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ORPHAN DISEASES
Zydus gets USFDA's orphan drug designation for beta-thalassemia productZydus Lifesciences announced a significant development for beta-thalassemia patients. The US Food and Drug Administration has granted Orpha...
To speed up delivery, govt exempts orphan drugs from testing at portsTo ensure timely access to life-saving orphan drugs for patients, the government has exempted mandatory sampling and testing at port office...
Zydus receives USFDA Orphan Drug Designation for Usnoflast to treat ALSZydus Lifesciences announced that the USFDA granted Orphan Drug Designation to Usnoflast, a novel oral NLRP3 inhibitor, for treating amyotr...
Zydus eyes M&A, licensing to build its US specialty businessZydus Lifesciences is exploring mergers, acquisitions, and licensing to bolster its specialty portfolio in the US, particularly for the pot...
High costs of orphan drugs: Patients pay the price for policy hurdles in IndiaIndia manufactures APIs for over 400 FDA-approved orphan drugs, but patients face high costs due to Indian pharmaceutical companies' reluct...
Sops likely for R&D on rare condition drugsIncentives could be offered to the private sector in the form of faster approvals and an extended period of exclusivity for orphan drugs. S...
European Medicines Agency grants Orphan Drug Designation to Zydus Cadila's Saroglitazar MgOrphan Drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare, life-threatening, or ch...
India can lead the charge for discovery of drugs for other rare diseases: NITI Aayog's Dr. Vinod PaulSpeaking specifically about orphan drugs, Paul said that with the support of the government, remedies for rare diseases can be discovered i...
USFDA grants orphan drug designation to Zydus Cadila's Saroglitazar MgZydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, includ...
Rhizen receives USFDA orphan drug designation for cancer drugThe US Food and Drug Administration (USFDA) has granted orphan drug designation for Tenalisib (RP6530) for the treatment of patients with p...
Britain moves closer to COVID-19 vaccine trials that infect volunteersPreliminary work for the trials, which aim to speed up the process of determining the efficacy of a vaccine candidate, is being carried out...
Piramal Pharma Solutions to tie up with Epirium Bio for orphan drugsAccording to the US health regulator, USFDA, 'orphan drug' is a drug or biologic that is used for the prevention, diagnosis, or treatment o...
50 cancer, rare disease drugs to get cheaperThe decision was taken at a high-level meeting with the Prime Minister’s Office earlier this month.
Rhizen receives USFDA orphan drug designation for cancer drugThe USFDA has granted orphan drug designation for Tenalisib (RP6530)... for the treatment of patients with peripheral T-cell lymphoma (PTCL...
Aten Porus Lifesciences: Firm is developing drugs to fight a host of rare diseases globallyTo begin with, the duo decided to focus on Niemann-Pick Type C (NPC) disorder that’s also referred to as Childhood Alzheimer’s.
Stempeutics' Stempeucel gets Orphan Drug status in EuropeAn orphan designation allows a company to benefit from incentives from the European Union to develop a medicine for a rare disease.
GVK Bio, USFDA in drug repositioning collaborationThe company is looking forward to continue working with the FDA with a view to further enhancing the utility of the product, the company sa...