Friday, June 13, 2025

Trump Administration Demands Pharma Companies Begin Drug Price Negotiations, A Day After Key Deadline

(6/12, Daniel Payne, STAT+) ..."Under President Trump's direction, HHS is demanding that pharmaceutical companies end their obstruction and come to the table—just as they already do with nearly every other economically comparable nation—to negotiate fair, transparent pricing for Americans," an agency spokesperson said in a statement to STAT, adding that the companies were "prevent[ing] progress of lowering prices for the American people." The spokesperson did not immediately clarify how companies were preventing that progress... Sub. Req’d

Industry Tells Congress Incentives Needed to Boost Domestic Drug Manufacturing

(6/12, Joanne S. Eglovitch, Regulatory Focus) ...John Murphy, the president and CEO of the Association for Accessible Medicines (AAM) concurred that the lack of government financial incentives hurts efforts to onshore pharmaceutical manufacturing...Murphy said that Congress can help boost domestic manufacturing by creating financial incentives for domestic manufacturing, and that Congress should provide the same level of support to the generic drug industry as it has done for the semiconductor industry with the recent CHIPS and Science Act... Full

Peters Leads Colleagues to Reintroduce Bipartisan Bill to Strengthen Critical Drug Supply Chains and Mitigate Shortages

(6/12, Homeland Security & Governmental Affairs) ...Drug shortages are lasting longer and continue to impact patients, hospitals, and health care providers, increasing the risk of medication errors, rationing, and delays in patient care. In a 2023 report, Peters found that at least 15 critical medications remained in shortage for over a decade. Many of the life-saving generic drug products that regularly experience shortages are complex to manufacture and cost pennies on the dollar. The legislation builds on recommendations from Peters' prior investigative reports in 2019 and 2023, which found that generic drug manufacturers' ability to surge production and store supplies are often limited because they regularly operate at or near full capacity... Full

July DOJ Listening Session Could Coincide With FTC Jump-Starting Case Against PBMs

(6/12, Gabrielle Wanneh, Donna Haseley, Inside Health Policy) ...The Justice Department and Federal Trade Commission's plan to hold a July 24 listening session on formulary and benefit barriers that keep drug prices high could coincide with a potential move by FTC to jump-start its stalled case against top pharmacy benefit managers...The three listening sessions will occur under the direction of Assistant Attorney General Gail Slater and FTC Chair Ferguson. They will focus on "improving the affordability of pharmaceuticals by increasing generic and biosimilar availability and promoting competition through drug formularies and benefits," DOJ said. They will also feature remarks by practitioners and scholars... Sub. Req’d

Makary: Biosimilar Confirmatory Trials May Not Be Needed

(6/12, Luke Zarzecki, Inside Health Policy) ...FDA Commissioner Marty Makary doubled down on the idea that confirmatory trials are not needed for biosimilars on a June 8 podcast, as the Department of Justice (DOJ) and the Federal Trade Commission (FTC) plan to host listening sessions on lowering drug prices, with increasing generics and biosimilars at the heart of the events... Sub. Req’d

Pharma Wins a Victory Over a Minnesota Law Designed to Provide Transparency into Drug Pricing

(6/12, Ed Silverman, STAT+) ...In a victory for the pharmaceutical industry, a U.S. appeals court upheld a lower court decision to halt a controversial Minnesota law that is designed to provide transparency into prescription drug pricing. The decision was issued as the result of a lawsuit filed three years ago by the Association for Accessible Medicines, which argued the law gives Minnesota the power to regulate interstate commerce and apply the law to prices charged in other states... Sub. Req’d

Eighth Circuit Court Rules Unanimously for AAM in Generic Pricing Appeal

(6/12, AAM) ..."AAM is very pleased that the Eighth Circuit, like the district court in Minnesota and every other court that has confronted this question, has ruled that states may not control prices charged outside their borders," said John Murphy III, President and CEO of AAM. "AAM and its members work every day to lower drug prices by making available lower-cost generic and biosimilar alternatives, and we look forward to continuing to work with states on policies that expedite patient access to these critical medicines."... Full

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous' Arkansas PBM Law

(6/12, Tim Casey, Pink Sheet) ...PBM owners recently sued the state of Arkansas in an effort to stop implementation of a law that would ban companies from owning PBMs and pharmacies in the state. The companies alleged the law was unconstitutional and could lead to pharmacy closures and job losses. Attorney Rahul Rao said more states are considering implementing similar legislation... Global Sub. Full

