros reported for 2024... Full

Hikma Pharmaceuticals Projects Midterm Revenue, Profit Growth

(5/15, Helena Smolak, Dow Jones) ...The British pharmaceutical company said Thursday that it forecasts group revenue growth between 6% and 8% and group core operating profit growth of 7% to 9% by 2027, compared with 2024 levels. Hikma Pharmaceuticals added that it expects to achieve $5 billion in revenue by 2030... Sub. Req’d

Sanofi Hops On the US Investment Bandwagon with $20B Commitment Through 2030

(5/14, Kevin Dunleavy, Fierce Pharma) ...On Wednesday, Sanofi said it will invest at least $20 billion through 2030 to beef up its R&D and manufacturing operations in the U.S. The Paris-based company said it will expand its manufacturing capacity at its current U.S. sites and will enhance its partnerships with other domestic manufacturers to help "ensure the production of medicines in the U.S." The increased investment will "create a significant number of high-paying jobs in multiple states," Sanofi added... Full

Lundbeck Raises Financial Guidance

(5/14, The Pharma Letter) ...Danish CNS specialist Lundbeck (LUND: CO) today released first-quarter 2025 financials, along with a raised guidance for the full year, sending its shares up more than 9% to 28.80 kroner. Lundbeck's total revenue grew by 16% at constant exchange rates (CER) (+18% DKK) to 6,235 million kroner ($945 million) in the first quarter of 2025, with all regions contributing to growth... Sub. Req’d

Marksans Pharma Arm Secures UK Health Regulator Nod for Epilepsy Treatment Drug

(5/15, CNBC TV-18) ...Marksans Pharma Ltd shares gained over 2% in morning trade on Thursday, May 15, after the company announced its UK subsidiary Relonchem Ltd had secured marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (UKMHRA) for its Gabapentin oral solution, 50 mg/ml. It is used for the treatment of nerve pain and epilepsy... Full

Biohaven Stock Sinks On Three-Month Delay for Neuro Drug's FDA Approval Decision

(5/15, Elizabeth Cairns, Endpoints News) ...Biohaven said late Wednesday that the FDA would be delaying the PDUFA date for its neurodegenerative disease therapy troriluzole and will also require an advisory committee meeting to review the drug. The agency's move came as a surprise to the company, which had said Monday that "the FDA has not conveyed any intention of holding an advisory committee meeting" for troriluzole... Sub. Req’d

Consumers Remain Averse to GLP-1 Costs, With Most Unwilling to Pay More Than $100 Out of Pocket Per Month: KPMG

(5/15, Andrea Park, Fierce Pharma) ...Despite broad awareness of the drugs' possible benefits, their price tags remained a major negative for consumers. When asked whether they'd be willing to pay higher insurance premiums if GLP-1s were covered, only a minority of all respondents said they would...The adults surveyed were overwhelmingly averse to out-of-pocket costs for GLP-1s. Only 20% said they'd be willing to pay up to $100 per month for the meds. Overall, per KPMG, more than 70% of those surveyed said they would not be willing to pay out of pocket for GLP-1s... Full

SABA Inhaler Carbon Emissions Have Dropped by One-Third Since 2020, NHS England Data Show

(5/14, Emma Wilkinson, The Pharmaceutical Journal) ...Pharmacy experts have told The Pharmaceutical Journal that the fall in carbon emissions is likely to be a result of incentives offered to primary care to switch patients from the Ventolin Evohaler (salbutamol sulfate; GSK) to the Salamol inhaler (salbutamol sulfate; Teva UK), which is associated with less than half the carbon emissions observed since 2020... Full

US Overdose Deaths Fell 27% Last Year, The Largest One-Year Decline Ever Seen

(5/14, Mike Stobbe and Geoff Mulvihill, Associated Press) ...There were 30,000 fewer U.S. drug overdose deaths in 2024 than the year before — the largest one-year decline ever recorded. An estimated 80,000 people died from overdoses last year, according to provisional Centers for Disease Control and Prevention data released Wednesday. That's down 27% from the 110,000 in 2023... Full

Overdose Deaths Drop to Lowest Level Since Before the Pandemic

(5/14, Rebecca Falconer, Axios) ...The drop in overdose deaths is partly due to the wider availability of naloxone which reverses an opioid overdose, per CBS News...Experts warn a Trump administration budget proposal that would cut health services threatens this decline. A group of medical doctors and academic experts on addiction warned lawmakers in a letter this week that "drastic" cuts to federal health agencies and their grant recipients could set back efforts to address overdoses, substance use disorder and mental health... Full

Most Favored Nation Policy ‘Lazy, Misguided,' But US Price Reforms Politically ‘Inevitable'

(5/15, Cathy Kelly, Pink Sheet) ...President Trump's executive order establishing a most favored nation policy for drug pricing in the US is "lazy and misguided," University of Washington professor Sean Sullivan said during the ISPOR 2025 conference in Montreal. Experts agreed the order is unlikely to lower prices in the US while raising prices abroad to preserve global investment in innovation. But drug pricing reforms in the US are politically "inevitable" and "there will be blood" from manufacturers, USC's Darius Lakdawalla said... Global Sub. Full

