Industry news
EC to procure 60 million doses of Valneva’s Covid-19 vaccine
11 November | vaccines
The European Commission (EC) has approved an agreement to purchase up to 60 million doses of the Valneva inactivated vaccine candidate VLA2001 for Covid-19 over a period of two years.
VLA2001 has inactivated whole SARS-CoV-2 virus particles with a greater density of S-protein, along with alum and Dynavax Technologies’ CpG 1018 adjuvant.
The vaccine could potentially be used for active immunisation of at-risk populations for Covid-19 prevention.
The latest contract would permit all member states of the EU to procure nearly 27 million vaccine doses next year.
It also includes an option for the member states to acquire up to 33 million extra doses in 2023 and to adapt the shot against novel variant strains of SARS-CoV-2.
The company plans to commence supply of the vaccine doses in April next year on securing approval from the human medicines committee of the European Medicines Agency (EMA).
10 november | opioids
OKLAHOMA SUPREME COURT OVERTURNS RULING AGAINST J&J IN $465M OPIOID LAWSUIT
The Oklahoma State Supreme Court in the US has overturned a 2019 judgement that had ruled Johnson & Johnson (J&J) and its Janssen Pharmaceutical Companies accountable for contributing to the opioid crisis.
The ruling was overturned after concluding that a lower court incorrectly construed the public nuisance law of Oklahoma.
This is reported to be the first case of its type to go for a trial in the US.
In the latest release, justice James Winchester noted: “We hold that the district court’s expansion of public nuisance law went too far.
“Oklahoma public nuisance law does not extend to the manufacturing, marketing, and selling of prescription opioids.”
10 november | regulation
BIOHAVEN AND PFIZER PARTNER TO MARKET MIGRAINE DRUGS OUTSIDE THE US
Pfizer has signed a collaboration and licence agreement to obtain rights to market Biohaven Pharmaceutical’s migraine drugs, rimegepant and zavegepant, outside the US.
An oral calcitonin gene-related peptide receptor antagonist (CGRP), rimegepant is marketed as Nurtec ODT in the US region
The drug is also indicated as preventive therapy in adults with episodic migraine.
The EMA and other regulatory agencies outside the US are currently reviewing applications seeking approval for rimegepant.
An increased affinity small molecule CGRP receptor antagonist, zavegepant is being analysed in an intranasal delivery and a soft-gel formulation in Phase III trials for treating migraine.
10 november | deals
US TO PROCURE 1.4 MILLION COURSES OF MOLNUPIRAVIR FOR $1BN
The US Government will buy 1.4 million courses of Merck (MSD) and Ridgeback Biotherapeutics’ molnupiravir for nearly $1bn.
This purchase is pursuant to obtaining emergency use authorisation or approval from the US Food and Drug Administration (FDA) for the experimental antiviral pill to treat Covid-19.
An oral form of a potent ribonucleoside analogue, molnupiravir hinders SARS-CoV-2 virus replication.
With the latest option exercised, the US Government has committed to buy a total of 3.1 million courses for approximately $2.2bn. The courses will be supplied between receipt of authorisation and early next year.
09 november | approvals
FDA APPROVES ETON-AZURITY’S EPRONTIA ORAL SOLUTION FOR SEIZURES AND MIGRAINES
The US FDA has granted approval to Eton Pharmaceuticals and Azurity Pharmaceuticals’ Eprontia (topiramate) oral solution to treat seizures and migraines.
A liquid formulation of topiramate, Eprontia is now indicated as a single agent to treat partial-onset or primary generalised tonic-clonic seizures in individuals aged two years and above.
The oral solution is also approved as an adjunctive treatment for partial-onset seizures, primary generalised tonic-clonic seizures or seizures linked with Lennox-Gastaut syndrome in people aged two years and above.
Eton noted that Eprontia can be used as a preventive therapy for migraine in patients aged 12 years and above.
09 november | vaccines
UK TO ADD WHO EUL-LISTED COVID-19 SHOTS TO APPROVED VACCINES LIST
The UK Government has issued guidance to include the Covid-19 vaccines of Bharat Biotech, Sinovac and Sinopharm Beijing on the approved list of shots for travellers entering the country.
From 22 November, travellers who are fully inoculated with a Covid-19 vaccine listed on the World Health Organization’s emergency use listing (WHO EUL) will not be required to self-isolate.
