01
What changed in pharma regulation and policy this week?
Government decisions, new rules and policy shifts reported this week.
02
The US Food and Drug Administration (FDA) has placed a clinical hold on enrollment for trials of Biohaven's epilepsy drug candidate, BHV-7000.
Read at fiercebiotech.com ↗03
On September 10, 2026, Bayer received approval for its drug Hyrnuo as a first-line treatment for non-small cell lung cancer (NSCLC).
Read at citeline.com ↗04
The National Commission into the Regulation of AI in Healthcare has published its recommendations for a future regulatory framework for AI in the UK healthcare sector.
Read at gov.uk ↗05
Jesse Mendelsohn, Senior Vice President at Model N, discusses the complexities of the 340B Drug Pricing Program in a Pharmaceutical Executive podcast episode.
Read at pharmexec.com ↗06
The Trump administration is actively negotiating new drug pricing agreements with pharmaceutical companies.
Read at bloomberg.com ↗07
The US Food and Drug Administration (FDA) granted accelerated approval to AstraZeneca's drug camizestrant on September 8, 2026.
Read at fiercebiotech.com ↗08
The US Food and Drug Administration (FDA) is implementing stricter enforcement measures regarding clinical trial data originating from China and other foreign countries.
Read at citeline.com ↗8 of 13 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 pharma this week?
The week’s notable investments, financing rounds, acquisitions and strategic deals.
09
GE HealthCare is reportedly in advanced talks to acquire the radiopharmaceutical developer Sofie Biosciences.
Read at fiercebiotech.com ↗10
Private equity firm Warburg Pincus has acquired a stake in the Indian pharmaceutical company Koye Pharmaceuticals.
Read at citeline.com ↗11
In August 2026, Chinese advanced molecular therapy firms continued to secure significant investment funding.
Read at citeline.com ↗12
Schrödinger has launched a new biotechnology company named Tectora Therapeutics, which will focus on immunology and inflammation research.
Read at fiercebiotech.com ↗13
Solstice Oncology has raised $225 million in a series A funding round.
Read at fiercebiotech.com ↗14
Solstice Oncology has raised $225 million in a new funding round to advance an immuno-oncology drug.
Read at biopharmadive.com ↗15
BrainChild Bio has raised $116 million in Series A financing to fund a pivotal Phase II trial for its lead CAR T-cell therapy candidate, BCB-276.
Read at genengnews.com ↗16
Health tech startup Forus has raised $150 million in a Series C funding round led by Bain Capital Ventures, bringing its total valuation to $3 billion.
Read at fiercehealthcare.com ↗8 of 15 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 pharma this week?
Notable product launches, releases and platform updates from the week.
17
Revolution Medicines received regulatory approval for its RAS inhibitor drug, Rasonque, indicated for the treatment of advanced pancreatic cancer.
Read at fiercebiotech.com ↗18
Clinical research company nPhase launched an end-to-end clinical data management platform on September 10, 2026.
Read at fiercebiotech.com ↗19
Beeline, a spinout company from Bristol Myers Squibb, plans to advance its lead TLR7/8 inhibitor candidate into pivotal clinical trials for the treatment of lupus.
Read at citeline.com ↗20
Interra Health has integrated support for the Centers for Medicare & Medicaid Services (CMS) GLP-1 Bridge program into its electronic prescribing platform.
Read at fiercehealthcare.com ↗21
AstraZeneca's R&D chief Sharon Barr announced that the company has secured an FDA priority review for its IL-33 antibody treatment for chronic obstructive pulmonary disease (COPD).
Read at fiercebiotech.com ↗22
Celltrion showcased its Omlyclo treatment for chronic urticaria and allergic asthma at the 2026 European Respiratory Society Congress held in Barcelona, Spain, from September 5 to 9.
Read at thelec.net ↗6 of 7 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 pharma this week?
Earnings, guidance and other financial results reported this week.
23
Novartis experienced a significant decline in market capitalization of approximately $30 billion following the failure of its Phase III clinical trial for the drug candidate delpacibart etedesiran (del-desiran).
Read at genengnews.com ↗24
Novartis shareholders are expressing concern over the company's M&A strategy following the failure of the muscle-wasting drug del-desiran in a late-stage trial.
