MedCity News

NOVEMBER 18, 2022

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

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European Pharmaceutical Review

JANUARY 13, 2023

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.

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MedCity News

MARCH 16, 2023

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.

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World of DTC Marketing

FEBRUARY 25, 2022

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.

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PharmExec

FEBRUARY 6, 2023

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

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PM360

NOVEMBER 29, 2022

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).

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European Pharmaceutical Review

JANUARY 16, 2023

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

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World of DTC Marketing

NOVEMBER 24, 2021

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.

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World of DTC Marketing

JULY 12, 2022

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.

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World of DTC Marketing

NOVEMBER 9, 2020

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.

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World of DTC Marketing

MAY 16, 2022

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.

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pharmaphorum

JANUARY 24, 2023

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.

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World of DTC Marketing

FEBRUARY 1, 2022

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

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European Pharmaceutical Review

NOVEMBER 25, 2022

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

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World of DTC Marketing

JANUARY 10, 2022

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

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European Pharmaceutical Review

JANUARY 10, 2023

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: .

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Pharmaceutical Technology

SEPTEMBER 6, 2022

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.

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European Pharmaceutical Review

NOVEMBER 22, 2022

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.

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European Pharmaceutical Review

NOVEMBER 18, 2022

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).

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World of DTC Marketing

DECEMBER 2, 2021

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.

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World of DTC Marketing

APRIL 7, 2022

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

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Pharma Marketing Network

MARCH 23, 2023

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.

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Pharmaceutical Technology

MARCH 15, 2023

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

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Pharmaceutical Technology

JULY 8, 2022

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.

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European Pharmaceutical Review

NOVEMBER 16, 2022

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

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Legacy MEDSearch

OCTOBER 25, 2022

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.

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Pharmaceutical Technology

FEBRUARY 23, 2023

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.

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European Pharmaceutical Review

NOVEMBER 4, 2022

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.

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Pharmaceutical Technology

NOVEMBER 20, 2022

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.

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MedCity News

FEBRUARY 16, 2023

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.

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Legacy MEDSearch

MARCH 21, 2023

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).

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Pharmaceutical Technology

JANUARY 25, 2023

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).

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PM360

AUGUST 29, 2022

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.

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Pharmaceutical Technology

MARCH 8, 2023

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.

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European Pharmaceutical Review

FEBRUARY 9, 2023

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.

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Pharma Leaders

MARCH 2, 2023

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.

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Clarivate

JUNE 23, 2022

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.

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Pharmatutor

FEBRUARY 2, 2023

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.

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Pharmaceutical Technology

JUNE 29, 2022

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?

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Pharmaceutical Technology

NOVEMBER 3, 2022

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.

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