article thumbnail

Non-profit sues FDA, requesting the agency withdraw approval for abortion drugs

MedCity News

The group complains that the FDA never studied the safety of the drugs under the labeled conditions of use. . Daily News SYN Top Story abortion drugs FDA mifepristone misoprostol U.S. Food and Drug Administration

article thumbnail

Pre-filled asthma pen approved for self-administration in EU

European Pharmaceutical Review

AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use auto-injector (AI) pen for severe asthma patients over 12 years.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

FDA Commissioner: Insurers Need To Support Studies In Accelerated Drug Approval Pathway

MedCity News

Physicians face a lot of barriers from insurers in completing studies on drugs in the accelerated approval pathway, declared Dr. Robert Califf, commissioner of food and drugs at the Food and Drug Administration.

article thumbnail

BMS: Delayed new drug to avoid paying billions?

World of DTC Marketing

billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec.

article thumbnail

Gilead's Breast Cancer Drug Gets U.S. FDA Approval for Third Indication

PharmExec

Food and Drug Administration has greenlighted the use of Trodelvy for a third indication.

article thumbnail

How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

article thumbnail

Switzerland and US sign drug inspection agreement

European Pharmaceutical Review

Good Manufacturing Practice for pharmaceutical drugs. The post Switzerland and US sign drug inspection agreement appeared first on European Pharmaceutical Review

article thumbnail

The current pricing of cancer treatments is unsustainable

World of DTC Marketing

needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S.

article thumbnail

Can we get healthcare right?

World of DTC Marketing

Patients on Medicare who don’t qualify for low-income subsidies could see out-of-pocket costs for the drug of over $12,000. A bill to lower drug prices via negotiations with Medicare is finally moving forward, but PhRMA has bought some politicians. Administration on Aging.

article thumbnail

Hope is not a reason to approve a drug

World of DTC Marketing

GOOD MORNING: The future of Biogen’s potential blockbuster Alzheimer’s treatment was thrown back into doubt on Friday when an unusually combative scientific panel contradicted the positive conclusions of staff at the US drug regulator. ” Biogen is desperate for approval of this drug.

article thumbnail

Lilly has a new blockbuster

World of DTC Marketing

Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. Some of the epidemiologists I spoke to are concerned about the drug’s side effects.

article thumbnail

Can genetic data be a magic bullet for drug R&D?

pharmaphorum

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates.

article thumbnail

A perfect storm for biotech stocks

World of DTC Marketing

Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen. introduced sweeping drug-pricing legislation. 1ne: More scrutinization by the FDA on new drug applications. Business of the drug industry Biotech M&A

article thumbnail

Promising schizophrenia drug faces tough competition

European Pharmaceutical Review

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5

article thumbnail

Pharma is in acquisition mode but small biotechs hurting for money

World of DTC Marketing

It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. billion, which was much lower than previous studies, which have placed the average cost of drug development as $2.8

article thumbnail

Potential blockbuster drugs to watch in 2023

European Pharmaceutical Review

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. Seven of the potential blockbuster Drugs to Watch in 2023 are: .

article thumbnail

US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy.

article thumbnail

Clinical trials authorised for 3D-printed ulcerative colitis drug

European Pharmaceutical Review

Due to the drug being able to reach a targeted segment of the colon, a lower drug dose via controlled-release is possible compared to the reference listed drug. Triastek, Inc.

article thumbnail

FDA approves first drug to delay type 1 diabetes

European Pharmaceutical Review

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA).

article thumbnail

A scientific approach to irrational consumer choices

World of DTC Marketing

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Subsequent research has indicated that people go online to learn more about an advertised drug.

article thumbnail

Three biggest threats to healthcare

World of DTC Marketing

Launch prices of new cancer drugs in the U.S. Food and Drug Administration (FDA). billion estimated cumulative spending on the new oral targeted cancer drugs by the end of 2018. Drug Prices Healthcare costs

article thumbnail

An Overview of the FDA’s Approval of Alzheimer’s Drug Leqembi

Pharma Marketing Network

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. The drug works by blocking an enzyme known as BACE1, which is responsible for producing beta-amyloid.

article thumbnail

AcelRx Pharmaceuticals to sell drug DSUVIA to Alora

Pharmaceutical Technology

AcelRx Pharmaceuticals has announced the sale of its drug DSUVIA (sufentanil sublingual tablet) to Alora Pharmaceuticals.

article thumbnail

Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients.

article thumbnail

$145 million pharma acquisition to help launch opioid overdose drug

European Pharmaceutical Review

The drug will support patients in the worsening opioid crisis in the US, driven by the increased prevalence of synthetic opioids, such as fentanyl. The post $145 million pharma acquisition to help launch opioid overdose drug appeared first on European Pharmaceutical Review

article thumbnail

EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

Legacy MEDSearch

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S.

article thumbnail

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound.

article thumbnail

First virtual clinical trial examines two promising Alzheimer’s drugs

European Pharmaceutical Review

The US-based researchers modelled personalised treatments for each virtual patient, assessing US Food and Drug Administration-approved aducanumab and donanemab, a therapy currently being evaluated and other potential AD therapies.

article thumbnail

NICE questions value and efficacy of five Covid-19 drugs with rejection

Pharmaceutical Technology

This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK. NICE rejects Covid-19 drugs.

article thumbnail

Health Transformation Alliance Teams up With Cognoa for Autism Diagnostic Device

MedCity News

Cognoa’s Canvas Dx product is authorized by the Food and Drug Administration and assists healthcare providers in diagnosing autism spectrum disorder for children ages 18 months through 72 months.

article thumbnail

Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Legacy MEDSearch

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA).

article thumbnail

Poxel’s PXL770, PXL065 molecules receive EC orphan drug designation

Pharmaceutical Technology

French biopharmaceutical firm Poxel has received orphan drug designation (ODD) from the European Commission (EC) for its molecules PXL770 and PXL065 to treat adrenoleukodystrophy (ALD).

article thumbnail

Digital Thread Solutions Can Speed Scale-up and Shorten Time to Market for Pharma

PM360

Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by shady actors or by accident by those of high repute.

article thumbnail

US FDA approves Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly.

article thumbnail

Could oral difelikefalin be first FDA-approved drug for notalgia paresthetica?

European Pharmaceutical Review

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica.

article thumbnail

Fresenius Kabi introduces pegfilgrastim biosimilar for cancer patients in US

Pharma Leaders

In September last year, Stimufend received approval from the US Food and Drug Administration (FDA) to be used in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs that The post Fresenius Kabi introduces pegfilgrastim biosimilar for cancer patients in US appeared first on Pharmaceutical Business review.

article thumbnail

Antibody drug conjugates and bispecifics seize the spotlight at ASCO 2022

Clarivate

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting.

article thumbnail

FDA Inspections - Overview

Pharmatutor

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

article thumbnail

Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

Most, if not all, of these therapies used the FDA’s Orphan Drug Designation to aid their development plans. So far this year, 176 drugs have already received this designation. Have orphan drug designations increased in recent years?

article thumbnail

Emalex raises $250m for Tourette syndrome drug development

Pharmaceutical Technology

Emalex Biosciences has raised Series D funds worth $250m led by Bain Capital Life Sciences to progress the development of an investigational new drug for Tourette syndrome. In prior trials, the drug was found to be well tolerated.