STAT

APRIL 16, 2025

  Isaac “Zak” Kohane is the chair of biomedical informatics at Harvard Medical School. Y ou’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine.  in computer science as well as an M.D.

Medical Schools

STAT

JANUARY 16, 2024

She had spent two years before going to medical school working as a policy analyst for Rita Redberg and Sanket Dhruva, medical safety experts at the University of California, San Francisco. Around 41% felt they understood the drug side. Continue to STAT+ to read the full story…

FDA

STAT

SEPTEMBER 17, 2024

Panelists include leaders from the Food and Drug Administration, the Centers for Disease Control and Prevention, a Harvard Medical School teaching hospital, and electronic health record giant Epic Systems.

Medical Schools

STAT

MARCH 7, 2023

BOSTON — FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools.

Medical Schools

European Pharmaceutical Review

MAY 19, 2023

This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus complex (ABC).

Hospitals

pharmaphorum

JUNE 11, 2021

The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest. . The post And then there were three: another FDA adcomm member quits over Aduhelm appeared first on. Aaron Kesselheim.

FDA

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA will consider the AdCom as it reviews the drug’s sNDA.

FDA

STAT

NOVEMBER 1, 2023

Bernstein, an assistant professor of diagnostic imaging at the Warren Alpert Medical School of Brown University, it all makes sense. But to Michael H. Bernstein says that “no better than a placebo” still means that it works, sort of. “If we expect to feel better, then we probably will,” he told me.

Medical Schools

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept. NPJ Digit Med. 2018 Jul 5;1:27.

Medical Schools

European Pharmaceutical Review

APRIL 27, 2023

The Phase III results from SUNSHINE and SUNRISE have also been submitted to the US Food and Drug Administration (FDA). Clinical trial data for Cosentyx The study data is based on two trials in the largest Phase III programme in HS: SUNSHINE and SUNRISE. A regulatory decision is expected later this year.

Medical Schools

The FDA Law Blog

AUGUST 23, 2022

By doing so, FDA has limited the number of tests that have reached the market, thereby reducing available supply and increasing prices. As FDA would acknowledge, the antigen tests are the fastest and most practical method for distributing testing in the general population. That could happen again.

Labelling

pharmaphorum

MARCH 10, 2021

A team based at Massachusetts General Hospital and Harvard Medical School has come up with an AI algorithm – called DRIAD (Drug Repurposing In Alzheimer’s Disease) – that it hopes will not only find treatments but also tease out new therapeutic targets.

Medical Schools

Pharmaceutical Technology

JULY 25, 2022

Margins in the generics market are overall being driven down, Harvard Medical School Health Economics professor Richard Frank, PhD, tells Pharmaceutical Technology. The FDA knows that developing specialty generics, particularly generic injectable products, can be challenging. The only way forward for generics producers.

Medical Schools

Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

Medical Schools

pharmaphorum

FEBRUARY 24, 2021

Paul Carlson, Principal Investigator, FDA. Fyza Shaikh, Instructor, John Hopkins Medical School. Ken Blount, CSO, Rebiotix. Gokul Swaminathan, Associate Principal Scientist, Investigational Biology, Merck Exploratory Science. Sonia Timberlake, VP, Research, Finch Therapeutics.

Medical Schools

The People's Pharmacy

JUNE 25, 2023

Instead, prescribers prefer FDA-approved medicines that are supported by clinical trials. There is currently no FDA-approved drug to treat this painful condition. We too like randomized, double-blind, placebo-controlled studies. But sometimes evidence comes in the form of experience, and sometimes experiments vindicate the old wives.

Medical Schools

The Honest Apothecary

APRIL 28, 2023

OF THE TOP 50 BRAND DRUGS – HALF CITED AS LOW BENEFIT “Of the 50 highest-selling brand-name drugs, 27 may provide low therapeutic benefit, according to a study of Medicare data from the Brigham and Women’s Hospital and Harvard Medical School. diff has been approved by the FDA. The study was published in JAMA.

Medical Schools

European Pharmaceutical Review

MAY 8, 2024

2 Driven by the success of FMTs with clinical efficacy in several indications 3-6 and the first two FDA-approved donor-derived products on the market for recurrent Clostridioides difficile infections, 7,8 a new and promising trend is emerging that combines the ‘whole ecosystem’ of FMTs with rational consortia design. Johannes B.

