Covid-19 mandates lifted even as cases climb
2 March | Covid-19
Numerous states and countries have begun lifting Covid-19 mandates even though there are more deaths due to the virus now than there were during the majority of the pandemic. For the past month, there have been more than 2,000 Covid-19 related deaths a day in the US reported, which has been the highest count since the first winter Covid-19 surge before vaccines were available. At present, Covid is attributed to 20% of all deaths worldwide. The demographics have now changed to younger and unvaccinated individuals dying, compared with older individuals who accounted for most of the casualties before vaccines were available.
These death counts are not surprising as data from the US Centres for Disease Control and Prevention (CDC) indicate that the chances of dying from Covid-19 are 14 times higher for unvaccinated adults than for vaccinated adults and 51 times higher for the unvaccinated than for vaccinated adults who have had a ‘booster shot’. Despite these statistics, vaccine hesitancy continues in younger individuals, often due to disinformation and the perception that younger people do not die of Covid-19, along with a growing acceptance of the risks associated with the virus. Governments and healthcare institutions will need to continue to push vaccine uptake in younger individuals and for more adults to get their booster shots.
8 March | COVID-19
GLOBAL COVID DEATHS PASS 6 MILLION
The global Covid death toll has passed the grim milestone of 6 million, with a figure of 6,007,367 according to researchers at Johns Hopkins University. Meanwhile, infections have continued past 447 million to a world wide figure of 447,894,535.
Moderna Inc. plans to start human trials for vaccines against 15 threatening viruses and other pathogens by 2025, part of a strategy to develop shots that could be made quickly in response to a future pandemic
The national increase in cases matched the average daily increase of less than 0.1% over the past week. California had the largest number of confirmed cases at 9.01 million, a 0.1% increase from the same time the previous day.
4 March | Funding
THE UK TO PROVIDE $347M INVESTMENT FOR HEALTHCARE RESEARCH
The UK Government has announced an investment of $347m (£260m) to enhance research and development (R&D), as well as the production of novel therapies, devices and diagnostics.
Up to $267m (£200m) of the funding will be invested to facilitate research to improve access to National Health Service (NHS) data leveraging Trusted Research Environments and digital trial services.
The Department for Business Energy & Industrial Strategy (BEIS) and the Department of Health and Social Care (DHSC) committed the $267m funding.
This will allow researchers to access critical data in a secure and rapid manner while maintaining increased privacy levels.
Furthermore, it will guarantee that the NHS could offer new life-saving therapies for patients quickly.
8 March | Deals
UCB CONCLUDES ACQUISITION OF BIOPHARMA FIRM ZOGENIX FOR $1.9BN
UCB has concluded the previously announced acquisition of international biopharmaceutical firm Zogenix in a deal valued at up to roughly $1.9bn (€1.7bn).
In January, UCB signed a definitive agreement for acquiring all outstanding shares of Zogenix.
According to the deal, the acquisition value comprises $26 for each share in cash and a non-tradeable contingent value right (CVR).
Additionally, the transaction value includes a CVR for a cash payment of $2 for each share on Fintepla obtaining approval in the EU by 31 December next year to treat seizures linked to Lennox-Gastaut syndrome (LGS).
8 March | Covid-19
MODERNA SIGNS MOU TO BUILD MRNA MANUFACTURING FACILITY IN KENYA
Moderna has signed a memorandum of understanding (MoU) with the Government of the Republic of Kenya to build a messenger ribonucleic acid (mRNA) manufacturing facility.
The MoU was signed by the company with assistance from the US Government.
Moderna is establishing this facility in Africa to manufacture up to 500 million vaccines doses per year.
The company plans to invest up to $500m in this new plant, which is intended to carry out drug substance production for Kenya.
The facility might be extended to incorporate fill/finish as well as packaging expertise at the site.
Simultaneously, Moderna is developing strategies to permit the new plant to begin to fill doses of its Covid-19 vaccine in Africa by next year.
