ANVISA Approves Concept Medical's MagicTouch SCB for CAD in Brazil
The approval enables commercial sales in Brazil, strengthening Concept Medical’s global footprint and advancing its mission to deliver safer and more effective treatment alternatives. The company is also undergoing ANVISA’s approval process for its wider DCB and DES portfolio, building on its robust clinical trial foundation.
India's Pharma Exports Rise Nearly 7 percent in August 2025
India’s exports of drugs and pharmaceuticals climbed 6.94 percent from USD 2.35 billion in August 2024 to USD 2.51 billion in August 2025.
Novartis has entered into a licensing agreement with Monte Rosa Therapeutics valued at up to 5.7 billion USD. The deal centres on developing medicines for immune-mediated diseases, where the immune system mistakenly attacks healthy tissue.
Cohance Lifesciences Jaggaiahpet API Plant Clears US FDA Inspection with Zero Observations
Cohance Lifesciences has announced that its API manufacturing facility in Jaggaiahpet, Andhra Pradesh, has successfully cleared a US Food and Drug Administration current Good Manufacturing Practices (cGMP) audit with zero Form 483 observations.
Abzena Enhances AbZelectPRO Cell Line Offering with New GS Knockout Platforms
Named AbZelectPRO-KO and AbZelectPRO-KO+, the new GS knockout platforms are available as a stand-alone CLD offering, or as a fully integrated GMP programme, with fully transparent pricing to IND with no royalty fees. This flexible offering will enable customers to select a CLD strategy that aligns with their project-specific goals, timeline and budget.
The partnership aims to speed up market entry for biopharma firms by combining Mycenax's biologics expertise with Spera Pharma’s high-potent fill-finish capabilities, offering an integrated, cost-effective ADC development platform.
Atavistik Bio Appoints Dr. Susan Pandya as Chief Medical Officer
As CMO, Dr. Susan Pandya will lead all clinical development strategy and execution for Atavistik Bio, including the ongoing Phase 1 clinical trial of its lead programme, ATV-1601.
Alembic Pharmaceuticals Receives US FDA Compliance Report for Panelav API Facilities
Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection conducted at its API-I and API-II facilities in Panelav, Gujarat.
Mycenax, SPERA PHARMA Form Alliance to Streamline ADC Manufacturing
Mycenax Biotech has formed a strategic alliance with Japan’s SPERA PHARMA to provide an integrated end-to-end development and manufacturing platform for antibody-drug conjugates (ADCs) and bioconjugates.
Akeso Doses First Patient in Global Trial of Cadonilimab for PD-1 Resistant Liver Cancer
COMPASSION-36, the first global Phase III trial of Cadonilimab, is underway in China, the US, and Europe. It marks a key step in Akeso's effort to advance cancer immunotherapy beyond single-target treatments.
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