Monday, January 6, 2025

Aetna Sues Drugmakers for Widespread Price-Fixing and Collusion

(1/3, Noah Tong, Fierce Healthcare) ...Aetna is taking legal action against Pfizer, Novartis, Teva Pharmaceuticals and others, saying the list of drugmakers conspired to overcharge the insurer, consumers and the federal government for generic drugs. The complaint, filed Dec. 31, claims the drugmakers communicated secretly at trade conferences or through phone calls, beginning in 2012, to determine the market share, prices and bids of certain drugs. If communication was in writing, they destroyed the evidence, Aetna claimed... Full

Novo Asks FDA to Restrict Victoza Compounding Amid GLP-1 Outsourcing Row

(1/3, Fraiser Kansteiner, Fierce Pharma) ...In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies to produce Victoza, also known as liraglutide, following a proposal by the trade group the Outsourcing Facilities Association (OFA) to add the molecule to its compounding roster... Full

Novo Nordisk Asks FDA Not to Allow GLP-1 Compounding

(1/6, Phil Taylor, Pharma Phorum) ...It argues that because generics of liraglutide are already available – specifically Teva's authorised generic version of the drug which launched in the middle of last year – there is "no liraglutide attribute that must be addressed by compounding." Moreover, Novo Nordisk also claims that it is difficult to manufacture liraglutide and "even small changes in the manufacturing process of liraglutide can substantially affect its chemical and physical stability, as well as its impurity profile," and this means that there could be safety concerns with compounding... Full

Kabi Widens The Net With US Aflibercept Deal, As Amgen Biosimilar Hearing Nears

(1/3, Dean Rudge, Generics Bulletin) ...With the US Eylea (aflibercept) 2mg market opened up recently to biosimilar competition from Amgen, Fresenius Kabi is looking to follow with its own rival to the blockbuster VEGF receptor, in a move that, if successful, will push the German firm into a new therapeutic category beyond its existing presence in oncology and immunology. Kabi has struck a licensing agreement with South Korea's SamChunDang Pharm, which gives it exclusive commercialization rights in the US to SamChunDang's aflibercept biosimilar candidate – carrying the candidate name SCD411 – in the US, as well as several countries in Latin America... Global Sub. Full

GSK's Nucala Bags Another China Approval, But Biggest Test Yet to Come

(1/3, Ayisha Sharma, Endpoints News) ...GSK's blockbuster respiratory drug Nucala has secured a China label expansion for certain patients with inflamed sinuses. But a more important challenge on the way to hitting its multibillion-dollar peak sales projections is on the horizon. Nucala could reach $2.35 billion in 2026 sales, according to GlobalData analysts. But this sky-high forecast is mainly driven by a potential new expansion in chronic obstructive pulmonary disease — the third leading cause of death worldwide. Late-stage data are still yet to be detailed, but a PDUFA date is set for May 7... Full

Roche Projected to Claim Pharma's 2025 Sales Crown as Novo, Lilly Climb Rankings: Evaluate

(1/3, Fraiser Kansteiner, Fierce Pharma) ...Lilly, which is on track to come out as 2024's 11th largest drugmaker by prescription sales, is expected to climb the ranks to the fourth position in 2025, Evaluate said in its report. Novo Nordisk, for its part, is expected to jump from 10th place to sixth this year, according to Evaluate Pharma's consensus forecasts. Nevertheless, it's Roche that's been tipped to stand at the front of the pack when it comes to prescription sales overall in 2025. Evaluate acknowledged that Roche's projected position as 2025's largest drugmaker by sales is "somewhat surprising" given the absence of any of its products from the same report's top drugs analysis... Full

Astellas, Endo Issue US Drug Recalls Over Empty Capsule, Ingredient Concerns

(1/3, Joseph Keenan, Fierce Pharma) ...Astellas, which issued its notice Dec. 23, is recalling one lot of Prograf 0.5mg (tacrolimus) and one lot of Astagraf XL 0.5mg (tacrolimus extended-release) capsules because bottles may contain empty capsules...In the case of Endo, the company issued its recall Dec. 20 for all unexpired lots of Adrenalin chloride solution (epinephrine nasal solution) 30mg/30mL vials, which is used as a vasoconstrictor for topical application... Full

Most Influential Drug Approvals of 2024: GoodRx

(1/3, Paige Twenter, Becker's Hospital Review) ...Of the hundreds of drugs that entered the U.S. market in 2024, GoodRx has named 19 of them as the most notable... Full

Ozempic ‘Microdosing' is the New Weight-Loss Trend: Should You Try It?

(1/5, Shiv Sudhakar, FOX News) ...Individuals may also microdose due to supply challenges, according to Dr. Amy Rothberg, clinical professor of medicine in the Division of Metabolism, Endocrinology & Diabetes at the University of Michigan. "Some feel they may derive a benefit from microdosing by being able to extend their supply and may perceive an effect," Rothberg, who is also the medical director of Rewind, a lifestyle program for type 2 diabetes patients, told Fox News Digital... Full

They May Be ‘Miracle' Drugs, But Obesity Meds Call for a Team Approach

(1/3, Elizabeth Cooney, STAT) ...Shortages undermine patients' progress and contribute to discontinuation, but so do barriers to access. A JAMA Network Open study published in May reported disparities in who no longer took GLP-1 drugs. Odds of stopping after one year were significantly higher among people who were Black or Hispanic, male, and enrolled in Medicare or Medicaid enrollees, or people who lived in areas with very high levels of social needs. While affordability of these drugs is a challenge, it's still not known why more than half of the people who start taking them quit after one year, regaining the weight they lost... Full

