The Pharma Data

NOVEMBER 4, 2020

A special diet may be a diet to lose weight or one aimed at improving health, such as a lower-carbohydrate diet for someone with diabetes, or avoiding gluten for someone who has Celiac disease. adults have diet-related chronic diseases, such as cardiovascular disease, high blood pressure or type 2 diabetes. 3 in the U.S.

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Disease Government Hospitals Research 52

The Pharma Data

JUNE 26, 2021

In line with our global leadership and our 7 0-year history of pro tecting people with influenza v accine s , w e will always focus on developing product s that demonstrate protection beyond flu , as we believe it is critical to demonstrate protecting patients from hospitalizations due to cardiovascular events and pneumonia.

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Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

NOVEMBER 6, 2020

Parents and physicians should be aware that morning joint stiffness may indicate early disease symptoms of polyarticular JIA and serve as a more reliable indicator than pain. Polyarticular JIA is a chronic form of the disease with symptoms of pain, swelling, stiffness or warmth in four or more joints. NEW YORK , Nov.

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Nurses Hospitals Disease Therapies 52

The Pharma Data

NOVEMBER 11, 2020

of women living in rural areas had high blood pressure as they started their pregnancies in 2018. The rates in the youngest women were still lower than in older women (40-44), but all of the age groups saw similar increases in high blood pressure rates between 2007 and 2018. WEDNESDAY, Nov. and 1.4%, respectively.

Hospitals 52

Hospitals International Research Disease 52

Eye on FDA

DECEMBER 6, 2023

While 2023 maintained virtual meetings, it is perhaps noteworthy that FDA has scheduled an in-person advisory committee meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee to be held February 6, 2024. Does this signal a return in 2024 to in-person meetings?

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The Pharma Data

NOVEMBER 1, 2020

Suhail qualified in Medicine at Dundee University in Scotland and completed his post-graduate medical training at Hope Hospital in the University of Manchester. Steve Jackson’s Cancer Research UK Laboratories at the University of Cambridge Gurdon Institute, and leading UK centres in neurodegenerative diseases.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

Drug Target Review

MAY 23, 2023

Inflammatory bowel disease (IBD) is an umbrella term that describes complex disorders that cause chronic inflammation in the digestive tract with alternating periods of relapse and remission. A changed composition of the gut microbiota is a characteristic trait of inflammatory bowel disease. More than 6.8

Drugs 75

Drugs Small Molecule Production Disease 75

The Pharma Data

NOVEMBER 10, 2020

P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease. Crohn’s Disease Therapeutics Market Size $4.7 Oral and nasal administration routes are both physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits.”.

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Clinical Trials Science Disease Trials 40

The Pharma Data

JANUARY 14, 2021

Headquartered in Cambridge, Massachusetts, the company specialized in the treatment of various diseases caused by oxidative stress, which is an imbalance between free radicals and antioxidants in the human body, and resultant tissue damage. More recently, he was a member of the Cohasset Board of Health between 2015 and 2018.

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Laboratories Clinical Research Hospitals Pharmaceuticals 52

The Pharma Data

DECEMBER 9, 2020

Lisa Mosconi, director of the Women’s Brain Initiative and an associate professor of neuroscience in neurology and radiology at Weill Cornell Medicine and NewYork-Presbyterian Hospital. A 2018 study Mosconi led estimated it provided 1.5 years of protection against the development of biomarkers for Alzheimer’s disease.

Science 52

Science Hospitals Disease Research 52

Broad Institute

JUNE 14, 2023

She is also a member of the board of trustees of the Massachusetts Health & Hospital Association. A trailblazer in cancer research, Glimcher's research identified key transcriptional regulators of protective immunity and the origin of pathophysiologic immune responses underlying autoimmune, infectious, and malignant diseases.

Medical Schools 52

Medical Schools Immune Response Science Hospitals 52

The Pharma Data

JUNE 28, 2021

Migraine is a Disabling Neurological Disease that Affects More Than 8.4 Having this treatment approved in Japan will enable us to ultimately serve more patients and help them find the right treatment for this disabling, neurological disease.” 1,7 Although approximately 8.4 became a wholly owned affiliate of Amgen Inc. in the U.S.

Treatment 52

Treatment Disease Clinical Trials Hospitals 52

The Pharma Data

JANUARY 24, 2021

Professor of Medicine, Section of Infectious Diseases and Global Health and director of the Duchossois Family Institute at the University of Chicago, has joined its scientific advisory board. His research focuses on the role of the microbiome in immune defense and disease resistance. “We

Research 40

Research Bioinformatics Laboratories International 40

The Pharma Data

JANUARY 21, 2021

Prior to joining Labcorp, she held multiple appointments with The Children’s Hospital of Philadelphia, including Patient Safety Officer, chief of the Division of Transfusion Medicine and Vice-Chief of Pathology and Laboratory Medicine. where he developed therapeutics to treat orphan eye diseases. since May 2018.

Laboratories 52

Laboratories Pharmaceuticals Clinical Development Engineering 52

The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. 1,2 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. About Severe Asthma Asthma is a complex and heterogeneous disease affecting an estimated 339 million people worldwide.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

MAY 31, 2022

Jude Children’s Research Hospital. Without treatment, infants do not achieve these milestones in the natural history of the disease. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S Food and Drug Administration in 2017.

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FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

DECEMBER 13, 2020

Professor Jie Wang from Cancer Hospital Chinese Academy of Medical Sciences is the leading principal investigator for the study. On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma.

