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INSIGHTS+

EMA Marketing Authorization of New Drugs in April 2026    

Shots:  The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma  CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS  The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…
3 days ago

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MAGAZINE

PharmaShots Magazine-May-2026 Edition

Shots: PharmaShots’ May Edition explores how AI is transforming commercial strategies across the healthcare ecosystem by enabling predictive analytics, personalized engagement, dynamic launch planning, and real-time omnichannel optimization while balancing compliance and measurable ROI. The magazine highlights key industry movements shaping global biopharma, including AI-driven drug discovery collaborations, strategic M&A activity, advancements in cell and…
May 14, 2026

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NEWS

BMS Partners with Hengrui Pharma in a Potential ~$15.2B Deal to Advance 13 Early-Stage Programs Across Oncology, Hematology, and Immunology

Shots: BMS has partnered with Hengrui to advance 13 early-stage programs, incl. 4 Hengrui onco/hemo assets, 4 BMS immunology assets, and 5 jointly discovered & developed candidates; expected to close in Q3’26 Hengrui will lead early clinical development, while BMS gains ex-China rights to Hengrui-originated assets & Hengrui will secure exclusive Greater China rights to…
May 12, 2026

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INSIGHTS+

Key Biosimilars Events of April 2026 

Shots:  Regulatory momentum stayed strong in April 2026, with key approvals including Poherdy (EC), Tuyory (EC), and multiple denosumab biosimilars in Canada, alongside NMPA IND clearances for Henlius’ HLX319 and HLX05-N and Mabwell’s Maiweijian sBLA acceptance.  Strategic activity expanded globally through Mochida–Qilu and Mabwell partnerships, while major M&A deals, Amneal–Kashiv and Sun Pharma–Organon, signaled growing biosimilar consolidation.  Pipelines and commercialization progressed with CuraTeQ’s P-III success for BP11 and Biocon’s US launch of Bosaya and Aukelso,…
May 5, 2026

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NEWS

UCB to Acquire Candid Therapeutics for ~$2.2B

Shots:  UCB has entered into a definitive agreement to acquire Candid Therapeutics, expanding its immunology pipeline with novel T-cell engagers (TCE) As per the deal, UCB will acquire Candid for $2B upfront & ~$200M in potential future milestone payments; closing is expected by end of Q2 or early Q3’26 Acquisition will add cizutamig, a BCMA…
May 4, 2026

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NEWS

Cue Biopharma Licenses Ascendant-221 from Ascendant Health Sciences in a ~$691.5M Deal

Shots: Cue Biopharma has entered into an exclusive license agreement with Ascendant Health Sciences to develop, manufacture and commercialize Ascendant-221 for the treatment of allergic diseases As per the deal, Cue will obtain global rights (excl. Greater China) to develop & commercialize Ascendant-221 in exchange for $15M upfront license fee, ~$676.5M in development, regulatory &…
May 1, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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INSIGHTS+

Key Biosimilars Events of March 2026 

Shots:  Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.  Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
April 7, 2026

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