IPP Bureau
USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
By IPP Bureau - July 24, 2023
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
By IPP Bureau - July 24, 2023
Aurobindo will respond to the US FDA within the stipulated timelines
Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
By IPP Bureau - July 24, 2023
This product would be manufactured at Lupin's Nagpur facility in India
Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin
By IPP Bureau - July 22, 2023
Good momentum in commercial CDMO business
Merck receives positive European Union CHMP opinion for Gefapixant
By IPP Bureau - July 22, 2023
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
By IPP Bureau - July 22, 2023
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
By IPP Bureau - July 22, 2023
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
By IPP Bureau - July 22, 2023
Luforbec® 100/6 pMDI aims to provide comprehensive support to patients and healthcare professionals
Glenmark Life Sciences reports robust 25% EBITDA growth in Q1FY24
By IPP Bureau - July 22, 2023
The net profit in the June quarter was also lower than Rs 146.3 crore reported in the March quarter.
Tillotts Pharma and TVM Capital form Mage Biologics to develop oral antibody therapy for ulcerative colitis
By IPP Bureau - July 21, 2023
Mage Biologics to develop a monoclonal antibody targeting ulcerative colitis
Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826
By IPP Bureau - July 21, 2023
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
Riparian Pharmaceuticals inks license and research agreement with Pfizer for cardiovascular programs
By IPP Bureau - July 21, 2023
Pfizer will make upfront and milestone payments, as well as pay royalties on sales of resulting therapeutics
Merck’s Phase 3 Keynote- A18 trial met PFS in patients with advanced cervical cancer
By IPP Bureau - July 21, 2023
KEYTRUDA plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients
M&A activity of pharma CMOs will continue despite challenging borrowing environment, says GlobalData
By IPP Bureau - July 20, 2023
CMOs showed an increasing reluctance to take on debt in 2022
