Calliditas Therapeutics AB

Activities: Pharmaceutical

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  1. ICROM has acquired HOLODIAG ICROM srl, an italian API CDMO, has acquired the French-based Contract Research Organization HOLODIAG sas specialized in solid state studies and crystallization services of...
  2. Lonza completes Visp microbial manufacturing facility expansion The company now hosts two 4,000L fermenters on its cGMP-compliant site, which was expanded due to the growing industry demand for biologics
  3. At CPHI Milan, TekniPlex Healthcare to Highlight New Solutions for Single-use Bioprocessing, Cell & Gene Therapies Company also will provide live demos of next-generation automatic filler-sealer for single-dose plastic vials, and showcase sustainability-minded blister packaging, as well as...
  4. PolTREG's Treg cell therapy exhibits long-term clinical remission in type 1 diabetes patients The clinical-stage biotech's lead candidate, PTG-007, has demonstrated its ability to induce clinical remission in T1D patients for up to 12 years
  5. Vetter manufactures first 100 clinical vial batches at its Austria site The CDMO has successfully completed the production of 100 liquid and lyophilised clinical batches for global clients

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Research & Development

Calliditas’ partner Everest Medicines announces China NMPA’s approval of Nefecon

China's National Medical Products Administration (NMPA) has approved Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression
Regulatory

EMA issues positive opinion on Calliditas' orphan drug

Calliditas' application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome has received a positive opinion from European Medicines Agency
Ingredients

Full details from Calliditas Therapeutics’ Phase 3 study released

Calliditas Therapeutics has announced publication in The Lancet of the full data from the Phase 3 NefIgArd Study with Nefecon delayed release capsules in adults with Primary IgA nephropathy
Drug Delivery

Chinese NMPA accepts Calliditas' partner Everest Medicines NDA

Chronic kidney disease is one of the most serious public health problems in China, where IgAN is estimated by Everest to affect around five million people

Calliditas budesonide therapy approved to reduce proteinuria

Proteinuria is associated with IgAN, however it has not yet been established whether the therapy slows kidney function decline in patients with the condition
Regulatory

Calliditas receives fast track FDA designation for PBC candidate

The FDA program facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions
Manufacturing

Calliditas and Everest Medicines enter $120m development deal in China

The agreement gives Everest Medicines exclusive rights to develop and commercialise Nefecon in five countries in East Asia
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