Pharma insights
Ingrezza, Austedo and Qalsody: Neurology's Quiet Rebuild in Movement Disorders and Rare Neuromuscular Disease
Beyond Alzheimer's and migraine, VMAT2 inhibitors, antisense oligonucleotides and gene therapies are redrawing the economics of Parkinson's, tardive dyskinesia, SMA and ALS.
Section 506C Decoded: The Legal Trigger That Forces Drugmakers to Warn FDA Before a Shortage Hits
A breakdown of the FDCA's 506C notification mandate, FDORA's 2023 risk-management add-on, and how a missed disclosure becomes a public enforcement problem.
Catalent's New Owner: How Novo Holdings' $16.5 Billion Bet Reshaped a CDMO and Solved a GLP-1 Bottleneck
Novo Holdings closed its acquisition of Catalent in December 2024, then flipped three fill-finish plants to Novo Nordisk for $11 billion, fusing a captive supply strategy with a still-independent CDMO business.
1,186 Active Shortages: A Procurement Playbook for Hospital Pharmacy Teams
With 1,186 drugs now listed as short-supplied, hospital pharmacy and sourcing teams need a systematic response, not just crisis management drug by drug.
Haematology's Great Divergence: From Generic Anticoagulants to $3 Million Gene Therapies
Haematology now spans dollar-a-day generics and single-dose gene therapies, with Revlimid's collapse, Eliquis's looming cliff and Casgevy's slow launch defining the next five years.
Beyond Anesthesia: GI, Endocrine and Oncology Shortages Quietly Total 283 Drugs
While anesthesia and psychiatry dominate headlines, gastroenterology, endocrinology/metabolism and oncology shortages combine for 283 active listings this week.
Eleven Approved Gene and Cell Therapies, One Shared Manufacturing Bottleneck
Beyond pricing headlines, gene and cell therapy's real constraint is viral vector capacity and vein-to-vein logistics, not patent expiry.
Why Sterile Injectables Eat America's Drug Shortage List, in Four Structural Failures
Injectables make up a fraction of the pharmacopeia but a majority of shortages. The reasons are economic and manufacturing structure, not accidents.
Inside the Orange Book: How a Patent List and a 30-Month Clock Still Decide When Generics Launch
The Orange Book and the Hatch-Waxman 30-month stay remain the legal chokepoint for generic entry, as Novartis's Entresto fight and the FTC's inhaler-patent purge show.
Novartis Bets Its Oncology Future on Radioligand Therapy, But Pluvicto's Supply Chain Still Runs Through Two Plants
Novartis has built a first-mover position in radioligand therapy with Pluvicto and Lutathera, but a manufacturing network anchored in New Jersey and northern Italy has repeatedly strained supply.
Bupivacaine's Seven NDCs and the Pfizer-Hospira Squeeze: Sterile Injectable Math Behind 192 Anesthesia Shortages
With 1,169 active US shortages, repeat NDC listings for bupivacaine, atropine and amino acids expose how few manufacturers actually stand behind anesthesia's supply.
Leqembi, Ocrevus and the CGRP Wave: Neurology's Post-Cliff Rebuild Reaches $50 Billion
Anti-amyloid antibodies, CGRP migraine drugs and antisense therapies are replacing a generation of small-molecule blockbusters now facing biosimilar and generic erosion.
Amino Acids, Atropine and the 165-Drug Pediatric Gap: This Weekend's FDA Shortage Ledger
With 1,169 active US shortages, pediatric and anesthesia drugs dominate the list, and B. Braun's amino acid injections show how deep the parenteral nutrition problem runs.
Humira's Fall, Skyrizi's Rise: AbbVie's Immunology Reshuffle and the $30 Billion Reset
AbbVie's Humira franchise collapsed under biosimilar pressure, but Skyrizi and Rinvoq prove the immunology market is being redrawn, not shrunk.
China's Grip on Penicillin's Building Blocks: The API Chokepoint Behind America's Antibiotic Shortages
Two countries make the bulk of the world's active pharmaceutical ingredients, and nowhere is that concentration more consequential than in antibiotics.
