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PharmaShots

PharmaShots

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Summarized, fast reads on pharma/biotech, devices and life sciences news.

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CPHI Middle East 2026 | 11-13 May, Riyadh
News•Mar 2, 2026

CPHI Middle East 2026 | 11-13 May, Riyadh

CPHI Middle East will return to Riyadh in May 2026, building on the 2024 edition that attracted over 30,000 visitors from more than 100 countries. The event promises expanded networking opportunities, direct market access, and the latest regulatory and innovation insights across the pharmaceutical supply chain. Organisers aim to showcase a broader portfolio of products and services, positioning the show as a hub for Middle Eastern pharma growth. Stakeholders anticipate heightened collaboration between multinational firms and regional players.

By PharmaShots
Vueway Expands Pediatric Use: Alberto Spinazzi Shares Bracco Group’s Vision
News•Mar 2, 2026

Vueway Expands Pediatric Use: Alberto Spinazzi Shares Bracco Group’s Vision

The European Union has granted approval for Vueway (gadopiclenol) to be used in neonates, infants, and toddlers, marking a pivotal expansion of pediatric MRI contrast agents. Vueway delivers diagnostic‑grade imaging at half the dose of conventional macrocyclic GBCAs, thanks to...

By PharmaShots
Zymeworks Raises $250M From Royalty Pharma Backed by Ziihera Royalties
News•Mar 2, 2026

Zymeworks Raises $250M From Royalty Pharma Backed by Ziihera Royalties

Zymeworks announced a $250 million non‑recourse, royalty‑backed note from Royalty Pharma, secured against 30% of worldwide tiered royalties on its Ziihera program licensed to Jazz Pharmaceuticals and BeOne Medicines. The note will be repaid until Royalty Pharma receives 1.65 times the principal...

By PharmaShots
Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia
News•Mar 2, 2026

Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia

The U.S. FDA granted accelerated approval to Ascendis’ Yuviwel (navepegritide) for increasing linear growth in children aged two years and older with achondroplasia and open epiphyses. Approval rests on three placebo‑controlled trials and up to three years of open‑label extension...

By PharmaShots
X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome
News•Mar 2, 2026

X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome

X4 Pharmaceuticals’ Xolremdi (mavorixafor) received a positive opinion from the European CHMP, recommending approval under exceptional circumstances with an EC decision expected in Q2 2026. The recommendation is based on the global Phase III 4WHIM trial involving 31 patients aged 12 and...

By PharmaShots
Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)
News•Mar 2, 2026

Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending conditional approval of Ipsen’s Ojemda (tovorafenib) as monotherapy for pediatric low‑grade glioma with BRAF fusions, rearrangements or V600 mutations. The recommendation is based on...

By PharmaShots
Zymeworks Secures $250M Royalty‑Backed Note From Royalty Pharma
Deals•Mar 2, 2026

Zymeworks Secures $250M Royalty‑Backed Note From Royalty Pharma

Zymeworks has raised $250 million from Royalty Pharma through a non‑recourse royalty‑backed note, with repayments tied to a share of worldwide royalties on its Ziihera product sold by Jazz Pharmaceuticals and BeOne Medicines. The note will be repaid until Royalty Pharma...

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Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia
News•Feb 27, 2026

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Ionis Pharmaceuticals received FDA acceptance of its supplemental NDA for olezarsen and a priority‑review designation, with a PDUFA action date of June 30, 2026. The decision is backed by two Phase III CORE studies—CORE (n=617) and CORE2 (n=446)—that evaluated once‑monthly subcutaneous...

By PharmaShots
Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases
News•Feb 27, 2026

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

Bayer announced that its phase‑III PEACE‑3 trial demonstrated a statistically significant overall‑survival benefit for the combination of Xofigo (radium‑223) and enzalutamide versus enzalutamide alone in patients with metastatic castration‑resistant prostate cancer (mCRPC) and bone metastases. Median overall survival extended to...

By PharmaShots
Post-Conference Highlights | 2026 ViVE | Feb 22–25 | Los Angeles, CA
News•Feb 26, 2026

Post-Conference Highlights | 2026 ViVE | Feb 22–25 | Los Angeles, CA

ViVE 2026 in Los Angeles marked a decisive shift from digital ambition to operational accountability across the health ecosystem. Leaders emphasized that AI adoption now hinges on governance, measurable ROI, and clinician trust, while interoperability is being treated as core...

By PharmaShots
Cara Medical Reports 510(k) Clearance of CARA System for Noninvasive Cardiac Conduction System Visualization
News•Feb 26, 2026

Cara Medical Reports 510(k) Clearance of CARA System for Noninvasive Cardiac Conduction System Visualization

Cara Medical announced that the U.S. FDA granted 510(k) clearance for its CARA System, a non‑invasive solution that creates patient‑specific 3‑D visualizations of the cardiac conduction system using CTA data. The platform pairs the CARA Metis™ Simulator for pre‑procedural mapping...

By PharmaShots
GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus
News•Feb 26, 2026

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

GlaxoSmithKline announced that China’s National Medical Products Administration has accepted the New Drug Application for linerixibat and placed it under priority review for treating cholestatic pruritus in primary biliary cholangitis (PBC). The filing is backed by the Phase III GLISTEN trial,...

By PharmaShots
Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs
News•Feb 26, 2026

Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs

Merck Animal Health announced that the U.S. FDA has approved Numelvi (atinvicitinib) for controlling pruritus linked to allergic dermatitis in dogs six months and older, with commercial availability slated for spring 2026. Numelvi is a second‑generation JAK inhibitor that demonstrates...

By PharmaShots
Argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)
News•Feb 26, 2026

Argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)

argenx announced topline Phase III ADAPT OCULUS data for Vyvgart (efgartigimod alfa + hyaluronidase‑qvfc) in adults with ocular myasthenia gravis. The trial met its primary endpoint, delivering a 4.04‑point improvement in Myasthenia Impairment Index PRO ocular scores versus 1.99 points for placebo at...

By PharmaShots
IDEAYA Biosciences Reports the First Patient Enrolment in P-I Trial of IDE034
News•Feb 25, 2026

IDEAYA Biosciences Reports the First Patient Enrolment in P-I Trial of IDE034

IDEAYA Biosciences announced the enrollment of the first patient in a Phase‑I dose‑escalation and expansion study of IDE034, a bispecific B7H3/PTK7 TOP1 antibody‑drug conjugate for solid tumours. The trial will assess safety, tolerability and pharmacokinetics of IDE034 as a monotherapy...

By PharmaShots
SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America
News•Feb 25, 2026

SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America

SteinCares has signed a strategic licensing agreement with Shilpa Biologicals to commercialize a biosimilar across Latin America. Under the deal, SteinCares receives exclusive rights to register, market and distribute the product throughout the region, while Shilpa Biologicals will complete development...

By PharmaShots
Candel Therapeutics Secures $100M Royalty Funding From RTW Investments
Deals•Feb 20, 2026

Candel Therapeutics Secures $100M Royalty Funding From RTW Investments

Candel Therapeutics announced a $100 million royalty financing agreement with RTW Investments to support the launch of its gene therapy Aglatimagene Besadenovec for localized prostate cancer. The deal grants RTW a capped, tiered royalty on U.S. net sales, contingent on...

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