Friday, April 4, 2025

Teva Shares Encouraging Patient Survey Data For Long-Acting Olanzapine

(4/3, Adam Zamecnik, Generics Bulletin) ...Doubling down on previously shared data from the firm's STELARIS trial, Teva has reported further findings from a survey featuring subjects and professionals involved in the Phase III study for its proposed long-acting olanzapine injectable. Over 92% of enrolled schizophrenia patients are happy with Teva Pharmaceuticals' long-acting olanzapine, based on new survey data sourced from patients and healthcare professionals involved in the Phase III SOLARIS trial that adds a further dimension to available data... Global Sub. Full

Glenmark Dodges UK Dapagliflozin Injunction Ahead Of Patent Trial Decision

(4/4, Dean Rudge, Generics Bulletin) ..."I acknowledge that status quo would favour the grant of an injunction had other factors been evenly balanced but, in my judgment, they are nowhere near being evenly balanced," [Michael Tappin, deputy UK High Court Justice,] summarized. According to court experts, UK sales of Forxiga – which is also indicated to treat heart failure and chronic kidney disease – have accelerated rapidly in recent years, shooting up to around £235m ($310m) in 2023... Global Sub. Full

AbbVie Cuts 2025 Profit Forecast on Acquisition Expenses

(4/4, Reuters) ...AbbVie on Thursday cut its 2025 adjusted profit forecast as the drugmaker expects to incur $248 million in acquisition expenses related to milestone payments as well as research and development costs. The company has been focusing on expanding its pipeline since its blockbuster arthritis drug, Humira, lost patent protection in 2023... Full

Big Pharma Is Heading to Barcelona and Here's Why

(4/4, Ashleigh Furlong, Bloomberg) ...Spain has a unique value proposition to entice would-be investors. The typical incentives are there, such as generous tax breaks, but the labor costs for highly specialized staff in Spain are also lower than many other European countries. Add in a relatively speedy regulatory process and it's not hard to see why Spain is now at the top of European rankings for clinical trials. There's also something else – the government is doing all it can to make doing business in Spain as easy as possible... Sub. Req’d

PBM Private Labeling Boosts Biosimilar Adoption, Raises Anticompetitive Concerns

(4/3, Lucy Hicks, Medscape) ...But rather than preferring multiple biosimilars on their formularies, these companies have created their own subsidiaries to co-produce these medications. With this approach, known as white or private labeling, these companies can produce a medication and subsequently prefer that same drug on their formularies. Experts are divided on whether these companies' control of multiple stages of the drug supply chain will be beneficial or detrimental to the biosimilars market. On one hand, these agreements had resulted in adalimumab biosimilars market share climbing to nearly 25% with medications priced more than 80% lower than the reference product... Full

M&A Recap: Big Pharma Starts the Year Mostly Avoiding Billion-Dollar Deals

(4/4, Jacob Bell, BioPharma Dive) ...The world's largest pharmaceutical companies mostly steered clear of billion-dollar acquisitions in the early months of this year, perhaps indicating how a tumultuous U.S. political environment has led would-be buyers to view bigger deals as too risky for the time being... Full

Trump's Next Tariffs Target Could Be Foreign-Made Medicines

(4/4, Rebecca Robbins, The New York Times) ...President Trump wants to bring pharmaceutical manufacturing back to the United States. Experts warn that tariffs could result in shortages and higher prices for generic drugs. The drug industry got a temporary reprieve on Wednesday when foreign-made medicines were exempted from President Trump's far-reaching new tariffs. But Mr. Trump has been saying for weeks that he plans to impose tariffs specifically on pharmaceuticals, with the goal of shifting overseas production of medications back to the United States... Sub. Req’d

Tariffs 'Hard to Come Back From', Says US Pharma Boss

(4/3, Simon Jack, BBC) ...In an exclusive interview, David Ricks described it as a watershed moment in US economic history, "I think it's a pivot in US policy and it feels like it'll be hard to come back from here." While Mr Ricks said he thought it may encourage some companies to relocate some manufacturing, he was doubtful it would also create hundreds of billions in additional revenue for the US promised by President Trump. He also added that the UK's status as a pharmaceutical and life sciences power was in decline. Eli Lilly is a pharmaceutical giant based in Indianapolis worth $750bn (£573bn; €676bn) with 50,000 employees across the US, Europe and Asia... Full

FTC Chief Warns US Companies Against Using Donald Trump's Tariffs to Raise Prices

