FDA expands EUA of Pfizer-BioNTech’s Covid-19 booster shot to adolescents

4 January | COVID-19

The US FDA granted an expanded emergency use authorization (EUA) for the Pfizer and BioNTech’s Covid-19 vaccine’s booster dose to adolescents aged 12 years and above.

The booster shot is of the same 30µg dosage as the approved primary vaccine regimen dose. Earlier, the FDA granted EUA to the booster shot for use in people aged 16 years and above who have completed the initial dosing regimen. In addition, the booster can be used in eligible adults aged 18 years and above who received primary vaccine series with a separate authorised Covid-19 shot.

Meanwhile, the agency has also amended the current EUA for lowering the booster inoculation time to a minimum of five months from at least six months after receiving primary doses for 12 years and older individuals.

10 January | DEALS

ASTRAZENECA’S ALEXION AND NEURIMMUNE SIGN ANTIBODY DEVELOPMENT DEAL

AstraZeneca’s Rare Disease group Alexion and Neurimmune have signed an exclusive worldwide partnership and licence agreement to develop NI006, a human monoclonal antibody. The investigational therapy is presently in the Phase Ib clinical trial to treat transthyretin amyloid cardiomyopathy (ATTR-CM). According to the deal, Alexion will receive an exclusive global licence for the development, production and marketing of NI006. Specifically targeting misfolded transthyretin, the antibody can potentially address ATTR-CM pathology directly by facilitating the amyloid fibril deposit elimination in the heart. This approach could aid in treating advanced ATTR-CM patients.

22 December | COVID-19

ARIDIS’ ANTIBODY COCKTAIL SHOWS ACTIVITY AGAINST COVID-19 VARIANTS

Aridis Pharmaceuticals has reported that its fully human monoclonal antibody (mAb) cocktail, AR-701, demonstrated broad activity against SARS-CoV-2 variants including the Omicron, Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome Coronavirus (MERS) and common cold human coronaviruses. Discovered through a partnership with the University of Alabama and Texas Biomedical Research Institute scientists, AR-701 is a combination of two fully human immunoglobulin G1 (IgG1) mAbs, AR-703 and AR-720. AR-701 is anticipated to offer substantial drug levels for up to a year from preventive or therapeutic treatment. 

10 January | deals

SANOFI AND EXSCIENTIA TO DEVELOP AI-DRIVEN CANCER AND IMMUNOLOGY MEDICINES

Sanofi and Exscientia have entered a research partnership and licensing agreement for the development of up to 15 new small-molecule medicines across oncology and immunology.

The precision-engineered medicines will be developed using Exscientia’s end-to-end artificial intelligence (AI)-driven platform using real patient samples. The alliance will identify and choose target projects using the tailored medicine platform of Exscientia. Sanofi will lead preclinical and clinical development, production and marketing of the candidates. Exscientia will handle design and oversee optimisation works of small molecule drugs until development candidate nomination, and target discovery.

22 December | M&A

SANOFI TO ACQUIRE IMMUNO-ONCOLOGY FIRM AMUNIX FOR $1BN

Sanofi has signed an agreement for the acquisition of immuno-oncology firm Amunix Pharmaceuticals for nearly $1bn in upfront payment. Amunix designs and develops masked T cell engagers (TCE) and cytokines to deliver potential immune-activating biotherapeutics to cancer patients utilising its XPAT, XPAC, XTEN and Pro-XTEN platforms. On closing of the acquisition, Sanofi will own various TCEs, cytokine therapies as well as platforms of Amunix. Amunix’s lead candidate AMX-818 is a masked HER2-directed TCE that will enter clinical trials earlier next year. AMX-818 is claimed to be a strategic fit to Sanofi’s focus area in immuno-oncology.

