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DATA COMPILATION #PharmaFlow

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US drug shortages reduce 16% YoY in Q1 2025; CNS drugs, antimicrobials face highest scarcities
The pharmaceutical industry in the United States continued to grapple with drug shortages during the first quarter (Q1) of 2025. According to the American Society of Health‑System Pharmacists (ASHP), the total number of active shortages stood at 270 as of March 31, 2025 — only slightly below the 277 reported in September 2024, but down 16.4 percent from an all‑time high of 323 reported in Q1 2024.These numbers imply that while dramatic surges in drug shortages may have subsided, underlying vulnerabilities in manufacturing, supply chains, and raw‑material sourcing continue to frustrate efforts towards a durable resolution.A deeper analysis of these drug scarcities reveals that 41 percent of the 270 active shortages first emerged in 2022 or earlier. This implies that many of the current disruptions have become chronic in nature and are exerting pressure on pharmacy operations. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available)CNS drugs dominate with 49 meds in short supply; antimicrobials face shortage of 39 drugsClass‑specific analysis reveals that central nervous system (CNS) agents remained the most disrupted category, with 49 distinct CNS drugs having faced scarcities during Q1. This group spans anxiolytics (anti-anxiety drugs) such as clonazepam and flurazepam, sedatives like lorazepam and midazolam, and stimulants such as methylphenidate and lisdexamfetamine. These shortages pose two challenges — controlling seizures and managing sedation in acute care settings. After CNS agents, antimicrobials was the second‑largest category, with shortages affecting 39 drugs. Key antibacterial and anti-fungal agents such as cefotaxime sodium powder for injection, clindamycin phosphate, rifampin, and metronidazole find themselves on ASHP’s active‑shortage roster, threatening both routine hospital protocols and emergency sepsis management.Fluids and electrolytes occupied the third spot, with 29 items facing shortage in Q1 2025. Hormone agents, including insulin analogs, ranked fourth with 24 drugs in short supply.Chemotherapy medications rounded out the top five categories, with 23 antineoplastic agents (a broad class of medications used to treat cancer) flagged as actively constrained in Q1 2025. Notable shortages included azacitidine, carboplatin, methotrexate, and streptozocin. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) US faces 26 new shortages; Pharmacopeia list warns of 100 vulnerable medicationsThe first quarter saw the emergence of 26 new shortage declarations, emphasizing that even drugs previously deemed reliably sourced can fall into scarcity. The US has been facing a shortage of attention deficit hyperactivity disorder (ADHD) drugs since 2022. The new shortages included ADHD transdermal patch methylphenidate, peginterferon alfa‑2a (Pegasys) used in chronic hepatitis B and C, and bacitracin ophthalmic ointment.The fragility of the pharmaceutical supply chains has been particularly evident in the aftermath of natural disasters. Hurricane Helene’s flooding at Baxter’s Marion, North Carolina, facility deeply affected IV‑solution supply lines. Baxter supplies roughly 60 percent of the US’ IV fluids and the ASHP report listed “hurricane” as the reason behind nine percent of drug shortages, as of January 2025.Regulatory and policy interventions continue to evolve. The US Pharmacopeia’s inaugural Vulnerable Medicines List, launched in 2025, identifies 100 drugs at the highest risk of future shortages, with a particular focus on injectables (comprising 71 percent of the list) and essential hospital care.Antibiotics, medications for pain management and oncology are the other drugs on the list. Although 61 percent of these vulnerable medicines were not in active shortage at the time of listing, their inclusion is intended to galvanize manufacturers and purchasing organizations to bolster inventories.Meanwhile, the Government Accountability Office in the US has called on the Department of Health and Human Services (HHS) to establish a formal coordination mechanism, warning that elimination of the HHS supply‑chain coordinator role in May 2025 risks fragmenting federal response efforts. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) Global shortages mirror US patterns; Europe launches monitoring platform Globally, we notice comparable trends. For instance, Europe has rolled out the European Shortages Monitoring Platform (ESMP) this year in order to centralize shortage reporting across member states. Critical‑medicine shortages in the EU — in areas such as oncology, ADHD, and critical care analgesics — mirror US patterns. The European Medicines Agency’s shortage list currently holds 37 human drugs.According to Health Canada’s May 12, 2025 update, its Tier 3 list had 18 drug shortages that are considered to have the greatest impact on Canada’s drug supply and health‑care system. Tier 3 designation is based on medical necessity and minimal availability of alternatives.In hematology and oncology, scarcity of essential drugs like Oncaspar for acute lymphoblastic leukemia, idarubicin and lomustine for leukemias and brain tumors, anagrelide for thrombocythemia, and preservative‑free methotrexate for various malignancies underscore the impact these drug shortages can have on treatment. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) Our viewThe global pharma supply chain is dealing with a fresh wave of uncertainties, especially with the likelihood of tariffs on drugs imported into the US. Analysts warn that the proposed pharmaceutical tariffs could exacerbate supply issues.Over 50 percent of drugs used in the US are manufactured abroad. Generic sterile injectable drugs — like chemotherapy medications and IV saline — are particularly vulnerable due to their complex manufacturing processes and low profit margins. Generic drugs (which account for 90 percent of prescriptions filled in the US) could face increased pressure, as many rely on raw materials from China and India. This could result in more severe drug shortages in the future. 

