News in Numbers

3%

As per the World Health Organization’s Global Vaccine Market Report, the African continent received only 3% of all Covid-19 vaccine doses in 2021.

7

In the backdrop of the United Nations’ COP27 meeting, seven major pharmaceutical companies announced their near-term emission reduction targets are aligned with the 1.5°C pathway.

$8 billion

Seasonal influenza vaccines for adults represented $8 billion in market value in 2021, as per the WHO’s Global Vaccine Market Report.

84

The European Medicines Agency (EMA) has given 84 positive opinions on new medicines in 2022 so far, as per its November report.

25

After a surge in cases over the summer, the number of daily monkeypox cases reported in the US dropped to 25 on November 9, as per the Centers for Disease Control and Prevention.

 Approvals

VEMLIDY

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

Source: PHARMACEUTICAL TECHNOLOGY

VIDPREVTYN BETA

The European Commission (EC) has granted approval for Sanofi and GSK’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above.

Source: PHARMACEUTICAL TECHNOLOGY

KINERET

The US FDA has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB’s (Sobi) Kineret (anakinra) to treat Covid-19 in adult patients who are hospitalised with pneumonia.

Source: Pharmaceutical Technology

LIBTAYO

The US FDA has approved Regeneron Pharmaceuticals’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) and chemotherapy combination as the first-line treatment for advanced non-small cell lung cancer (NSCLC).

Source: Pharmaceutical Technology

Clinical Trials

Instil Bio halts subject enrolment in trials due to manufacturing issues

Instil Bio has voluntarily halted subject enrolment in its clinical trials analysing two cancer therapies, ITIL-168 and ITIL-306, due to manufacturing issues. The company alerted the regulatory agencies in the US, UK, and Canada about the issue.  

Source: Clinical Trials Arena

IGM and ADC enter clinical trial partnership deal for lymphoma treatment

IGM Biosciences has signed a clinical trial partnership and supply agreement with ADC Therapeutics to analyse the combination of imvotamab and Zynlonta (loncastuximab tesirine-lpyl) to treat relapsed/refractory (R/R) B cell non-Hodgkin’s lymphoma (NHL).

Source: Clinical Trials Arena

Blue Lake reports positive data from Phase I RSV vaccine trial

Blue Lake Biotechnology has reported positive interim findings from a Phase I clinical trial of its intranasal vaccine candidate, BLB201, to prevent severe respiratory syncytial virus (RSV)-linked disease. As per the data, 64% of participants showed a rise in serum anti-RSV antibody responses above the baseline levels.

Source: Clinical Trials Arena

Clearside Biomedical reports positive data from wet AMD therapy trial

Clearside BioMedical has reported positive data from its OASIS Phase I/IIa clinical trial of CLS-AX (axitinib injectable suspension) to treat neovascular age-related macular degeneration (wet AMD) patients. CLS-AX met the primary endpoint and showed a positive safety profile at all timepoints, and doses were well-tolerated.

Source: Clinical Trials Arena

Castor unveils new offering for post-marketing trials’ simplification

Castor has introduced a new offering, Castor Real-World Evidence (RWE), to streamline post-marketing clinical trials. This offering can expand international reach, merge real-world data (RWD), and carry out trial process automation to cut down expenses of the trial by 30%.

Source: Clinical Trials Arena

Longeveron completes subject enrolment in Alzheimer’s Disease therapy trial

Longeveron has concluded subject enrolment in the Phase IIa CLEAR MIND trial of its lead investigational therapeutic candidate, Lomecel-B, for the treatment of Alzheimer’s Disease (AD). The Phase IIa trial will assess the safety of single and multiple infusions of two different Lomecel-B dose levels.

Source: Clinical Trials Arena