3 January | COVID-19

NOVAVAX FILES COVID-19 VACCINE DATA WITH FDA AHEAD OF EUA APPLICATION

Novavax has submitted the final data package with the US Food and Drug Administration (FDA) to satisfy the requirements for seeking emergency use authorization (EUA) for its Covid-19 vaccine with Matrix-M adjuvant, NVX-CoV2373. Engineered from the genetic sequence of the initial SARS-CoV-2 viral strain, the recombinant nanoparticle protein-based shot has purified protein antigen and cannot replicate or cause disease. As per the FDA guidelines, the company plans to seek EUA for the NVX-CoV2373 vaccine in a month. In the PREVENT-19 clinical trial that enrolled 25,452 subjects in the US and Mexico, the vaccine demonstrated an overall efficacy of 90.4%.

In brief

EC expands indication for Gilead’s Veklury to treat Covid-19 patients


The European Commission (EC) granted a Conditional Marketing Authorization (CMA) variation for Gilead Sciences’ antiviral Veklury (remdesivir) to include adult Covid-19 patients who do not need supplemental oxygen and are at greater disease progression risk. 

FDA grants EUA for Pfizer’s Covid-19 oral antiviral Paxlovid


The US FDA granted an emergency use authorization (EUA) for Pfizer’s oral antiviral Paxlovid to treat mild-to-moderate Covid-19 in adults and paediatric individuals aged 12 years and above. The treatment is given as two tablets of nirmatrelvir and one tablet of ritonavir together twice a day for five days.

EC approves Vertex’s combination therapy for cystic fibrosis in children


The European Commission approved the label extension of the combination regimen of Vertex Pharmaceuticals’ Kaftrio (ivacaftor / tezacaftor / elexacaftor) with ivacaftor to treat cystic fibrosis (CF) in children aged six to 11 years. This is intended for patients with a minimum of one F508del mutation in the CFTR gene.

NICE approves lung cancer combination drug therapy for NHS use


The UK National Institute for Health and Care Excellence (NICE) approved a combination of pembrolizumab (Keytruda) plus chemotherapy drugs, carboplatin and paclitaxel, to treat patients with untreated, squamous non-small cell lung cancer, which has spread to other body parts.


BMS and Century partner for allogeneic cell therapy development


Bristol Myers Squibb (BMS) and Century Therapeutics will develop and market up to four induced pluripotent stem cell (iPSC)-derived, engineered natural killer cell (iNK) and/or T cell (iT) programmes. The first two programmes comprise one each in acute myeloid leukaemia and in multiple myeloma.


4 January | COVID-19

IMMUNITYBIO AND AMYRIS CONCLUDE COVID-19 VACCINE COMMERCIALISATION JV

ImmunityBio and Amyris have concluded a joint venture (JV) agreement to speed up the marketing of a next-generation vaccine for Covid-19. The companies, which signed the 50:50 arrangement in November last year, merged their key vaccine technology and production expertise through the JV. On concluding the human trials and obtaining regulatory approval, the JV intends to commence supply of the second-generation Covid-19 shot this year. This move is aimed at offering access to underserved regions globally where present vaccine technology is challenged due to limitations in price and supply chain.

11 January | Deals

BMS AND CENTURY PARTNER FOR ALLOGENEIC CELL THERAPY DEVELOPMENT

Bristol Myers Squibb (BMS) has signed a research partnership and license agreement with Century Therapeutics for hematologic malignancies and solid tumour therapy development. The companies will develop and market up to four induced pluripotent stem cell (iPSC)-derived, engineered natural killer cell (iNK) and/or T cell (iT) programmes. The first two programmes comprise one each in acute myeloid leukaemia and in multiple myeloma, which could integrate either the iNK or a gamma delta iT platform.

23 November | DEALS

ARROWHEAD AND GSK SIGN DEAL FOR RNAI THERAPEUTIC ARO-HSD

Under the agreement, GSK will develop and market Arrowhead’s ARO-HSD for nonalcoholic steatohepatitis (NASH) treatment. A ribonucleic acid interference (RNAi) therapeutic, ARO-HSD acts on the HSD17B13 as a potential therapy for individuals with alcohol-related and nonalcohol associated liver diseases such as NASH.

Arrowhead is entitled to $120m in upfront payment from GSK, which will also make further payments of $30m on commencing a Phase II trial.

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.