Impressions: 448

https://www.pharmacompass.com/radio-compass-blog/us-drug-shortages-reduce-16-yoy-in-q1-2025-cns-drugs-antimicrobials-face-highest-scarcities

#PharmaFlow by PHARMACOMPASS
22 May 2025

STOCK RECAP #PipelineProspector

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Pipeline Prospector Feb 2024: Novo’s parent buys Catalent for US$ 16.5 bn, FDA okays Iovance’s cell therapy
February was a good month for the pharma sector, complete with some important deals, successes from clinical trials and healthy fourth quarter (Q4) results announced by some drugmakers. The market cheered the good news — the Nasdaq Biotechnology index gained 1 percent from 4,385.06 to 4,428.56, the SPDR S&P Biotech ETF index spiked 12 percent to 98.42 after ending January at 87.43. The S&P Biotechnology Select Industry Index (SPSIBI) soared 16 percent from 6,815.3 to 7,896.47 in February.The month saw some big acquisitions. Novo Holdings, the parent company of Novo Nordisk, acquired contract development and manufacturing organization (CDMO) Catalent for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. Novo’s game plan hasn’t gone down well with its arch rival in the diabetes and obesity segment Eli Lilly. The Indianapolis-headquartered drugmaker has called for a scrutiny of the deal as it relies on Catalent for some of its diabetes and obesity drugs that compete with Novo’s meds.Both Novo and Lilly have been struggling to meet the demand for their weight loss meds. With the acquisition of this key CDMO, Novo has scored an edge over competition.Meanwhile, Gilead boosted its liver portfolio with the US$ 4.3 billion acquisition of CymaBay Therapeutics. And Novartis announced the acquisition of cancer treatment developer MorphoSys for € 2.7 billion (US$ 2.9 billion). With this buyout, Novartis gets a late-stage, rare bone-marrow cancer treatment — pelabresib — that holds plenty of promise.Several drugmakers announced their Q4 results last month. Notable amongst them was Eli Lilly, as it posted a 28 percent increase in revenues — from US$ 7.3 billion in Q4 2022 to US$ 9.4 billion led by its new products Mounjaro and Zepbound. GSK touted the “exceptional launch of Arexvy”, the world's first RSV vaccine, as it brought in sales of £ 1.2 billion (US$ 1.52 billion) in 2023. And Merck’s Keytruda saw a 19 percent increase in its sales in 2023 — at US$ 25 billion.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel)FDA okays Iovance’s T-cell therapy; Roche’s asthma med okayed for food allergiesThe US Food and Drug Administration (FDA) granted accelerated approval to Iovance Biotherapeutics’ cell therapy — Amtagvi (lifileucel) — for treating the deadliest form of skin cancer. Amtagvi is the first and only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. Iovance hopes to start reporting noteworthy revenue in the second quarter of 2024, despite the fact that Amtagvi comes with a boxed warning (the highest safety warning) for treatment-related mortality. FDA also approved Takeda’s Eohilia as the first oral treatment for an allergic inflammation of the esophagus. Eohilia (budesonide oral suspension) was on course to becoming the first treatment for eosinophilic esophagitis (EoE) until it was rejected by the FDA in December 2021.In January, Sanofi and Regeneron’s jab Dupixent had pipped Eohilia to become the first FDA drug approved for EoE. The chronic condition can make it very hard for patients to consume food. Dupixent (dupilumab) is injected weekly or biweekly and two pens cost US$ 3,803.20. In contrast, Takeda’s drug is taken twice daily and costs US$ 1,875 per month.Roche and Novartis’ asthma drug Xolair (omalizumab) became the first FDA-approved med to help people with food allergies avoid severe reactions following accidental exposure. This opens the drug to around 17 million people in the US whose allergies can potentially be deadly.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) Boehringer’s obesity candidate, Lilly’s tirzepatide show promise in trials for MASHBoehringer Ingelheim announced promising phase 2 trial data for its experimental obesity drug survodutide in treating metabolic dysfunction-associated steatohepatitis (MASH), a liver disease. The drug is being developed in collaboration with Zealand Pharma. It had received a fast-track designation from the FDA in June 2021. MASH causes histologic liver damage and occurs in patients who are not alcoholics and who are often obese or have type 2 diabetes.The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. The companies said this potentially positions it as a “best-in-class” treatment. The drug belongs to the glucagon-like peptide 1 (GLP-1) class of drugs.In another trial, Eli Lilly announced positive results from a phase 2 study of tirzepatide in adults with MASH — 74 percent of participants were cured of MASH and their fibrosis also did not worsen at 52 weeks (as compared to nearly 13 percent for participants in the placebo group).Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) J&J’s autoimmune drug posts trial gains; Sanofi’s frexalimab shows benefit in MSOne of Johnson & Johnson’s most watched experimental drugs — nipocalimab — posted positive results in trials for the treatment of two autoimmune disorders. In a phase 3 study, nipocalimab significantly reduced symptoms of generalized myasthenia gravis (GMG). And, in a phase 2 study, it helped reduce the severity of Sjögren’s disease (SjD). GMG weakens the skeletal muscles and particularly affects control of the limbs, throat, mouth, and eyes. SjD is an immune disorder that is identified by symptoms like dry eyes and dry mouth. J&J expects over US$ 5 billion from this drug. In a phase 2 trial, Sanofi’s frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS). In December last year, the French multinational had named frexalimab as one of three “pipeline-in-a-product” assets with the potential of generating annual peak sales in excess of €5 billion (US$ 5.4 billion). The phase 2 results give credence to those expectations.In trial failures, Gilead (stock down 8 percent) said the FDA has paused all trials of its drug magrolimab in the treatment of two blood cancers – acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) – because of increased risk of patient death (when used in combination with azacitidine plus venetoclax). Magrolimab was the lead candidate of Gilead’s US$ 4.9 billion acquisition of Forty Seven in 2020.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) Our viewThe year has gotten off to a good start with drugmakers posting healthy Q4 results and the indices showing some positive growth month-on-month. Several drugmakers have entered 2024 with a simplified business model and an increased strategic focus on R&D. Given the favorable demand, we are hopeful of a better year for the industry, as opposed to the volatility of the last two years.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) 

