Biopharmaceuticals

Seoul -- September 9, 2026 -- MegazoneCloud has begun system development on 'Hanmi Q-Agent,' an AI agent designed to cut Hanmi Pharmaceutical's quality assurance document workload by more than 40%, with build work starting September 7.

MegazoneCloud deploys RAG-based agent across 4,000 quality documents

The Seoul-based AI and cloud company will build a search-based AI agent covering roughly 4,000 quality documents accumulated by Hanmi Pharmaceutical, using its enterprise AI OS 'AIR Studio.' The retrieval-augmented generation (RAG) system will retrieve and summarize documents, then compare them against the latest pharmaceutical regulations to flag non-conforming items.

Tokyo – September 16, 2026 -- The Galien Foundation will hold the inaugural Prix Galien Japan Forum and Awards Ceremony on Thursday, February 25, 2027, at the Hotel New Otani in Tokyo, marking the first time the life sciences prize has been presented in Japan.

Six award categories will honor pharmaceutical, biotech and digital health innovators

The ceremony will present awards across six categories: Best Pharmaceutical Product, Best Biotechnology Product, Best Product for Rare/Orphan Diseases, Best Medical Technology, Best Digital Health Solution, and Best Startup. Winners will be selected by the Prix Galien Japan Awards Committees, made up of biomedical scientists and industry executives from Japan and abroad.

Maidenhead, United Kingdom – September 16, 2026 -- CSL Seqirus has published pivotal Phase 3 results for its MF59-adjuvanted, cell-based, higher-dose quadrivalent influenza vaccine (aQIVc) in The Lancet Infectious Diseases, reporting superiority over an adjuvanted egg-based comparator across all four influenza strains and age groups tested in a 7,699-participant trial.

Trial enrolled nearly 7,700 adults aged 50 and older across eight countries

The randomised, observer-blind study recruited participants in Canada, Denmark, Estonia, Germany, Pakistan, the Philippines, the United Kingdom and the United States, comparing aQIVc against an MF59-adjuvanted egg-based quadrivalent vaccine and a recombinant quadrivalent vaccine. The vaccine met its primary objectives, showing non-inferiority versus the recombinant comparator for three of four strains in the 50-plus group and four of four strains in those aged 65 and above.

Boston – September 16, 2026 -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) said Chief Financial Officer Tom Fitzgerald is retiring, effective immediately, and will be succeeded on an interim basis by John Tattory.

Fitzgerald exits after eight years steering TransCode through IPO and acquisitions

Fitzgerald has served as CFO since July 2018, a tenure spanning the company's initial public offering, the launch of clinical development for lead candidate TTX-MC138, the acquisition of Polynoma, and a license agreement with Oncolytics. He resigns as CFO and as a company director effective immediately but will remain to provide transition services.

Chairman and CEO Philippe P. Calais credited Fitzgerald with keeping the company funded from its early discovery-stage days. "Tom has worked tirelessly to keep us funded and on track," Calais said.

Toronto – September 16, 2026 -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has filed a preliminary short form base shelf prospectus in Canada and a corresponding Form F-10 registration statement with the U.S. SEC, enabling the life sciences company to raise up to US$150 million over a 25-month period.

Shelf filing permits future issuance of shares, debt and warrants

The filings, made under the U.S./Canada Multijurisdictional Disclosure System, would allow Cardiol to offer Class A common shares, debt securities, warrants, subscription receipts, units, or combinations thereof, once a final receipt is issued and the Registration Statement becomes effective. No securities are being offered under this announcement, and the Company said there is no assurance an offering will occur.

London – September 16, 2026 -- Hikma Pharmaceuticals PLC said regulators in the United States, Europe, and the UK have accepted for review its investigational epinephrine nasal spray, a needle-free treatment for anaphylaxis, with an additional filing lodged in Canada.

FDA accepts 505(b)(2) application for non-injectable anaphylaxis treatment

The US Food and Drug Administration has taken up a New Drug Application submitted under the 505(b)(2) pathway, which includes the required non-clinical and clinical data package supporting approval of the nasal spray for emergency anaphylaxis treatment.

San Mateo, Calif. – September 15, 2026 -- Helix has launched Whole Exome+ Sequencing (WES+), a diagnostic test that combines exome sequencing, mitochondrial genome analysis, and genome-wide digital karyotype into a single order for patients with unexplained developmental delay, neurological conditions, and rare genetic disease.

WES+ integrates four diagnostic capabilities in one order

The test covers 99% of clinically relevant exome regions, includes mitochondrial testing that other labs typically bill as a separate add-on, and performs high-resolution chromosomal copy number analysis via a digital karyotype. Helix says the digital karyotype feature may eliminate the need for a standalone chromosomal microarray (CMA) in many clinical scenarios, though the company notes CMA or additional cytogenetic testing may still be clinically indicated in some cases.

Boston – September 15, 2026 -- EMD Serono, Inc., the U.S. and Canada healthcare business of Merck KGaA, Darmstadt, Germany, has acquired two preclinical fertility drug programs from Boston-based biotech PostEra, the companies announced.

EMD Serono takes over two AI-designed oral fertility candidates

The deal covers PostEra's Follicle-Stimulating Hormone Receptor (FSHR) agonist program for ovarian stimulation in IVF and its Luteinizing Hormone/Choriogonadotropin Receptor (LHCGR) agonist program for male infertility and ovulation triggering. Both programs originated from PostEra's proprietary Proton AI platform, developed over the past two years to target small-molecule alternatives in Women's Health and Fertility, markets the company describes as almost entirely dependent on injectable medications.

Columbia, Md. – September 15, 2026 -- The Foundation Fighting Blindness has renamed its venture philanthropy arm, formerly the Retinal Degeneration Fund (RD Fund), to the Gund Vision Fund, honoring more than 50 years of support from Gordon Gund and the Gund family.

Fund has deployed $100 million into 20 companies since 2018

Since launching in 2018, the vehicle has managed more than $140 million in strategic capital and deployed over $100 million directly into a portfolio of 20 companies. It has syndicated with more than $1.5 billion in institutional capital from over 60 co-investors, positioning it as one of the most active venture philanthropy models in the retinal disease space.

Las Vegas – – September 15, 2026 -- The obesity therapeutics market across the seven major markets was valued at approximately USD 16 billion in 2025 and is projected to grow at a 27% CAGR through 2036, according to DelveInsight, as a wave of next-generation candidates threatens to disrupt the Eli Lilly-Novo Nordisk duopoly.

Oral GLP-1 Therapies Accelerate Patient Uptake

Novo Nordisk's oral WEGOVY surpassed 5 million cumulative U.S. prescriptions within 30 weeks of launch, while Eli Lilly's oral FOUNDAYO (orforglipron) gained significant traction among patients initiating obesity treatment by mid-2026. Aparna Thakur, Project Manager of Forecasting & Analytics at DelveInsight, said FOUNDAYO's once-daily oral formulation positions it for rapid uptake as a more convenient alternative to injectable therapies.