AstraZeneca bets up to $2B on Jacobio’s pan-KRAS inhibitor for cancer
Ayisha Sharma / endpoints - AstraZeneca is spending $100 million upfront to secure ex-China rights for an early-stage cancer drug developed by Jacobio Pharma. The UK drugmaker will be responsible for advancing and selling the oral pan-KRAS inhibitor, JAB-23E73, in ...
AI Summary: Reports indicate that AstraZeneca has struck a global licensing agreement with Jacobio Pharma for its investigational pan‑KRAS inhibitor. With a deal value of up to $2 billion and an upfront commitment, the move is set to reinforce AstraZeneca’s oncology pipeline with next‑generation targeted therapy.
Sanofi buys hepatitis B vaccine maker Dynavax for $2.2B; gets CRL for MS drug
Elizabeth Cairns / endpoints - Sanofi is set to supplement its vaccine offering with the acquisition of Dynavax Technologies for $2.2 billion in cash, the companies said Wednesday. Separately, Sanofi said the ...
AI Summary: Two separate reports confirm that Sanofi has completed a $2.2 billion deal to acquire Dynavax Technologies. This strategic move strengthens Sanofi’s vaccine lineup by adding a commercially proven hepatitis B vaccine and a clinical‐stage shingles candidate, positioning the company for enhanced market competitiveness amid global pressures.
FDA Approved Rucaparib for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
oncodaily - On December 17, 2025, the FDA issued a regular approval for rucaparib (Rubraca®), marking the formal conversion of its earlier accelerated authorization into full approval for BRCA-mutated metastatic castration-resistant prostate […]
AI Summary: The FDA has granted full approval to rucaparib (Rubraca®) for treating adults with BRCA‐mutated metastatic castration‐resistant prostate cancer, converting its prior accelerated approval into standard approval. This landmark decision offers a new treatment option for patients with this genetic profile.
Carolyn Bertozzi Returns to Eli Lilly and Company Board of Directors 2025
oncodaily - Eli Lilly and Company has announced the election of Carolyn R. Bertozzi, Ph.D., as a returning member of its Board of Directors, effective December 8, 2025. In her renewed role, […]
AI Summary: Eli Lilly has announced the return of renowned scientist Carolyn Bertozzi to its Board of Directors. Her comeback underscores the company’s commitment to a research‐intensive strategy and reinforces its focus on cutting–edge oncology and other therapeutic innovations.
FDA approves 1st gene therapy for Wiskott-Aldrich syndrome
Ella Jeffries / beckershospitalreview - The FDA has approved Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome, a rare and life-threatening immune disorder. Waskyra is indicated for pediatric patients 6 months and older, as well as adults with Wiskott-Aldri…
AI Summary: In a landmark decision, the FDA approved Waskyra – the first gene therapy for Wiskott‐Aldrich syndrome – offering new hope for patients with this rare and life‐threatening immune disorder. The agency’s flexible approach in handling rare disease treatments marks a turning point in precision medicine.
Novel Endocrine Therapy Giredestrant Improves Disease-free Survival Over Standard of Care for Patients With Early-stage Breast Cancer in Phase III lidERA Trial
Kathleen Medora / aacr - SAN ANTONIO – The investigational, oral selective estrogen receptor degrader (SERD) giredestrant given as an adjuvant therapy showed significant improvement in invasive disease-free survival (iDFS) compared with the current standard-of-care endocrine ther…
AI Summary: An international Phase III trial led by UCLA reveals that giredestrant, a novel endocrine therapy, significantly reduces recurrence risk in early‐stage breast cancer compared with standard care. The robust findings promise to shift hormonal treatment paradigms—even if skeptics may raise a wry eyebrow at yet “another” incremental advance in a crowded field.
Startup Protego Bio Lands $130M for First-in-Class Drug’s Pivotal Test in Rare Plasma Disorder
Frank Vinluan / medcitynews - Protego Biopharma’s lead program is a potential treatment for the rare disease light chain amyloidosis. The startup says the novel mechanism of its oral small molecule should have better outcomes than antibodies from AstraZeneca and Prothena that failed t…
AI Summary: Two reports reveal that Protego Bio has raised $130M to fund pivotal clinical testing of its novel therapy for AL amyloidosis, a rare plasma disorder. This funding milestone, backed by industry leaders, marks a significant advance in treatment options for a challenging condition.
A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes
fiercehealthcare - Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.
AI Summary: A dozen former FDA commissioners have fiercely criticized the proposed overhaul of U.S. vaccine regulations spearheaded by FDA official Vinay Prasad, warning it could undermine decades‐old safety standards and erode public trust in immunization.
FDA approves all ages gene therapy for spinal condition
Ella Jeffries / beckershospitalreview - The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and adults. The therapy is designed to address the genetic …
AI Summary: The FDA has given the green light to Novartis’ gene replacement therapy Itvisma for the treatment of spinal muscular atrophy, a development that extends its use to patients of all ages. The approval, which responds to long‐standing concerns over safety and patient eligibility, marks a significant milestone in SMA care.
