Quality Systems

Novartis’ scemblix (asciminib) is designed to provide a single treatment option to patients struggling with chronic myeloid leukemia.

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.

Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drop to receive FDA approval for the treatment of presbyopia.

The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

EMA’s CHMP concluded that a booster dose of Moderna’s Spikevax vaccine may be considered in people aged 18 and older.

Genentech’s Susvimo (ranibizumab injection) is approved for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration.

Otsuka has submitted an initial marketing authorization application to EMA for vadadustat as a treatment of anemia associated with CKD in adults.

The National Institutes of Health (NIH), FDA, and fifteen private organizations are partnering together to form the Bespoke Gene Therapy Consortium.

MHRA has granted a license to Gedeon Richter for Ryeqo to treat moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

The panel voted 17 to 0 to recommend that FDA grant Emergency Use Authorization for Pfizer-BioNTech’s COVID-19 vaccine in children aged 5 to 11 years old.

FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.

The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.

EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.

FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

The council voted 19-0 to recommend that FDA authorize booster doses of the J&J COVID-19 vaccine just one day after granting Moderna a similar recommendation.

The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.

Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years

After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.

Navigating a complex global regulatory landscape involves upfront research into the expectations of the different regulatory bodies, thorough documentation of every step of the API manufacturing process, and good communication.