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By PharmaCompass
2025-12-18
Impressions: 347 Article || 1 Video || 3 Listen
As the year draws to a close, the US Food and Drug Administration (FDA) appears busy approving drugs at a fast pace. This week, it approved the first biologic, add-on maintenance therapy for severe, difficult to treat asthma.
In oncology, the agency expanded the approval of Johnson & Johnson’s Akeega (niraparib and abiraterone acetate) for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. It also okayed the combination of AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) and Roche’s Perjeta (pertuzumab) as a first-line treatment for unresectable or metastatic HER2-positive breast cancer.
Additionally, it approved Milestone Pharmaceuticals’ Cardamyst (etripamil) nasal spray to treat acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT), a type of abnormal heart rhythm. The week also saw two approvals for gonorrhea — FDA expanded the label of GSK’s Blujepa (gepotidacin) for gonorrhea and approved Innoviva’s oral antibiotic Nuzolvence (zoliflodacin) to treat uncomplicated gonorrhea.
In deals, Sobi agreed to acquire Arthrosi Therapeutics for up to US$ 1.5 billion to bolster its gout pipeline. US-based Yarrow Bioscience struck a licensing deal worth up to US$ 1.37 billion for a China-developed autoimmune thyroid antibody, and Sanofi signed a pact with South Korea’s Adel for an Alzheimer’s antibody therapy.
In regulatory news, FDA issued an ‘Official Action Indicated’ status to Sun Pharma’s Baska manufacturing facility in Gujarat. And the White House is reportedly preparing deals with more drugmakers as part of its “most favored nation” (MFN) pricing push.
FDA approves GSK’s Exdensur — first biologic to treat eosinophilic asthma
FDA has approved GSK’s Exdensur (depemokimab) as an add-on maintenance treatment for patients aged 12 and older with eosinophilic asthma, a severe, difficult to treat asthma. The drug becomes the first biologic for asthma that is dosed twice a year. Earlier this week, the UK had approved Exdensur for both asthma and nasal polyps.
Okays Milestone’s nasal spray for heart disease: FDA has approved Milestone Pharmaceuticals’ Cardamyst (etripamil) nasal spray to treat acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT), a type of abnormal heart rhythm. This is Milestone’s first FDA approval, and Cardamyst is the first self-administered treatment that allows patients to manage PSVT episodes outside of a hospital setting.
Clears two drugs for gonorrhea: FDA has approved a label expansion for GSK’s Blujepa (gepotidacin), introducing a new class of treatment to gonorrhea for the first time in over 30 years. The approval allows oral use in adults and pediatric patients (aged 12 and older) when standard injectable therapy is contraindicated or not tolerated. The agency also approved Innoviva’s oral antibiotic Nuzolvence (zoliflodacin) to treat uncomplicated gonorrhea. The approval addresses growing antibiotic resistance, as gonorrhea has become resistant to most available treatments.
FDA clears J&J’s Akeega for prostate cancer, Enhertu-Perjeta combo for breast cancer
Johnson & Johnson has received FDA approval to expand the use of Akeega (niraparib and abiraterone acetate) for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. The approval makes Akeega the first precision-medicine combination for this patient group. Patients with BRCA2 mutations often have more aggressive disease.
Enhertu-Perjeta combo: FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Roche’s Perjeta (pertuzumab) as a first-line treatment for unresectable or metastatic HER2-positive breast cancer.
FDA classifies Sun Pharma’s Baska facility in Gujarat as Official Action Indicated
Sun Pharmaceutical Industries has said the FDA has classified its Baska (Gujarat) manufacturing facility as “Official Action Indicated” (OAI), following an inspection conducted from September 8 to 19, 2025. The company said the classification means regulatory or administrative action is recommended based on the inspection findings. Sun Pharma has said it will work with the regulator to bring the facility to full compliance.
Sobi to acquire Arthrosi for up to US$ 1.5 bn to strengthen gout portfolio
Swedish Orphan Biovitrum (Sobi) has agreed to acquire US-based Arthrosi Therapeutics for up to US$ 1.5 billion to expand its gout treatment pipeline. Arthrosi, headquartered in San Diego, is developing an experimental gout therapy that has shown effectiveness in mid-stage trials.
Yarrow in US$ 1.37 bn deal for thyroid antibody: US-based Yarrow Bioscience has licensed an antibody therapy ((GS-098), developed by Shanghai Scizeng Medical Technology (a subsidiary of Changchun GeneScience). The deal is worth up to US$ 1.37 billion. Meanwhile, Yarrow Bioscience and VYNE Therapeutics have entered an all-stock merger to form a combined company, Yarrow Bioscience, focused on advancing the clinical-stage anti-thyroid-stimulating hormone receptor antibody for Graves’ disease and thyroid eye disease.
Sanofi signs licensing deal with South Korea’s Adel for its Alzheimer’s antibody
Sanofi has entered into a licensing agreement with Seoul-based biotech Adel for ADEL-Y01, an experimental antibody therapy for Alzheimer’s disease. Under the deal, Sanofi will pay US$ 80 million upfront to Adel, with potential milestone payments of up to US$ 1.04 billion, plus royalties. ADEL-Y01 targets a specific modified form of the tau protein, which plays a key role in Alzheimer’s and other neurodegenerative diseases.
BMS in deal with China’s Harbour BioMed: Bristol Myers Squibb has entered into a collaboration and licensing agreement with China-based Harbour BioMed to develop multi-specific antibody therapies. Under the deal, BMS will pay Harbour US$ 90 million upfront and could provide up to US$ 1.035 billion more in milestone payments and royalties.
Genentech, Caris in AI-driven cancer drug deal: Roche’s subsidiary Genentech has entered into a partnership with AI-focused Caris Life Sciences to support the discovery and development of new treatments for solid tumors. Under the agreement, Genentech will pay US$ 25 million upfront and could provide up to US$ 1.1 billion in other milestone payments.
White House ‘preparing new deals with drugmakers’ as part of MFN pricing push
In July this year, US President Donald Trump had sent letters to 11 drugmakers demanding they reduce cash-pay prices and give better deals to government programs. This week, a Reuters report citing sources has said the White House is preparing to unveil several new deals with large drugmakers on Friday as part of the administration’s “most favored nation” pricing push.
So far, Pfizer, AstraZeneca, Eli Lilly, Novo Nordisk and EMD Serono have struck deals with the US government. Later this week, AbbVie and four others are expected to announce agreements with the US government.
Affordable Care Act subsidy to expire: The Affordable Care Act subsidy, which was extended in 2021 through 2025-end due to the pandemic, is set to expire. The House passed a healthcare bill this week that did not address expiring Affordable Care Act tax credits. According to estimates, premium payments will increase by an average of US$ 1,016 in 2026.
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