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US Food and Drug Administration (FDA)

Novartis submit BLA for tislelizumab for oesophageal cancer treatment

15 September 2021 | By Anna Begley (European Pharmaceutical Review)

US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.

Close up of a 3D printing head about to start a print on the printing bed

article

3D printing – current pharmaceutical applications and future directions

14 September 2021 | By Hannah Balfour (European Pharmaceutical Review)

3D printing has the potential to revolutionise the pharmaceutical manufacturing industry; however, few 3D-printed products have been approved since the first in 2015. In this article, EPR’s Hannah Balfour explores the technologies currently being evaluated for use in the 3D printing of pharmaceuticals, and the work of key market players…

news

Data integrity is a key concern with microbial methods, says expert

10 September 2021 | By Hannah Balfour (European Pharmaceutical Review)

Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.

Diverse group of scientist collaborating on research/a project in a lab

article

Embedding inclusion in pharmaceutical design

10 September 2021 | By Raafi-Karim Alidina (Included)

In this article, Included’s Raafi-Karim Alidina explores biases in product design, outlining how they impact pharmaceuticals as well as technologies, and practical steps to enhance diversity and ensure inclusion.

First patient dosed with novel RNA modifying enzyme inhibitor

news

Moderna and ILCM to develop Crigler-Najjar syndrome therapeutic

8 September 2021 | By Anna Begley (European Pharmaceutical Review)

Moderna and the Institute for Life Changing Medicines (ILCM) are collaborating to develop an mRNA therapeutic for Crigler-Najjar syndrome.

news

FDA reaches over 100 Competitive Generic Therapy approvals

3 September 2021 | By Anna Begley (European Pharmaceutical Review)

The FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.

news

EC approves Ultomiris for children and adolescents with PNH

3 September 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).

Scared woman holding head in hands, indicating schizophrenia

news

FDA approves Invega Hayfera^™ for the treatment of schizophrenia

2 September 2021 | By Anna Begley (European Pharmaceutical Review)

Janssen announced US FDA approval of Invega Hayfera, the first and only twice-yearly treatment for adults with schizophrenia.

Man clutching heart, implying heart failure

news

Jardiance^® displays 21 percent risk reduction in heart failure patients

31 August 2021 | By Anna Begley (European Pharmaceutical Review)

Jardiance displayed a 21 percent risk reduction in adults with heart failure with preserved ejection fraction in Phase III study.

article

‘Magic bullets’ for all: democratising biologics by rethinking antibody development, manufacturing and delivery

31 August 2021 | By Brian Finrow (Lumen Bioscience), Craig Behnke (Lumen Bioscience)

Antibody therapeutics revolutionised how diseases like cancer are treated in the developed world, but their high manufacturing cost and cumbersome distribution and administration leave them out of reach for most. In this guest article, Lumen Bioscience’s CEO, Brian Finrow, and EVP of Production & Development, Craig Behnke, discuss how new…

Photomicrograph of diffuse B-cell lymphoma

news

Minjuvi^® receives EC approval to treat large B-cell lymphoma

27 August 2021 | By Anna Begley (European Pharmaceutical Review)

European Commission (EC) approves Minjuvi with lenalidomide for the treatment of large B-cell lymphoma in adults.

news

Vaxneuvance™ meets immunogenicity and safety endpoints in Phase III trial

27 August 2021 | By Anna Begley (European Pharmaceutical Review)

Merck announces positive results from a Phase III study evaluating Vaxneuvance™ against a pneumococcal conjugate vaccine in infants.

news

FDA application to be submitted for Comirnaty^® booster dose

26 August 2021 | By Anna Begley (European Pharmaceutical Review)

Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.

tablets and capsules surrounding an overflowing spoonful of sugar on a red background - idea of paediatric medicines

article

Paediatric medicines: just a spoonful of sugar?

26 August 2021 | By Dave Elder (David P Elder Constultancy)

Here, Dave Elder discusses the ever increasing importance of child-friendly medications and the specific challenges associated with their development.

Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].

news

Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine

24 August 2021 | By Anna Begley (European Pharmaceutical Review)

Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.

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US Food and Drug Administration (FDA)