Friday, June 20, 2025

Investigating Generics: America's Overlooked Drug Crisis

(6/19, Emma Yasinski, MedShadow Foundation) ...Generic drugs are required by the FDA to be fully interchangeable with their brand-name counterparts. But the more MedShadow investigated, the more it became clear: that's not always the case. And what makes matters even more complicated: Despite all the aforementioned problems with generic medications, many studies continue to suggest there's very little difference between brand-name and generic drugs... Full

The Push To Onshore US Pharma Manufacturing: What's On the Table?

(6/19, Patricia Van Arnum, DCAT) ...AAM's Murphy also suggested government grants to support construction, alteration, or renovation of US-based facilities manufacturing drugs on the List of Essential Medicines as well as providing grants to manufacturers relocating facilities back to the US to cover expenses in moving production and funding to offset the cost of building new factories and research centers... Full

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

(6/19, Sarah Karlin-Smith, Pink Sheet) ...Sponsors should not follow FDA advice if they know the suggested trial will not work, Janet Woodcock said she tells sponsors. Woodcock said sponsors should "do the right thing" and conduct studies they believe will generate solid data. Woodcock argued her advice is consistent with FDA statutory authority... Global Sub. Full

194 Drugs Currently in Shortage: FDA

(6/19, Alexandra Murphy, Becker's Hospital Review) ...As of June 19, 194 drugs were in shortage, according to the agency's database of current and resolved drug shortages, which is updated daily. The current figure reflects an increase from earlier this year, with 114 listed in shortage in January 2022. Recent additions to the FDA shortage list include ketamine hydrochloride injection, used for anesthesia; sodium chloride 0.9% injection, a critical IV fluid; and rifampin capsule, a front-line antibiotic for tuberculosis... Full

10 Drug Shortages Causing the Greatest Strain in Hospitals: Vizient

(6/19, Alexandra Murphy, Becker's Hospital Review) ...The following are the top 10 high-impact drug shortages reported by hospitals. These shortages span a range of essential drug categories, including sedatives, crash cart medications, pain management treatments and oncology treatments... Full

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

(6/19, Sue Sutter, Pink Sheet) ...AI presents a robust avenue for engaging patients, FDA officials said. However, AI tools used for clinical research must be built with patients in mind and with input from the patient, caregiver and health care communities. Agency officials hope to leverage AI technologies to enable a real-time regulatory environment, FDA's chief AI officer said... Global Sub. Full

MedinCell Initiated with An Outperform at Evercore ISI

(6/20, The Fly) ...Currently partnered with Teva on their LAI atypical antipsychotics used in schizophrenia, Uzedy royalties will get them to profitability in 2027, but the main focus is on LAI olanzapine, which is expected to launch into a market with essentially zero competition in 2026, if approved, the analyst tells investors... Full

Endo Offloads Paladin As Shareholders Approve Mallinckrodt Merger

(6/19, Dave Wallace, Generics Bulletin) ...Endo has completed the divestment of its International Pharmaceuticals business, primarily Canada-based Paladin Pharma, to Knight Therapeutics. The deal is worth up to $105m, a fraction of the $1.6bn paid by Endo to acquire Paladin back in 2013. Meanwhile, Endo and Mallinckrodt shareholders have now provided the necessary approvals for the companies to combine in a $6.7bn merger... Global Sub. Full

Bio-Thera Solutions Receives Positive CHMP Opinion for USYMRO®(Ustekinumab), A Biosimilar Referencing Stelara®

(6/20, Bio-Thera Solutions Inc.) ...This positive CHMP opinion on USYMRO® was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of USYMRO® was conducted and supports biosimilarity with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of USYMRO® with both the EU and US reference product in healthy volunteers... Full

FDA Approves Monjuvi, Rituximab and Lenalidomide Combination for Relapsed or Refractory Follicular Lymphoma

(6/19, Logan Lutton, Formulary Watch) ...The FDA has approved Incyte's Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma (FL), according to a news release published yesterday. This approval provides a new chemotherapy-free treatment option for FL patients, a population with a disease that is typically indolent but chronic and prone to relapse... Full

Celltrion Strengthens Global Collaborations at BIOUSA, Bolsters Innovation and Partnerships

(6/20, Kim Min-jee, Korea IT Times) ...The company notably focused on exploring collaboration opportunities around its current pipeline of drug candidates, including antibody-drug conjugates (ADCs), multi-specific antibodies, novel antibody therapies, and peptides. According to officials, these technology-centered partnerships aim to strengthen their new drug development capabilities and lay a solid foundation for transitioning into a major global new drug innovator... Full

Sanofi, Regeneron Get FDA Approval for Dupixent to Treat Rare Skin Disease

(6/20, Adrià Calatayud, The Wall Street Journal) ...France's Sanofi and Tarrytown, N.Y.-based Regeneron said Friday that the FDA gave the green light for Dupixent as a treatment of adult patients with bullous pemphigoid, a skin disease that mainly affects elderly people and is characterized by itch, blisters and lesions, as well as a reddening of the skin. The approval was based on the results of a pivotal study that showed more patients on the drug achieved sustained disease remission and itch reduction than those on placebo, the companies said... Sub. Req’d

Eli Lilly Says India Response to Obesity Drug Mounjaro is 'Positive', Will Focus On Meeting Demand

(6/20, Rishika Sadam, Reuters) ...Eli Lilly said the response for its blockbuster drug Mounjaro has been "positive" in India, adding that it is focusing on meeting demand for the drug in the world's most populous country...The global demand for Lilly's Mounjaro and Novo's version Wegovy has skyrocketed in the last few years, even leading to shortages in a few countries, including the U.S. "Since 2020, Lilly has invested over $50 billion to increase production capacity (for global supply). We remain fully committed to meeting the demand for our medicines across the country," the company said on Thursday... Full

