Oculis to Acquire Full Global Rights to Privosegtor from Accure Therapeutics

Shots: Oculis will acquire Accure’s worldwide development & commercial rights to Privosegtor (ACT-01), terminating its existing license & giving Oculis greater control and economic upside as the neuro-ophthalmology asset advances Deal also incl. ACT-02, a preclinical neurology candidate. Total consideration incl. $3.8M upfront cash & ~2.05M Oculis shares, incl. milestone-linked shares. Closing is expected by…

ByRidhi RastogiAugust 10, 2026

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Samsung Bioepis Launches Opuviz 40 mg/mL PFS (Biosimilar, Eylea) in the EU

Shots: Samsung Bioepis has reported the commercial launch of Opuviz 40 mg/mL solution (PFS), a biosimilar version of Eylea (aflibercept) across the EU Opuviz (aflibercept) is a VEGF inhibitor that blocks abnormal blood vessel growth and leakage in the eye. Samsung Bioepis launched the 40 mg/mL vial in May’26. The PFS formulation received a positive CHMP opinion in Nov’25 for the same indications Opuviz 40…

ByRidhi RastogiAugust 10, 2026

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Innate Pharma Collaborates with Sobi to License Lacutamab in Cutaneous T-cell Lymphoma (CTCL)

Shots: Innate Pharma & Sobi have entered into a strategic partnership to initiate P-III (TELLOMAK-3) trial of lacutamab in CTCL, supporting a planned accelerated approval filing in Sézary syndrome TELLOMAK-3 is expected to support full approval filings in Sézary syndrome & mycosis fungoides. Sobi will gain exclusive global commercialization rights upon potential accelerated approval &…

ByRidhi RastogiAugust 10, 2026

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Almirall Partners with CrystalO to Advance Novel Small Molecules in Medical Dermatology

Shots: Almirall & CrystalO have partnered to advance drug discovery research in medical dermatology, leveraging CrystalO's scientific expertise in ion channels with Almirall's experience in medical dermatology R&D As per the deal, CrystalO will use its AI & structure-based drug discovery platform for compound discovery, optimization, IND-enabling studies, & early clinical development through PoC. Almirall…

ByRidhi RastogiAugust 10, 2026

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Elanco’s CLiK Extra Secures US FDA EUA for New World Screwworm (NWS) Prevention

Shots: FDA has granted Emergency Use Authorization for CLiK Extra (dicyclanil topical suspension) wound spray to prevent NWS infestations in livestock & select captive and wild animal species The spray can be applied around wounds, including those caused by birth or surgery, in sheep, cattle, goats, swine, camelids and several cervid and bison species. It…

ByRidhi RastogiAugust 10, 2026

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Innovent and Daiichi Sankyo Partner to Commercialize Vanflyta in China

Shots: Innovent Biologics has entered into an exclusive agreement with Daiichi Sankyo to commercialize Vanflyta (quizartinib) in China As per the deal, Daiichi Sankyo will handle the development, manufacturing & supply of Vanflyta while Innovent will hold sole commercialization rights for Vanflyta in China Vanflyta was approved in China in Jun’26 for newly diagnosed FLT3-ITD-positive AML in…

ByRidhi RastogiAugust 10, 2026

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Health Canada Approves Regeneron’s Libtayo for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma

Shots: Health Canada has approved Libtayo (cemiplimab) for the adj. treatment of adults with CSCC who are at high risk for recurrence after surgery & radiation Approval was based on the P-III (C-POST) trial assessing adj. Libtayo (n=209) vs PBO (n=206) to treat high-risk CSCC pts (N=415) Trial showed a 68% reduction in disease recurrence…

ByRidhi RastogiAugust 7, 2026

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US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

Shots: FDA has accepted the sBLA of Enflonsia to prevent RSV lower respiratory tract disease (LRTD) in children (<2yrs.) at increased risk for severe RSV disease through their second RSV season (PDUFA: Mar 22, 2027); application is also under EMA review Submissions were supported by P-III (SMART/MK-1654-007) trial assessing Enflonsia in infants & children over…

ByRidhi RastogiAugust 7, 2026

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Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

Shots: Co-Diagnostics submitted a Dual FDA 510(k) premarket notification with a concurrent CLIA Waiver application for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro platform Submission was backed by clinical & analytical performance studies, incl. study of over 1,400 symptomatic pts across 9 US sites, & 27…

ByRidhi RastogiAugust 7, 2026

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Bavarian Nordic Reports EC Approval of Imvanex Against Smallpox & Mpox for Children Aged 2 to Less than 12 Years

Shots: The EC has approved type II variation MAA for Imvanex (MVA-BN) smallpox & mpox vaccine, extending its use to include children aged 2 to less than 12yrs. Approval was based on P-II trial data involving 227 children (2 to <12yrs.) & 224 adults, which showed non-inferior immune responses & a similar safety profile in children…

ByRidhi RastogiAugust 7, 2026

Ridhi Rastogi

Oculis to Acquire Full Global Rights to Privosegtor from Accure Therapeutics

Innate Pharma Collaborates with Sobi to License Lacutamab in Cutaneous T-cell Lymphoma (CTCL)

Almirall Partners with CrystalO to Advance Novel Small Molecules in Medical Dermatology

Elanco’s CLiK Extra Secures US FDA EUA for New World Screwworm (NWS) Prevention

Innovent and Daiichi Sankyo Partner to Commercialize Vanflyta in China

Health Canada Approves Regeneron’s Libtayo for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

Bavarian Nordic Reports EC Approval of Imvanex Against Smallpox & Mpox for Children Aged 2 to Less than 12 Years

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