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INSIGHTS+

The US FDA New Drug Approvals in April 2026 

Shots:  Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.  Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…
May 12, 2026

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Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing

Shots: Piramal Pharma Solutions has entered into a strategic collaboration with Ajinomoto Bio-Pharma Services to support antibody-drug conjugate (ADC) development and manufacturing programs Under the agreement, Piramal will refer customers to Ajinomoto’s AJICAP platform for site-specific ADC conjugation, while Ajinomoto will direct clients to Piramal for CDMO manufacturing services across development and commercialization The collaboration…
April 17, 2026

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Mabwell  Collaborates with a Strategic Business Partner to Commercialize of Mailishu and Maiweijian (Biosimilar, Prolia and Xgeva) in Malaysia   

Shots:  Mabwell has entered a licensing and commercialization agreement with a Malaysian partner for its denosumab biosimilars, Mailishu (biosimilar, Prolia) and Maiweijian (biosimilar, Xgeva)  As per the deal, the partner will handle registration and commercialization in Malaysia  While Mabwell will oversee the development, manufacturing, and supply of the products  Ref: Mabwell |  Image:  Mabwell |  Press Release Related News:  Mabwell Initiates P-III Trial for 9MW2821 in TNBC…
April 16, 2026

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Mochida Pharmaceutical Collaborates with Qilu Pharmaceutical to Develop & Commercialize of Follitropin Alfa (Biosimilar, Gonal‑f) Across Japan 

Shots:  Mochida Pharmaceutical has entered into a development and commercialization agreement with Qilu Pharmaceutical for a biosimilar of follitropin alfa in Japan  As per the deal, Mochida will lead development to secure marketing approval in Japan, collaborating with Qilu for early launch, and strengthening its position in Japan’s biosimilar market  Follitropin alfa is a recombinant FSH used for…
April 15, 2026

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The US FDA New Drug Approvals in March 2026 

Shots:  Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact.  Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…
April 14, 2026

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Telix Partners with Regeneron to Develop and Commercialize Radiopharmaceutical Therapies for Pain in a ~$2.1B

Shots: Telix and Regeneron have entered into a collaboration to jointly develop and commercialize next-generation radiopharmaceutical therapies Telix will receive a $40M upfront from Regeneron for four initial programs, with options to expand. The companies will share commercialization costs and profits, while Telix may opt to earn up to $535M per program in development and…
April 13, 2026

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Haisco Partners with AbbVie to Develop Novel Medicines for Pain in a ~$745M Deal

Shots: Haisco Pharma entered an exclusive licensing deal with AbbVie, granting later global rights (ex-China, Hong Kong & Macau) to develop, manufacture & commercialize novel pain therapies As per the deal, Haisco will receive $30M upfront, with the potential to receive up to $715M in development, regulatory, and commercial milestones, along with tiered royalties on future…
April 13, 2026

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DeepCyte Secures $1.5M to Advance AI-Driven Single-Cell Toxicology in Drug Development

Shots: DeepCyte, a techbio startup focused on advancing AI-powered toxicology for drug development, has officially launched with $1.5 million in seed funding, introducing two solutions to help biopharma teams detect, predict, and understand drug toxicity in human cells at single-cell resolution DeepCyte's MetaCore, a high-throughput single-cell metabolomics platform, leverages laser-based sampling and mass spectrometry to…
April 9, 2026

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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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