Uncategorized

In 2016, the FAIR Guiding Principles for scientific data management and stewardship were published, laying out guideposts for scholarly data producers to make their data discoverable and usable in the future. The FAIR principles seek to ensure that data is Findable, Accessible, Interoperable, and Reusable. At the time of their publication, they articulated and centralized many points…

Amylyx Pharmaceuticals (Nasdaq:AML) has received Health Canada approval for Albrioza (AMX0035). The FDA is anticipated to decide on Albrioza, which consists of sodium phenylbutyrate and ursodoxicoltaurine, by September 29, 2022. Amylyx is the first new therapy for ALS to win approval in Canada since 2018. The approval also is the first global regulatory approval for…

Novavax (Nasdaq:NVAX) has won unanimous backing from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) for its NVX-CoV2373 COVID-19 vaccine. Voting 21 to 0 with one abstention, the VRBPAC recommended that FDA grant emergency use authorization (EUA) to the vaccine for adults 18 and older. The Novavax would be the fourth vaccine to…

Postpartum depression is one of the most common psychological conditions after childbirth, affecting roughly one in eight new mothers. “Postpartum depression is one of the most common — often underdiagnosed complications of childbirth,” said Dr. Samantha E. Meltzer-Brody, director of the University of North Carolina Center for Women’s Mood Disorders. The pandemic has likely only…

Vertex Pharmaceuticals Inc. (Nasdaq: VRTX) has won marketing authorization for the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis who are between the ages of 6 and 11 years old. The latest approval covers children with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine. Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older. In its submission, Moderna included data gathered…

Novartis (NYSE:NVS) has inked a deal with the biopharma Carisma Therapeutics focused on the production of human epidermal growth factor receptor 2 (HER2)-targeted chimeric antigen receptor macrophages (CAR-M) to potentially treat solid tumors. Carisma is headquartered in Philadelphia. As part of the deal, Carisma will shift manufacturing to a Novartis cell therapy site in Morris…

GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine. Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine.  Known as Covifenz, the vaccine makes use of plant-based virus-like…

Having recently sold an equity stake in Samsung Bioepis for up to $2.3 billion, Biogen (NSDQ:BIIB) has announced a licensing deal with Xbrane Biopharma (STO:XBRANE), a Swedish biosimilar developer. The agreement relates to the development of Xcimzane, a preclinical monoclonal antibody referencing Cimzia (certolizumab pegol) from UCB. Having first won FDA approval in 2018 for moderate to…

An all-time-high $86 billion of venture capital investments in the U.S. and Europe last year bested 2020’s record haul by more than 30 percent and grew more than 150 percent from 2019, according to a new analysis by Silicon Valley Bank. After record-setting quarters in the first half, however, VC investment slowed due to poor…

Janssen (NYSE:JNJ) recently presented new data on Tremfya (guselkumab) related to active psoriatic arthritis (PsA) at the American College of Rheumatology (ACR) Convergence while also publishing data in Arthritis & Rheumatology. Notably, guselkumab provided durable joint symptom and disease activity improvement with a consistent safety profile through week 100 in adults with active psoriatic arthritis (PsA).…

CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy. CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins…

Johnson & Johnson’s Janssen division (NYSE:JNJ) has requested that FDA expand the emergency use authorization (EUA) for its Ad26.COV2.S COVID-19 vaccine to include boosters for people 18 and older. The previous EUA covered a single dose of the vaccine. On October 14 and 15, FDA will convene meetings of its Vaccines and Related Biological Products…

India is vying to create domestic mRNA COVID-19 vaccines, with Gennova Bio (Maharashtra) emerging as a frontrunner. The company’s investigational HGCO19 vaccine will be the focus of a Phase 2/3 study. The vaccine, developed in collaboration with privately-held Seattle-based HDT Bio, has received funding from India’s Department of Biotechnology and Ministry of Science and Technology.…

Regeneron Pharmaceuticals (NSDQ:REGN) and Roche (OTCQX: RHHBY) are touting positive results from a Phase 2/3 study investigating the potential of REGEN-COV (casirivimab and imdevimab) antibody cocktail in hospitalized COVID-19 patients. The study met its primary endpoint of reducing viral load within one week in seronegative patients needing low-flow or no supplemental oxygen. REGEN-COV, known as…

The biopharma TFF Pharmaceuticals (NSDQ:TFFP) has announced that its inhalation powder of the immunosuppressive drug tacrolimus was well tolerated in a Phase 1 trial in lung transplant patients. Tacrolimus is a traditional option for preventing rejection of a transplanted organ, albeit in tablet or capsule form. It is common for lung transplant recipients to have…

Many large drug developers employ individual groups or teams independently working on discrete steps in the drug development process. Rare disease biopharma Insmed (NSDQ:INSM) differentiates itself through its focus on patients with rare diseases. To that end, the company works to ensure collaboration between various departments to consider questions related to the applicability of a…

Israeli researchers report that an additional dose of Pfizer (NYSE:PFE) and BioNTech’s (NISDQ:BNTX) COVID-19 vaccine leads to notable improvements in immunity in people 60 and older. The protection against infection increased fourfold 10 days after administration of the third dose, according to scientists at the Gertner Institute (Ramat Gan, Israel) and KI Institute (Kfar Malal, Israel).…

Madison, Wis.–based FluGen has announced that its Bris2007 M2SR flu vaccine candidate demonstrated protection against a multi-seasonal, seven-year drifted influenza strain in a Phase 2 study. Some 54% of M2SR vaccine recipients were infected after exposure to a flu strain. Conversely, 71% of placebo recipients were infected, indicating that the vaccine was 24% effective against…

As Medicare officials review evidence about Biogen’s (NSDQ:BIIB) Aduhelm (aducanumab) to determine if and how it will cover the drug, two high-level House Democrats are asking Biogen about its dealings with FDA.  Yesterday, Carolyn Maloney (D-N.Y.) and Frank Pallone, Jr. (D-N.J.) sent a letter to Biogen CEO Michel Vounatsos asking for details about the company’s communications with…

U.S. government authorities have decided to immediately pause the distribution of Eli Lilly’s bamlanivimab and etesevimab over concerns that the monoclonal antibody cocktail is ineffective against some SARS-CoV-2 variants. CDC recently concluded that the Gamma variant (P.1) and the Beta variant (B.1.351) make up 11% of COVID-19 infections. They are also continuing to become more…

After CureVac (NSDQ:CVAC) revealed that its first-generation vaccine candidate has an interim efficacy of 47% in a pivotal trial, its stock lost about half its value. The company, however, is undeterred. Speaking in a call with investors and analysts, CureVac CEO Franz-Werner Haas said the company would continue to seek the authorization of its CVnCoV vaccine…

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years…

FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B). The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use. In clinical trials, Novo Nordisk people…

The rare disease biotech ProQR (NSDQ:PRQR) has a mission of reversing blindness from inherited retinal diseases. The company seems to be on track to realize that ambition, having recently announced promising data in treating a condition known as Leber congenital amaurosis type 10 in clinical studies. One patient with the childhood form of blindness gained…