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4142 News Found

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
Drug Approval | July 24, 2023

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo will respond to the US FDA within the stipulated timelines


Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
Drug Approval | July 24, 2023

Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

This product would be manufactured at Lupin's Nagpur facility in India


Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
Drug Approval | July 22, 2023

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU


Boehringer Ingelheim receives FDA approval for NexGard Plus
News | July 22, 2023

Boehringer Ingelheim receives FDA approval for NexGard Plus

The maker of ivermectin/pyrantel, the #1 vet-recommended and #1 dog-preferred real beef chew introduces the latest innovation in its portfolio


Lupin launches Luforbec 100/6 for adult asthma and COPD treatment in Germany
News | July 22, 2023

Lupin launches Luforbec 100/6 for adult asthma and COPD treatment in Germany

Luforbec® 100/6 pMDI aims to provide comprehensive support to patients and healthcare professionals


Glenmark Life Sciences reports robust 25% EBITDA growth in Q1FY24
News | July 22, 2023

Glenmark Life Sciences reports robust 25% EBITDA growth in Q1FY24

The net profit in the June quarter was also lower than Rs 146.3 crore reported in the March quarter.


Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826
News | July 21, 2023

Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826

The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023


Merck’s Phase 3 Keynote- A18 trial met PFS in patients with advanced cervical cancer
Clinical Trials | July 21, 2023

Merck’s Phase 3 Keynote- A18 trial met PFS in patients with advanced cervical cancer

KEYTRUDA plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients


Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories
Drug Approval | July 20, 2023

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories

Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial


M&A activity of pharma CMOs will continue despite challenging borrowing environment, says GlobalData
News | July 20, 2023

M&A activity of pharma CMOs will continue despite challenging borrowing environment, says GlobalData

CMOs showed an increasing reluctance to take on debt in 2022