IPP Bureau
Glenmark receives sANDA approval for Abiraterone Acetate tablets
By IPP Bureau - May 20, 2022
According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million
Bristol Myers Squibb highlights progress in treatment for cancer and blood disorders
By IPP Bureau - May 20, 2022
First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm
USFDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain
By IPP Bureau - May 20, 2022
Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages
Olympus announces exclusive U.S. co-marketing agreement with Bracco Diagnostics
By IPP Bureau - May 20, 2022
The partnership will further strengthen Olympus leadership in the diagnosis and staging of liver disease
Dxcover to release new data on early detection liquid biopsy for multiple cancer types
By IPP Bureau - May 20, 2022
Dxcover announced that it will be presenting new data at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3-7
Propanc Biopharma undertaking PRP manufacturing & development for human use
By IPP Bureau - May 20, 2022
PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection
Motilal Oswal Private Equity (MOPE) invests in Pathkind Diagnostics
By IPP Bureau - May 20, 2022
A primary investment of Rs 194.4 crore has been made
Grand Opening of Kodiak Sciences’ bioconjugation facility
By IPP Bureau - May 19, 2022
Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases
IAVI and Moderna launch first-in-Africa clinical trial of mRNA HIV vaccine
By IPP Bureau - May 19, 2022
Phase I trial in Rwanda and South Africa aims to evaluate mRNA HIV vaccine antigen for safety and immunogenicity and strengthen regional scientific capacity
Don’t be left short-changed post approval – plan in change orders early for accelerated pathways: Stephanie Gaulding
By IPP Bureau - May 19, 2022
A post approval change order is often necessary, but innovators should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a new full clinical study
Pharmapack Europe awards winners 2022
By IPP Bureau - May 19, 2022
Pharmapack Europe recognizes excellence and innovation from exhibitors across connected devices, sustainability, supply chain logistics, route of administration, and packaging innovation, as well from the wider industry for patient-centric design and eco-design
Biocon Biologics and Viatris launch Abevmy in Canada
By IPP Bureau - May 19, 2022
Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020
Janssen’s icare4u to assist people living with skin, joint and digestive disorders
By IPP Bureau - May 19, 2022
The icare4u program features a dedicated website, with comprehensive information about the diseases, videos with medical experts, and a social media community for patients and caregivers on Facebook and YouTube
CDSCO approves Jardiance for heart failure with preserved ejection fraction
By IPP Bureau - May 19, 2022
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
Synexa Life Sciences acquires Finnish CRO Syrinx Bioanalytics
By IPP Bureau - May 19, 2022
Expansion of leading biomarker and bioanalysis company enhances bioanalytical solutions for targeted radiopharmaceuticals