Impressions: 2979

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-feb-2024-novo-s-parent-buys-catalent-for-us-16-5-bn-fda-okays-iovance-s-cell-therapy

#PharmaFlow by PHARMACOMPASS
07 Mar 2024

NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2025/05/05/3073937/35575/en/Aptose-Provides-Clinical-Update-for-the-Tuspetinib-based-Triple-Drug-Frontline-Therapy-in-Newly-Diagnosed-AML-Patients-from-the-Phase-1-2-TUSCANY-Trial.html

GLOBENEWSWIRE
05 May 2025

https://www.accessnewswire.com/newsroom/en/biotechnology/inside-information-faron-announces-positive-phase-ii-results-in-higher-risk-myelodysp-1014827

ACCESSWIRE
15 Apr 2025

https://www.globenewswire.com//news-release/2025/02/03/3019460/0/en/Salarius-Pharmaceuticals-Announces-Patient-Enrollment-to-Resume-in-Investigator-initiated-Phase-1-2-Clinical-Trial-Using-Seclidemstat-with-Azacitidine-to-Treat-Hematologic-Cancers.html

GLOBENEWSWIRE
03 Feb 2025

https://www.globenewswire.com/news-release/2025/01/13/3008436/0/en/ORYZON-Announces-First-Patient-Dosed-in-NCI-Sponsored-Iadademstat-in-Combination-With-Venetoclax-and-Azacitidine-Clinical-Trial-in-First-Line-Acute-Myeloid-Leukemia.html

GLOBENEWSWIRE
13 Jan 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215765

FDA
15 Oct 2024

https://www.globenewswire.com/news-release/2024/09/18/2948005/0/en/ImCheck-Receives-FDA-Fast-Track-Designation-for-ICT01-in-Combination-with-Azacitidine-and-Venetoclax-in-First-Line-Acute-Myeloid-Leukemia-for-Patients-Unfit-for-Induction-Chemother.html

GLOBENEWSWIRE
18 Sep 2024