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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…

The Swiss pharma giant Roche (OTCMKTS:RHHBY) has canceled two Phase 2 COVID-19 studies while looking to identify a new site to conduct a clinical study for the oral antiviral AT-527, which it is developing with Atea Pharmaceuticals (NSDQ:AVIR.O). The two companies were looking to launch a trial in the U.K., but falling COVID-19 cases there have…

A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug. The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body. Genus…

Peripheral cytokines from COVID-19 vaccines could cause or exacerbate tinnitus, or ringing in the ears, theorized Shaowen Bao, an associate professor of neuroscience and physiology at the University of Arizona.  Recent articles on Drug Discovery & Development on the possible link between tinnitus and COVID-19 vaccines have attracted hundreds of comments.  Some 0.65% of COVID-19 vaccine recipients who…

While the origins of the COVID-19 remain unknown, a likely theory is that wildlife farms in southern China are most likely to blame for seeding the pandemic, according to a World Health Organization member (WHO). While most scientists believe bats were the source of the virus that would later infect humans, it was unclear how humans contracted the…

Moderna posted mixed fourth-quarter results today with a larger-than-expected loss but beat the consensus forecast for revenue. The company boosted its outlook for the rest of the year, citing strong demand and maturing commercialization capabilities. The Cambridge, Mass.-based vaccine developer reported revenue of $570.7 million for the three months ended Dec. 31, 2020. That figure…

Last year, herd immunity seemed like a comforting promise as researchers worked on dozens of COVID-19 vaccine candidates and a silver-lining to the rampant spread of the virus — the more people who got infected, the more natural immunity that would develop over time. There are now dissenting opinions about how the term relates to…

Catalent (NYSE:CTLT) has entered into a definitive agreement to purchase a dry-powder inhaler (DPI) capsule manufacturing and packaging facility from Acorda Therapeutics (NSDQ:ACOR). The acquisition will enable Catalent to establish a center of excellence for spray-dried dispersion for DPI capsule manufacturing. The transaction will also expand Catalent’s existing U.S.-based commercial-scale capabilities in metered-dose inhalers and nasal…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have decided to offer to inform clinical trial volunteers in its COVID-19 vaccine whether they received a vaccine or placebo. Those who received a placebo will be eligible to receive the first dose of vaccine by March 1 and stay in the study. A second dose will be administered roughly three weeks…

The FDA has OK’d human clinical trials for Anixa Biosciences (NASDAQ: ANIX) and Cleveland Clinic’s novel breast cancer vaccine that immunizes against the alpha-lactalbumin protein.  Within the mammary gland, the alpha-lactalbumin protein is involved in lactose synthase production, which, in turn, is required to make lactose and milk. Typically expressed later in pregnancy and during lactation,…

AstraZeneca (LON:AZN) and its collaborators at the University of Oxford have published data related to their ChAdOx1 nCoV-19 vaccine against the novel coronavirus in the Lancet, becoming the first vaccine developers to publish full Phase 3 results in a peer-reviewed journal.  The efficacy rate of 62.1% achieved in clinical trial participants receiving two full doses of the…

The United Kingdom today approved its first COVID-19 vaccine, created through a partnership between Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The Medicines and Healthcare products Regulatory Agency (MHRA) approval came after a “rolling review” in which assessment takes place as the packages of data become available from ongoing studies on a staggered basis. The idea is to…

An independent panel advising FDA is sharing its perspective on the approval process for COVID-19 vaccine. Much of the virtual Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is focused on the complexities of the pandemic and regulatory best practices. The optic of an independent panel of scientists discussing the prospect of safe and…

Massachusetts federal prosecutors today claimed that Teva Pharmaceuticals funneled $300 million from a pair of charitable foundations to subsidize Medicare copayments for a multiple sclerosis drug. Teva Pharmaceuticals and Teva Neuroscience, the maker of Copaxone, simultaneously raised the drug’s price by 329%, allegedly violating the Anti-Kickback Statute and False Claims Act, according to the complaint…

Johnson & Johnson (NYSE:JNJ)  today reported fourth-quarter earnings that beat the consensus forecast on Wall Street, but its sales numbers were slightly off amid declining medical device revenue. The New Brunswick, N.J.–based pharmaceutical, medical device and consumer products giant reported profits of $4.0 billion, or $1.50 per share, on sales of $20.7 billion for the three…

Chemical industry digital supply chain company Elemica (Wayne, Pa.) said recently that it has extended its offerings to the pharmaceutical industry. Pharma companies using Elemica solutions will now benefit from improved collaboration, visibility, quality management, traceability and speed of execution across their global supply chains, according to Elemica. The company has been building digital solutions…

Redesign Science and OpenEye Scientific announced that they have entered into a strategic partnership to integrate OpenEye’s Orion computational platform into Redesign’s drug-discovery platform. Santa Fe, N.M.-based OpenEye makes “cheminformatics” software for drug discovery, providing a reliable application programming interfaces (API) that customers use to build customizable programs and workflows. Its newly released Orion computational…