Industry Leaders Grapple With Trump's Most Favored Nation Pricing Plan

(5/15, Jessica Merrill, Pink Sheet) ..."At this point we probably have more questions than answers," Merck & Co. Human Health US President Jannie Oosthuizen said during the Bank of America Global Healthcare Conference. "We will definitely learn more over the next few weeks, as CMS probably starts to engage on the topic and the list of to-dos that they have."..."There's the obvious questions like how's this going to work?" he added. "What's going to be possible to implement under an executive order versus potential legislation? Will it have to go through Congress? What elements will have to go through Congress?"..."All of those are just questions in terms of how this is really going to shape up," Oosthuizen said... Global Sub. Full

Roche Says Trump's Drug Price Order Threatens its $50 Billion US Investment Plans

(5/14, Maggie Fick, Reuters) ..."Should the proposed EO (Executive Order) go into effect, Roche's ability to fund the significant investments previously announced in the U.S. will be in question," the company said in a statement. Roche said it did not expect the executive order to affect its business in 2025, and said it would continue engaging with the Trump administration and Congress..."We are working both in the U.S. and Europe to advocate for necessary changes, including reducing the role of PBMs (pharmacy benefit managers) and correcting significantly low pricing in Europe," the company said in an emailed statement to Reuters. "These discussions will take time, and we do not expect any changes to happen quickly."... Full

US Health Secretary Kennedy Says He Would Work with Democrats to Lower Drug Prices

(5/14, Ahmed Aboulenein, Katharine Jackson, Reuters) ...U.S. health secretary Robert F. Kennedy Jr. said on Wednesday at a Senate Committee on Health, Education, Labor & Pensions hearing that he is willing to work with Democrats on lowering prescription drug prices. "I look forward to working with you on legislation or any way that we can to get there," Kennedy said in response to a question from Senator Bernie Sanders, an independent who votes with Democrats... Full

RFK Jr. Open To Working With Sanders On ‘Most Favored Nation' Bill

(5/14, Maaisha Osman, Inside Health Policy) ...Sanders' plan to introduce a new bill on MFN policy comes after President Donald Trump signed an executive order Monday (May 12) that gives drug makers 30 days to voluntarily bring U.S. prices down to those of other developed countries or face formal regulatory action by the administration requiring them to do so...Kennedy responded that he supports the concept and is willing to work with Sanders on the upcoming legislation... Sub. Req’d

RFK Jr. Defends HHS Staff Cuts, Reorganization Plans in House, Senate Hearings

(5/14, Zachary Brennan, Endpoints News) ...HHS Secretary Robert F. Kennedy Jr. faced hours of congressional grilling on Wednesday over his proposed budget cuts and planned overhaul of the agency that's expected to shrink the workforce by 20,000 employees. Speaking at his first Capitol Hill briefings since taking the job, Kennedy tried to stay on the offensive, reiterating his "Make America Healthy Again" principles to reduce childhood chronic diseases and making clear that the steep staff cuts were meant to return HHS to its size prior to the pandemic... Sub. Req’d

E&C Passes Medicaid Reforms After 26-Plus Hours Of Debate, 100 Failed Democratic Amendments

(5/14, Dorothy Mills-Gregg, Sigi Ris, Inside Health Policy) ...House Energy & Commerce Committee Republicans were united throughout the 26-plus hour markup of the reconciliation bill -- the last 15 hours of which were driven by Democrats introducing amendments to counteract the issues they and Medicaid stakeholders have with the bill's provisions to impose national Medicaid work requirements on the expansion population, freeze provider taxes, reform state-directed payments, and increase cost sharing policies, among others... Sub. Req’d

Dr. Scott Gottlieb On the Impact of Pres. Trump's Policies On Big Pharma and R&D

(5/14, CNBC) ...Former FDA Commissioner Dr. Scott Gottlieb joins ‘Squawk Box' to discuss the impact of President Trump's tariff policy and executive order on the pharmaceutical industry, impact on R&D and new drug development, and more... Full

Ensuring Most-Favored Nation Drug Pricing Doesn't Sicken Us

(5/15, Darius Lakdawalla and Dana P. Goldman, STAT) ...Drugmakers should come to grips with how their products are valued by consumers and revise pricing accordingly...[P]ricing should hinge on effectiveness. If a drug produces health gains, it should be rewarded, and if not, its manufacturer should issue refunds. Drugs should enter the market at low introductory prices, rise as they prove their worth and value, and drop again when patents expire and generic versions become available... Full

