pharmaphorum

FEBRUARY 13, 2022

German drugmaker Merck KGaA has reached an agreement to pilot an artificial intelligence platform developed by Quris that aims to identify potential safety problems with new therapeutic candidates as early as possible in the drug discovery process. Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity.

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Scienmag

FEBRUARY 13, 2022

A new study shows hotspots of SARS-CoV-2 infections in Canadian cities across four provinces, linked to occupation, income, housing and proxies for structural racism. The study, which looked at infections in 16 urban centres in British Columbia, Manitoba, Ontario and Quebec, is published in CMAJ (Canadian Medical Association Journal) [link] The COVID-19 pandemic has had […].

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Drug Patent Watch

FEBRUARY 13, 2022

Annual Drug Patent Expirations for SUBOXONE Suboxone is a drug marketed by Indivior Inc and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent expiration for Indivior Inc drug SUBOXONE appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Scienmag

FEBRUARY 13, 2022

Nitrogen fertilizers are critical for growing crops to feed the world, yet when applied in excess can pollute our water for decades. A new study provides six steps to address nitrogen pollution and improve water quality. Since nitrogen persists for so long, management efforts may seem futile and unattractive because it can take a long […].

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Clinical Research

Drug Patent Watch

FEBRUARY 13, 2022

Annual Drug Patent Expirations for KYNMOBI Kynmobi is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are eighteen…. The post New patent expiration for Sunovion Pharms drug KYNMOBI appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

pharmaphorum

FEBRUARY 13, 2022

Germany’s Ada Health has added another $30 million to its second-round financing first announced last year, saying it will use the new cash to strengthen its presence in the US market. The Berlin-based digital health company – best known for its app to help patients diagnose conditions from symptoms – opened the Series B with a $90 million raise led by Bayer’s venture capital arm last May.

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NY Times

FEBRUARY 13, 2022

The people who need treatments the most may be the least likely to get them. .

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Drugs 71

The Pharma Data

FEBRUARY 13, 2022

One of the U.S. Food and Drug Administration’s top priorities is to improve the health of Americans through better nutrition. We are pleased to see the U.S. Department of Agriculture (USDA) Food and Nutrition Service’s final rule issued today on transitional nutrition standards for school-based meals, an action that supports ongoing whole-of-government efforts to improve nutrition, reduce chronic disease and help create a healthier food supply for all.

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Drug Patent Watch

FEBRUARY 13, 2022

This chart shows the pharmaceutical companies with the most patents in Malaysia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Malaysia? appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 52

The Pharma Data

FEBRUARY 13, 2022

Today, the U.S. Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction. The agency issued draft guidance to provide recommendations to companies developing non-opioid analgesics for acute pain lasting up to 30 days, typically in response to some form of tissue injury, such as trauma or surgery.

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

pharmaphorum

FEBRUARY 13, 2022

Eli Lilly has been granted an emergency use authorisation from the FDA for bebtelovimab, its second COVID-19 antibody drug and a rival to GlaxoSmithKline and Vir Biotech’s fast-growing Xevudy. The US regulator has cleared bebtelovimab (LY-CoV1404) for mild-to-moderate COVID-19 in patients aged 12 or over who are at high risk of progressing to severe illness, the same indication awarded to Xevudy (sotrovimab) in December.

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The Pharma Data

FEBRUARY 13, 2022

The U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial.

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The Pharma Data

FEBRUARY 13, 2022

A nationwide study from the U.S. Centers for Disease Control and Prevention (CDC) is the first to show that immunity against severe COVID-19 disease begins to wane 4 months after receipt of the third dose of an mRNA vaccine (Pfizer or Moderna). Waning immunity was observed during both the Delta and Omicron variant waves in similar fashion to how mRNA vaccine effectiveness wanes after a second dose.

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The Pharma Data

FEBRUARY 13, 2022

Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke. Asundexian is an oral inhibitor of Factor XIa (FXIa) that Bayer is developing as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke as well as for two additional conditions: atrial fibrill

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

The Pharma Data

FEBRUARY 13, 2022

FDA a ccepts Dupixent ® (dupilumab) for Priority Review in c hildren a ged 6 m onths to 5 y ears with m oderate-to-severe a topic d ermatitis. If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on maintenance treatment

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The Pharma Data

FEBRUARY 13, 2022

WHO’s prequalification adds to several mechanisms already in place to improve access to Actemra/RoActemra for people with COVID-19 in low- and middle-income countries Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra, as recommended in global treatment guidelines Twelfth Roche medicine or test to be prequalified.

Medicine 40

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The Pharma Data

FEBRUARY 13, 2022

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospi

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