Pharma News

Johnson & Johnson announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.

Schematic of the main protease of SARS CoV-2 (left), the protein residue network of the main protease of SARS CoV-2 (center), and a zoomed-in view of the region around the binding site as detected by Estrada (right). CREDIT: Ernesto Estrada

As the COVID-19 pandemic caused by the coronavirus SARS-CoV-2 continues to spread around the world, many researchers are studying epidemiological models to predict its propagation.

In the current pandemic scenario, global supplies of nasopharyngeal (NP) swabs are not dependable resulting in supply chain delays, escalating prices and variable quality. CSIR-National Chemical Laboratory (CSIR-NCL), Pune, has developed an indigenous NP swab for collecting samples from the throat cavity of COVID-19 patients. The need for making available domestic technology for NP swabs was flagged by CSIR to NCL in mid-April.

Researchers from the Indian Institute of Integrative Medicine (IIIM), Jammu, have identified a potent compound that has shown cancer-inhibiting activity in their primary studies on pancreatic cancer. For this compound, they have received Investigational New Drug (IND) approval from the New Drugs Division of the Central Drugs Standard Control Organization (CDSCO). It has been recognized as a potent anti-cancer, New Chemical Entity (NCE) effective against pancreatic cancer after completion of preclinical development and IND submission.

A team of researchers from IIT Madras, Cancer Institute, Sree Balaji Dental College and Hospital, Chennai, and Indian Institute of Science (IISc) Bengaluru have identified a specific microRNA (miRNAs) called ‘miR-155’ that is over-expressed in tongue cancer. MicroRNAs (miRNAs) are small Ribo Nucleic Acid. They are non-coding RNAs involved in the regulation of a variety of biological and pathological processes, including the formation and development of cancer. This finding is important in that molecular strategies can potentially be devised to manipulate miR-155 expression to develop therapeutics for tongue cancer.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted marketing authorisation for DARZALEX®? (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM). Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation­. In addition, only the first dose of daratumumab SC needs to be administered in an environment where resuscitation facilities are available. The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to.

Novartis announced that full results from the Phase IIIb ARGON study were published online in Respiratory Medicine. These results show that once-daily treatment with single inhaler, high- and medium-dose Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) demonstrated non-inferiority to a free combination of twice-daily, high-dose salmeterol xinafoate/fluticasone propionate (Sal/Flu) plus once-daily tiotropium (Tio), delivered in two different devices, in improving quality of life in people with uncontrolled asthma. Among secondary analyses, improvements in lung function, asthma control, health status, and reductions in moderate exacerbations were observed with high-dose once-daily IND/GLY/MF compared to high-dose Sal/Flu plus Tio.

Bristol Myers Squibb announced results from the open-label switch period of Early AMPLE, a Phase IV exploratory biomarker study assessing the differences by which Orencia (abatacept) and another treatment, adalimumab, interfere with disease progression in moderate-to-severe early rheumatoid arthritis (RA) patients who tested positive (seropositive) for certain autoantibodies. Findings of the open-label switch period showed that early seropositive RA patients treated with Orencia demonstrated substantial clinical improvements at week 48, sustaining the level of responses achieved at week 24 compared to adalimumab. In seropositive patients switching from adalimumab to Orencia, the efficacy responses generally increased over the open-label period to week 48. These results are featured in a poster presentation at the European E-Congress of Rheumatology (EULAR) 2020.