Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Shots:The EC has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference productApproval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…

ByRidhi RastogiApril 30, 2026

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Chiesi Group to Acquire KalVista Pharmaceuticals for ~$1.9B

Shots:Chiesi Group has entered into a definitive agreement to acquire KalVista Pharmaceuticals, expanding Chiesi's rare immunology portfolioAs per the deal, Chiesi will acquire KalVista for $27/share, representing the total deal value of ~$1.9B, with the transaction expected to close in Q3’26 & remaining shares acquired later via a second-step mergerUpon completion, Chiesi…

ByRidhi RastogiApril 30, 2026

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Teva to Acquire Emalex Biosciences for ~$900M

Shots:Teva has entered into a definitive agreement to acquire Emalex Biosciences, incl. its lead asset, ecopipam, expanding its neuroscience pipeline & accelerating Teva’s pivot to growth strategyAs per the deal, Teva will acquire Emalex for $700M upfront, & ~$200M in commercial milestones, plus royalties on global net sales of ecopipam, subject to regulatory approval; closing is expected in Q3’26…

ByRidhi RastogiApril 29, 2026

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HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

Shots:The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED's sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatmentNDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had…

ByRidhi RastogiApril 29, 2026

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InnoCare Doses First Patient with Orelabrutinib in P-III Trial for Systemic Lupus Erythematosus

Shots:InnoCare has dosed the first patient with orelabrutinib in the P-III trial for the treatment of systemic lupus erythematosus (SLE), assessing its efficacy & safety against PBO, with the SRI-4 response rate at Wk. 52 as the 1EP Orelabrutinib was assessed in the P-IIb trial, which met its 1EP, where orelabrutinib (75mg, QD) showed…

ByRidhi RastogiApril 29, 2026

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Kestrel Therapeutics Inks AbbVie Deal Worth up to $1.45B with Option to Acquire

Shots:Kestrel has entered into a strategic agreement with AbbVie, structured as a warrant deal, granting AbbVie an exclusive option to acquire Kestrel upon achievement of key development milestonesAs per the deal, AbbVie will fund development of KST-6051, with an exclusive option to acquire Kestrel based on development & regulatory milestone completion, representing the…

ByRidhi RastogiApril 29, 2026

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Profluent Signs ~$2.25B Pact with Eli Lilly to Advance AI-Designed Recombinases for Genetic Medicines

Shots:Profluent has entered into a multi-program strategic research collaboration with Eli Lilly to develop & commercialize custom site-specific recombinases to address diseases with unmet needsAs per the deal, Profluent will use its AI models to design & optimize site-specific recombinases for multiple genomic targets, while Lilly will gain exclusive rights to selected assets…

ByRidhi RastogiApril 29, 2026

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CareDx to Acquire Naveris for ~$260M

Shots:CareDx has entered into a definitive agreement to acquire Naveris, extending CareDx’s Precision Medicine Testing Services strategy into specialty oncologyAs per the deal, CareDx will acquire Naveris for $160M upfront & up to $100M in revenue milestones; closing is expected in Q3’26Naveris’ liquid biopsy platform uses TTMV DNA to detect viral DNA…

ByRidhi RastogiApril 29, 2026

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The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

Shots:The US FDA has accepted NDA & granted priority review as well as BTD to GSK's bepirovirsen for the treatment of adults with chronic hepatitis B (CHB)NDA & designation were supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline…

ByRidhi RastogiApril 28, 2026

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AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma

Shots:The US FDA has approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) for the maintenance treatment of asthma in pts (≥12yrs.); regulatory review is ongoing in the EU, Japan & ChinaApproval was based on the P-III (LOGOS & KALOS) trials evaluating Breztri Aerosphere vs PT009, Symbicort, and PT009 + Symbicort in ~4,300…

ByRidhi RastogiApril 28, 2026

Ridhi Rastogi

Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Chiesi Group to Acquire KalVista Pharmaceuticals for ~$1.9B

Teva to Acquire Emalex Biosciences for ~$900M

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

InnoCare Doses First Patient with Orelabrutinib in P-III Trial for Systemic Lupus Erythematosus

Kestrel Therapeutics Inks AbbVie Deal Worth up to $1.45B with Option to Acquire

Profluent Signs ~$2.25B Pact with Eli Lilly to Advance AI-Designed Recombinases for Genetic Medicines

CareDx to Acquire Naveris for ~$260M

The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma

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