EMA to review Sandoz biosimilars adalimumab and infliximab
Sandoz announced that the EMA has accepted for regulatory review for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab)...
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First treatment for 5q spinal muscular atrophy approved by EU
1 June 2017 | By Niamh Marriott, Junior Editor
The EC has granted marketing authorisation for Ionis Pharmaceuticals’ Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA)...
Aptar Pharma’s electronic lockout device approved by EMA
1 June 2017 | By Niamh Marriott, Junior Editor
The European Medicines Agency (EMA) has approved Aptar Pharma’s integrated electronic nasal lockout device (e-Lockout) following a partnership with Takeda.
Atlantic develops tablet formulations of alicaforsen to treat Crohn’s disease
1 June 2017 | By Niamh Marriott, Junior Editor
Atlantic Healthcare announces the development of two separate tablet formulations of alicaforsen, for targeted delivery in the GI tract...
Emblem acquires land in preparation for the cannabis market
1 June 2017 | By Niamh Marriott, Junior Editor
Emblem has agreed to purchase land in preparation for the anticipated demand stemming from the proposed legalisation of adult recreational use in Canada...
New EMA guidelines on biosimilar medicines
1 June 2017 | By Niamh Marriott, Junior Editor
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines...
Studying century-old drug as potential new approach to autism
31 May 2017 | By Niamh Marriott, Junior Editor
In a small, randomised Phase I/II clinical trial, researchers at UC San Diego School of Medicine say a 100-year-old drug called suramin...
42Gears solves Alkem’s field device misuse problem
31 May 2017 | By 42Gears Mobility Systems
42Gears recently worked with Alkem Laboratories, one of the biggest Indian pharmaceutical companies, to help secure on-field mobile devices from misuse and to enhance workforce productivity.
FDA approves first generic Strattera for the treatment of ADHD
31 May 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration has approved the first generic versions of Strattera (atomoxetine) to treat (ADHD) in pediatric and adult patients...
Biologics before triple therapy not cost effective for rheumatoid arthritis
30 May 2017 | By American College of Physicians
Stepping up to biologic therapy offers minimal incremental benefit over using a combination of drugs known as triple therapy, yet incurs large costs...
Quotient Clinical appoints Azhar Kalim as Chief Commercial Officer
30 May 2017 | By Quotient Clinical
Appointment supports Quotient’s strategy to further develop its global commercial footprint following two recent US acquisitions...
FDA approves expanded use of Novartis’ lung cancer drug Zykadia
30 May 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) approved the expanded use of Novartis’ Zykadia (ceritinib) to include patients with NSCLC...
FPS has provided High containment Integrated system for Pharmaceutical application in India
26 May 2017 | By F.P.S. Food and Pharma Systems Srl
FPS has recently delivered a high containment Integrated systems for an Oncology plant in Bangalore...
New medicine shows potential to reduce oral steroid use in severe asthma patients
26 May 2017 | By Niamh Marriott, Junior Editor
A trial led by a McMaster University respirology professor shows promising results for a new medicine for severe asthma patients.
Abeona Therapeutics receives FDA orphan designation for gene therapy
26 May 2017 | By Niamh Marriott, Junior Editor
The FDA has granted Orphan Drug Designation for Abeona Therapeutics’s EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa...
