Last edition
News about
CDSCO Launches Nationwide Inspections of Drug Manufacturing Units After Cough Syrup Deaths
The Central Drugs Standard Control Organisation (CDSCO) has initiated risk-based inspections of drug manufacturing units in six Indian states following reports of child fatalities linked to contaminated cough syrups.
AbbVie Cuts 2025 Profit Forecast Following USD 2.7 Billion R&D Charge
The company plans to reduce its adjusted earnings per share guidance to a range of USD 10.38 to USD 10.58, down from its prior forecast of USD 11.88 to USD 12.08.
FDA Flags Lupin's Pithampur Manufacturing Facility with Official Action Indicated Status
Lupin stated that it is actively engaging with the U.S. regulator and remains committed to maintaining full compliance with current Good Manufacturing Practice (cGMP) standards across all its manufacturing sites.
The collaboration unites XenoSTART’s repository of clinically annotated Patient-Derived Xenograft (PDX) models with Minerva Imaging’s advanced molecular imaging and radionuclide therapy expertise, creating a single-source solution spanning discovery, translational research, and manufacturing.
Following reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, the Union Health Ministry has directed all pharmaceutical manufacturers to strictly comply with the Revised Schedule M for Good Manufacturing Practices (GMP).
FDA Announces New ANDA Prioritisation Pilot to Support US Generic Drug Manufacturing and Testing
More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India.
Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis
Sitryx’s SYX-5219 is a first-in-class, oral, disease-modifying, anti-inflammatory therapy, targeting pyruvate kinase M2 (PKM2), a critical enzyme that regulates cell metabolism.
Indian Pharmaceutical Alliance Welcomes New Leadership
Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, and Vice President, Indian Pharmaceutical Alliance (IPA), has been appointed President of the alliance, while Glenn Saldanha, Chairman and Managing Director, Glenmark, will serve as the new Vice President.
Illumina Launches BioInsight to Drive Multiomic Data and AI-Powered Drug Discovery
Illumina, Inc., a global leader in genomics and precision health, has announced the launch of BioInsight, a new business designed to meet the growing demand for deeper biological insights driven by large-scale multiomic data.
CDSCO approves AstraZeneca's Trastuzumab Deruxtecan for More HER2-Positive Tumours
With this, Trastuzumab Deruxtecan becomes India’s first Antibody Drug Conjugate (ADC) approved for a tumour-agnostic indication.
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy