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INSIGHTS+

The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
1 hour ago

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NEWS

GSK to Acquire Nuvalent for ~$10.6B

Shots: GSK has entered an agreement to acquire Nuvalent, accelerating its entry into lung cancer As per the deal, GSK will acquire Nuvalent through a tender offer of $124 per share in cash, valuing the company at ~$10.6B (£8.0B); net of acquired cash, GSK’s total investment is estimated at $9.4B (£7.1B). Closing is expected in…
7 hours ago

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VIEWPOINTS

Jared Kelly on Immune Priming & Survival Outcomes: Oncolytics Biotech’s Vision for Pelareorep

Shots:  Oncolytics Biotech is advancing pelareorep beyond the traditional standalone therapy model, positioning the platform as a potential immune-priming backbone capable of enhancing immunotherapies, checkpoint inhibitors, chemotherapies, and other oncology treatments across multiple difficult-to-treat tumor settings.  The company continues generating growing survival and immune-engagement data across colorectal, pancreatic, and anal cancers, while emphasizing pelareorep’s potential to “turn cold tumors…
June 3, 2026

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NEWS

Oncolytics Biotech Reports Initial Preclinical Data of Pelareorep with RAS Inhibitors

Shots: Oncolytics has reported initial data from a preclinical study assessing pelareorep, a systemically active immunotherapy, in combination with RAS inhibitor modalities, which showed greater anti-tumor activity in a solid tumor model vs either therapy alone Based on the findings, Oncolytics is planning additional studies of the combination in pancreatic ductal adenocarcinoma & colorectal cancer…
June 3, 2026

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INSIGHTS+

Key Biosimilars Events of May 2026 

Shots:  May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.  Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.  Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
June 2, 2026

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NEWS

Pfizer and Innovent Biologics Partner to Accelerate 12 Oncology Programs in a Deal Valued at ~$10.5B

Shots:   Innovent will advance the early-stage & de novo cancer therapies, incl. ADCs through P-I before Pfizer assumes global development, with Pfizer securing exclusive global rights to 4 programs & will be responsible for the global development costs Also, Pfizer will obtain exclusive ex-Greater China rights to 4 additional programs & fund the majority of development…
May 29, 2026

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THOUGHTSPOT

Is Immune Priming the Missing Piece in Oncology? Oncolytics Biotech Thinks So

The oncology landscape is increasingly recognizing that the future of cancer treatment may depend just as much on immune engagement and combination strategies as on standalone therapeutic activity.  That shift in thinking is shaping much of the scientific attention surrounding pelareorep, the lead immunotherapeutic candidate being advanced by Oncolytics (NASDAQ: ONCY).  For years, oncology drug candidates were largely evaluated through…
May 28, 2026

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NEWS

Olympus to Acquire BioProtect for ~$270M

Shots: Olympus has entered into a definitive agreement to acquire BioProtect, incl. its Balloon Spacer system designed to protect healthy tissue during prostate cancer radiotherapy As per the agreement, Olympus will acquire BioProtect in a deal valued at ~$270M, with certain amounts held in escrow subject to uninterrupted business operations; closing is expected by the…
May 26, 2026

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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…
May 19, 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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