News in Numbers

$2.6bn

Seagen and RemeGen have entered into an exclusive global licencing agreement worth up to $2.6bn to develop and market a new cancer drug.

$27bn

Wall Street analysts expect Pfizer and BioNTech SE’s Covid-19 vaccine to eclipse the current single-year sales record for a drug, with 2021 revenue predicted to reach $27bn.

8,600

The number of patients that German authorities believe may have been impacted after a Red Cross nurse was accused of swapping vaccine doses with saline.

3

The US FDA has revised authorisations for the Pfizer-BioNTech and Moderna’s Covid-19 vaccines to enable the use of a third dose in some immunocompromised people.

57%

In a recent GlobalData survey, 57% of participants responded that they expect virtual trials to be used frequently within one or two years.

Approvals

Bavencio (avelumab)

The Scottish Medicines Consortium has approved Merck and Pfizer’s Bavencio (avelumab) for use as a first-line maintenance therapy for adults with advanced urothelial carcinoma.

Source: Scottish Medicines Consortium

Verzenios

After rejecting Eli Lilly’s Verzenios for breast cancer therapy earlier this year, NICE has relented, recommending the drug for routine NHS use alongside hormonal therapy fulvestrant.

Source: Pharmaphorum

Nexviazyme (avalglucosidase alfa-ngpt)

The US FDA has approved Sanofi’s Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilitating muscle disorder that impairs a person’s ability to move and breathe.

Source: Sanofi

Welireg (belzutifan)

The US FDA has approved Welireg for adult patients with Von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.

Source: Merck

JNJ-78436735

India has approved Johnson & Johnson’s single-dose Covid-19 vaccine (JNJ-78436735) for emergency use, expanding the total number of anti-SARS-CoV-2 vaccines authorised in the country to five.

Source: Pharmaceutical Technology

Clinical Trials

WHO’s Solidarity clinical trial enters a new phase

The World Health Organization (WHO) has announced the next phase in its Solidarity trial: Solidarity PLUS will enroll hospitalised patients to test three new drugs in hospitalised Covid-19 patients.

Source: WHO

Valneva initiates further Phase III clinical trial for its Covid-19 vaccine candidate

VLA2001-304 aims to generate data in the elderly and is also designed to potentially enable variant-bridging through immune-comparability. Data from this study is expected to complement ongoing clinical trials and support additional regulatory submissions.

Source: Valneva

Axsome Therapeutics’ AXS-05 shows promising results in treatment-resistant depression

Axsome Therapeutics has announced that its pipeline product AXS-05 (bupropion + dextromethorphan) achieved primary and key secondary endpoints in the MERIT Phase II trial for treatment-resistant depression.

Source: Clinical Trials Arena

Aprea Therapeutics announces clinical hold on lymphoid malignancy programme

The US FDA has placed a clinical hold on Aprea Therapeutics’ clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. No additional patients can be enrolled until the clinical hold is resolved.

Source: Aprea Therapeutics

I-Mab’s plonmarlimab lowers mortality rate in Phase II/III Covid-19 trial

I-Mab has reported positive interim results from the Phase II/III trial of plonmarlimab (TJM2 or TJ003234) to treat cytokine release syndrome in severe Covid-19 patients in the US.

Source: Pharmaceutical Technology

Moderna’s Covid-19 vaccine shows durable effectiveness against variants

Moderna has reported that its Covid-19 messenger ribonucleic acid vaccine provided durable efficacy in producing neutralising antibodies against SARS-CoV-2 variants of concern in a study.