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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. 

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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

WEEKLY NEWS RECAP #Phispers

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FDA approves Emergent’s smallpox vaccine for mpox; Lilly inks up to US$ 1 bn deal with Haya to target obesity
This week saw the US Food and Drug Administration (FDA) respond to the global monkeypox (mpox) public health emergency by expanding the approval of Emergent BioSolutions’ smallpox vaccine ACAM2000 for mpox.Eli Lilly has signed a potential US$ 1 billion multi-year deal with Swiss biotech Haya Therapeutics in order to deepen its capabilities in the obesity space.In the realm of multiple sclerosis (MS), Sanofi’s tolebrutinib has missed primary endpoints in two late-stage trials. However, it became the first drug to demonstrate a reduction in disability progression for non-relapsing secondary progressive MS.Recursion Pharmaceuticals reported mixed data for its AI-identified drug candidate REC-994 in treating a rare brain condition. And Arrowhead’s plozasiran showed promise in treating a rare lipid disorder in a late-stage trial.Meanwhile, Semnur Pharmaceuticals, a developer of non-opioid pain therapies, is merging with a special purpose acquisition company Denali Capital Acquisition in a deal worth US$ 2.5 billion. The new entity will be publicly listed. Similarly, Eli Lilly’s partner BioAge has revealed its plans to come out with an initial public offering (IPO), the proceeds of which will be used to capitalize on the obesity market.And a Reuters report has revealed that despite price negotiations under the Inflation Reduction Act (IRA), the 10 drugs with maximum price under Medicare still cost double or more than what drugmakers have agreed upon in Australia, Canada, Japan and Sweden.FDA approves Emergent Bio’s smallpox vaccine for monkeypoxFDA has signed off on the approval of Emergent BioSolutions’ smallpox vaccine ACAM2000 for mpox. ACAM2000 joins Bavarian Nordic’s Jynneos as the only FDA-approved shots for mpox. Both contain the vaccinia virus that is closely related to though less harmful than the viruses that cause mpox and smallpox. Unlike an injection, ACAM2000 is a bifurcated vaccine needle used to make a series of small pokes on the skin. Emergent’s shot cannot be administered to people with weakened immune systems, like those with HIV.Lilly signs up to US$ 1 bn deal with Haya; shares knowhow to make Olumiant in AfricaEli Lilly is deepening its prowess in the obesity space and has signed a potential US$ 1 billion multi-year deal with Swiss biotech Haya Therapeutics. Lilly will utilize Haya’s RNA-guided genome platform to target obesity and other metabolic conditions.The drugmaker is also licensing its manufacturing know-how for its rheumatoid arthritis (RA) treatment — Olumiant — to Egypt’s Eva Pharma. This will help localize the drug’s production in Africa. Eva would supply Olumiant to 49 countries in Africa by 2026.Sanofi’s tolebrutinib misses two endpoints, but hits goal in treating non-relapsing MSThe most advanced MS drug candidate in Sanofi’s pipeline, tolebrutinib, has missed primary endpoints in two late-stage trials, the French drugmaker said. While tolebrutinib failed to best Sanofi’s established MS drug Aubagio (teriflunomide), it surprisingly hit its main goal in a third phase 3 study, making it the first and only med to show a reduction in disability progression in non-relapsing secondary progressive multiple sclerosis (nrSPMS). While less common, nrSPMS has no approved therapies and a population with significant unmet medical need. Sanofi got its hand on the drug via its US$ 3.68 billion acquisition of Principia Biopharma in 2020.Recursion’s rare brain disease drug shows mixed data: Nvidia-backed Recursion Pharmaceuticals said its investigational molecule REC-994 met its safety and tolerability goals, the primary endpoints of a mid-stage study on patients with a rare brain-related condition, known as cerebral cavernous malformation. However, REC-994, which was identified by its AI-driven platform Recursion OS, showed mixed