•  12/2/2020 08:58 AM

Today, the Food and Drug Administration issued a draft guidance for industry, “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” The guidance assists sponsors of investigational new drug applications and new drug applications during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving acid-reducing agents (ARAs).

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  •  12/2/2020 08:55 AM

JW Pharmaceutical said Wednesday its gout treatment, URC102, has won the approval to conduct clinical trials in China from the National Medical Products Administration. Under the clinical plan, Simcere, JW’s partner company, tests safety, resistance and other factors on 40 healthy Chinese participants at Shanghai Public Health Clinical Center.

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  •  12/2/2020 08:45 AM

Today, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

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  •  12/2/2020 08:37 AM

On December 1, 2020, the Food and Drug Administration approved pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

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  •  12/2/2020 07:39 AM

Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) announced that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multicentre and randomised controlled study, which will include safety and immunogenicity study.

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  •  12/2/2020 06:25 AM

Researchers have identified a potential genetic target for treating an especially painful and invasive form of endometriosis. Michigan State University researchers have identified a potential genetic target for treating an especially painful and invasive form of endometriosis.

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  •  12/2/2020 05:20 AM

More than 40 value-based payment models — from direct contracting to bundled payments — have been introduced into the Medicare program in the past 10 years, with the goal of improving care while lowering costs. Hopes were high that they would be successful.

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  •  12/1/2020 07:23 AM

ay, the U.S. Food and Drug Administration launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for developers of novel drug development tools (DDTs). This pilot creates a pathway for developers to submit proposals for novel approaches that do not have an existing regulatory path.

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  •  12/1/2020 06:58 AM

Vegpro International of Sherrington, QC CAN is recalling Fresh Attitude baby spinach (5oz and 11oz) with Best before dates of Dec 4th (for 11oz) and Dec 4th & 5th (for the 5oz), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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  •  12/1/2020 06:27 AM

Hyperglycemia at hospital admission — regardless of diabetes status — is a key predictor of COVID-19-related death and severity among noncritical patients, new research from Spain finds. The observational study, the largest to date to investigate this association, was published online November 23 in Annals of Medicine by Francisco Javier Carrasco-Sánchez, MD, PhD, and colleagues.

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  •  11/30/2020 08:52 AM

The government is paying about $30 million, or Tk 260 crore, more than the price set by AstraZeneca to buy three crore doses of the Oxford COVID-19 vaccine from its manufacturer Serum Institute of India through its local vendor Beximco Pharmaceuticals.

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  •  11/30/2020 08:24 AM

The Serum Institute of India issued a statement on Sunday regarding a participant in its Covid vaccine trial falling seriously ill during the trial stating that "there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer".

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