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What changed in biotechnology regulation and policy this week?
Government decisions, new rules and policy shifts reported this week.
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Two U.S. House Republicans have requested that the FDA increase oversight of clinical trial data originating from China.
Read at pharmavoice.com ↗03
Biotech company uniQure is preparing to file a Biologics License Application (BLA) for its gene therapy targeting Huntington's disease.
Read at citeline.com ↗04
On September 3, 2026, the US Food and Drug Administration (FDA) announced the cancellation of several postmarketing clinical trials for COVID-19 vaccines.
Read at citeline.com ↗05
The US Food and Drug Administration (FDA) has released updated guidance on therapeutic equivalence, facilitating faster rating requests for 505(b)(2) drug applications.
Read at citeline.com ↗06
The Chinese government has accelerated the approval of brain-computer interface (BCI) devices and provided state subsidies to domestic startups to compete with Neuralink.
Read at semafor.com ↗07
Researchers from Seoul National University, led by Professor Moo Sun Hong, published a study on the evolution of continuous biomanufacturing processes.
Read at genengnews.com ↗08
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use, supply, and sale of the drug Tavneos to new patients as of September 1, 2026.
Read at citeline.com ↗8 of 11 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 biotechnology this week?
The week’s notable investments, financing rounds, acquisitions and strategic deals.
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GSK has entered into a licensing agreement with Hutchmed to acquire a first-in-class oncology candidate targeting KRAS-EGFR.
Read at fiercebiotech.com ↗10
Australian biotech company ENA Respiratory has secured $2.98 million in funding from the government-backed Biointelect Venturer program.
Read at startupdaily.net ↗11
Roche has agreed to pay $190 million upfront to acquire a UCN2 analog for obesity treatment.
Read at fiercebiotech.com ↗12
Roche has entered into a licensing agreement with Simcere Zaiming to acquire global rights for a preclinical trispecific antibody designed to treat B-cell-mediated diseases.
Read at fiercebiotech.com ↗13
Eli Lilly has agreed to acquire Merida Biosciences for up to $2.88 billion in cash to expand its portfolio into autoimmune disease treatments.
Read at thestreet.com ↗14
Eli Lilly has entered into a definitive agreement to acquire Merida Biosciences for a total consideration of up to $2.875 billion.
Read at fiercebiotech.com ↗15
Eli Lilly and Company has announced the acquisition of Merida for $2.9 billion.
Read at biopharmadive.com ↗16
Eli Lilly & Co. has announced plans to acquire Merida Biosciences Inc. for up to $2.88 billion in cash.
Read at bloomberg.com ↗8 of 16 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 biotechnology this week?
Notable product launches, releases and platform updates from the week.
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Ionis Pharmaceuticals has received regulatory approval for a treatment targeting Alexander disease, a rare genetic disorder.
Read at fiercebiotech.com ↗18
The FDA has approved a new HIV combination medication developed by Gilead Sciences.
Read at pharmavoice.com ↗19
On September 4, 2026, Chinese regulatory authorities approved the world's first nine-month prophylactic antibody treatment for infant Respiratory Syncytial Virus (RSV).
Read at citeline.com ↗20
The U.S. Food and Drug Administration (FDA) approved Ionis Pharmaceuticals' drug zilganersen, branded as Zanvastro, for the treatment of Alexander disease in children and adults.
Read at medcitynews.com ↗21
Ionis Pharmaceuticals has received approval for Zanvastro, the first disease-modifying drug for Alexander disease.
Read at citeline.com ↗22
PMV Pharmaceuticals plans to submit a regulatory filing for its drug candidate Rezatapopt in the first quarter of 2027.
Read at citeline.com ↗23
The startup Atlas has launched the Atlas 1.0, a $499 wearable EEG device designed to track brain activity, electrodermal activity, and movement.
Read at gizmodo.com ↗24
GSK and other pharmaceutical companies are seeking to enter the mRNA influenza vaccine market following the recent regulatory approval of Moderna's mRNA flu shot.
Read at citeline.com ↗8 of 10 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 biotechnology this week?
Earnings, guidance and other financial results reported this week.
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Electra Therapeutics has filed for an initial public offering (IPO) in 2026.
Read at fiercebiotech.com ↗26
Global biotech startup funding in 2026 is projected to remain stable between $36 billion and $40 billion, consistent with recent years.