Treatment 40

Treatment Clinical Trials Biosimilars Pharmaceutical Companies 40

The Pharma Data

NOVEMBER 17, 2020

Dr. Anderson moved to North Carolina to work at Presbyterian Hospital under the direction of Dr. Klaus Wiemer in 1992. She speaks nationally and internationally on how cancer and autoimmune disease therapies affect reproductive health and fertility, ovarian aging, primary ovarian insufficiency and genetics. Karen R. .

Laboratories 52

Laboratories Nurses Doctors International 52

The Pharma Data

SEPTEMBER 5, 2021

. “This new analysis from NAVIGATOR is exciting for the up to one in five severe asthma patients who have comorbid nasal polyps,” said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, the principal investigator of the NAVIGATOR trial.

Trials 52

Trials Clinical Trials Therapies Treatment 52

The Pharma Data

DECEMBER 17, 2020

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases.

Small Molecule 52

Small Molecule Clinical Development Engineering Pharmaceuticals 52

Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. Stenzel had joined the agency as Office Director in 2018 and helmed the OHT7 through the pandemic.

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FDA Laboratories Regulations Clinical Trials 40

Agency IQ

JUNE 7, 2024

Dietary supplement products may only make “structure/function” claims – claims that the product affects the structure or function of the body – or claims of nutritional support, and may not make any claim that a supplement treats or prevents a specific disease.

FDA 40

FDA Science Production Marketing 40

Broad Institute

JULY 6, 2023

The accuracy of these scores has improved for some diseases and groups of people, but they continue to fall short for those of non-European ancestry, mainly because the genetic datasets used to calculate these scores have largely come from people of European ancestry.

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Disease DNA Hospitals Medical Schools 97

Broad Institute

MAY 2, 2024

In 2018, she graduated with a bachelor’s degree in computer science and biology and joined the lab of Gad Getz at the Broad Institute of MIT and Harvard to complete her master’s. If we can understand how those processes work, we can better develop drugs to target these multifaceted diseases. You think, “I’ve created something new.”

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Science Medical Schools Hospitals Disease 124

The Pharma Data

DECEMBER 17, 2020

17, 2020 — Lower socioeconomic status (LSS) is associated with worse outcomes for inflammatory bowel disease (IBD), according to a study published in the December issue of The American Journal of Gastroenterology. For those with Crohn disease, the impact of LSS was greater than for those with ulcerative colitis. THURSDAY, Dec.

Disease 52

Disease Hospitals Pharmaceuticals Research 52

Agency IQ

APRIL 19, 2024

FDA advisors endorse minimal residual disease (MRD) as accelerated approval endpoint for multiple myeloma Last week, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously in favor of using minimal residual disease (MRD) as an accelerated approval endpoint for multiple myeloma.

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FDA Disease Trials Clinical Trials 40

The Pharma Data

JULY 8, 2021

“Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need,” said David M. Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018. Reese, M.D., About Severe Asthma.

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

MARCH 16, 2022

The Independent Data Monitoring Committee recommended that the EMPA-KIDNEY trial be stopped early, following a formal interim assessment EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease to date Detailed results are expected to be presented later this year.

Trials 52

Trials Disease Hospitals Clinical Trials 52

The Pharma Data

SEPTEMBER 30, 2021

We anticipate to sharing developments from our leading vaccines pipeline which underscore our ongoing commitment to uncovering insights which will help prevent severe infectious diseases at every stage of life, especially in diseases with an unmet need like respiratory syncytial virus.”. Poster presentation number 1137. In the U.S.,

Vaccine 52

Vaccine Research Virus Disease 52

FDA Law Blog: Biosimilars

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

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Production FDA Treatment Disease 53

The Pharma Data

MARCH 3, 2022

“Today’s decision is a pivotal next step in our path towards potential regulatory approval for our maternal RSV vaccine candidate and is an important milestone in our efforts to help address the detrimental impact RSV disease has on infants,” said Kathrin U. Jansen, Ph.D., 4,5,6,7 In the United States alone, approximately 2.1

Virus 52

Virus Vaccine Clinical Trials Trials 52

The Pharma Data

JUNE 26, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S.

Doctors 52

Doctors Hospitals Treatment Clinical Trials 52

The Pharma Data

APRIL 17, 2021

MS is an inflammatory disease that attacks the central nervous system and, if not treated in a timely manner and following standard protocol, can lead to disability due to irreversible neurological damage. MS is a life-long, progressive, autoimmune neurologic disease of the central nervous system (CNS).

Treatment 52

Treatment Clinical Trials Disease Trials 52

The Pharma Data

MARCH 29, 2022

Masahiro Yasaka, MD, PhD, National Hospital Organisation Kyushu Medical Centre, Fukuoka, Japan, said: “FXa inhibitors are essential medicines for people prone to developing blood clots, but they can also present a risk of uncontrolled bleeding and related complications, which can be fatal if left untreated.

Trials 52

Trials Hospitals Science Clinical Trials 52

The Pharma Data

JUNE 29, 2021

“With the approval of ENSPRYNG, we now have a treatment option with a favourable safety profile that significantly reduces relapses in AQP4-IgG seropositive adults and adolescents after their first NMOSD attack or in more advanced disease, either as a monotherapy or in combination with IST. Europe and Japan.

Treatment 52

Treatment Therapies Disease Clinical Development 52

The Pharma Data

OCTOBER 30, 2020

Previously approved under an Emergency Use Authorization (EUA), Veklury is now fully cleared for the treatment of hospitalized patients with COVID-19. hospitals. A revised EUA for the unapproved use of Veklury is in effect for hospitalized pediatric patients less than 12 years of age weighing at least 3.5

FDA Approval 52

FDA Approval Hospitals Treatment FDA 52

The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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