Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval for Ireland-headquartered Jazz Pharmaceuticals’ Modeyso (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. 7 August 2025
Biotechnology
Further evidence that US Department of Health and Human Services (HHS) secretary Robert F Kennedy Junior (RFK Jr) is willing to act on his vaccine skepticism emerged Tuesday. 6 August 2025
Pharmaceutical
Pfizer posted second-quarter 2025 earnings and revenue that exceeded analyst estimates and raised its full-year profit outlook, pushing its shares higher by 4% in Tuesday morning’s trading. 5 August 2025
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A clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases.
Recent news
Biotechnology
US biotech Iovance Biotherapeutics is cutting 19% of its workforce due to slower-than-expected launch of its tumor-infiltrating lymphocyte (TIL) therapy Amtagvi (lifileucel), Iovance Biotherapeutics is axing around 19% of its workforce. 8 August 2025
Biotechnology
Shares in Gilead Sciences were a massive 9% higher in Friday’s early trading after the US biotech major lifted its full-year financial guidance. 8 August 2025
Generics
India’s pharmaceutical sector continues to assert its dominance on the global stage, driven by a surge in generic drug launches that are reshaping access to affordable healthcare. A flurry of filings and approvals are turning India’s pharma sector into a hotbed of innovation and investment, reports The Pharma Letter’s India correspondent. 8 August 2025
Pharmaceutical
US pharma major AbbVie recently announced top-line results from one of two parallel studies of the pivotal Phase III UP-AA trial evaluating upadacitinib in severe alopecia areata (AA). 8 August 2025
Biotechnology
The cancer immunotherapy market is bracing for its next growth phase as bispecific T-cell engagers gain momentum, according to a new report from analytics group GlobalData. These therapies, which connect a patient’s T-cells directly to tumor targets, are forecast to expand their share of the immuno-oncology market from 10% in 2024 to 35% by 2031. 8 August 2025
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Pharmaceutical
7 August 2025 The initial small tariff on pharmaceutical imports will be increased to 150% within 18 months and eventually to 250%, according to President Trump’s comments in a CNBC interview.
Pharmaceutical
31 July 2025 US pharma major AbbVie is considering a $1-billion acquisition of Gilgamesh Pharmaceuticals, Bloomberg News reported on Wednesday, citing people familiar with the matter.
Conferences
30 May 2025 3 June 2025 Chicago, IL, McCormick Place
30 September 2025 2 October 2025 Basel, Switzerland, Hall 1, Messe Basel
23 September 2025 25 September 2025 Dubai, UAE, Dubai World Trade Centre
16 September 2025 18 September 2025 Basel, Switzerland, Hall 1.0, Messe Basel
15 September 2025 16 September 2025 Paris, France, Maison de la Chimie
10 September 2025 13 September 2025 Hong Kong, China, Hong Kong Convention and Exhibition Centre (HKCEC)
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Pharmaceutical
Pharmaceutical regulation is undergoing its biggest shake-up in decades. On both sides of the Atlantic, policymakers are redrawing the rules that govern how medicines are developed, evaluated and made available. 6 August 2025
Pharmaceutical
The Russian government plans to increase procurements of drugs against hepatitis C due to a significant increase in the number of cases of such disease in the country in recent years, The Pharma Letter’s local correspondent reports. 6 August 2025
Biosimilars
Biosimilars, once met with skepticism, are now an undeniable force in the global pharmaceutical market. As several blockbuster biologics lose exclusivity, biosimilars are stepping in to capture market share and drive savings for healthcare systems worldwide. While adoption in the USA has lagged behind other regions, there are signs that this may be changing. Despite ongoing challenges, the US market is seeing increasing uptake, with biosimilars poised to reshape competition and access to life-saving treatments. 4 August 2025
Biosimilars
After nearly 27 years as a division of Swiss giant Novartis, generics and biosimilars specialist Sandoz went its own way in October 2023. 2 August 2025
Biosimilars
US tariffs have served as a significant catalyst for Indian pharmaceutical companies to reassess their strategies, leading to accelerated efforts in market and product diversification. The challenging environment has encouraged a strategic shift towards higher margin products, reports The Pharma Letter’s India correspondent. 31 July 2025
Pharmaceutical
For millions in low- and middle-income countries (LMICs), lifesaving medicines remain out of reach. While the pharmaceutical industry continues to deliver record-breaking innovation, access to those breakthroughs is often determined by cruel lotteries of geography and income. 28 July 2025
Generics
Hospitals are rationing cancer treatments. Pharmacies are scrambling to fill routine antibiotic prescriptions. And across the USA, patients are facing growing delays, substitutions, or outright denials of essential medicines, not because the drugs don’t exist, but because the supply chains behind them have buckled. 24 July 2025
One to Watch Companies
One to watch
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.
One to watch
Privately-held GAIA is focused on the development of evidence-based, safe and accessible AI-powered digital therapeutics (DTx) that help patients restore and maintain their mental and physical health.
One to watch
Exsilio Therapeutics is developing genomic medicines that can be delivered in lipid nanoparticles to durably and safely treat a broad range of diseases, including genetic diseases, cancer, and autoimmune conditions.
One to watch
Aphaia Pharma is a clinical-stage biopharmaceutical company with headquarters in Switzerland, Canada and Puerto Rico.
Boardroom
Biotechnology
US clinical-stage biotech Keros Therapeutics has announced a strategic realignment designed to reallocate resources towards the development of its key clinical program, KER-065. 8 August 2025
Biotechnology
Biologics-focused contract manufacturing and research organization Abenza announced that Geoffrey Glass has been appointed chief executive (CEO), effective immediately. Mr Glass has served as chairman of the board since 2022. 6 August 2025
Biotechnology
Privately-held US clinical-stage biotech Cellergy Pharma announced the appointment Christopher Cano as chief executive (CEO). 5 August 2025
Pharmaceutical
Novo Nordisk today announced that Maziar Mike Doustdar has been appointed as president and chief executive officer, effective August 7, 2025. Mr Doustdar succeeds Lars Fruergaard Jørgensen, who will step down as president and chief executive officer on the same date. The company also announced other executive-level changes, effective August 7. 4 August 2025
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