Remove 2008 Remove Communication Remove Vaccines
article thumbnail

4mn dose shortage of GSK’s childhood rotavirus vaccine expected

European Pharmaceutical Review

According to Reuters , Kenya, Tanzania, Senegal and Cameroon have either run out of or are close to running out of vaccines to protect children against the deadly rotavirus infection following undisclosed “manufacturing challenges” at GSK. We are witnessing the largest sustained drop in childhood immunisation in a generation.

article thumbnail

Why pharma needs a revolution in culture

pharmaphorum

As we come up on a year and a half of the COVID-19 pandemic, with the global roll out of vaccines slowly gathering pace and big pharma riding high in the opinion charts, the biopharmaceutical sector would do well to learn lessons from the banks. Compliance systems by themselves are not enough. Of course, having rules is necessary.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Accommodating Multiple Modalities in the Same Facility

ISPE

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Viral antigen vaccines. For example: Live vaccine manufacturing. Complete Data Gathering.

article thumbnail

Meet the company on a mission to transform research and advance healthcare

Pharmaceutical Technology

You were the chief operating officer (COO) at Viroclinics-DDL before the acquisition, joining Viroclinics-DDL in 2008. The capabilities of Viroclinics and DDL allowed us to rapidly test repurposed drugs, new vaccines and antiviral solutions for the prevention and treatment of patients affected by COVID-19 in 2020.

article thumbnail

Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence

ISPE

Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.

article thumbnail

Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry. While production volumes have now fallen, future vaccine demand is hard to predict, as booster shots could be needed at any point to control emerging variants.

article thumbnail

FDA-Approved Labeling: Is Enough Enough?

The FDA Law Blog

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5