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ANVISA Approves Concept Medical's MagicTouch SCB for CAD in Brazil

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.

| 16/09/2025 | By 365

India's Pharma Exports Rise Nearly 7 percent in August 2025

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.

| 16/09/2025 | By 594

Novartis Enters USD 5.7 Billion Licensing Deal with Monte Rosa Therapeutics Targeting Immune Diseases

Novartis Enters USD 5.7 Billion Licensing Deal with Monte Rosa Therapeutics Targeting Immune Diseases

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.

| 15/09/2025 | By 343

Cohance Lifesciences Jaggaiahpet API Plant Clears US FDA Inspection with Zero Observations

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.

| 15/09/2025 | By 402

Abzena Enhances AbZelectPRO Cell Line Offering with New GS Knockout Platforms

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.

| 15/09/2025 | By 255

Mycenax and Spera Pharma Partner to Streamline ADC Drug Substance and Drug Product Manufacturing Services

Mycenax and Spera Pharma Partner to Streamline ADC Drug Substance and Drug Product Manufacturing Services

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.

| 15/09/2025 | By 314

Atavistik Bio Appoints Dr. Susan Pandya as Chief Medical Officer

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.

| 15/09/2025 | By 229

Alembic Pharmaceuticals Receives US FDA Compliance Report for Panelav API Facilities

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.

| 15/09/2025 | By 723

Mycenax, SPERA PHARMA Form Alliance to Streamline ADC Manufacturing

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.

| 15/09/2025 | By 176

Akeso Doses First Patient in Global Trial of Cadonilimab for PD-1 Resistant Liver Cancer

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.

| 15/09/2025 | By 282

 
 

 

 

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