Novo submits high-dose Wegovy for FDA approval using voucher
Max Bayer / endpoints - Novo Nordisk submitted a higher dose of its obesity drug Wegovy for FDA approval and is using a recently-won voucher to expedite the review. The company said Wednesday that it submitted ...
AI Summary: Novo Nordisk has formally submitted its application to the FDA to approve a higher-dose formulation of its flagship obesity drug, Wegovy. Leveraging a recently secured priority voucher, the filing is set to potentially expand treatment options for weight management as the review process begins.
Novo Nordisk GLP-1 fails to slow Alzheimer’s in trials
Ella Jeffries / beckershospitalreview - Novo Nordisk’s GLP-1 drug semaglutide did not demonstrate a statistically significant effect in slowing progression of Alzheimer’s disease in two late-stage clinical trials. According to a Nov. 24 news release from the company, two double-blinded, placebo…
AI Summary: Novo Nordisk’s much‑talked‑about GLP‑1 drug, famed for its weight‐loss benefits, has hit an unexpected wall in Alzheimer’s trials. In two separate reports – one on the standard injectable and another on a pill form – semaglutide showed no statistically significant impact on slowing brain decline. Who knew obesity meds couldn’t multitask?
New nasal nanodrops wipe out brain tumors in mice
sciencedaily - A new nasal-delivered nanotherapy shows promise against aggressive glioblastoma tumors. By activating the STING immune pathway using gold-core spherical nucleic acids, researchers were able to reach the brain without invasive surgery. When paired with dru…
AI Summary: A novel nasal‐delivered nanotherapy that triggers the STING immune pathway via gold‐core nanoparticles has been shown in mice to nearly wipe out aggressive brain tumors. This noninvasive approach offers hope for a radically new treatment modality in glioblastoma.
FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukaemia with a NPM1 Mutation
esmo - Evidence for efficacy is based on the results from the KO-MEN-001 study
AI Summary: The FDA has granted full approval for ziftomenib—a novel agent aimed at treating relapsed or refractory acute myeloid leukemia, especially in patients with NPM1 mutations. Backed by the KO‐MEN‐001 trial data, this decision marks a significant step forward for a patient group in dire need of new therapeutic options.
Novo Nordisk rolls out lower prices for Ozempic and Wegovy
medicalxpress - People paying out of pocket for Ozempic or Wegovy may soon see lower costs, as Novo Nordisk rolls out new price discounts for its popular GLP-1 medications.
AI Summary: In a bid to ease the financial burden on self‐pay patients, Novo Nordisk has unveiled deep price cuts for its flagship GLP-1 drugs, Ozempic and Wegovy. The new pricing strategy comes amid intensifying market pressures and aims to broaden access to these critical therapies for weight management and type 2 diabetes.
Mikael Dolsten removes himself from board candidacy at Novo; Bavarian Nordic chairman resigns
Alex Hoffman / endpoints - → In what appears to be another blow to Novo Nordisk, ex-Pfizer CSO Mikael Dolsten has withdrawn his nomination to join the company's board of directors due to ...
AI Summary: Merck has made a blockbuster move by finalizing a $9.2 billion deal to acquire Cidara Therapeutics’ late‐stage anti‐influenza candidate. This acquisition underscores Merck’s commitment to expanding its antiviral portfolio and marks a key strategic investment in advancing flu prevention amid evolving global health threats.
FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths
go - The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year
AI Summary: The FDA has revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy, adding a boxed safety warning and stricter usage conditions following reports of two patient deaths. The update reflects mounting safety concerns that have prompted closer regulatory oversight.
Bacteria Inside Brain Tumors May Affect Tumor Behavior
oncodaily - Traces of bacteria inside brain tumors may affect tumor behavior Researchers found bacterial genetic and cellular elements inside brain tumor cells that appear biologically active and may influence tumor progression […]
AI Summary: Researchers discovered unexpected traces of bacteria within brain tumors, suggesting these microbial signals might influence tumor progression. The findings, detailed in two nearly identical reports, could open new avenues for targeted therapies and a deeper understanding of the tumor microenvironment.
Pfizer’s Sweeter $10B Offer Beats Novo Nordisk in Bidding War for Obesity Biotech Metsera
Frank Vinluan / medcitynews - Pfizer’s offer of up to $86.25 in cash for each share of obesity drugs developer Metsera share tops the up to $86.20 Novo Nordisk was willing to pay. The financial consideration and the greater certainly of a deal close tipped the balance in Pfizer’s favo…
AI Summary: In a dramatic showdown over obesity biotech firm Metsera, Pfizer’s up-to-$10B cash offer edged out Novo Nordisk’s bid. The fiercely competitive deal highlights the high stakes and intense market focus on innovative therapeutics in obesity management.
Pfizer poised to buy Metsera in $10 bn deal after bidding war
medicalxpress - Pfizer was poised to seal a takeover of Metsera on Saturday after its improved offer won over the biotechnology startup's board and Danish challenger Novo Nordisk called a halt to a back-and-forth bidding war.
AI Summary: In a dramatic bidding war for a promising biotech startup, Pfizer’s improved $10 billion offer prevailed—until Novo Nordisk raised its bid yet again. This high-stakes takeover tussle underscores the fierce competition and strategic importance of emerging therapies.