World of DTC Marketing

FEBRUARY 2, 2022

While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. Food and Drug Administration on Biogen Inc.’s ” A physician on STAT News wrote, “the consequences of FDA approval are as disturbing as they are vast. .’s

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Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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Pharma Leaders

JUNE 14, 2023

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. It offers dual advantage of providing a longer duration of pain relief, with less systemic side effects, stated the company.

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. Some of the most common side effects of nitisinone include low platelet count, elevated tyrosine levels, eye pain, white or cloudy cornea from scarring, and pink eye.

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Pharma Leaders

APRIL 19, 2023

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). Diarrhea was the most common side effect using Xphozah in clinical trials. It has a new action mechanism and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3).

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Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). Paxlovid’s most common side effect is diarrhoea.

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies. Together, Cerner Enviza and John Snow Labs have all the right expertise, data and technology to make it happen.”

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European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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World of DTC Marketing

JULY 15, 2021

Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. According to STAT News, “acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.”

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European Pharmaceutical Review

DECEMBER 22, 2023

It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

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European Pharmaceutical Review

OCTOBER 14, 2022

RemeGen has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG). Telitacicept is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases.

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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. The FDA’s action plan. The first AdCom was critical of the study’s robustness.

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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.

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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.

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European Pharmaceutical Review

NOVEMBER 3, 2023

The most common side effects of Litfulo are headache, diarrhoea, dizziness, acne, rash, inflammation of the hair follicles that may be itchy or painful and an increase in an enzyme called creatine phosphokinase, shown by blood test.

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European Pharmaceutical Review

JANUARY 3, 2023

The US Food and Drug Administration (FDA) has given the first approval of a treatment for advanced alveolar soft part sarcoma (ASPS) to atezolizumab (Tecentriq), for adults and children two years and older with ASPS that has spread to other parts of the body or cannot be removed by surgery.

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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.

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pharmaphorum

OCTOBER 26, 2022

Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. Food and Drug Administration approved Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist and the first FDA-approved steroid-free topical medication in its class. Side effects, front and centre.

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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.

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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.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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pharmaphorum

DECEMBER 4, 2022

“Obviously, we want to be extremely careful and certain that it will work well before putting a device in a human, but we’ve submitted, I think, most of our paperwork to the FDA,” he said, according to video from the event posted in Musk’s Twitter platform. Take action! Retweet this thread and tell @elonmusk to release the tapes!

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European Pharmaceutical Review

DECEMBER 1, 2022

Rebyota, the first faecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people 18 years and older after being given antibiotics for recurrent CDI, has been approved by the US Food and Drug Administration (FDA). Further clinical study data for Rebyota.

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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.

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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.

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European Pharmaceutical Review

OCTOBER 21, 2022

The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B. A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017.

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PM360

NOVEMBER 29, 2022

Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA. A drug label exploration tool was deployed using FDA Drug Labels, EMA Drug Labels, as well as several European local databases.

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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.

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Pharmaceutical Technology

JUNE 16, 2023

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. Earlier this month, the US Food and Drug Administration (FDA) approved the drug’s investigational new drug application (IND) to start this trial.

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European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.” There are no FDA-approved medications to treat sarcopenia.

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Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. In its announcement, the FDA advised individuals to keep their electronic or printed health records from the past year ready while seeking treatment.

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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. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31

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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.

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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.

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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.

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Pharmaceutical Technology

JULY 28, 2022

One potential benefit of cobitolimod’s unique route of administration is that local administration via rectal enema has the potential to limit systemic absorption and the immune-related side effects that plague some marketed agents. Abivax is developing obefazimod, another agent with a first-in-class mechanism.

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