Why Americans Pay So Much More for Prescription Drugs

(5/14, Karen Gilchrist, CNBC) ..."Americans pay more for drugs than Europeans. Full stop. That is correct," Emily Field, head of European pharmaceutical research at Barclays, told CNBC's "Squawk Box Europe" on Tuesday. "Trump doesn't like that [they're] getting a bad deal," she added. Field noted, however, that although U.S. consumers typically pay more for branded drugs, the picture is far from clear cut. "Although the branded market for U.S. pharmaceuticals is very expensive and very convoluted with very little price transparency, when you take a step back there are surprisingly parts of the U.S. system that are very, very efficient and good at lowering costs," she said... Full

AAFA Calls for Comprehensive Reform to Make Medicines Accessible and Affordable for All

(5/15, AAFA) ...Our research tells us that high cost remains a primary barrier to treatment for people with asthma. However, we are deeply concerned that the proposed Most-Favored-Nation (MFN) pricing framework—while well-intentioned—fails to address the underlying complexities of the U.S. drug pricing ecosystem and risks creating unintended consequences that could restrict access for patients who rely on life-saving medications... Full

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year's Delay

(5/14, Eliza Slawther, Pink Sheet) ...The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation "sooner, rather than later," but divergence between member states could push negotiations back another year, a European Commission policy officer said today... Global Sub. Full

England's Drug Approval Body Resists Pharma Pressure to Loosen Processes

(5/14, Anna Gross and Hannah Kuchler, Financial Times) ...As part of efforts to prove its contribution to growth, Nice, an arm's-length body of the Department of Health and Social Care, has started producing financial estimates of the economic benefits of efficient drug rollout, it told the Financial Times. The estimates are in part aimed at persuading ministers and the NHS to buy more of the medicines it recommends as value for money and increase supply... Sub. Req’d

Big Pharma is Using Tariffs to Hold Europe to Ransom

(5/15, Nick Dearden and Peter Maybarduk, Politico) ...Under the pretense that Europe is no longer a profitable place to invest and manufacture, drug makers are demanding all manner of concessions, including looser regulation on clinical trials and tighter monopoly protection of the intellectual property that underpins their power. Most of these have nothing to do with making Europe a better place to manufacture drugs and everything to do with raising prices. And it should make us very suspicious of lobby group claims that "unless Europe delivers rapid, radical policy change then pharmaceutical research, development and manufacturing is increasingly likely to be directed towards the US."... Full

UK-India FTA Could Offer ‘Significant Benefits' For Generics And Biosimilars

(5/14, Dave Wallace, Generics Bulletin) ...A free trade agreement struck between the UK and India promises to cut costs and generate savings. Medicines UK believes the deal could offer "significant benefits for the generic and biosimilar sectors." The UK trade association has urged further agreements to build on the FTA, covering regulatory pathways and security of supply... Global Sub. Full

Indian Drugmakers See Potential Tail Wind in Trump's MFN Drug Pricing Plan

(5/14, Viswanath Pilla, Moneycontrol) ...Indian pharmaceutical companies are viewing US President Donald Trump's revived "Most Favoured Nation" (MFN) pricing policy not as a threat, but as a potential tailwind, especially for generics and biosimilars. Industry executives feel that the direct-to-government sales could open new channels, giving generic manufacturers some advantage in the US market, known for the steep pricing pressure... Full

Denmark's Economy Boomed On Drug Exports — Trump's Tariffs Threat Won't Be What Slows it Down

(5/15, Holly Ellyatt, CNBC) ...Denmark's economic growth, which was driven by what economists described as an "exceptional surge" in pharmaceutical exports, is expected to weaken this year. The looming threat of U.S. tariffs on the pharma industry won't be much of a factor on that moderation, however, the International Monetary Fund said Tuesday... Full

Russian Patients Call On State to Increase Procurements of Biogen's Spinraza

(5/14, The Pharma Letter) ...Representatives of Russian patent unions have sent an appeal to the Russian Scientific Center for Expertise of Medical Products to provide a protocol for the compliance of Lantesens, a drug for the treatment for spinal muscular atrophy (SMA), which is produced by the Russian drugmaker Generium, a copy of the original drug Spinraza (nusinersen) from US biotech Biogen, reports The Pharma Letter's local correspondent... Sub. Req’d

Germany's Merck Drops China Surcharge On Orders After US-China Tariff Deal

(5/14, Andrew Silver, Reuters) ...German healthcare and materials group Merck KGaA has dropped a surcharge on life sciences sector orders within China following the U.S.-China agreement to pause sky-high tariffs on each other, the company said Wednesday..."Following the joint statement ... on reciprocal tariffs, our Life Science business sector has discontinued the temporary surcharge on orders within China, effective immediately," a Merck spokesperson told Reuters in response to queries about fees... Full

Fears Over Trump's Drug Price Cuts Overblown But Risks Remain for Korean Biotechs

(5/15, Nam Hyun-woo, The Korea Times) ...U.S. President Donald Trump sent jitters through Korea's biotechnology industry by announcing plans for drug price cuts of up to 90 percent. The announcement dragged down shares of major Korean biotech firms amid fears over the potential impact, but the actual executive order he signed Monday (local time) is now prompting views that those concerns may have been overblown... Full

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