Nintedanib already secured approval from the US Food and Drug Administration (FDA), Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) as the first treatment for
Orphan Drug Designation is an important regulatory milestone granted to drugs that are intended to treat rare diseases and conditions, such as CAPS. CAPS is a rare, autoinflammatory
The company, which has administered the first doses in healthy human volunteers, is also planning to initiate a phase 2/3 study this October. The phase I clinical trial
Further, Glenmark has announced a price reduction of 27% for FabiFlu®. The new MRP is INR 75 per tab from the earlier INR 103 per tab. The price
The two of the firms’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine programme, including BNT162b1 and BNT162b2, are being developed to treat SARS-CoV-2. BioNTech chief medical
The companies will also partner on a second earlier stage program. Kymera will receive $150 million in cash upfront and may receive more than $2 billion in potential development, regulatory and sales
More than 20 biopharmaceutical companies have collaborated to establish the AMR Action Fund, which will help focus on medicines that address most resistant bacteria and life-threatening infections. The
mRNA-1273 is Moderna’s second mRNA vaccine for an infectious disease to complete enrollment of a Phase 2 study, following the Company’s CMV Phase 2 study, which was fully
The EC approval allows using Lynparza as a maintenance treatment for adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed
Batten disease, a common name for a rare class of diseases called neuronal ceroid lipofuscinoses (NCL), affects an estimated 2-4 out of every 100,000 children in the United
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