Lundbeck Advances Leadership in Migraine With New Data at the American Headache Society 67th Annual Scientific Meeting

(6/19, Lundbeck) ...Lundbeck US, the US subsidiaries of H. Lundbeck A/S, today announced it will present one oral and eight poster presentations at the 67th Annual Scientific Meeting of the American Headache Society (AHS) in Minneapolis from June 19-22, 2025. The data presentations reinforce the need to look beyond monthly migraine days (MMDs) and the importance of a holistic approach to migraine care as suggested by data from eptinezumab-jjmr post-hoc analyses... Full

NATCO Pharma Gets 7 Observations from FDA for Hyderabad Manufacturing Unit

(6/19, Jomy Jos Pullokaran, CNBC TV-18) ...NATCO Pharma Limited on Thursday (June 19) announced the completion of a US Food and Drug Administration (FDA) inspection at its pharmaceutical manufacturing division located in Kothur, Hyderabad. The inspection was conducted over 10 days, from June 9-19, 2025. Following the conclusion, the company received seven observations in Form 483 from the FDA... Full

Mark Cuban Says Were He To Become President For A Day, He Would Make These Two Simple Moves To Overhaul US Healthcare

(6/20, Ananya Gairola, Benzinga) ...On Thursday, Cuban responded to a question about what two changes he would make to fix the U.S. healthcare system, if he had full power for one day as president. Instead of just giving two, he outlined several bold policy ideas targeting one major issue: prescription drug pricing and healthcare payment systems. He proposed separating formularies from pharmacy benefit managers (PBMs) and any companies they own...The billionaire also suggested a rule that would force Medicare Advantage and Part D plans to buy from any provider offering a lower price than what patients currently pay out of pocket... Full

Migraine Takes the Spotlight at the European Parliament: EMHA Calls for its Inclusion in the EU Neurological Health Strategy

(6/19, The European Migraine & Headache Alliance) ...Despite its high prevalence and impact, it remains underdiagnosed, undertreated, and underfunded across most health systems. The event brought together MEPs, EU policymakers, neurologists, and European and international patient advocates. Discussions focused on concrete policy recommendations based on EMHA's recently published white paper. Endorsed by 60 patient organisations and sponsored by AbbVie, the paper presents expert insights from more than 20 countries and calls for timely diagnosis, better access to innovation, and formal recognition of migraine as a neurological disease to secure funding and resources... Full

How Weight-Loss Drugs Blew Out the U.S. Trade Deficit

(6/20, Chelsey Dulaney and Jared S. Hopkins, The Wall Street Journal) ...Planes have been jetting from Ireland to the U.S. this year carrying something more valuable than gold: $36 billion worth of hormones for popular obesity and diabetes drugs. The frantic airlift of those ingredients—more than double what was imported from Ireland for all of last year—reflects the collision of two powerful forces: tariff-driven stockpiling and weight-loss drug demand. The peptide and protein-based hormones feed into a category of drugs that include wildly popular GLP-1 treatments and newer types of insulin known as analogues... Sub. Req’d

China, U.S. Slash Drug Approval Times Amid Biosecurity Push

(6/20, Choi Mun-hee, Business Korea) ...As the pharmaceutical and biotech industries emerge as key tools for national security, regulatory agencies in various countries are rushing to ease regulations and provide incentives. The aim is to enhance "biosecurity" by increasing the speed of drug development and production to strengthen their country's pharmaceutical and biotech competitiveness... Full

What Will It Take to Get the Pharma Industry to Onshore Production?

(6/20, Eli DeLuca, Alliance for American Manufacturing) ...During a recent series of expert panels, the Center for Strategic and International Studies (CSIS) Summit on Resilient U.S. Medical Supply Chains on June 16 helped answer that question. The first panel, "The Landscape of Supply Chain Innovation", focused on the problems our domestic supply chain currently faces, ranging from reliance on foreign countries for Active Pharmaceutical Ingredients (API) and high start-up costs. Stephen Colvill, an assistant research director at Duke University, said the U.S. needs to focus on building a resilient supply chain rather than focusing on who can be the cheapest. Colvill thinks purchasers also see the benefits of more resilient suppliers, and he highlighted programs that aid in that goal... Full

Japan's Shortage of Generics Could End in FY29, Says Industry Group

(6/20, The Yomiuri Shimbun) ...Japan's yearslong shortage of generic drugs will be resolved by fiscal 2029, according to an estimate announced by the Japan Generic Medicines Association (JGA)...The association forecast demand for generic drugs from fiscal 2024 to fiscal 2029, assuming the drugs would account for 90% of the market in fiscal 2025 and that prescriptions for all kinds of drugs would increase. Then it calculated supply based on the plans of the 14 companies to increase production... Full

New Purdue Opioid Crisis Settlement Builds ‘Momentum' for Canada: B.C. AG

(6/20, Sean Boynton, Global News) ...Recent settlements in U.S. government lawsuits against opioid manufacturer Purdue Pharma and the firm that allegedly consulted on boosting its sales have B.C.'s attorney general feeling "heartened" as she pursues similar lawsuits in Canada...The announcement of the U.S. settlement came after the B.C. Supreme Court on Friday certified a class-action lawsuit by the province against McKinsey & Company, which is accused of advising Purdue and other drugmakers on how to market their opioid products in Canada... Full

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