Gov. Landry Threatens Special Session Over Failed Prescription Drug Prices Bill

(6/12, Greg LaRose and Julie O'Donoghue, Louisiana Illuminator) ...The eight-week regular session ended with lawmakers backing the less stringent of two measures aimed at regulating pharmacy benefit managers, often referred to as PBMs or "middlemen" that oversee prescription drug programs for insurance companies and large employers...Landry wanted lawmakers to pass a more aggressive bill that would have prohibited companies from owning drug stores and pharmacy benefit managers, which would have threatened companies such as CVS who own both... Full

PCMA Statement On Dangerous Louisiana Pharmacy Closure Legislation

(6/12, PCMA) ..."We urge the Louisiana Senate to reject HB 358, which could force a significant number of pharmacy closures in Louisiana, putting the state's veterans, seniors, and most vulnerable patients suffering from complex health conditions at severe risk of disruption to their health care. The latest version of legislation threatens to reduce patients' ability to get prescription drugs through home delivery programs and specialty pharmacies. The result of the revised bill could lead to worse health outcomes and higher drug costs for patients..."... Full

Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

(6/12, Dean Rudge, Generics Bulletin) ...Regeneron is closely monitoring Amgen's Pavblu 2mg aflibercept biosimilar, which has recently gained market traction through financial incentives targeting physicians. Regeneron's CFO, Chris Fenimore, highlighted at the Goldman Sachs Global Healthcare Conference that the primary differentiator for Pavblu seems to be its financial strategy, as they contend that no other competitive advantage exists in the market. Regeneron aims to stabilize Eylea while promoting Eylea HD, a high-dose version of the treatment for wet age-related macular degeneration... Global Sub. Full

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

(6/13, Dean Rudge, Generics Bulletin) ...Xbrane Biopharma has formed a partnership with Indian CDMO OneSource Specialty Pharma to enhance the commercial manufacturing of its biosimilars, including its much-delayed product in the US, Ximluci (ranibizumab). The agreement involves technology transfer of selected products, notably Ximluci, to OneSource's Bangalore facility, aiming to strengthen Xbrane's global supply chain and expedite regulatory approvals... Global Sub. Full

Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

(6/13, Dave Wallace, Generics Bulletin) ...Endo and Mallinckrodt have announced that their generics and sterile injectables business – which is to be spun off after the two firms complete their merger – will be called Par Health. Par Health will be led by Stephen Welch, the current head of generics at Mallinckrodt, who will become president and CEO of the business once spun off. Until the spin-off occurs, Par Health will operate as a segment of the merged company, with Welch reporting to Mallinckrodt CEO Siggi Olafsson, who will lead the combined firm... Global Sub. Full

FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation

(6/12, Ryan Livingston, HCPLive) ...The US Food and Drug Administration (FDA) has approved prednisolone acetate ophthalmic suspension, USP 1%, a sterile, topical anti-inflammatory agent, for the treatment of steroid-responsive ocular inflammation. In addition to the approval, parent company Amneal Pharmaceuticals, Inc. announced a planned launch of the product for the third quarter of 2025... Full

Samsung Bioepis Presents Long-Term Safety Data of Epysqli

(6/12, The Pharma Letter) ...South Korea's biosimilar drug developer Samsung Bioepis today presented the long-term safety data of Epysqli (eculizumab; SB12), a biosimilar to AstraZeneca's Soliris, in paroxysmal nocturnal hemoglobinuria (PNH) at the European Hematology Association (EHA) Congress 2025 held at Milan, Italy from June 12 to 15...Soliris generated global sales of $1.44 billion in the first half of 2024. In the USA, Epysqli is partnered with Israel's Teva Pharmaceutical Industries... Sub. Req’d

Biosimilar FYB202 Confirms Therapeutic Equivalence to Ustekinumab for Plaque Psoriasis

(6/12, Cameron Santoro, The Center For Biosimilars) ...Biosimilar FYB202 or ustekinumab-aauz (Otulfi; Fresenius Kabi) had no clinically relevant effect on efficacy, safety, or immunogenicity and demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate to severe plaque psoriasis, supporting its therapeutic equivalence and potential for broader application in other indications, according to a study published in Advances in Therapy... Full

