Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced the final design of the Expedited Investigational New Drug (IND) Pilot. Accelerating clinical trial timelines and eliminating regulatory hurdles to maintain American leadership in global medical innovation is a core priority for the Trump Administration. 16 September 2026
Biotechnology
UK pharma major GSK today announced it has entered an agreement to acquire a potential best-in-class trispecific T cell-engager (TCE) from Chimagen Biosciences, a privately held biotechnology company. 15 September 2026
Biotechnology
German biotech company BioNTech and its US partner OncoC4 have put a firm number on a survival benefit they had been describing in general terms for more than a year, reporting mature overall survival (OS) data from the first stage of their Phase III lung cancer trial. 14 September 2026
Biotechnology
US pharma major AbbVie announced positive top-line results from the Phase III LUNA study, which evaluated Qulipta (atogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of menstrual migraine in adults. 11 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday granted accelerated approval for German pharma major Bayer’s Hyrnuo (sevabertinib), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. 10 September 2026
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Features
Pharmaceutical
Medicine shortages have shifted over the past two years from a problem managed in hospital pharmacies to a matter of industrial and trade policy on both sides of the Atlantic. Active shortages in the USA peaked in early 2024 and have since fallen, while Europe has built a list of critical medicines, a reporting platform and, in May 2026, a provisional deal on its Critical Medicines Act. 16 September 2026
Pharmaceutical
An Expert View from Mike D’Ambrosio, Senior Vice President and Global Head, Real World Research, Parexel, and Tala Fakhouri, Ph.D., M.P.H., Chief AI and Regulatory Strategy Officer, Parexel. 16 September 2026
Pharmaceutical
Real-world data is the information generated when patients are treated in ordinary practice rather than in a clinical trial: hospital and family doctor records, insurance claims, disease registries and, increasingly, readings from wearable devices. Real-world evidence is what emerges when that information is analyzed to answer a question about how a medicine performs in use. 15 September 2026
Pharmaceutical
The Indian pharmaceutical industry is entering a new phase of global integration, marked by partnerships with Chinese drugmakers that could fundamentally reshape the economics of oncology and specialty medicines. 15 September 2026
Company Spotlight
A biotech company developing novel therapies for autoimmune diseases by leveraging regulatory T cells (Tregs) with its next-generation cell reprogramming platform.
Recent news
Biotechnology
UK precision oncology company Vivan Therapeutics and Ad Atomica, the London-based AI-native drug discovery firm, have announced a discovery collaboration. 16 September 2026
Pharmaceutical
The US Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of US pharma major AbbVie’s tavapadon for Parkinson’s disease. 16 September 2026
Pharmaceutical
Israeli hybrid drug developer Remepy today announced the appointment of Dr Eran Harary as chief medical officer (CMO), effective October 1, 2026. 16 September 2026
Pharmaceutical
US clinical-stage biopharma Sling Therapeutics today announced the close of a $123 million Series C financing. The proceeds will support the continued clinical advancement of linsitinib, an oral small molecule inhibitor of IGF-1R (insulin-like growth factor 1 receptor), a validated target for the treatment of thyroid eye disease (TED). 16 September 2026
Pharmaceutical
David Samra, managing director at Artisan Partners, the US fund manager, has called for changes to the board of Novartis, telling Reuters that "the party is over" for the Swiss pharma major after a run of clinical setbacks wiped billions off its market value. 16 September 2026
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In Brief
Pharmaceutical
25 August 2026 Spanish drugmaker PharmaMar has announced that health authorities in Canada, Qatar and South Korea have approved Zepzelca (lurbinectedin) in combination with atezolizumab (Roche’s Tecentriq) for the maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following first-line induction therapy with atezolizumab, carboplatin and etoposide.
Pharmaceutical
6 August 2026 There are "no discussions" ongoing between AstraZeneca and Bristol Myers Squibb over a potential deal, a senior source close to the matter told Reuters on Wednesday, quashing the prospect of a mooted mega merger between the drugmakers.