Novel Test Can Detect Different Types of Asthma Via Nasal Swab

(1/2, Aria Bendix, NBC News) ...A new paper describes a test that can differentiate between different types of asthma via a nasal swab. Researchers hope the test can eventually be used to help match patients with better treatments. The research focused on Black and Puerto Rican children, who have higher rates of asthma and asthma-related deaths than white children... Full

Respiratory Virus Activity Continues to Climb: 5 Notes

(1/3, Alexandra Murphy, Becker's Clinical Leadership) ...Respiratory illness activity remains high nationwide, with emergency department visits and positive test rates rising for COVID-19, seasonal influenza and respiratory syncytial virus, according to a Jan. 3 news release from the CDC. Eleven states, including Utah, Arizona, Texas, Oklahoma, Kansas, Louisiana, Florida, Georgia Kentucky, Tennessee and New Hampshire reported "very high levels," according to the updated CDC data... Full

‘Not a Good Look': Premiums Could Jump If Trump's CMS Drops Part D Demo

(1/3, Leslie Small, Pink Sheet) ...President-elect Donald Trump's HHS secretary and CMS administrator likely will face a difficult choice early in their tenures on whether to extend the Part D Premium Stabilization Demonstration. Republicans have criticized the program and worry about its budgetary impact, but may not want to end the program and face blame for premium increases. The Trump administration could decide to trim or revise the program... Global Sub. Full

Lilly, If Added To Lawsuit, Could Challenge Compounding During Shortages

(1/3, Jessica Karins, Inside Health Policy) ...If Lilly is granted leave to intervene in the case, it could shift to incorporate questions larger than whether FDA was right to remove tirezepatide drugs Mounjaro and Zepbound from the shortage list. In its motion to intervene, Lilly says its believes compounders should not be permitted to make copies of its drugs even if the drugs are in shortage, a challenge to FDA's interpretation of the law and compounders' belief that their services are vital to preserving patient access when brand-name drug manufacturers can't meet demand... Sub. Req’d

Florida Car Dealer Joins Insulin Pricing Fight Against Eli Lilly, Sanofi

(1/3, Nicole DeFeudis, Endpoints News) ...A Florida-based car dealer has joined mounting litigation against Eli Lilly, Novo Nordisk and Sanofi over what it calls the "exorbitant" price of insulin. Braman Motors is the first private company to enter the multidistrict litigation, joining state attorneys general, cities, counties and unions...In addition to drugmakers, the lawsuit names the country's three largest pharmacy benefit managers: CVS Caremark, Express Scripts and Optum Rx. The Dec. 31 complaint calls insulin the "poster child for skyrocketing pharmaceutical prices," accusing the drugmakers and PBMs of participating in a scheme to drive up insulin prices... Full

Trump's FDA Transition Team Takes Shape with Former Hahn Adviser, Courts Top Capitol Hill Aide

(1/3, Rachel Cohrs Zhang, STAT+) ...The Trump administration's Food and Drug Administration transition team is taking shape, with a former adviser to ex-Commissioner Stephen Hahn and a top executive of a communications firm that has worked with Trump's FDA commissioner pick Marty Makary. The team is in conversations with a top Capitol Hill aide about a key role at the agency... Sub. Req’d

Trump Aides Ready ‘Universal' Tariff Plans — With One Key Change

(1/6, Jeff Stein, The Washington Post) ...President-elect Donald Trump's aides are exploring tariff plans that would be applied to every country but only cover critical imports, three people familiar with the matter said — a key shift from his plans during the 2024 presidential campaign. If implemented, the emerging plans would pare back the most sweeping elements of Trump's campaign plans but still would be likely to upend global trade and carry major consequences for the U.S. economy and consumers... Sub. Req’d

Retiring CDER Deputy Director: Misconception That US FDA Regulators Cannot Change

(1/3, Sarah Karlin-Smith, Pink Sheet) ...Douglas Throckmorton told the Pink Sheet that the FDA is more willing to change course than it is given credit. Regulatory flexibility can reinforce faith in the agency, he argued. Incorporating artificial intelligence and real-world evidence into agency decision-making are two of the FDA's biggest upcoming challenges, the retiring CDER deputy director said... Global Sub. Full

Insud And Apotex Chiefs Take Lead As IGBA Shuffles CEO Committee

(1/3, Dave Wallace, Generics Bulletin) ...Fresh leadership has been announced for the CEO Advisory Committee of the International Generic and Biosimilar medicines Association, with Insud Pharma chief executive Lucas Sigman moving up from his previous position of vice-chair to become chair. Allan Oberman, president and CEO of Apotex, has been named as the new vice-chair... Global Sub. Full

Health Canada Proposes Major Regulatory Overhaul To Combat Drug, Device Shortages

(1/3, Vibha Sharma, Pink Sheet) ...Health Canada has proposed significant changes to its drug and medical device regulations to address and mitigate public health risks caused by product shortages, with major cost implications for both industry and government...Key proposed amendments include requirements for maintaining safety stocks, developing shortage prevention plans, and reporting demand surges. Health Canada is also seeking feedback on new and revised guidelines and regulatory tools to help drug and device companies comply with the proposed changes... Global Sub. Full

Govt Issues Draft Notification to Extend Deadline for Implementation of Revised Schedule M for SME Units

(1/6, Pharmabiz.com) ...The draft amendment provides for small and medium manufacturers with turnover of below Rs. 250 crore to seek extension of the timeline for implementation. These units shall make an application to the Central License Approving Authority in a form provided with the notification within a period of three months from the notification, along with the plan of upgradation. "For such manufacturers the deadline for implementation shall be extended till December 31, 2025," said the draft amendment... Full

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