Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.
Akorn announces fraud case launched by Fresenius has been denied by US courts, shortly after fourth quarter financials revealed problems within its manufacturing network.
Camber and Macleods voluntarily recall losartan tablets lots, after trace amounts of a possible carcinogen found in an API ingredient manufactured at the same third-party facility.
Novartis exercises its option to license Ionis’ RNA-targeting cardiovascular drug, adding to its cardiovascular treatment portfolio, as Entresto reaches the three-year mark on its patent.
Haselmeier to provide assembly, labeling, and packaging services for its drug-device combination products following recent permission given to Germany-site.
US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
The FDA issued a warning letter to McKesson for violations concerning a possible distribution of illegitimate opioid products while calling for action in securing the supply chain from illegitimate medications, especially opioids.
US FDA is reaching out to the industry to agree upon ‘voluntary consensus standards’ to promote the development of drugs and reduce manufacturing cost.
US FDA Psychopharmacologic Drug Advisory Committee recommends Spravato, an intranasal form of esketamine, for approval based on its favorable benefit-risk profile.
Hugh Pullen, EMVO’s president, explains what the launching of the EMVS means for the industry, and details how a potential no-deal Brexit will impact the system.
Mylan’s recently FDA-approved Advair Diskus generic to be offered at 70% cost reduction to its reference drug, and 67% less than GSK’s generic version.
US FDA initiates a pilot project testing innovations in an aim to inform the development of the tracking and verification systems going into effect with the DCSA in 2023.
France, Germany, and the UK recently formed INSTEX to be able to secure trade despite US sanctions on Iran, a move that has been welcomed by Novo Nordisk.
The voluntary recall, originally initiated due to a product compliant in October 2018 for mislabeling, continues for anti-seizure drug, Levetiracetam injection in single-dose bags.
As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for ‘economic stability’ and to bring affordable drugs to patients.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
The approval of the farm bill has intensified interest in CBD but Nexien BioPharma CEO warns pharma-grade products are needed for patients with serious conditions.
FDA provided an update on its valsartan contamination investigation and suggested it had discovered two possible causes of the carcinogenic impurities.
Novartis joined industry associations in expressing concerns over the impact that a ‘hard’ or ‘disorderly’ Brexit could have on the life sciences sector.
The EMA announces further details on its move from current London headquarters to Amsterdam, which will begin on March 1 and see staff working in its new offices on March 11.
MedPharm expands its US Center of Excellence in Durham, North Carolina, in response to increasing demand for its topical and transdermal formulation development, and performance testing services.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
Novo Nordisk Pharmatech selected DKSH to distribute its pharmaceutical grade compounds to the company’s growing customer base in the Asia-Pacific region.
The FDA approved Teva's generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition.
After a low cost of manufacturing goal was achieved by a consortium for the development of a bioproduction system for vaccines, Univercells will launch its NevoLine system.
Akorn received a warning letter from the FDA on January 4, relating to the inspection of its manufacturing facility in Decatur, Illinois, in April and May 2018.