A new FDA guidance provides answers to questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.

Plastic primary packaging could help prevent supply chain shortages associated with high demand for COVID-19 vaccines.

The agency describes the requirements for retaining reserve samples of test articles and reference standards used in an in-vivo bioavailability and in-vivo or in-vitro bioequivalence study.

FDA published guidance regarding the development of treatments for acute myeloid leukemia.

FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.

The acquisition will give Sanofi access to Principia’s Bruton tyrosine kinase (BTK) inhibitors to add to its portfolio of next-generation transformative treatments for autoimmune diseases.

The cell banks were created using current good manufacturing practices and can be used each time CombiGene produces new plasmids for the production of its gene therapy, CG01.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

SK bioscience will manufacture the vaccine antigen component for use in the final drug product at its vaccine facility in Andong L-house, South Korea.

ANA will use Quotient’s formulation and manufacturing knowledge to develop and supply the drug product for clinical trials by the third quarter of 2020.

FDA has approved Evrysdi (risdiplam) for treating spinal muscular atrophy in adults and children.

In combination with BARDA’s previous award, the commitment for early access to Moderna’s vaccine candidate has now reached to up to $2.48 billion.

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

Atomwise’s technology, AtomNet, works to eliminate the barriers of physical screening for small molecule drug discovery.

Veklury (remdesivir) is an investigational antiviral drug that Gilead is developing to treat COVID-19.

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The companies will work to establish an operational footprint across North America and Europe that will offer customers supply chain assurance for a combined portfolio of leading solutions.

The COVID-19 pandemic has highlighted the challenges and complications of sourcing, tracking, and testing materials for pharmaceuticals. Pharmaceutical Technology spoke with Joe DiMartino, Luminata solution manager at ACD/Labs about the impact COVID-19 is having on the pharmaceutical supply chain and how companies can prepare for these challenges.

The company will use the acquisition to further its drug development pipeline in women’s healthcare.

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine, with no supporting clinical trial results.

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

Citing undisclosed allegations against Kodak, the DFC placed a hold on a potential $765 million loan to launch US-based API manufacturing.

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.