Medical Schools

Pharmaceutical Technology

FEBRUARY 20, 2023

It is difficult to accurately diagnose FTD at early stages, writes Dr. Sami Barmada, associate professor of neurology at University of Michigan’s Medical School in Ann Arbor, in an email to Pharmaceutical Technology. The therapy received an orphan designation from both the FDA and the European Commission last year.

Medical Schools

pharmaphorum

NOVEMBER 22, 2021

Celebrating 20 years of FDA approval and high efficacy profiles, kinase inhibitors have changed the face of oncology treatment. Turbocharge the Development of the Best-In-Class Kinase Inhibitor Products, to Enhance Specificity, Overcome Resistance to Deliver Safe & Durable Clinical Responses.

Medical Schools

pharmaphorum

SEPTEMBER 16, 2022

The FDA granted lebrikizumab Fast Track designation in December 2019. He has been a research fellow at Harvard Medical School, Boston, the University of California, San Francisco, and University Spital Zürich, Switzerland, where his research focused on atopic dermatitis and the complexity of the skin barrier.

Medical Schools

European Pharmaceutical Review

SEPTEMBER 2, 2022

As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. She also has been conducting fundamental research as an academic in several universities, with her last academic position held at Harvard Medical School. About the author. References.

Adverse Reactions

The People's Pharmacy

MAY 4, 2023

Doctors learned in medical school that there was no evidence to support their use. We started writing about readers’ remedies for nasty nail fungus years before the FDA approved expensive prescription drugs to treat this problem. By the end of the 20th century, almost all of these had fallen out of favor.

Medical Schools

European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. In addition, we have received Fast Track designation by the FDA in September 2023 highlighting the impact this combination treatment can have for patients. Dr Harstrick received his M.D.

Immunization

European Pharmaceutical Review

DECEMBER 27, 2023

Prof Nagler received his medical training at the Hebrew University-Hadassah Medical School, Jerusalem, specialising in Internal Medicine and Hematology at the Rambam Medical Center, Haifa, and in Hematopoiesis at TA University. FDA; 2022 [cited 2023 Mar]. References Liu D. 2021;3(S1):6–10.

Adverse Reactions

Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

Vaccines

The Checkup by Singlecare

MAY 1, 2024

The FDA has approved these devices for mild to moderate hearing loss. Average cost of hearing aids The average cost for a pair of hearing aids is around $4,500, although prices may range from under $1,000 to more than $8,000. They are easy to find at your local pharmacy, retail stores, and online.

Health and Personal Care Stores

STAT

JANUARY 10, 2023

The Food and Drug Administration’s approach to evaluating some new medical devices might actually increase the risk that those devices will later be recalled over safety concerns. That process is roughly equivalent to how regulators review new medicines.

FDA

The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

FDA

STAT

JULY 24, 2025

“This is not a trivial decision, and the emotional rollercoaster for families is unfair and vicious.” ” Elevidys, intended to slow a neurodegenerative disease that is ultimately fatal, had previously been a source of hope for many families, and remains so for many of them.

Insurance

STAT

FEBRUARY 27, 2024

Yet these measures, according to those involved in the original FDA decision along with regulatory scholars, were originally put in place in an effort to be especially cautious, given the political controversy around the pill.

Medical Schools

European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). How has the autologous T-cell immunotherapy field progressed in recent years? References National Cancer Institute.

Medical Schools

European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

Medical Schools

Policy Prescription

OCTOBER 22, 2024

Rome, MD, MPH Author Affiliations: Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts (Lalani, Hwang, Kesselheim, Rome); Harvard Medical School, Boston, Massachusetts (Lalani, Hwang, Kesselheim, Rome).

Insurance

pharmaphorum

NOVEMBER 16, 2022

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been contemporaneously approved by the FDA. ImmunoGen, Inc.

FDA

PharmaShots

MAY 19, 2023

Alimera Acquires Rights from EyePoint Pharmaceuticals to Commercialise Yutiq in the US Date: May 19, 2023 | Tags: Alimera, EyePoint Pharmaceuticals, Yutiq, Iluvien, chronic non-infectious uveitis, US, Pharma Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A Date: May 19, 2023 | Tags: Sobi, Efanesoctocog Alfa, (..)

Medical Schools

The Checkup by Singlecare

FEBRUARY 17, 2024

“No one really knows what causes skin tags, but they tend to grow in areas of friction,” says Annie Truss, MD , a clinical instructor at the Department of Family Medicine at Rutgers Robert Wood Johnson Medical School and RWJ Barnabas Health Medical Group.

Medical Schools