(4/4, Hindustan Times) ...The Federal Trade Commission (FTC) chairperson, Andrew Ferguson, on Thursday warned the US companies against using the Donald Trump administration's tariffs on imports as an excuse to raise prices, saying that the FTC will be watching the situation closely... Full

F.D.A. Layoffs Could Raise Drug Costs and Erode Food Safety

(4/3, Christina Jewett, New York Times) ...Trump cutbacks were supposedly aimed at administrators. But scientists in food-and-drug-testing labs and policy experts who advance generic drug approvals were also dismissed. Health Secretary Robert F. Kennedy Jr. announced wide-ranging cutbacks at federal health agencies, including the Food and Drug Administration, that would eliminate duplicative services and paper pushers... Sub. Req’d

Industry Leaders React to HHS Being ‘Reduced to a Shell'

(4/3, Meagan Parrish, Amy Baxter, PharmaVoice) ...A massive round of job cuts hit HHS this week, impacting a wide range of staffers of all rank and file. And more details about who exactly got the boot are starting to emerge. An entire team devoted to FDA communications was among the 3,500 agency employees who were fired on Tuesday, NPR reported. Staffers inside the FDA's Office of New Drugs, Office of Policy and International Engagement and Office of Regulatory Programs were also let go, according to CNN... Full

Trump Layoffs Begin to Erode FDA Drug Review System

(4/4, Ahmed Aboulenein, Julie Steenhuysen in Chicago, Maggie Fick, Reuters ) ..."These deep cuts and the loss of experienced leadership at virtually all the major centers that regulate the safety of food, drugs, devices is quite high risk," said Dr. Jesse Goodman, former chief scientist at the FDA and director of Georgetown University's Center on Medical Product Access, Safety and Stewardship. "If there is a safety issue with blood or a medical product or some vaccines, it's very important that you detect that and respond to it quickly, and it takes people who really understand it to do that," Goodman added... Full

Drug Patent, Pricing Bills Approved by Senate Committee

(4/3, Christopher Yasiejko, Bloomberg Law) ...The committee, chaired by Sen. Chuck Grassley (R-Iowa), advanced all six of the bills by voice vote. The panel previously approved versions of the bills in February 2023, he said at the proceeding's outset, but they weren't considered by the full Senate. "These bills will help shine a light on prescription drug pricing and clamp down on the abusive practices that continue to unfairly drive up drug costs," Grassley said in a statement after the markup... Sub. Req’d

Senate Judiciary Passes Patent Reforms Aimed A Lowering Drug Costs

(4/3, Jessica Karins, Inside Health Policy) ..."Americans facing skyrocketing prescription drug costs are eager for Congress to act. It's why reducing prescription drug costs is one of my highest priorities. These bills will help shine a light on prescription drug pricing and clamp down on the abusive practices that continue to unfairly drive up drug costs for Iowans," Senate Judiciary Chair Chuck Grassley (R-IA) said in a statement Thursday... Sub. Req’d

FTC Case Against Drug Middlemen to Continue With Chairman's Move

(4/3, Justin Wise, Bloomberg Law) ...Ferguson, who had previously recused himself from the case along with his Republican colleague Melissa Holyoak, said he changed his decision in light of the firings of Alvaro Bedoya and Rebecca Kelly Slaughter, who at the time of their dismissals were the only commissioners overseeing it. He posted on X Thursday that he had recused himself from the vote authorizing the case because of his past work as Virginia's solicitor general relating to pharmacy benefit managers... Sub. Req’d

Chairman Scott, Sens. Moody and Justice Ask FDA to Prioritize Foreign & Domestic Drug Quality and Protect Seniors

(4/1, United States Senate Special Committee on Aging) ...Today, Chairman Rick Scott and Committee members Senator Ashley Moody and Senator Jim Justice sent a letter to the Food and Drug Administration's (FDA) Commissioner, Dr. Martin Makary, requesting information on the steps the FDA is taking to establish parity between domestic and foreign drug quality and how the agency is actively ensuring the medicines America's seniors rely on are safe and of the highest quality... Full

FDA Inspection Operations Face Risk of Further Disruption Amid Mass HHS Layoffs: Report

(4/3, Fraiser Kansteiner, Fierce Pharma) ...While the FDA's inspection figures for drug manufacturing facilities have yet to fully recover from the COVID-19 pandemic, sweeping staff cuts have raised questions about how the agency plans to ensure drug quality with fewer resources. Senior FDA leaders are anticipating that the agency's already lagging rate of routine food and drug inspections will experience a downturn following HHS' recent announcement that it's cutting 10,000 jobs across the department, CBS News reported Wednesday, citing multiple FDA officials... Full

