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ORPHAN DRUGS
Indian pharma leaving generics era behind, but the Street hasn't caught up yet: Nandan KulkarniIndian pharma is shifting from generics to innovation. This transformation, extending to 2035, is creating significant new opportunities. C...
Hantavirus scientists were close to vaccine but ran out of moneyScientists in Chile developed antibodies that successfully neutralised the deadly Andes hantavirus in lab and animal studies, raising hopes...
Zydus’ Desidustat gets USFDA orphan drug status for sickle cell diseaseZydus Lifesciences announced a significant development today. The US Food and Drugs Administration has granted Orphan Drug Designation to D...
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...
Pharma MNCs seek relief from price control for patented drugsThe Organisation of Pharmaceutical Producers of India (OPPI) is requesting exemptions for patented and orphan drugs from government price c...
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...
Lupin enters pact with Medis to distribute orphan drug in EuropeNDM disorders are a group of rare, inherited neuromuscular disorders which is characterized by the inability to relax muscles following vol...
Zydus Cadila receives orphan drug status from USFDA for its novel malaria drugDrug maker Cadila Healthcare (Zydus Cadila), on Thursday said its antimalarial drug ZY19489 (MMV253), currently in development together wit...
PLI scheme for pharma to benefit 55 firms, says CentreThe first category included biopharmaceuticals, complex generic drugs, patented drugs or drugs nearing patent expiry, cell-based or gene th...
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...
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...
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.