Quality Systems

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NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

NICE Issues Positive Recommendation for Use of Kineret to Treat Still’s Disease

EMA's CHMP has issued a positive opinion for Diurnal's second product in Europe, Chronocort (Efmody), to treat CAH.

Diurnal Gains Positive Opinion for Second Product in Europe

The EC has approved Roche's treatment for 5q spinal muscular atrophy (SMA), Evrysdi (risdiplam).

EC Approves Roche’s Home Treatment for SMA

NICE has recommended carfilzomib in combination with lenalidomide and dexamethasone (KRd) as a treatment for adult patients with multiple myeloma who have already had one previous therapy.

NICE Recommends Second Line Triple Therapy for Multiple Myeloma Patients

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

Celltrion Receives a Positive Opinion from CHMP for Regdanvimab

The Janssen Pharmaceutical Companies of Johnson & Johnson revealed that EMA's CHMP has issued a positive opinion for Ponvory (ponesimod) for the treatment of RMS.

CHMP Issues Positive Opinion for Janssen’s RMS Treatment

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany. 

EMA Approves BioNTech’s COVID-19 Vaccine Manufacturing Site

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The need for added revenues to fund billion-dollar infrastructure improvements has fueled challenges to industry pricing practices. 

Drug Pricing Moves to Top of Legislative Agenda

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.





EMA Adopts Recommendations to Increase COVID-19 Vaccine Capacity

Abecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

Regulatory Oversight and Compliance