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Manufacturing and Production

Dupilumab significantly reduces atopic dermatitis in children

A pivotal Phase III trial evaluating dupilumab for the treatment of children aged six months to five years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints.

The data show adding Dupixent to standard of care topical corticosteroids (TCS) significantly reduced overall disease severity and improved skin clearance, itch, and health-related quality of life measures at 16 weeks compared to TCS alone.

Bone Therapeutics knee osteoarthritis Phase III study misses primary endpoints

Bone Therapeutics, the cell therapy company addressing unmet medical needs in orthopaedics and other diseases, announced that the Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004 did not meet the primary and consequently the key secondary endpoints.

The primary objective of the JTA-004 Phase III study was to demonstrate the efficacy of JTA-004 in reducing osteoarthritic knee pain compared to placebo as measured by the WOMAC(R) pain subscale three months after treatment.

AlzeCure’s Alzheimer’s project receives approval to start phase I study

AlzeCure Pharma AB, a pharmaceutical company that develops a broad portfolio of candidate drugs for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, announced that the company has received approval from the regulatory authorities in Sweden to begin the next clinical phase I study (multiple ascending dose, MAD) with the candidate drug ACD856 focused on Alzheimer's disease.

The MAD Phase I study is AlzeCure's third clinical study with ACD856, the lead candidate drug within the company’s NeuroRestore platform.

New Zealand woman dies after receiving Pfizer COVID vaccine

New Zealand has reported what they believe to be the first death associated with the Pfizer vaccine.

An independent vaccine safety monitoring board said the woman's death was "probably" due to myocarditis, which is an inflammation of the heart muscle.

It also noted there were other medical issues which could have "influenced the outcome following vaccination".

European regulators say myocarditis is a "very rare" side effect, and it’s important to note that the vaccine's benefits outweigh the risks.

Malaria sickness could be cut by 70%, study finds

Researchers from the London School of Hygiene & Tropical Medicine (LSHTM) have found a new approach to protecting young African children from malaria could reduce deaths and illness from the disease by 70%.

RTS,S vaccines, created by GSK over 20 years ago, were administered before the worst season, in addition to preventative drugs, to 6,000 children aged under 17 months in Burkina Faso and Mali.

Stelis Biopharma appoints Mark Womack as new CEO

Published on: 25/08/21

Stelis Biopharma Limited has announced the appointment of Mark W Womack as the new Chief Executive Officer.

Womack is also the Managing Director designate and shall be inducted to the Board later, subject to necessary statutory clearances and processes.

Arun Kumar, Founder, Strides Group, said, "We are delighted to onboard Mark as the new CEO of Stelis. Mark's strong background in commercial leadership, rich management consulting experience, and network within the biotech CDMO space make him exceptionally well suited to drive this transition for Stelis.”

PureTech appoints Julie Krop as Chief Medical Officer

Published on: 25/08/21

Clinical-stage biotherapeutics company PureTech has appointed Julie Krop as Chief Medical Officer.

Krop will oversee all clinical development, Regulatory, CMC, and medical affairs for the company’s advancing Wholly Owned Pipeline.

Daphne Zohar, Founder and Chief Executive Officer of PureTech, said: "Julie is a biopharmaceutical industry veteran with a wide breadth of expertise across multiple therapeutic areas and orphan indications.

Tracey Lodie appointed Chief Scientific Officer of Quell Therapeutics

Published on: 25/08/21

Quell Therapeutics has announced the appointment of Tracey Lodie as Chief Scientific Officer.

Dr Lodie brings to Quell more than 20 years of experience in the biopharmaceutical industry focused on the discovery and development of cell therapies and novel biologics in the areas of autoimmunity, transplant biology, and immune-oncology.

Dr Lodie joins Quell from Gamida Cell, a clinical-stage, Nasdaq-listed cell therapy company, where she served as CSO with responsibility for strategic oversight of its entire cell therapy pipeline.

RareCan appoints Dr Anita Cooper as Non-Executive Director

Published on: 25/08/21

Cancer research company RareCan has appointed Dr Anita Cooper as Non-Executive Director.

Cooper has over 30 years’ experience in global business and is currently a Non-Executive Director for Simbec-Orion, a leading Clinical Research Organisation.

Piers Kotting, CEO of RareCan, commented: “We are thrilled to welcome Anita to the Board of RareCan. Anita’s wealth of industry experience will help us to accelerate rare cancer research by maximising the value of RareCan to both the global life sciences and pharmaceutical services industries.”

Laura Steele appointed President and General Manager for Lilly UK

Published on: 25/08/21

Eli Lilly and Company have announced that Laura Steele has been appointed President and General Manager (GM) for UK, Ireland & Northern Europe. Laura succeeds Ashley Diaz-Granados, who assumes a senior role within Lilly USA leading the company’s Immunology division.

Laura will lead Lilly’s commercial business operations in six countries, across the company’s current and emerging portfolio in Diabetes, Oncology, Immunology, and Neuroscience.

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