Boehringer Struggles to Sway Court in Fight Over Drug Price Cuts

(4/3, Nyah Phengsitthy, Bloomberg Law) ...The manufacturer told the US Court of Appeals for the Second Circuit that a lower court was wrong to reject its challenge against an Inflation Reduction Act plan established under former President Joe Biden. The Medicare Drug Price Negotiation Program gives the US powerful authority to negotiate with the pharmaceutical industry over the costs for some of the most widely used and expensive medicines covered by Medicare... Sub. Req’d

Congress Must Stop 'Pill Penalty' to Ensure Medicine Research Continues

(4/4, Eddie Pauline, The Columbus Dispatch) ...The so-called "pill penalty" — a flaw in the act's drug pricing provisions — disproportionately harms small-molecule drugs, which account for more than 90% of prescriptions in the United States. These medicines treat a wide range of common and life-threatening conditions, including cancer, cardiovascular disease and mental illness. Without action, this policy misstep will discourage investment in small-molecule innovation, limiting treatment options for millions of patients... Full

FDA Will Consolidate to Five 'Shared Services Offices,' According to Memo to Hill Staffers

(4/3, Max Bayer, Endpoints News) ...The FDA is being consolidated into five "shared services offices," according to a memo from HHS distributed to staff on Capitol Hill that was reviewed by Endpoints News. The memo lays out a broad set of changes that have been part of firing roughly 10,000 staff at US health agencies and reorganizing government functions over the last week, led by HHS Secretary Robert F. Kennedy Jr... Sub. Req’d

US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People

(4/3, Derrick Gingery, Pink Sheet) ...Layoffs, retirements and buyouts have cost the US Food and Drug Administration's drug center more than 17% of its staff so far in 2025. Internal data obtained by the Pink Sheet indicate that the Center for Drug Evaluation and Research now has less than 5,000 employees after starting calendar year 2025 with 6,058, a decrease of more than 1,000 people... Sub. Req’d

Dr. Oz Takes The Over CMS Amid Major Transformation Of Medicare Part D

(4/4, Cathy Kelly, Pink Sheet) ...Mehmet Oz will take the reins at the Centers for Medicare and Medicaid Services as it continues to implement Inflation Reduction Act policies that are the most significant changes to the Part D benefit since its inception in 2006. The Senate voted 53-45 along party lines on 3 April to confirm Oz as CMS administrator. The Part D redesign and Medicare negotiation program were enacted two years ago under the Biden Administration, but development of the process for "effectuating" the negotiated prices is ongoing... Global Sub. Full 

AAM Congratulates Dr. Oz on Confirmation as Administrator of the Centers for Medicare & Medicaid Services

(4/3, AAM) ..."Congratulations to Dr. Oz on confirmation to lead CMS," said John Murphy III, President and CEO of the Association for Accessible Medicines. "Generic and Biosimilar medicines provide the greatest cost savings in health care for all patients, especially for Medicare and Medicaid. We are 90% of the medications dispensed in the U.S. and only 13% of the total drug spending. AAM and the Biosimilars Council look forward to working with Dr. Oz and his team at CMS to ensure lower-cost medicines are always available for America's patients."... Full

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

(4/4, Vibha Ravi, Pink Sheet) ...Trump called India Prime Minister Narendra Modi a friend, but added that he told Modi "You're not treating us right." Claiming the country imposes a 52% tariff on American imports, he said countries on which reciprocal tariffs are being imposed understand the "little bit of tough love."... Global Sub. Full

India in Active Talks with Domestic Pharma Exporters amid New US Tariff Threat

(4/4, IANS) ...The Commerce Ministry is in active talks with Indian pharmaceutical exporters amid growing concerns over possible US tariffs on the sector, which was exempted in the first tranche of reciprocal tariffs by US President Donald Trump. The discussions between the government and pharma exporters began after Trump hinted at imposing "never-seen-before" tariffs on pharmaceutical imports... Full

U.K. Officials Signal Willingness to Embrace Reform in Bid to Attract Pharma Investment

(4/4, Andrew Joseph, STAT) ...The pharma industry has for several years complained about the scheme under which the National Health Service buys medicines, with drug companies having to pay a portion of their sales back to the government when drug spending increases past a certain level. Those criticisms have grown louder this year as the rebate rate for new medicines reached roughly 23%, far above expectations and higher than the 15% clawback rate last year... Sub. Req’d

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