Drug Safety

New drug for treatment-resistant forms of tuberculosis approved

15 August 2019 | By Rachael Harper (European Pharmaceutical Review)

Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.

FDA to deactivate out-of-date drug listings in its database

14 August 2019 | By Rachael Harper (European Pharmaceutical Review)

In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.

Letter highlights issues with US drug returns verification requirements

14 August 2019 | By Victoria Rees (European Pharmaceutical Review)

An open letter has underscored the challenges of return failure in the US drug supply chain, especially after the introduction of the Drug Supply Chain Security Act in November.

Voluntary recall issued for lidocaine cream and liquid gel products

13 August 2019 | By Rachael Harper (European Pharmaceutical Review)

Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.

Novartis could face legal action over Zolgensma application

8 August 2019 | By Victoria Rees (European Pharmaceutical Review)

The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.

Philippines may re-introduce controversial dengue vaccine

7 August 2019 | By Rachael Harper (European Pharmaceutical Review)

The Philippines is considering re-introducing a dengue vaccine whose use was ceased because of links to several deaths.

Perigord

Liposomal medicine names to be changed to avoid errors

6 August 2019 | By Rachael Harper (European Pharmaceutical Review)

The EMA has requested that liposomal medication names be changed to avoid the risk of confusion.

Surge in negative verifications of saleable returns could cost pharma industry billions

31 July 2019 | By Riya Cao

The pharmaceutical industry is set to face some major changes in the near future, to improve the quality of returned drugs and medications.

Cannabidiol-based treatment receives marketing approval from EMA

30 July 2019 | By European Pharmaceutical Review

EMA’s human medicines committee had cleared the cannabidiol oral solution, Epidiolex, for use to treat seizures.

Two lots of Kogenate^® recalled due to mislabelling

24 July 2019 | By European Pharmaceutical Review

Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.

Altaire issues sterile product voluntary recall

16 July 2019 | By Victoria Rees (European Pharmaceutical Review)

Altaire Pharmaceuticals has announced a recall of 31 products due to a lack of sterility assurance from their manufacturing facility.

FDA publishes guidance for Inactive Ingredient Database

13 July 2019 | By Victoria Rees (European Pharmaceutical Review)

The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.

FDA sends warning letter to sterile injectables plant

12 July 2019 | By Victoria Rees (European Pharmaceutical Review)

A pharmaceutical manufacturing site in New Jersey receives FDA warning letter for failing to thoroughly investigate quality problems and data integrity issues.

FDA issues three warning letters to API re-packers

3 July 2019 | By Victoria Rees (European Pharmaceutical Review)

Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.