FDA grants Tentative Approval for Yutrepia to treat pulmonary arterial hypertension – Liquidia Corpn

Liquidia Corporation has announced that the FDA granted tentative approval for Yutrepia (treprostinil) inhalation powder, previously referred to as LIQ 861. Yutrepia is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. Tentative approval indicates that Yutrepia has met all regulatory standards for […]

The Bristol-Myers Squibb-Pfizer Alliance welcomes the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis Patents

The Bristol-Myers Squibb-Pfizer Alliance issued the following statement: We welcome the decision by the Court of Appeals for the Federal Circuit’s to affirm the U.S. District Court’s August 2020 decision finding the composition of matter (COM) patent (US 6,967,208) and formulation patent (US 9.326,945) covering Eliquis valid and infringed. Given today’s decision, the earliest that generic manufacturers are permitted to […]

FDA approves Amplatzer Amulet Device to treat people with atrial fibrillation at risk of stroke – Abbott

Abbott has announced that the FDA approved the company’s Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The device offers immediate closure of the left atrial appendage (LAA) – an area where blood clots can form in people suffering from AFib – reducing their risk of stroke and […]

Positive new data for Johnson & Johnson single-shot COVID-19 vaccine on activity against Delta variant and long-lasting durability of response

Johnson & Johnson announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. The two preprint study summaries have been […]

Hansa Biopharma announces long term follow-up data demonstrating 3-year graft survival of 84% after imlifidase treatment and transplantation

Hansa Biopharma, announced three-year follow-up data in crossmatch positive patients who received imlifidase prior to kidney transplantation. As reported in an article, which has been accepted for publication in the American Journal of Transplantation, 84% of patients still had a functioning allograft after three years, three allograft losses occurred during the first six months with two further losses occurring between […]

Dessicated liposome technology improves vaccine stability

Mountain Valley MD, Ontario, Canada The results of the first study to evaluate the stability of Trivalent Inactivated Poliovirus Vaccine (tIPV) formulated in desiccated liposomes (QuIcksometm) has yielded promising results. The technique involves laying down a film of desiccated liposomes containing the vaccine in a vial. The vaccine is the reconstituted using Water for Injection at the point of administration. […]

Merck Inc provides update on Keytruda indication in third-line gastric cancer in the US

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New Soliqua data shows improved blood sugar control without weight gain versus premixed insulin – Sanofi

A new study of Soliqua (insulin glargine 100 Units/mL and lixisenatide, (iGlarLixi) met its two primary endpoints and all key secondary endpoints in a head-to-head comparison against premixed insulin (biphasic insulin aspart 30, BIAsp 30) in adults living with type 2 diabetes , the most common form of diabetes, uncontrolled on insulin and one or two oral anti-diabetic medicines. The […]

Investigational 2.0 mg dose of once weekly Ozempic demonstrates superior reductions in blood sugar vs Ozempic 1.0 mg in type II diabetes – Novo Nordisk

Novo Nordisk presented data showing that an investigational 2.0 mg dose of Ozempic (semaglutide) provided statistically significant and superior reductions in blood sugar (HbA1C) compared with Ozempic 1.0 mg. These data were the outcome of the SUSTAIN FORTE trial, a phase IIIb, 40-week, efficacy and safety trial comparing once-weekly semaglutide 2.0 mg vs Ozempic 1.0 mg as add-on to metformin […]

Heart disease is in the eye of the beholder

In the paper published in EClinical Medicine by The Lancet, the research team examined lesions of the retina, the inner-most, light-sensitive layer of the eye, to determine if a cardiovascular disorder may be present. “The eyes are a window into our health, and many diseases can manifest in the eye; cardiovascular disease is no exception,” said lead author Mathieu Bakhoum, MD, PhD, […]