Read at crunchbase.com ↗What court rulings and legal actions hit biotechnology this week?
Court rulings, filings and legal actions reported this week.
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Genetic testing company Natera has agreed to an $8.25 million settlement to resolve a class-action lawsuit regarding the accuracy of its Panorama and Vasistera prenatal tests.
Read at courthousenews.com ↗What research was published in biotechnology this week?
New research findings and studies published this week.
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Tal Zaks, the former chief medical officer of Moderna, has seen his significant financial investment in cancer treatment research begin to yield results.
Read at businessinsider.com ↗29
Novartis and its partner Ionis Pharmaceuticals reported that their experimental drug targeting Lp(a) failed to reduce the risk of major cardiovascular events in a Phase 3 clinical trial.
Read at fiercebiotech.com ↗30
Researchers at University College London, led by Professor Jennifer Rohn, developed a 3D human micro-bladder model to study recurrent urinary tract infections (UTIs).
Read at genengnews.com ↗31
Researchers at Emory University conducted a study on 24 rhesus macaques infected with SIV, finding that a 10-day course of the cancer drug venetoclax, administered alongside antiretroviral therapy (ART), significantly reduced the intact viral reservoir.
Read at genengnews.com ↗32
Researchers from Stanford University, Xi'an Jiaotong-Liverpool University, Shanghai Jiao Tong University, and the University of Chinese Academy of Sciences discovered that plasmalogens found in sea squirts can reverse aging signs in mice.
Read at sciencedaily.com ↗33
AbbVie announced positive phase 3 clinical trial results for its bispecific T-cell engager, etentamig, on September 3, 2026.
Read at fiercebiotech.com ↗34
A patient in the United States has survived for a record 271 days with a transplanted pig kidney.
Read at bbc.co.uk ↗35
Ultragenyx Pharmaceutical reported that its phase 3 clinical trial for an Angelman syndrome treatment failed to meet its primary endpoints.
Read at fiercebiotech.com ↗8 of 32 research events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What incidents and outages hit biotechnology this week?
Incidents, outages and safety events reported this week.
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Novartis and Bristol Myers Squibb have halted clinical studies for their autoimmune CAR-T cell therapies due to safety concerns.
Read at pharmavoice.com ↗1 of 2 incidents and safety events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What partnerships were announced in biotechnology this week?
Partnerships, integrations and joint projects announced this week.
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OpenEvidence has partnered with a leading, unnamed U.S. cancer center to integrate a precision oncology knowledge base into its AI platform.
Read at fiercehealthcare.com ↗38
Carelon Research, led by president Mark Cziraky, has signed a partnership agreement with Manifold to enable life sciences researchers to analyze Carelon's real-world data (RWD) alongside third-party datasets.
Read at pharmexec.com ↗39
Carelon Research and Manifold have entered into a partnership to provide Manifold's research teams with access to Carelon's real-world data (RWD) sets.
Read at pharmexec.com ↗3 of 8 partnerships events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.
What else happened in biotechnology this week?
Developments from the week that fit none of the other sections.
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The Wall Street Journal published a market analysis on September 3, 2026, covering the healthcare sector.
Read at wsj.com ↗41
The U.S. Bureau of Labor Statistics projects a 35% growth in data science occupations between 2025 and 2035, creating 95,400 new jobs.
Read at biospace.com ↗42
The commercial growth of CAR-T cell therapies is currently hindered by the difficulty of scaling patient-specific manufacturing processes into a unified, reliable system.
Read at biopharmadive.com ↗43
Teva Pharmaceutical Industries reported positive results in a study for a celiac disease therapy, describing it as having 'pipeline-in-a-product' potential.
Read at biopharmadive.com ↗44
The article discusses the manufacturing challenges of CAR-T cell therapies, specifically the difficulty of scaling patient-specific production runs into a reliable system.
Read at pharmavoice.com ↗45
At the 2026 Bio-Process Systems Alliance (BPSA) International Single-Use Summit held in Boston in July, industry experts including Eric Langer of BioPlan Associates discussed the maturation of single-use technologies in biopharmaceutical manufacturing.
Read at genengnews.com ↗6 of 10 other developments events are listed; the rest were ranked lower by importance and multi-source corroboration and are not shown.