Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron

Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels; bivalent vaccine candidate exhibited a 9.1 and 10.9-fold increase against Omicron Geometric mean ratios for Omicron neutralizing antibody response consistent with regulatory requirement of superiority … [Read more…]

Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA

In the EPIC-SR study of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, as previously reported Data from standard-risk patients, both vaccinated and unvaccinated, while not all statistically significant, are supportive of efficacy data observed in EPIC-HR study … [Read more…]

Immunome Announces Data Demonstrating COVID-19 Antibody Cocktail Potently Clears Omicron BA.1 Variant in Hamster Model and Retains Activity Against BA.2 Subvariant

– Data show that combination of two antibodies in Immunome’s cocktail successfully neutralized the Omicron variant in vivo in hamsters – – IMM20253 antibody also retained activity against BA.2 subvariant in pseudovirus testing in vitro, with additional testing underway – EXTON, Pa.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B … [Read more…]

Blue Spark Technologies Raises $40 Million in Growth Funding Led by Ghost Tree Partners to Advance AI-Based Remote Patient Monitoring

Funding will accelerate company’s growth and widespread adoption of continuous wearable remote patient monitoring solutions CLEVELAND–(BUSINESS WIRE)–Blue Spark Technologies, Inc., a leader in wearable remote patient monitoring solutions, today announced that it has raised a $40 million intellectual property-based debt solution to fund growth led by GT Investment Partners (“Ghost Tree Partners”) with support from … [Read more…]

Bicycle Therapeutics Announces Updated Preclinical Data on SARS-CoV-2 Antivirals at the 2022 Microbiology Society Annual Meeting

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced updated preclinical results providing further evidence for Bicycles as a potential novel antiviral modality against SARS-CoV-2. The results will be presented in an oral presentation … [Read more…]

United Therapeutics Announces the Publication of Tyvaso DPI™ BREEZE Clinical and Long-term Data in the Journal Pulmonary Circulation

In subjects with PAH, transition from Tyvaso® to Tyvaso DPI™ demonstrated safety and tolerability with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes Tyvaso DPI safety confirmed through 51 weeks of optional extension phase data with no study drug-related serious adverse events FDA action on the New Drug Application … [Read more…]

Immunome Reports Fourth Quarter and Full Year 2021 Financial Results

– Immunome Receives Safe-to-Proceed Notification from U.S. FDA for IMM-BCP-01 Investigational New Drug Application – – Immunome Continues to Progress IMM-BCP-01 Towards Phase 1b Clinical Trial – – Ongoing Progress on Oncology Pipeline, Including Lead Program Targeting IL-38, a Novel Innate Immunome Checkpoint – EXTON, Pa.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes … [Read more…]

FDA Lifts Clinical Hold on Immunome’s IMM-BCP-01 IND Application for the Treatment of COVID-19

EXTON, Pa.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01) for the treatment of … [Read more…]

Celltrion Submits Investigational New Drug (IND) Application to Initiate a Global Phase III Clinical Trial Evaluating an Inhaled COVID-19 Antibody Cocktail Therapy

Celltrion submitted an IND application for a global Phase III clinical trial of inhaled antibody cocktail therapy with CT-P59 and CT-P63; the company expects to enrol 2,200 patients with mild-to-moderate symptoms of COVID-19 The inhaled COVID-19 antibody cocktail therapy and CT-P63 maintained strong neutralising ability against the Omicron variant (B.1.1.529) The inhaled COVID-19 antibody cocktail … [Read more…]

Applied DNA to Deploy Linea™ 1.0 COVID-19 Assay for Rapid Detection of New Omicron Subvariant BA.2

– Announcement Follows First Cases of BA.2 Identified in New York State Where the Majority of COVID-19 Testing Clients Reside – – Linea 1.0 Assay’s Unique Double S-gene Target Design Likely Allows for the Identification of Samples that Contain a Mutation Profile Indicative of BA.2 – STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #COVID19Testing—Applied DNA Sciences, Inc. (NASDAQ: … [Read more…]