Conferences
16 September 2026 18 September 2026 Shenzhen, China, Shenzhen Convention & Exhibition Center (SZCEC)
23 September 2026 24 September 2026 Boston, Massachusetts, USA, Hynes Convention Center
26 September 2026 30 September 2026 Boston, MA, Thomas M. Menino Convention & Exhibition Center
28 September 2026 29 September 2026 Virtual
28 September 2026 2 October 2026 Milan, Italy, Allianz MiCo
30 September 2026 3 October 2026 New Delhi, India, Yashobhoomi
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Pharmaceutical
Real-world data is the information generated when patients are treated in ordinary practice rather than in a clinical trial: hospital and family doctor records, insurance claims, disease registries and, increasingly, readings from wearable devices. Real-world evidence is what emerges when that information is analyzed to answer a question about how a medicine performs in use. 15 September 2026
Pharmaceutical
The Indian pharmaceutical industry is entering a new phase of global integration, marked by partnerships with Chinese drugmakers that could fundamentally reshape the economics of oncology and specialty medicines. 15 September 2026
Pharmaceutical
Three documents now define how the two largest medicines regulators think about artificial intelligence in drug development. The European Medicines Agency published a reflection paper in September 2024. The US Food and Drug Administration issued draft guidance in January 2025. In January 2026 the two agencies published a joint set of principles. 11 September 2026
Pharmaceutical
The Medicare Drug Price Negotiation Program is now running three cycles at once. Negotiated prices for the first ten products took effect in January 2026. A second set of 15 takes effect in January 2027. Talks on a third set of 15 close this autumn, and a fourth cycle is already in formal rulemaking. 11 September 2026
Pharmaceutical
For the past 20 months the European Union has been running a single, shared review of the evidence behind certain new medicines, replacing part of the work that 27 countries used to do separately. The system began operating on 12 January 2025. It published its first finished report in June 2026, and three more have followed since. 10 September 2026
Biosimilars
Swiss generics and biosimilars major's chief commercial officer tells The Pharma Letter that disciplined pipeline selection, in-house manufacturing and 20 years of launch experience are what separate Sandoz from a crowded field of biosimilar challengers. 8 September 2026
Pharmaceutical
The US Food and Drug Administration's Oncology Center of Excellence (OCE) launched Project Optimus in 2021 as an initiative to reform how doses and schedules are selected in cancer drug development. The supporting guidance for industry, Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases, was published in August 2024 after a draft issued in January 2023. 8 September 2026
One to Watch Companies
One to watch
A biotech company focused on the development of a p300/CBP inhibitor to treat specific cancer types.
One to watch
A clinical-stage biotechnology company developing novel T-cell engagers for autoimmune and inflammatory diseases, Candid Therapeutics launched in 2024 with $370 million in Series A financing and agreed to a $2.2 billion acquisition by UCB in May 2026.
One to watch
A privately-held French biotech advancing a clinical pipeline of gamma delta T-cell-focused antibodies for cancer and autoimmune diseases.
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.
Boardroom
Pharmaceutical
Israeli hybrid drug developer Remepy today announced the appointment of Dr Eran Harary as chief medical officer (CMO), effective October 1, 2026. 16 September 2026
Pharmaceutical
New York, USA-based neuropsychiatric firm LB Pharmaceuticals yesterday announced the appointment of Dr Susan Kozauer as chief medical officer (CMO). 16 September 2026
Pharmaceutical
Diasome Pharmaceuticals, a US biopharma developing liver-targeted therapies for metabolic disease, has appointed Sangeeta Sawhney as chief medical officer, as it prepares to advance its lead candidate, HDV-Insulin, into Phase III development. 15 September 2026
Biotechnology
Singapore-based biotech Hummingbird Bioscience today announced the appointment of Dr James Garner as president. Dr Garner will join Hummingbird’s leadership team and work alongside Piers Ingram, co-founder and chief executive. 15 September 2026
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