US FDA Approves Expanded Use of Moderna's RSV Vaccine for At-Risk Adults

(6/12, Mariam Sunny, Sriparna Roy and Surbhi Misra, Reuters) ...The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a lower group of adults aged 18 to 59 years at increased risk for disease...While the FDA approval is a necessary step, the U.S. Centers for Disease Control and Prevention still has to recommend the shots before they are available for the age group. The CDC currently recommends the vaccine for adults aged 75 and older, as well as for adults aged 60 to 74 who are at increased risk of infection... Full

GSK Applies to EU Regulator for Expanded Use of RSV Vaccine

(6/13, Pushkala Aripaka, Reuters) ...GSK has applied to the European Medicines Agency to expand use of its respiratory syncytial virus (RSV) vaccine to adults below the age of 50 who are at risk of the disease, the British drugmaker said on Friday. If approved in the European Union, the vaccine, Arexvy, would compete in the 18-49 age group with Pfizer's Abrysvo... Full

AstraZeneca Pens $5.3B Pact to Use CSPC's AI Platform to Develop Oral Drugs for Chronic Diseases

(6/13, James Waldron, Fierce Biotech) ...This morning's deal, which AstraZeneca said "strengthens the ongoing collaboration" between the two companies, will also see CSPC eligible for up to $1.62 billion in potential development milestone payments and up to $3.6 billion in sales milestones, along with single-digit royalties should any resulting drugs make it to market...The British pharma said the pact with CSPC "furthers AstraZeneca's presence in China."... Full

UCB Touts Plan for 'Major' US Investment to Boost Biologics Capacity

(6/12, Eric Sagonowsky, Fierce Pharma) ..."This investment reflects our growing impact in the US and our ambition to bring our forthcoming pipeline to patients around the world," UCB CEO Jean-Christophe Tellier said in a statement. "By expanding our biologics manufacturing footprint, we're not only reinforcing our global supply chain—we're also contributing to the vitality of biomedical innovation, high-skilled jobs, and long-term economic impact in the US."... Full

Cardinal Health Boosts Profit View Banking On Specialty Drugs Unit Growth

(6/12, Padmanabhan Ananthan, Reuters) ...Demand for specialty medicines, which help treat complex conditions such as rheumatoid arthritis and cancer, have helped boost profits for Cardinal and peers Cencora and McKesson in recent quarters. The companies are also expanding their presence in the specialty medicines market by acquiring cancer center operators to diversify beyond drug distribution. Cardinal now expects profit from its specialty medicines unit to grow 12% to 13% in fiscal 2025, compared with its previous projection of 11.5% to 12.5% growth... Full

Replacements Named As Eder Leaves Stada And Medicines For Europe

(6/13, Dave Wallace, Generics Bulletin) ...Stephan Eder has left his role as executive vice-president for Western Europe and Germany at Stada, at the same time departing from his position as president of industry association Medicines for Europe. Stada has set out details of how Eder will be replaced within the company, while Polpharma CEO Markus Sieger has been named interim president of Medicines for Europe with immediate effect. Sieger has set out policy priorities ahead of Medicines for Europe's annual conference that is coming up in two weeks... Global Sub. Full

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

(6/12, Eliza Slawther, Pink Sheet) ...EU authorities must "take advantage" of the upcoming Biotech Act to reassess the bloc's policies and "offset existing challenges" for small and midsized enterprises, trade association EUCOPE has said... Global Sub. Full

Polish Industry Welcomes Pharma Agreement But Has Competition Concerns

(6/13, Paulina Mozolewska, Euractiv) ...The Polish government has claimed a significant diplomatic victory after brokering a landmark agreement among EU member states on the most sweeping overhaul of pharmaceutical regulations in two decades. Both generic and innovative Polish drug manufacturers have commended the Polish Presidency for its pivotal role in steering the complex negotiations to a successful conclusion... Full

Russian Pharmaceutical Market Showing Positive Dynamics

(6/13, The Pharma Letter) ...According to the latest report of the Russian research agency Kontur.Fokus, over the past three years, the Russian pharmaceutical industry has grown both in the number of players and in total revenue. Despite the exodus of some foreign players, that was compensated by domestic drugmakers, many of which decided to accelerate their expansion in the domestic market... Sub. Req’d

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