FDA grants fast track designation to Lundbeck’s next-generation narcolepsy drug candidate
The FDA’s Fast Track designation highlights the potential of Lu AH69593 to address a significant unmet need in narcolepsy treatment
The FDA’s Fast Track designation highlights the potential of Lu AH69593 to address a significant unmet need in narcolepsy treatment
At the second edition of Indian Pharma Post E-Conference, India’s brightest scientific minds outline the innovation, manufacturing and policy priorities needed for India to emerge as a global biologics powerhouse
The Indian approval is supported by Takeda's global clinical development program comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants
Innovator semaglutide becomes India's first and only GLP-1 receptor agonist approved for adults with non-cirrhotic MASH and moderate-to-advanced liver fibrosis
Proposed acquisition strengthens Samsung Biologics' presence in peptide therapeutics, including GLP-1s, and expands its footprint across the US, Europe and India
The global biopharma company said the CALM-1 study achieved its primary endpoint
Shilpa will develop and exclusively manufacture the cancer immunotherapy biosimilar, while Orion secures exclusive commercial rights across Europe.
The partnership aims to generate critical clinical evidence, strengthen domestic capabilities in advanced therapeutics and make cutting-edge cancer treatments more accessible and affordable for Indian patients
India conducts only about 4% of global clinical trials, while annual pharmaceutical R&D spending remains at $2–3 billion, compared with $70–75 billion in the US
Collaboration combines Formycon’s biosimilar development expertise with OneSource’s integrated biologics manufacturing platform for global markets
Recognition highlights company's people-first culture and contribution to healthcare access, community development and nation-building
The product will be offered as a pre-filled, multi-dose injectable pen in two strengths—2 mg/1.5 mL and 4 mg/3 mL—enabling flexible once-weekly dosing
Both the companies are evaluating pharmaceutical-grade ingredients with established safety profiles as potential excipients for biologic formulations
Under the licensing agreement, AstraZeneca will pay $600 million upfront, with up to $900 million in additional payments tied to development, regulatory and commercial milestones
A key highlight will be the latest findings from the global Phase-3 Masupirdine study, including demographic and clinical characteristics of enrolled patients
As studies confirm comparable results to Eylea in eye disease treatment
The approval advances company’s goal of launching 20 biosimilar products in the U.S. by 2030
This marks a major step forward in the company’s efforts to develop advanced cell therapies for hard-to-treat cancers
Company consolidates 100% stake in subsidiary as it sharpens focus on biologics and biosimilars
Government-backed project aims to advance personalised chemotherapy screening using patient-derived tumour organoids
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