results with regard to its efficacy. Though the MRI showed benefits, after 12 months, there were no improvements reported by patients or doctors.Keytruda flunks phase 3 lung, skin cancer trials: Merck is scrapping two late-stage trials of Keytruda (pembrolizumab) in early-stage non-small cell lung cancer (NSCLC) in those who are inoperable or have refused surgery, and a type of skin cancer called cutaneous squamous cell carcinoma. Interim analysis showed Keytruda with radiation failed to demonstrate an improvement in event-free survival or overall survival compared to a placebo and radiation.Arrowhead touts late-stage data from lipid disorder study on plozasiranOne of the highly anticipated results seen at the European Society of Cardiology was from Arrowhead Pharmaceuticals’ late-phase trial of plozasiran for a rare lipid disorder. The siRNA candidate reduced triglycerides by 80 percent and reduced the risk of developing acute pancreatitis by 83 percent. After 12 months, less than 5 percent of patients taking plozasiran had an acute pancreatitis event compared to 20 percent taking the placebo. This could set up a market clash with Ionis that also has an RNA-based therapeutic for lipid diseases in its pipeline.Bayer’s Kerendia cuts heart risk: In a late-stage trial, Bayer’s Kerendia (finerenone) slashed the risk of cardiovascular death and first and recurrent heart failure events by 16 percent compared to a placebo. The med is approved for chronic kidney disease associated with type 2 diabetes.Semnur to go public via US$ 2.5 bn SPAC merger with Denali CapitalSemnur Pharmaceuticals, a wholly-owned subsidiary of Scilex Holding Company, is merging with a special purpose acquisition company (SPAC) Denali Capital Acquisition, in a deal worth US$ 2.5 billion. The new company will be called Semnur Pharmaceuticals, Inc. and be publicly listed. Semnur focuses on the development and commercialization of novel non-opioid pain therapies.BioAge’s IPO: Lilly’s partner BioAge has revealed its plans to come out with an IPO whose proceeds will be used to capitalize on the obesity market. BioAge has a candidate in phase 2 trials — azelaprag — that works by mimicking apeline, a protein that the body secretes in response to exercise. The trial is assessing azelaprag with Lilly’s tirzepatide to help lower body weight.Despite price negotiations under IRA, Americans still pay double or more for medsThe US government recently unveiled the new maximum prices for the first set of 10 high cost medicines. These negotiations were held under the Biden Administration’s Inflation Reduction Act.As per a Reuters news report, despite negotiations, these drugs cost double and in some cases five times what drugmakers have agreed to in four other high-income countries — Australia, Japan, Canada and Sweden.US to ease shortage of ADHD drugs: The US has been facing a shortage of ADHD drugs for years. In order to meet the shortfall, the US Drug Enforcement Administration (DEA) has raised the production limit for Takeda’s ADHD drug Vyvanse (and its generic versions) by 24 percent. 

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https://www.pharmacompass.com/radio-compass-phisper/fda-approves-emergent-s-smallpox-vaccine-for-mpox-lilly-inks-up-to-us-1-bn-deal-with-haya-to-target-obesity

#Phispers by PHARMACOMPASS
05 Sep 2024

NEWS #PharmaBuzz

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https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-3-2025-81425.pdf

FDA
03 Sep 2025

https://www.fiercepharma.com/pharma/takeda-looks-toward-inflection-point-it-eyes-new-launches-shake-vyvanse-generic-impacts

FIERCE PHARMA
09 May 2025

https://granulesindia.com/wp-content/uploads/2025/01/Granules-Strengthens-ADHD-Portfolio-with-FDA-Approval-for-Lisdexamfetamine-Dimesylate-Capsules.pdf

PRESS RELEASE
30 Jan 2025

https://granulesindia.com/wp-content/uploads/2024/12/Granules-India-Limited-Announces-FDA-Approval-for-ADHD-Treatment-Addressing-Drug-Shortages-in-the-U.S.pdf

PRESS RELEASE
17 Dec 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219258

FDA
16 Dec 2024

https://www.fiercepharma.com/pharma/takeda-plots-path-profitability-900m-restructuring-plan

FIERCE PHARMA
10 May 2024