Viatris, Inc. is a global healthcare company, which engages in the provision of access to medicines and sustainable operations. It also offers support services such as diagnostic clinics, educational seminars, and digital tools. The firm operates through the following segments: Developed Markets, Greater China, JANZ, and Emerging Markets. The Developed Markets segment consists of operations primarily in North America and Europe. The Greater China segment includes operations in mainland China, Taiwan and Hong Kong. The JANZ segment consists of operations in Japan, Australia and New Zealand. The Emerging Markets segment encompasses operations with developing markets and emerging economies including countries in Asia, the Middle East, South and Central America, Africa and Eastern Europe. The company was founded on February 14, 2019 and is headquartered in Canonsburg, PA.
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- Japan's Ministry of Health, Labour and Welfare approved WAKIX (pitolisant) for narcolepsy types 1 and 2 and for excessive daytime sleepiness associated with obstructive sleep apnea syndrome. - WAKIX becomes the first histamine H3 receptor antagonist/inverse agonist approved in Japan for these indications and is not classified as a controlled substance. - Approval was supported by positive domestic Phase 3 trial data in Japan plus international studies in narcolepsy and in OSAS patients with residual sleepiness on CPAP. - Viatris holds Japan-only licensing rights to pitolisant, which was discovered by Bioprojet and is already approved in more than 38 countries for narcolepsy.
- Lupin expects biosimilar turnover of close to $500 million over the next five years, anchored by its recently approved pegfilgrastim biosimilar and upcoming ranibizumab launches. - The company has invested about ₹500 crore in biosimilar manufacturing capacity and plans to raise total investment to roughly ₹700 crore. - Lupin has begun raising external funding for Kaveri Therapeutics, its oncology-focused spin-off housing two specialised oncology programmes, while intending to remain majority shareholder. - Biosimilars of nivolumab, dinutuzumab and pertuzumab are planned for India, alongside existing etanercept biosimilar sales in Europe and Japan through partnerships.
- Peer-reviewed LYNX-1 results show 21% of patients on 0.75% phentolamine drops gained at least three lines on a dim-light eye chart by day 15 versus 3% on placebo. - The once-nightly drop produces moderate pupil constriction lasting at least 20 hours by blocking iris dilator muscle receptors without engaging the ciliary muscle. - The FDA has granted Fast Track designation for night driving impairment, while confirmatory LYNX-3 topline results are expected in the first half of 2026. - Investigators caution the trial measured eye chart scores and symptoms, not real-world driving performance or crash risk, and the drug remains unapproved for night vision.
- Shield Therapeutics posted H1 2026 total revenues of $30.4 million, up from $21.5 million in H1 2025, driven by a $7.9 million milestone payment from ASK in China and 21% prescription growth. - ACCRUFeR® (ferric maltol) achieved c.102,000 prescriptions dispensed in H1 2026, and the company signed its first Group Purchasing Organisation contract providing access to over 400 clinics. - MEDLEAP Pharma enrolled the first patient in a Phase II clinical trial of ferric maltol for pulmonary arterial hypertension in Japan, with a planned Phase III trial to follow. - Pediatric indication extensions were secured in the US (ages 10+), Europe (ages 12+), and the UK (ages 12+), expanding the addressable patient population.
- The global intravenous iron drugs market is projected to grow from US$ 3.2 billion in 2024 to US$ 7.4 billion by 2034, at a CAGR of 8.8%. - Ferric carboxymaltose led the market with a 44.1% share in 2024, while chronic kidney disease was the dominant application segment at 38.5%. - A 2025 real-world evaluation of ferric derisomaltose reported a 65.1% clinical response rate and a serious allergic reaction rate of just 0.04%. - North America led the market in 2024 with over 45.4% share, driven by advanced infrastructure and high adoption of intravenous iron therapies.
- Pharmaceutical R&D is under structural pressure from patent expirations, rising development costs, regulatory complexity, and increasing shareholder scrutiny, forcing companies to reassess capital allocation and asset prioritization. - A leading PharmaCo's 5R framework increased R&D success rates from approximately 4% to 19%, demonstrating the measurable impact of rigorous, data-driven portfolio prioritization. - Bristol Myers Squibb's institutionalized asset "fast lane" accelerated development timelines through higher company attention, faster committee access, bootcamps, more trial sites, and A-teams. - AI-driven modeling and scenario tools promise better forecasting, but organizations remain uncertain about data maturity, bias risks, and governance implications.
- FDA's OPDP sent an untitled letter to Sanofi over promotional emails for Beyfortus that misleadingly suggested the monoclonal antibody prevents all RSV disease, rather than only lower respiratory tract disease. - Viatris received an untitled letter for a DTC TV ad for TOBI Podhaler that implied the cystic fibrosis treatment can be administered anywhere, contradicting FDA-approved instructions requiring adequate lighting and stable conditions. - Both companies must respond within 15 working days and take immediate corrective action, including pulling the violative promotional materials. - This marks Sanofi's second untitled letter since the FDA's advertising enforcement crackdown began in September 2025.
- The DHSC has issued a tier two medicine supply notification for nifedipine modified-release tablets across multiple strengths, with several brands out of stock through late 2026. - Tensipine MR, Dexipress MR, Adalat LA, and Neozipine XL brands face shortages, while Adanif XL has been discontinued; alternative brands and Coracten capsules remain available. - A separate DHSC notification warns that Viatris-manufactured oxcarbazepine 150mg tablets are out of stock until mid-July 2026, with Novartis's Trileptal available to meet demand. - Nifedipine is a calcium-channel blocker for hypertension, angina, and Raynaud's; oxcarbazepine is an anticonvulsant used to control seizures in epilepsy patients.
- Novartis and agency partner Fallon Minneapolis won the 2026 Pharma Lions Grand Prix at Cannes for the "Relax Your Tight End" prostate cancer awareness campaign that debuted during Super Bowl LX. - The campaign recruited current and former NFL tight ends including Rob Gronkowski and George Kittle to encourage men to get screened, using humor to normalize conversations around prostate cancer screening. - Jury president Tracey Brader praised the work as "genuinely funny" and credited its use of celebrities, the Super Bowl platform, and a patient who had been saved. - Additional winners included Viatris (Gold), TuPharma 365 and Novartis (Silver), and Gilead Sciences Canada, Tata 1mg, and Jazz Pharmaceuticals (Bronze) across various pharma communication categories.
- The generic drug industry is shifting from traditional small-molecule generics toward biosimilars, complex generics, and specialty injectables as price erosion pressures margins on commodity generics. - Sandoz reported Q1 2026 net sales of $2.76 billion with biosimilars growing 18% year-over-year, now accounting for nearly one-third of total revenues. - Teva, the world's largest generic drugmaker, expects its biosimilars business to generate $800 million in revenues by 2027, supported by its strategic partnership with Alvotech. - The Zacks Medical–Generic Drugs industry has surged approximately 44% over the past year, outperforming both the broader Zacks Medical sector and the S&P 500 Index.