Semglee, Cyltezo and the Interchangeability Trap: Why Most Biosimilars Still Can't Reach the Pharmacy Counter Alone
The BPCIA created two tiers of biosimilars, only one of which pharmacists can substitute without a new prescription, and that legal distinction is quietly determining market share.
Baxter's IV Fluid Monopoly Problem: How One North Carolina Plant Exposed America's Saline Supply Chain
Hurricane Helene's 2024 shutdown of Baxter's North Cove plant revealed how concentrated the US IV fluid supply has become, and why the fix is still incomplete.
Three Manufacturers, One Drug Class: Amphetamine Shortages Anchor Psychiatry's 152-Drug Backlog
With 1,171 active FDA shortages, psychiatry and pediatric drugs remain the most exposed categories, and amphetamine salts are the clearest case study in fragile generic supply.
Inhalers, Biologics and CFTR: Mapping the $60 Billion Respiratory Drug Map Before the Next Patent Wave
Asthma, COPD, CF and IPF now span four distinct pharmacologic eras, and each faces its own patent-cliff and biosimilar timeline over the next five years.
Heparin, Iohexol and the Single Supplier Problem Still Running Through US Drug Supply Chains
Decades after the 2008 heparin crisis, most generic APIs still trace to one plant or one country, and buyers are only now paying to fix it.
From Form 483 to Warning Letter: How Intas Pharmaceuticals' Ahmedabad Plant Exposed the Machinery Behind Drug Shortages
A single FDA inspection report can freeze a plant's US exports for years. The Intas case shows how 483s and warning letters move from paperwork to shortage.
Dr. Reddy's Labs: Betting 678 NDC Listings on the Biosimilar Patent Cliff
India's second-largest drugmaker is leaning on its 15 FDA-registered sites and a deep generics base to fund a biosimilar push into Stelara, Eylea and Prolia territory.
Three Furosemide Listings, One Manufacturer: What Repeat NDCs Reveal About America's Injectable Shortage Math
With 1,170 active FDA shortages, repeat listings from single manufacturers like Meitheal expose how thin the US sterile-injectable supply chain has become.
Anesthesia's 209-Drug Problem: Meitheal's Injectables Dominate This Weekend's Shortage List
With 1,170 active FDA shortages, anesthesia and pediatric drugs lead the list, and one generic injectables supplier keeps showing up across categories.
Beyond Biologics: How IL-23, TYK2 and OX40 Drugs Are Redrawing Dermatology's Map
Psoriasis and atopic dermatitis have become a $30 billion battleground of interleukin blockers, oral JAK and TYK2 drugs, and a fast-approaching biosimilar reckoning for Stelara and Cosentyx.
WuXi Biologics and the BIOSECURE Overhang: Can the World's Top Biologics CDMO Outrun Washington?
WuXi Biologics built an 18-site global manufacturing network serving nearly every major drugmaker. The unresolved BIOSECURE Act now forces clients to hedge anyway.
1,176 and Counting: Inside America's Chronic Drug Shortage Ledger
With 1,176 active FDA-tracked shortages led by psychiatry, pediatric and anesthesia drugs, the pattern points to structural failures in sterile injectable and generic manufacturing, not one-off supply shocks.
Ohtuvayre, Brinsupri and the New Mechanisms Breaking COPD's 20-Year Drought
Respiratory pharma is splitting into two markets: commoditizing inhalers facing device-patent-delayed generics, and a biologics/novel-mechanism wave redefining COPD and bronchiectasis care.
Rare Disease Drugmakers Confront a $3.5 Million Question as Gene Therapy Collides With Biosimilar Erosion
Zolgensma, Casgevy and Hemgenix are redefining orphan economics even as biosimilars finally reach first-generation drugs like Soliris and Cerezyme.
These articles are editorial analysis compiled from public FDA data (establishment registrations, the NDC directory, the Orange Book and the drug-shortage database) and other publicly reported information. They are not medical advice and are independent of, and not endorsed by, the FDA.