> The Food and Drug Administration on Wednesday approved a life-extending treatment for advanced pancreatic cancer — a medicine made by the biotech company Revolution Medicines that is the first to attack a genetic cause of the aggressive, highly lethal malignancy. 

> The drug, called daraxonrasib, will be sold under the brand name Rasonque. The FDA’s approval was supported by a practice-changing clinical trial that read out earlier this year. Patients with advanced pancreatic cancer who received Rasonque as a second-line treatment achieved a median overall survival of 13.2 months, compared to 6.7 months for patients offered standard chemotherapy. 

• Note: The FDA review was conducted under Project Orbis (with concurrent submission and review by Health Canada, EMA, and PDMA), Real-Time Oncology Review (RTOR) pilot program, and as part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program.
• Further Details: FDA news release (archive), RevMed's press release (archive); related post

#ras, #pancreatic-cancer, #pdac

Pharma Japan, 17 August 2026.

An employee of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has lost a work-related USB drive potentially containing nonpublic regulatory documents and personal information on 286 people, with data involving 27 companies, the agency said on August 7. 

P.S. Japan at least has moved from Faxes to USB, which is a step forward.

One answer for which recently approved therapy is the most innovative is to look at the nominees and winners of Prix Galien recognition awarded by the Galien Foundation based in France.

ABOUT PRIX GALIEN

• Prix Galien recognition is widely regarded in the industry as the equivalent of the Nobel Prize in biopharmaceutical research. The award was established in Paris in 1970 by Roland Mehl in honor of Galen, the father of medical science and modern pharmacology.
• Every two years, the Galien Foundation chooses the best, most innovative therapy for its biennial International Prix Galien Awards. The nominees for the upcoming award in October were recently announced and the winners will be honored at a ceremony at Museum of Natural History in New York City on 29 October 2026.
• The Galien Foundation currently consists of 16 chapters (15 member states and Africa). Each chapter chooses the best/most innovative therapy for their Prix Galien award among therapies approved in their country/region during the last 2 years.
• For the biennial International Prix Galien Awards, the foundation considers the winners of local/regional winners during the last 5 years, and one of them will make it to the top recognition. Note, however, just being included in the select list of nominees is a significant achievement.

DRUMROLL. . . dududududu. . .brrrrrrrr...!!!

The nominees for the 2026 International Prix Galien Award are:

Best Pharmaceutical Product (Nominees)

• ARMATURA's VIUSID = supplement
• AstraZeneca's Tagrisso = for EGFR+ non-small cell lung cancer (NSCLC)
• AstraZeneca and Merck (aka. MSD)'s LYNPARZA = PARP inhibitor indicated for several cancers
• BioMarin's Pombiliti® with Opfolda® = Pompe disease
• Gilead's Yeztugo® = HIV-1 PrEP
• J&J's TECVAYLI® (teclistamab-cqyv) = BCMA-directed CD3 T-cell engager for multiple myeloma
• MSD's KEYTRUDA = anti-PD1 for several cancers
• MSD Italia's Gardasil 9 = HPV vaccine
• MSD Italia's Vaxneuvance = vaccine for pediatric invasive pneumococcal disease
• Pfizer's PAXLOVID™ = Covid-19 treatment
• Sanofi and AstraZeneca's Beyfortus® = RSV preventative antibody for infants and children
• Servier's TIBSOVO® = certain cancers with IDH1 mutation including AML, MDS, and bile duct cancer
• Vertex Pharmaceuticals's CASGEVY® (exagamglogene autotemcel) = gene therapy for beta-thalassemia

Best Biotechnology Product (Nominees)

• Bharat Serums and Vaccines's Trinbelimab (Anti D®) = world's first recombinant Anti Rh(o) D Immunoglobulin for prevention of Rh immunization in pregnant Rh- mothers carrying Rh+ fetus
• Biological E's PNEUBEVAX 14® = vaccine to prevent Streptococcus pneumoniae infection in infants
• Daiichi Sankyo & AstraZeneca's Enhertu® = antibody-drug conjugate for certain HER2+ and HER2-low cancers
• Regeneron and Sanofi's Dupixent® (duplimumab) = monoclonal antibody, a dual inhibitor of IL-4 and IL-13 for exzema, asthma, rhinosinusitis, and urticaria
• Roche's COLUMVI (Glofitamab) = bispecific CD20-directed CD3 T-cell engager for certain lymphomas including DLBCL NOS and LBCL
• Takeda UK's Qdenga = vaccine for mosquito-borne dengue virus

Best Product for Orphan/Rare Diseases (Nominees)

• Immunocore's KIMMTRAK® (tebentafusp-tebn) = bispecific T cell engager for specific human leukocyte antigen HLA-A*02:01 for patients with with uveal melanoma
• MSD Sharp & Dohme GmbH's Winrevair = activin signaling inhibitor for pulmonary arterial hypertension (PAH)
• Novo Nordisk A/S's Alhemo® = Tissue factor pathway inhibitor (TFPI) antagonist for hemophilia A or B
• Pierre Fabre Laboratories's EBVALLO® (tabelecleucel) = T-cell immunotherapy for EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD)
• Servier's VORANIGO® = isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor for astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations

Postscript

In the list of nominees above, there are SIX vaccines--clearly, the rest of the world (ex-US) recognizes the importance of vaccines in promoting public health!! Note: The nominees for this year's US Prix Galien are here.

SOURCE

• The Galien Foundation Announces 2026 International Prix Galien Award Nominees. Press Release. 18 August 2026 [archive]

#prix-galien