Search This Blog

Tuesday, October 18, 2022

Vir Starts Phase 2 Trial of VIR-2482 for Antibody Prophylaxis of Influenza A

 First clinical trial evaluating the role of a monoclonal antibody in preventing seasonal flu –

– Announcement follows recent U.S. government award from the Biomedical Advanced Research and Development Authority supporting development of VIR-2482 –

 Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first participant has been dosed in the Phase 2 PENINSULA (Prevention of Illness Due to Influenza A) trial evaluating VIR-2482 for the prevention of illness due to influenza A. This trial is the first to evaluate the role of a monoclonal antibody in the prevention of influenza A illness.

VIR-2482 is an intramuscularly administered investigational monoclonal antibody that has demonstrated in vitro the ability to neutralize all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. It is designed to be a universal prophylactic against both seasonal and pandemic influenza A, and has been engineered to have an extended half-life, providing the potential for protection throughout an entire flu season.

https://finance.yahoo.com/news/vir-biotechnology-announces-first-patient-120000431.html

Roche Q3 results show steep fall-off in COVID product sales

 Roche’s third-quarter results have revealed a clear sign that the bumper sales boosting companies that have provided products to diagnose, treat or prevent COVID-19 since the start of the pandemic are starting to tail off.

The Swiss pharma group reported “significantly lower” sales of COVID-19-related products that offset growth in other products like Ocrevus (ocrelizumab) for multiple sclerosis, haemophilia therapy Hemlibra (emicizumab), Evrysdi (risdiplam) for spinal muscular atrophy, and breast cancer drug Phesgo (pertuzumab/trastuzumab/hyaluronidase).

COVID-19 diagnostic sales fell from CHF 1 billion ($1.01 billion) this time last year to CHF 600 million, while therapeutics Ronapreve (casirivimab/imdevimab) and Actemra/RoActemra (tocilizumab) shrank around CHF 1 billion “as the pandemic continued to weaken in many countries in 2022,” said the company in its quarterly update (PDF).

Despite the fall-off, Roche managed to grow its top line for the first nine months of the year by 2% at constant currencies, supported by a 6% gain overall for its diagnostics unit that was aided by the launch of a digital PCR diagnostic platform and new cancer tests.

The diagnostics performance helped to prop up flat pharma sales, pegged back by biosimilar competition to Roche’s older antibody products including Avastin (bevacizumab), Herceptin (trastuzumab), and MabThera/Rituxan (rituximab).

The four growth medicines mentioned above – plus new ophthalmic medicine Vabysmo (faricimab) – collectively added CHF 2.2 billion to Roche’s pharma sales in the third quarter and accounted for CHF 8.8 billion of its total pharma sales of CHF 33.19 billion in the nine-month period.

Among the highlights was a doubling in sales of Evrysdi – the only SMA medicine that can be administered at home – to CHF 793 million, a 150% gain for Phesgo to CHF 526 million, and a CHF 282 million contribution for Vabysmo in its first few months on the market, having been approved for age-related macular degeneration and diabetic macular oedema earlier this year.

“Group sales grew 2% despite the expected sharp decline in COVID-19-related products in both divisions in the third quarter,” said Roche chief executive Severin Schwann of the third-quarter numbers.

“The demand for our newer medicines for multiple sclerosis, haemophilia, spinal muscular atrophy. and cancer remains high,” he added. “I am particularly pleased that so many patients with severe eye disease have already accessed our new medicine Vabysmo and started treatment.”

For 2022 as a whole, Roche is predicting either stable sales or sales growth in the low-single-digit range at constant exchange rates.

https://pharmaphorum.com/news/roche-q3-results-show-steep-fall-off-in-covid-product-sales/

Syneos cut to Neutral from Overweight by JPMorgan

 Target to $53 from $85

https://finviz.com/quote.ashx?t=SYNH&ty=c&ta=1&p=d

LG Chem to Acquire AVEO Oncology for $15.00 Per Share in Cash

 

  • Acquisition Provides LG Chem’s Life Sciences Division a Commercial Footprint in the U.S., Diversifies its Pipeline with a Broad Range of Oncology Therapies and Accelerates LG Chem’s Efforts to Deliver Continued Growth

  • AVEO Will Have Enhanced Ability to Deliver on its Mission to Improve the Lives of Patients with Cancer

  • AVEO to Establish and Operate as the U.S. Commercial Foundation for LG Chem Life Sciences’ Oncology Segment

  • Transaction Price Represents a 43% Premium to AVEO’s Closing Price on October 17, 2022

Acutus Files Application for AcQBlate Force Sensing Ablation Catheter & System

 Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced submission of pivotal clinical data from the AcQForce Flutter trial designed to gain marketing approval from the U.S. Food & Drug Administration (FDA) for the AcQBlate Force Sensing Ablation Catheter and System (AcQBlate FORCE). Catheter ablation procedures to treat right atrial flutter account for approximately 30% of ablations in the US and are expected to reach 200,000 by 20251.

https://finance.yahoo.com/news/acutus-medical-announces-submission-premarket-100000955.html

Illumina and GenoScreen Partner to Expand Access to Genomic Testing for TB

 Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, and GenoScreen, an innovative genomics company, today announced a partnership to accelerate progress to end tuberculosis (TB) worldwide. The partnership will expand capabilities for countries most impacted by tuberculosis to more effectively detect and combat multidrug-resistant TB (MDR-TB). This alliance will enable global access to a package combining Illumina sequencing products and the GenoScreen Deeplex® Myc-TB assay, a targeted next-generation sequencing (NGS) based test for rapid and extensive detection of anti-TB drug resistance, to promptly inform treatment decision. This will help advance the World Health Organization's (WHO) strategy to end the global TB epidemic by 2035.

https://finance.yahoo.com/news/illumina-genoscreen-partner-expand-access-100000900.html

Merck, Gates Medical Research Institute in Licensing Agreement for Novel TB Antibiotic Candidates

 Merck, (NYSE: MRK), known as MSD outside of the United States and Canada, and the Bill & Melinda Gates Medical Research Institute (Gates MRI) today announced a licensing agreement for two preclinical antibacterial candidates for evaluation as potential components of combination regimens for the treatment of tuberculosis (TB). These candidates were discovered by Merck scientists as part of the TB Drug Accelerator (TBDA). The TBDA is a collaboration established among biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeutic candidates against TB. The initiative was established with support and leadership from the Bill & Melinda Gates Foundation.

https://finance.yahoo.com/news/merck-bill-melinda-gates-medical-104500541.html