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Gerresheimer and Portal Instruments Strengthen Alliance for PRIME NEXUS Reusable Autoinjector
Gerresheimer is expanding its collaboration with medical device company Portal Instruments to commercialise the Prime NEXUS reusable, connected autoinjector platform.
Singapore fast-tracks medtech innovation with first regulatory reliance pilot: GlobalData
The six-month pilot of the Medical Device Regulatory Reliance Programme, running from 1 September, 2025 to 28 February, 2026, aims to expedite market access for Class B, C and D medical devices by reducing duplicate regulatory reviews and leveraging each other's approvals.
NATCO Pharma's Kothur Facility Receives FDA EIR with VAI Classification
The US Food and Drug Administration (FDA) has completed an inspection at NATCO Pharma’s Pharma division located in Kothur, Hyderabad, India.
Biocon Biologics Secures US FDA Approval for Denosumab Biosimilars Bosaya and Aukelso
The US Food and Drug Administration (FDA) has approved Biocon Biologics' denosumab biosimilars, Bosaya (denosumab-kyqq) 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection in a single-dose vial, biosimilars of Prolia and Xgeva, respectively.
GAIASO Theranostics Appoints Dr. Tracey Brown as New CEO
GAIASO Theranostics, an Australia-based biotech company pioneering next-generation precision radiopharmaceuticals for women’s cancers, has appointed Dr. Tracey Brown as its new Chief Executive Officer (CEO).
Harvard Bioscience Expands Fisher Scientific Distribution Network in US
The expansion covers the United States and adds more products to the line-up. Fisher Scientific will now distribute Harvard’s pumps, spectrophotometers, and BTX electroporation systems in the U.S. market, in addition to existing European markets.
Lupin Secures US FDA Approval for Lenalidomide Capsules
The approved Lenalidomide Capsules, bioequivalent to Revlimid by Bristol-Myers Squibb, will be produced at Lupin’s Pithampur site in India.
VarmX and CSL Sign Deal Worth up to USD 2.2 Billion
Under the agreement, CSL will fully fund clinical development of VMX-C001 and pay VarmX shareholders USD 117 million upfront for an exclusive option to acquire VarmX, in a transaction worth up to USD 2.2 billion
CDSCO Clarifies Regulatory Pathway: Cocrystals of Approved Drugs to Be Treated as New Drugs
The Central Drugs Standard Control Organisation (CDSCO) has issued a clarification stating that cocrystals of already approved active substances will be treated as new drugs under Indian regulations.
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