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Latest Industry News - Page 335

USFDA Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations

USFDA issues ten observations for Alkem Labs Baddi facility

Ruchika Sharma28 March 2024 11:29 AM IST
Mumbai: Alkem Labs has announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483 with ten observations at the...
Advent to Sell Zentiva to Private Equity GTCR in USD 4.8 Billion Deal, Closing Expected in 2026

Novo Nordisk to acquire Cardior Pharma for up to 1.025 billion Euros

Ruchika Sharma27 March 2024 1:30 PM IST
Denmark Novo Nordisk and Cardior Pharmaceuticals have announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros,...
Johnson and Johnson Agrees to Cut US Drug Prices in Deal with Trump Administration to Avoid Tariffs

USFDA grants Fast Track designation to JnJ nipocalimab to reduce fetal neonatal alloimmune thrombocytopenia risk in alloimmunized pregnant adults

Ruchika Sharma27 March 2024 12:30 PM IST
Spring House: Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for...
USFDA Approves Bionpharmas Generic HIV Drug Etravirine

Merck gets USFDA nod for WINREVAIR (sotatercept-csrk) for adults with pulmonary arterial hypertension

Ruchika Sharma27 March 2024 11:51 AM IST
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has approved...
CDSCO Panel Approves IQVIAs Protocol Amendment Proposal For Anti-cancer Drug Xevinapant

CDSCO Panel Approves IQVIA's Protocol Amendment Proposal For Anti-cancer Drug Xevinapant

Dr. Divya Colin27 March 2024 5:30 AM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Indoco Remedies arm begins commercial production of Pharmaceutical Intermediates

Indoco Remedies arm begins commercial production of Pharmaceutical Intermediates

Ruchika Sharma26 March 2024 3:30 PM IST
Mumbai: Warren Remedies Private Limited, a Wholly Owned Subsidiary of Indoco Remedies Limited has commenced its commercial production from its...
AstraZeneca Gets SEC Nod to Update Lokelma Prescribing Information for Hyperkalemia Treatment

AstraZeneca Pharma India names Vinay Sharma as Business Unit Head

Ruchika Sharma26 March 2024 2:12 PM IST
Bangalore: AstraZeneca Pharma India Limited has announced the appointment of Vinay Sharma as Business Unit Head - Rare Disease unit with effect...
AstraZeneca Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus

AstraZeneca Ultomiris gets USFDA approval for adults with neuromyelitis optica spectrum disorder

Ruchika Sharma26 March 2024 12:52 PM IST
Ultomiris, a long-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition.
Health Ministry Reduces Clinical Trial Approval Time from 90 to 45 Days

Bharat Biotech begins clinical trial of Tuberculosis vaccine MTBVAC in India

Ruchika Sharma26 March 2024 12:34 PM IST
Hyderabad: Clinical trials of MTBVAC, the Spanish tuberculosis vaccine, the first live attenuated vaccine of Mycobacterium tuberculosis isolated...
AstraZeneca Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus

CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal For Anti-cancer Drug Osimertinib

Dr. Divya Colin25 March 2024 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Lupin Manufacturing Solutions, PolyPeptide Group forge long term Peptide alliance

Bayer, Thermo Fisher Scientific join hands to increase patient access to precision cancer medicines

Ruchika Sharma25 March 2024 12:30 PM IST
Berlin: Bayer AG and Thermo Fisher Scientific Inc. have announced a collaboration to develop next-generation sequencing (NGS)-based companion...
Aurobindo Pharma arm to acquire 20% additional ownership in Luoxin Aurovitas for Rs 45 crore

Lonza to buy large-scale biologics Vacaville site from Roche for USD 1.2 billion

Ruchika Sharma25 March 2024 10:00 AM IST
Basel: Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, has announced it has signed an agreement...
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Editorial

Efficacy and Safety of Dapagliflozin-Vildagliptin in Indian T2DM Patients with CV Risk Factors

Efficacy and Safety of Dapagliflozin-Vildagliptin in Indian T2DM Patients with CV Risk Factors

SURPASS-2: Superior HbA1c and Weight Reduction With Tirzepatide vs. Semaglutide

SURPASS-2: Superior HbA1c and Weight Reduction With Tirzepatide vs. Semaglutide

Regulatory Approval Granted for Reformulated Ranitidine

Regulatory Approval Granted for Reformulated Ranitidine

Robust Glycemic Control & Cardio-Renal Protection: Meeting the Advanced Needs of Indian Uncontrolled T2D with Empagliflozin, Sitagliptin, Metformin

Robust Glycemic Control & Cardio-Renal Protection: Meeting the Advanced Needs of Indian Uncontrolled...

Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

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Evening People Found More Likely to Have Poor Cardiovascular Health: Study Shows

'Evening People' Found More Likely to Have Poor Cardiovascular Health: Study Shows

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