A government statement said: “From 4am on Monday 22 November, we will recognise the following vaccines: Pfizer BioNTech, Oxford AstraZeneca (including Covishield), Moderna and Janssen (Johnson and Johnson), and WHO EUL including Sinovac, Sinopharm Beijing and Covaxin.
In brief
ICR researchers find drug combination to treat brain cancer in children
Researchers from the Institute of Cancer Research in the UK have identified a new combination of two approved cancer drugs that can be used to treat children suffering from incurable brain cancer.
Ocugen seeks FDA EUA for Covid-19 vaccine use in children
Ocugen has sought EUA from the US FDA for its Covid-19 vaccine candidate, BBV152, for use in children in the age group of two to 18 years.
Developed by Ocugen’s partner, India-based Bharat Biotech, and the Indian Council of Medical Research – National Institute of Virology, the whole-virion, inactivated vaccine is called Covaxin.
FDA declines to grant EUA for NRx’s Zyesami to treat Covid-19 patients
The US FDA has declined to grant an EUA for NRx Pharmaceuticals’ therapy, Zyesami (aviptadil), to treat critical Covid-19 patients who have respiratory failure.
In a letter to the company, the agency noted that its decision comes due to inadequate evidence on the known and possible benefits of the treatment and its risks in critical Covid-19 patients with respiratory failure.
Novartis and Dunad sign deal to develop protein degrader drugs
Novartis and UK-based company Dunad Therapeutics have signed a strategic partnership and licence agreement to develop oral targeted protein degrader small molecule therapies.
EMA stops rolling review of Lilly’s antibodies for Covid-19
The EMA has ended the rolling review of the marketing authorisation application for Eli Lilly Netherlands’ antibodies, bamlanivimab and etesevimab, to treat Covid-19.
09 november | Clinical trials
REGENERON’S THERAPY OFFERS LONG-TERM PROTECTION AGAINST COVID-19 IN TRIAL
Regeneron Pharmaceuticals has reported positive data from a Phase III clinical trial of a single dose of its experimental therapy, REGEN-COV, for Covid-19 prevention in uninfected people.
The placebo-controlled, double-blind Phase III trial was conducted in collaboration with the National Institute of Allergy and Infectious Diseases.
08 November | Funding
BIT.BIO RAISES $103M THROUGH SERIES B ROUND TO DEVELOP CELL THERAPIES
UK-based bit.bio has raised $103m through a Series B funding round to accelerate the clinical development of cell therapies.
Investors included National Resilience, Puhua Capital, Charles River Laboratories, Foresite Capital, Arch Ventures, Metaplanet and Tencent.
The funds will be used to speed up the clinical development of the cell coding technology opti-ox, which is a gene engineering approach.
In brief
ICR researchers find drug combination to treat brain cancer in children
Researchers from the Institute of Cancer Research, UK, have identified a new combination of two approved cancer drugs that can be used to treat children suffering from incurable brain cancer.
Ocugen seeks FDA EUA for Covid-19 vaccine use in children
Ocugen has sought EUA from the US FDA for its Covid-19 vaccine candidate, BBV152, for use in children in the age group of two to 18 years.
Developed by Ocugen’s partner, India-based Bharat Biotech, and the Indian Council of Medical Research – National Institute of Virology, the whole-virion, inactivated vaccine is called Covaxin.
FDA declines to grant EUA for NRx’s Zyesami to treat Covid-19 patients
The US FDA has declined to grant an EUA for NRx Pharmaceuticals’ therapy, Zyesami (aviptadil), to treat critical Covid-19 patients who have respiratory failure.
In a letter to the company, the agency noted that its decision comes due to inadequate evidence on the known and possible benefits of the treatment and its risks in critical Covid-19 patients with respiratory failure.
Novartis and Dunad sign deal to develop protein degrader drugs
Novartis and UK-based company Dunad Therapeutics have signed a strategic partnership and licence agreement to develop oral targeted protein degrader small molecule therapies.
EMA stops rolling review of Lilly’s antibodies for Covid-19
The EMA has ended the rolling review of the marketing authorisation application for Eli Lilly Netherlands’ antibodies, bamlanivimab and etesevimab, to treat Covid-19.
