Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

Side effects 64

Side effects Food and Drug Administration Safety Physicians 64

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.

Food and Drug Administration 52

Food and Drug Administration Side effects Prospecting FDA 52

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. There are only two marketed treatments for ALS in the US. The FDA’s action plan.

FDA 98

FDA Food and Drug Administration Physicians Side effects 98

Pharmaceutical Technology

OCTOBER 13, 2022

The news of the offer came just weeks after Myovant and its partner, Pfizer , received the US Food and Drug Administration's (FDA) expanded approval of Myfembree (estradiol + norethindrone acetate + relugolix) for the management of moderate to severe pain associated with endometriosis.

Pharma 52

Pharma Food and Drug Administration Side effects FDA 52

European Pharmaceutical Review

DECEMBER 7, 2022

The common, expected side effects were within expectations for a vaccine in this age group. In November 2021, the US Food and Drug Administration (FDA) authorised the emergency use of COVID-19 vaccine Comirnaty ® in children aged five to 11 years. Data that facilitated the line extension of Comirnaty ® for Covid-19.

Food and Drug Administration 77

Food and Drug Administration Patients Side effects Medicine 77

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. million people in the UK and 2.7

Food and Drug Administration 141

Food and Drug Administration Pharmacology Side effects Physicians 141

World of DTC Marketing

JULY 5, 2022

Lilly’s new diabetes drug is being talked about all over social media because of its weight loss properties, but what’s not mentioned is that it requires a diet modification and has side effects that can cause more severe health issues.

Insurance 200

Insurance Doctors Pharma Side effects 200

European Pharmaceutical Review

NOVEMBER 9, 2023

In this Q&A, Brager highlighted that to date, “there are no oral TNF-a inhibitor drugs available on the market [and no other TNF-a inhibitor] besides MYMD-1 have reached Phase II trials yet.” In addition, it has not been shown to cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.

Food and Drug Administration 98

Food and Drug Administration Side effects Pharmaceutical Leads 98

World of DTC Marketing

FEBRUARY 4, 2021

Food and Drug Administration (FDA) is meant to help patients and warn of potential drug side effects but a Vice report indicates something more. Misuse Federal Data to Falsely Claim COVID Vaccines Are Dangerous.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

pharmaphorum

OCTOBER 13, 2022

In October 2022, the companies announced their plan to file exagamglogene autotemcel, the CRISPR/Cas9- edited therapy, for a rolling review with the FDA. Earlier this year, the US Food and Drug Administration (FDA) approved the first potentially curative gene therapy to treat beta-thalassemia.

Food and Drug Administration 52

Food and Drug Administration Side effects Patients FDA 52

Pharmaceutical Technology

APRIL 24, 2023

The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance. While Imbruvica maintained a previously strong position on the market, competition has chipped away at the inhibitor’s market share. billion in the same year.

Food and Drug Administration 52

Food and Drug Administration Side effects Sales Food 52

pharmaphorum

AUGUST 11, 2022

Identifying those variations helps to target medication changes that can be safer and more effective. Some people are hyper-metabolisers, meaning a drug may move too fast through their system and not deliver the intended therapeutic effect; while others may metabolise a drug too slowly, triggering an adverse side effect or overdose.

Side effects 97

Side effects Medical Prescription Patients 97

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).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Pharmaceutical Technology

JUNE 16, 2023

While the drug is marketed in other countries, it is not registered in the US. But while available adjunctive options work well, they come at the cost of safety, said Buntinx, and ANT01 could offer these benefits without additional side effects.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

Pharmaceutical Technology

JULY 28, 2022

Cobitolimod, an agent being developed for patients with moderate to severely active UC, has both a novel MOA and a route of administration that is unique among marketed agents. Takeda’s intravenous formulation of Entyvio is a strong competitor in the UC market.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects Marketing 98

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. This conclusion was based on the same data submitted to the FDA.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

Pharmaceutical Representative Training

JUNE 22, 2024

Technological advancements, shifting market dynamics, and updated regulations are leading to significant changes within the pharmaceutical industry. Communication Skills: Effective communication is essential when interacting with HCPs in order to build relationships in sales. billion settlement for its role in the opioid crisis.

Sales 52

Sales Pharmaceutical Ethics Pharmaceutical Sales 52

Clarivate

JUNE 26, 2023

In their first Guidance in the Patient-Focused Drug Development (PFDD) series, the Food and Drug Administration (FDA) references the importance of obtaining patient preference data as part of contextualizing the patient journey through their condition.

Food and Drug Administration 52

Food and Drug Administration Patients Side effects Medicine 52

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration 89

Food and Drug Administration Patients Leads Side effects 89

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration 88

Food and Drug Administration Patients Leads Side effects 88

European Pharmaceutical Review

NOVEMBER 4, 2022

based treatment concomitant with reductions in traditionally unavoidable and problematic side effects. Type A Meeting Between FDA and Athenex Discusses Oral Paclitaxel Plus Encequidar for Metastatic Breast Cancer [Internet]. FDA Feedback Leads to Discontinuation of Tesetaxel Development in Solid Tumors [Internet].

Food and Drug Administration 76

Food and Drug Administration FDA Pharmaceutical Patients 76

Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward.

Food and Drug Administration 52

Food and Drug Administration Food FDA Safety 52

World of DTC Marketing

SEPTEMBER 1, 2021

SUMMARY: Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency because the White House is getting ahead of the agency on COVID booster shots. I would argue, however, that the FDA is a bureaucratic mess with changes needed at all levels of leadership.

FDA 165

FDA Food and Drug Administration Side effects Food 165

Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Food 52

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

FDA 83

FDA Food and Drug Administration Side effects Safety 83

Pharma Marketing Network

JUNE 11, 2020

With me, today is John Mack, the original creator of Pharma Marketing and also known as Pharma Guy from far and wide. But to market that patent, we developed the, we had a listserv. Yeah, I even wanted to wear the shirt to this FDA meeting. What got you started on blogging, about pharma marketing? John Mack (PG): Right.

Media 52

Media Pharma Ethics Consulting 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 72

Food and Drug Administration Safety Patients Leads 72

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

Prescription 52

Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects FDA 98

Pharmaceutical Technology

FEBRUARY 23, 2023

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical Food Side effects 98