Read at pharmexec.com ↗25
Novartis CEO Vas Narasimhan defended the company's recent mergers and acquisitions strategy on September 11, 2026.
Read at citeline.com ↗What court rulings and legal actions hit pharma this week?
Court rulings, filings and legal actions reported this week.
26
A Fifth Circuit panel heard arguments on September 9, 2026, regarding Louisiana's attempt to block the FDA's 2023 decision to remove in-person dispensing requirements for mifepristone.
Read at courthousenews.com ↗What research was published in pharma this week?
New research findings and studies published this week.
27
Researchers from the Wellcome Sanger Institute, University of Cambridge, and University College London published a study in Nature Genetics on September 11, 2026, regarding the impact of cancer treatments on healthy tissue.
Read at genengnews.com ↗28
Disc Medicine presented Phase II clinical trial data for its investigational agent DISC-3405.
Read at citeline.com ↗29
Researchers from Georgia Tech and Vanderbilt University have developed a bone marrow-on-a-chip model to study the development and behavior of antibody-producing plasma cells.
Read at genengnews.com ↗30
Researchers at the Salk Institute, led by Gerald Shadel, have identified a biological pathway where chronic exposure to interferon II (IFN-II) causes mitochondrial dysfunction, leading to immunosuppression in cancer.
Read at genengnews.com ↗31
A survey by the Pew Research Center reveals that approximately 80% of U.S. adults currently take at least one health supplement.
Read at pewresearch.org ↗32
Researchers at Cedars-Sinai Health Sciences University identified that the protein PD-L2 helps senescent cells evade the immune system, contributing to age-related dysfunction.
Read at genengnews.com ↗33
Novartis announced that its neuromuscular drug candidate delpacibart etedesiran failed the Phase III HARBOR trial for myotonic dystrophy type 1 (DM1) after missing the primary endpoint of vHOT improvement.
Read at genengnews.com ↗34
A recent study found that GLP-1 drug prescriptions for children aged 8 to 11 without diabetes increased between 2019 and 2026 in the United States.
Read at gizmodo.com ↗8 of 29 research events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What incidents and outages hit pharma this week?
Incidents, outages and safety events reported this week.
35
The hacking group ShinyHunters leaked data belonging to 6.4 million individuals following a cyberattack on the medical supplier McKesson.
Read at theregister.com ↗36
Google's Mandiant threat intelligence team reported that extortion groups are increasingly targeting proprietary AI data, including models and research, for ransom.
Read at theregister.com ↗What partnerships were announced in pharma this week?
Partnerships, integrations and joint projects announced this week.
37
Employers Health and Judi Health have partnered to launch StarkRx, a new cost-plus pharmacy benefit management (PBM) model.
Read at fiercehealthcare.com ↗38
ProBioGen and Transgene have expanded their existing collaboration through a new license agreement for the AGE1.CR.pIX cell line.
Read at genengnews.com ↗39
Carelon Research, led by President Mark Cziraky, has entered into a partnership with Manifold to enable researchers to analyze Carelon's real-world data alongside third-party datasets.
Read at pharmexec.com ↗40
Interra Health announced on September 10, 2026, that its health tech platform now supports the Medicare GLP-1 Bridge program.
Read at medcitynews.com ↗What people moved in and out of pharma roles this week?
Executive appointments and departures reported this week.
41
Chris Klomp, the architect of the Trump administration's drug pricing deals, is scheduled to face Senate confirmation hearings on September 15 and 16, 2026.
Read at citeline.com ↗42
In August 2026, the biopharmaceutical industry saw 12 companies announce workforce reductions affecting 526 employees, representing a 90% decrease compared to August 2025.
Read at biospace.com ↗43
The U.S. Food and Drug Administration (FDA) has appointed permanent leaders for its Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
Read at biopharmadive.com ↗44
The US Food and Drug Administration (FDA) has appointed permanent directors for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Read at citeline.com ↗45
On September 7, 2026, the U.S. Department of Health and Human Services (HHS) announced four permanent senior leadership appointments at the FDA.
Read at pharmexec.com ↗5 of 10 people moves events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.