Biopharma

FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia

20 April 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

The FDA has approved Crysvita, the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia, a rare, inherited form of rickets...

KL1333 receives FDA ODD for mitochondrial diseases

20 April 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

NeuroVive Pharmaceutical AB has been granted Orphan Drug Designation for its project KL1333 for treatment of inherited mitochondrial respiratory chain diseases...

Could statins ease deadly heart condition in rare neuromuscular disease?

19 April 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

Penn study shows that cholesterol drug may help Friedreich's ataxia patients...

JRS Pharma

Whitepaper: The effect of silicification on the roller compaction performance of MCC

17 April 2018 | By JRS Pharma

Roller compaction, or dry granulation, is a manufacturing method for pharmaceutical and nutraceutical tablets that continues to gain importance...

Whitepaper: Applying single-use efficiencies to room-to-room fluid transfer

17 April 2018 | By AdvantaPure

This white paper explains how a wall pass-through system that incorporates single-use processes can reduce contamination risks and the use of valuable natural resources and waste disposal while increasing productivity and efficiency...

Nivolumab reduces size of some lung cancer tumours, relapse rate after surgery

16 April 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

A drug given to early-stage lung cancer patients before they undergo surgery showed major tumour responses in the removed tumour...

Biopharma Processing & Development In-Depth Focus 2018

16 April 2018 | By European Pharmaceutical Review

In this In-Depth Focus; enabling the manufacture of robust biologic drug products, automating biopharmaceutical development, and greater compatibility and ease of use for bioproduction monitoring of monoclonal antibodies.

First-in-Human trial of cannabis-based therapy for Parkinson’s initiated

12 April 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

GB Sciences, Inc. is planning to file an Exploratory IND and perform a Phase 0 Clinical Trial to gather valuable First-In-Human data on its proprietary cannabis-based therapies...

Second patent awarded for AdvantaPure®’s AdvantaPass® clean room wall pass-through system

12 April 2018 | By AdvantaPure

Significant Improvements Prompt Issuance...

Issue #2 2018 – Digital Version

12 April 2018 | By European Pharmaceutical Review

In this issue; recent developments in turning promising compounds into drug candidates, reviewing the latest trends in pharmaceutical microbiology and their implications, and a roundtable debate featuring the views of five industry leaders.

FDA expands approval of Blincyto for treatment of B-cell precursor ALL

5 April 2018 | By European Pharmaceutical Review

The FDA has granted accelerated approval to Blincyto to treat adults and children with B-cell precursor acute lymphoblastic leukaemia (ALL)...

EC approves Alofisel for complex perianal fistulae in Crohn’s disease

3 April 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

The EC has approved Alofisel for the treatment of complex perianal fistulae in adult patients with nonactive/mildly active luminal Crohn’s disease...

A simple method developed for 3D bio-fabrication based on bacterial cellulose

29 March 2018 | By European Pharmaceutical Review

Researchers have developed a simple, customisable process that uses superhydrophobic interfaces to finely engineer the bacteria access to oxygen in three dimensions and in multiple length scales.

Does genome sequencing increase downstream costs?

26 March 2018 | By European Pharmaceutical Review

A pilot study has found that whole genome sequencing of healthy individuals and cardiology patients did not increase health care spending outside of the sequencing costs.