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What changed in pharmaceuticals regulation and policy this week?
Government decisions, new rules and policy shifts reported this week.
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The FDA approved the drug Tavneos in 2021 with a requirement for a postmarket safety study, but as of late 2025, only 21 of the planned 300 patients had been enrolled.
Read at kffhealthnews.org ↗03
President Donald Trump announced that all U.S. states have agreed to participate in a program to align Medicaid drug prices with those in other wealthy nations.
Read at nytimes.com ↗04
The National Institute for Health and Care Excellence (Nice) has approved the drug Enhertu for routine use on the NHS in England for women with incurable HER2-low advanced breast cancer.
Read at theguardian.com ↗05
The US Food and Drug Administration (FDA) held a public hearing on September 15, 2026, to discuss safety, access, and administration protocols for potential psychedelic medicines.
Read at fiercehealthcare.com ↗06
The US Food and Drug Administration (FDA) convened a public hearing on September 15, 2026, to discuss the regulatory framework for the potential first approval of a psychedelic medicine.
Read at fiercebiotech.com ↗07
The FDA has approved Scholar Rock's drug Isembyld for the treatment of spinal muscular atrophy (SMA).
Read at biopharmadive.com ↗08
The Trump administration's Most Favored Nation (MFN) policy, comprising the GLOBE and GUARD models, aims to align US Medicare drug prices with international benchmarks from 19 countries.
Read at thestreet.com ↗8 of 23 regulation and policy events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What funding rounds and acquisitions happened in pharmaceuticals this week?
The week’s notable investments, financing rounds, acquisitions and strategic deals.
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Bristol Myers Squibb has terminated its development of a degrader-antibody conjugate asset acquired from Orum Therapeutics for $100 million.
Read at fiercebiotech.com ↗10
The UK government's Sovereign AI Fund is in negotiations to invest in the London-based drug discovery startup Potential Sciences.
Read at sifted.eu ↗11
Venture studio Palomar Labs has spun out its first portfolio company, Ariadne Bio, to develop a non-hallucinogenic serotonin 2A receptor agonist named AB-300.
Read at genengnews.com ↗12
Novo Nordisk has acquired three early-stage obesity drug programs from the New York-based biotech company Kallyope.
Read at fiercebiotech.com ↗13
Electra Therapeutics raised $350 million through an upsized initial public offering on the Nasdaq.
Read at fiercebiotech.com ↗14
North Immunology has announced plans to go public through a reverse merger.
Read at fiercebiotech.com ↗15
Novartis has exercised an option to acquire a brain delivery platform from Sironax for $125 million.
Read at fiercebiotech.com ↗16
GSK has entered into a deal worth up to $750 million with Chimagen Biosciences to develop a trispecific T-cell engager for multiple myeloma.
Read at fiercebiotech.com ↗8 of 11 funding and m&a events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What products launched in pharmaceuticals this week?
Notable product launches, releases and platform updates from the week.
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Goa Therapeutics has emerged from stealth mode on September 17, 2026, with the goal of developing a therapeutic drug designed to rapidly sober up individuals who have consumed excessive alcohol.
Read at fiercebiotech.com ↗18
The FDA has approved Fayuvi, a gene therapy developed by Ultragenyx Pharmaceutical, as the first treatment for Sanfilippo syndrome type A (MPS IIIA).
Read at medcitynews.com ↗19
The U.S. Food and Drug Administration (FDA) has approved Telix Pharmaceuticals' Pixclara, marking the first FET-PET imaging agent for brain cancer.
Read at fiercebiotech.com ↗20
Cullinan Oncology and Taiho Pharmaceutical are preparing their drug candidate zipalertinib to compete with Johnson & Johnson's Rybrevant in the non-small cell lung cancer (NSCLC) market.
Read at citeline.com ↗4 of 5 product launches events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What financial results were reported in pharmaceuticals this week?
Earnings, guidance and other financial results reported this week.
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Ultragenyx has set the price for its Sanfilippo syndrome gene therapy at $4 million.
Read at biopharmadive.com ↗22
On Holding has signed a partnership with Kylian Mbappé to develop football products and represent the brand.
Read at bloomberg.com ↗23
A biotech company, which held $268 million in cash, announced a 46 percent workforce reduction following a failed drug trial.
Read at inc.com ↗3 of 5 financial results events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What court rulings and legal actions hit pharmaceuticals this week?
Court rulings, filings and legal actions reported this week.
