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The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157)
Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…
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The US FDA has granted Fast Track designation to Lu AH69593 for the treatment of patients with narcolepsy
Lu AH69593 is a small-molecule orexin 2 receptor agonist being developed by Lundbeck for narcolepsy to regulate arousal, wakefulness, & sleep-wake stability
Lu AH69593 is being evaluated in a P-Ib clinical program, with Lundbeck continuing to…
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In a thought-provoking conversation with PharmaShots CXO Talks, Venkat Nelabhotla, Co-Founder, President & CEO of Vyome Holdings, discussed how disciplined execution, strategic capital allocation, and focused innovation are shaping the company's approach to developing therapies for high unmet medical needs while strengthening the US–India biotech innovation corridor.
Venkat highlighted Vyome's strategy of leveraging drug…
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Insilico has entered into a multi-target strategic alliance with Bora to combine its Pharma.AI platform with Bora's expertise in drug development, manufacturing, quality, & commercialization
Insilico will provide end-to-end AI solutions and R&D strategies to accelerate Bora’s AI- & automation-driven drug discovery & development, with plans to expand AI across development planning, process optimization,…
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The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment.
Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical…
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PharmaShots' latest report chronicles the transformation of the global biopharma industry from 2006–2025, highlighting how innovation, strategic M&A, AI adoption, and evolving commercialization strategies have reshaped the competitive landscape while companies navigated patent cliffs, pricing pressures, and shifting market dynamics.
The report tracks the rise and fall of leading biopharma companies over two decades driven by…
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Rani Therapeutics has entered into a research and development collaboration with PegBio to evaluate delivery of multiple obesity & metabolic disease candidates using its proprietary RaniPill platform
As per the deal, Rani and PegBio will collaborate on the preclinical development of RaniPill formulations for selected obesity & metabolic disease candidates, aiming to advance the…
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OTR has partnered with LG Chem to identify, evaluate & develop novel oncology assets from China, leveraging OTR's R&D platform & LG Chem's global development expertise & commercial infrastructure
As per the deal, OTR will identify & advance oncology assets through early clinical development in China, while LG Chem will jointly evaluate & license…
Shots:
June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine.
Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.
Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.
Celltrion Seeks…
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Astex has entered into an exclusive, worldwide research collaboration & license agreement with Genentech to identify small molecules with selective inhibitory activity for the treatment for breast cancer
Astex will license compounds from its breast cancer discovery program to Genentech and jointly optimize lead compounds through preclinical candidate selection, after which Genentech will lead…