3 March | Deals
ADAGENE AND SANOFI SIGN ANTIBODY DEVELOPMENT PARTNERSHIP AGREEMENT
Adagene and Sanofi have entered a partnership and exclusive licence agreement to develop and commercialise masked monoclonal and bispecific antibodies.
According to the deal, Adagene will handle initial stage research activities and leverage its SAFEbody technology for developing masked versions of Sanofi candidate antibodies.
Sanofi will be fully in charge of late-stage research as well as all the clinical, product development and marketing efforts.
Adagene is entitled to receive an upfront payment of $17.5m from Sanofi.
It could progress two initial antibody candidates of Sanofi in the alliance, with an option for two more candidates.
Furthermore, Adagene will receive a total of up to $2.5bn in potential development, regulatory and commercial milestone payments for progressing the candidates.
EC approves Boehringer-Lilly’s Jardiance for chronic heart failure
The European Commission (EC) has granted marketing authorisation to Boehringer Ingelheim and Eli Lilly and Company’s Jardiance (empagliflozin) to treat symptomatic chronic heart failure in adult patients.
With the latest development, Jardiance became the first treatment to be approved for use in all adult patients with symptomatic chronic heart failure.
Taiwan approves Eisai’s Lenvima combo for endometrial carcinoma
Eisai has reported that its therapy Lenvima (lenvatinib mesylate) obtained approval in Taiwan to treat advanced endometrial carcinoma patients along with Merck’s (MSD) Keytruda (pembrolizumab).
An orally available inhibitor of multiple receptor tyrosine kinase, Lenvima hinders the kinase activities of vascular endothelial growth factor (VEGF) receptors.
BMS obtains FDA approval for Opdivo combo for non-small cell lung cancer
The US FDA has granted approval to Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) plus platinum-doublet chemotherapy for adult resectable non-small cell lung cancer (NSCLC) patients in the neoadjuvant setting.
According to the approval, a 360mg intravenous dose of Opdivo should be used along with platinum-doublet chemotherapy every three weeks for three cycles for resectable NSCLC patients with tumours ≥4cm or node-positive.
Health Canada approves BeiGene’s Brukinsa for marginal zone lymphoma
Health Canada has granted marketing approval to BeiGene’s Brukinsa (zanubrutinib) to treat relapsed or refractory marginal zone lymphoma (R/R MZL) in adult individuals.
Brukinsa is indicated for patients who were previously treated with a minimum of one anti-CD20-based therapy.
The recommended dosage of Brukinsa is either oral 160mg given twice a day or 320mg once a day.
FDA grants approval to Janssen’s Carvykti for multiple myeloma treatment
The US Food and Drug Administration (FDA) has granted approval to Johnson & Johnson’s first cell therapy Carvykti (ciltacabtagene autoleucel; cilta-cel) to treat relapsed or refractory multiple myeloma (RRMM) in adults.
It is indicated for usage following four or more previous lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
4 March | Litigation
PURDUE AND SACKLERS ENTER $6BN OPIOID SETTLEMENT AGREEMENT WITH US STATES
Purdue Pharma and owners, the Sackler family, have entered an agreement with a group of US state attorneys general to pay up to $6bn in cash to settle the opioid claims in the country.
The latest deal was reached after eight states and the District of Columbia objected to and appealed a prior agreement that does not offer protection to the Sackler families from any liability linked to the opioid crisis in the future.
3 February | Regulatory
FDA GRANTS ORPHAN DRUG STATUS TO SYROS’ MYELODYSPLASTIC SYNDROME THERAPY
The FDA has granted orphan drug designation to Inhibrx’s INBRX-101 to treat alpha-1 antitrypsin deficiency (AATD).
INBRX-101 is a recombinant human AAT-Fc fusion protein.
It can safely attain and preserve AAT levels observed in healthy people with a favourable safety profile and the possibility of dosing once a month.
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.