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Donald Trump's nominee for US surgeon general, Dr. Nicole Saphier, reported $270,605 in business income from her company Empower MD, LLC, which sells dietary supplements under the brand Drop RX.
Read at theguardian.com ↗25
Dompé U.S. Inc. has agreed to pay $32 million to settle allegations of violating the Anti-Kickback Statute and the False Claims Act in California.
Read at insurancejournal.com ↗What research was published in pharmaceuticals this week?
New research findings and studies published this week.
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Dr. Barbara Bendlin from the University of Wisconsin–Madison and Dr. Federico Ray have conducted over a decade of research into the gut-brain connection.
Read at thestreet.com ↗27
Scientists at Stanford University have successfully implanted human neurons into the brains of mice, creating models where human cells account for nearly half of the brain volume.
Read at futurism.com ↗28
Eli Lilly presented early clinical data at the Psych Congress 2026 in New Orleans on September 18, 2026, regarding its GIP/GLP-1 receptor agonist candidate brenipatide.
Read at genengnews.com ↗29
Anthropic has confirmed the operation of a wet biology lab in San Francisco to conduct physical experiments using its AI models.
Read at techcrunch.com ↗30
Researchers at the University of Vermont, led by Brian Cunniff and Victoria Gibson, have developed a new mesothelioma treatment that targets the PRX3 enzyme using the antibiotic thiostrepton.
Read at sciencedaily.com ↗31
A 3-year-old boy with metastatic hepatoblastoma in Texas achieved complete remission after receiving experimental CAR T cell therapy targeting glypican-3.
Read at gizmodo.com ↗32
A study by Humana Pharmacy Analytics and Consulting published on September 17, 2026, in the Expert Review of Pharmacoeconomics & Outcomes Research found that specialty pharmacy care coordination for cancer patients leads to better health outcomes.
Read at fiercehealthcare.com ↗33
At the WCLC 2026 conference held in September 2026, clinical trial results demonstrated that the drug Ivonescimab achieved a superior overall survival (OS) outcome compared to Keytruda in first-line (1L) non-small cell lung cancer (NSCLC) patients with high PD-L1 expression.
Read at citeline.com ↗8 of 32 research events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What partnerships were announced in pharmaceuticals this week?
Partnerships, integrations and joint projects announced this week.
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Roche has entered into a partnership with Dualitis to develop novel bispecific antibodies targeting immunology and inflammation (I&I) indications.
Read at citeline.com ↗35
Danish pharmaceutical company Novo Nordisk has announced a partnership with AI firm Anthropic to accelerate drug discovery.
Read at semafor.com ↗36
Novo Nordisk and Anthropic have entered into a strategic alliance to utilize Anthropic's Claude large language models for drug discovery.
Read at citeline.com ↗37
Novo Nordisk and Anthropic announced a strategic partnership on September 16, 2026, to integrate AI into drug discovery and software development workflows.
Read at pharmexec.com ↗38
Cellares and GenomeFrontier Therapeutics have entered a partnership to evaluate the automated manufacturing of the investigational CAR T-cell therapy GF-CART01 using the Cellares Cell Shuttle platform.
Read at genengnews.com ↗39
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Malaysian health officials held high-level discussions in Kuala Lumpur on September 15, 2026.
Read at gov.uk ↗40
The inaugural GLP-1 Shopper Summit is scheduled for November 12, 2026, at the Hilton Chicago.
Read at consumergoods.com ↗7 of 12 partnerships events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What people moved in and out of pharmaceuticals roles this week?
Executive appointments and departures reported this week.
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David Khougazian has been appointed as the new CEO of the Italian pharmaceutical company Chiesi.
Read at citeline.com ↗42
Wendy Short Bartie, formerly a senior vice president at Bristol Myers Squibb, transitioned to the role of executive vice president and chief corporate affairs officer in June 2025.
Read at pharmexec.com ↗2 of 4 people moves events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What else happened in pharmaceuticals this week?
Developments from the week that fit none of the other sections.
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Investors in Novo Nordisk are urging the company to pursue new acquisitions and accelerate the development of new drugs.
Read at ft.com ↗44
Novo Nordisk has rebranded as 'Novo' and introduced a new cultural framework, 'The Novo Way,' under CEO Mike Doustdar.
Read at pharmexec.com ↗45
Reckitt is executing a $600 million multiyear transformation of its U.S. business operations.
Read at consumergoods.com ↗3 of 21 other developments events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.