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NEWS

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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Bavarian Nordic
NEWS

Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya

Shots: Swissmedic has approved Vimkunya (recombinant, adsorbed) for active immunization against CHIKV disease in individuals (≥12yrs.) Vimkunya is a single-dose, prefilled VLP-based chikungunya vaccine for individuals ≥12 years, designed to trigger rapid immunity with responses starting as early as 1 week Bavarian Nordic has submitted a Health Canada application, with potential chikungunya vaccine approval in…
April 17, 2026

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NEWS

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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Merck new
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Merck Report the EC Approval of Enflonsia for RSV Prevention in Infants 

Shots:  The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants  The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. Enflonsia reduced RSV-associated medically attended LRIs…
April 15, 2026

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NEWS

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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NEWS

Mabwell  Reports NMPA’s sBLA Acceptance of Maiweijian (Biosimilar, Xgeva) 

Shots:  The NMPA has accepted the sBLA of Maiweijian (Denosumab; 120mg), a biosimilar version of Xgeva, developed by its subsidiary T-mab, for preventing skeletal-related events in multiple myeloma and bone metastases from solid tumors  Maiweijian is China’s first approved 120 mg denosumab biosimilar, initially cleared in March 2024 for adults and skeletally mature adolescents with unresectable giant cell tumor of bone or cases where surgery may…
April 15, 2026

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INSIGHTS+

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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NEWS

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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