European Pharmaceutical Review

DECEMBER 22, 2023

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.

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Food and Drug Administration Side effects Safety Food 93

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). In response to the approval news, some pointed concerns about long-term safety.

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Food and Drug Administration FDA Side effects Safety 59

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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Side effects Food and Drug Administration Safety Physicians 64

Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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FDA Side effects Prescription Patients 52

Contrarian Sales Techniques

FEBRUARY 25, 2023

This includes potential side effects or adverse reactions to medications. Clinical studies play an essential role in determining the safety and efficacy of new drugs before they can be approved for the public. This is before a drug can be approved for public use.

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Side effects Medical sales reps Insurance Pharmacology 52

European Pharmaceutical Review

DECEMBER 7, 2022

The common, expected side effects were within expectations for a vaccine in this age group. The Commission on Human Medicines (CHM), which endorsed the authorisation, advises ministers on the safety, efficacy and quality of medicinal products. Data that facilitated the line extension of Comirnaty ® for Covid-19.

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Food and Drug Administration Patients Side effects Medicine 83

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). diff</em> appeared first on European Pharmaceutical Review.

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Food and Drug Administration Side effects Food Safety 85

Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. All three treatments are monoclonal antibodies.

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European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

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Food and Drug Administration Side effects Pharmaceutical Leads 104

Pharmaceutical Technology

NOVEMBER 14, 2022

The] main the main issue is that there aren't that many sites in the US where MSCs can be produced in sufficient quantities in FDA-certified labs,” says Gilkeson. The CAR-T therapies for conditions like lupus continue to look promising, but their safety is a concern, says Gilkeson.

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Side effects Patients Manufacturing Safety 144

Pharmaceutical Technology

JUNE 16, 2023

This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology. The company has already contacted funds based in Europe and in the US, said Buntinx.

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Food and Drug Administration Side effects Safety Recruitment 52

pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen.

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Management Side effects Patients Safety 76

Pharmaceutical Technology

JULY 28, 2022

This pipeline includes agents such as Abivax’s obefazimod; InDex Pharmaceuticals’ cobitolimod; three interleukin-23 (IL-23) inhibitors, namely AbbVie ’s Skyrizi (risankizumab), Eli Lilly ’s mirikizumab, and Janssen’s Tremfya (guselkumab); and Takeda ’s subcutaneous formulation of Entyvio (vedolizumab) in the US.

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Food and Drug Administration Safety Side effects Marketing 98

European Pharmaceutical Review

OCTOBER 21, 2022

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). 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.

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Patients Food and Drug Administration Side effects Food 73

Pharmaceutical Technology

MARCH 7, 2023

In this subset, CNM-Au8 therefore has promising potential as an adjacent therapy for patients who are already on DMTs to reduce MS progression and relapses, especially as the agent exhibits a good safety profile, with most common side effects being headache, upper respiratory infection, and sore throat.

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Side effects Patients Leads Safety 100

PM360

OCTOBER 13, 2023

One participant summed up these perceptions by stating “It’s a pharmaceutical site, you know. And while they’re excited about the drugs’ results and limited side effects now, many also noted concerns about the lack of safety data and long-term risks. Arcutis received FDA approval for its Zoryve (roflumilast) cream 0.3%

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Healthcare Healthcare Doctors Pharma 59

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). Internet] Vera Therapeutics. cited 2024Mar].

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Food and Drug Administration Side effects Leads Patients 93

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). Internet] Vera Therapeutics. cited 2024Mar].

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Food and Drug Administration Side effects Leads Patients 92

PM360

NOVEMBER 29, 2022

Researchers are diligently creating new methods for cell and gene editing as well as therapeutic delivery to increase safety, accessibility, and affordability. The advanced therapy industry has shown great promise in treating rare and genetic diseases, but have encountered roadblocks in safety, affordability, and accessibility.

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Patients Safety Marketing Side effects 111

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). For example, in the U.S.,

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Networking Consulting Safety Side effects 59

European Pharmaceutical Review

JULY 20, 2023

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. More recently, the FDA granted approval of Roctavian in June 2023.

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Consulting Manufacturing Side effects Safety 58

PM360

SEPTEMBER 21, 2023

Jeff Casberg, MS, RPh, Senior Vice President of Clinical Pharmacy at IPD Analytics, a managed care and pharmaceutical consultancy, highlighted a wide range of 2023 key events that will affect managed care professionals by the end of the year. billion in sales. This is a big opportunity for payers and hospital systems,” Casberg said.

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Management Manufacturing Sales Competition 105

PM360

AUGUST 9, 2022

This allows patients to complete the whole treatment process, from drug preparation and drug administration to treatment monitoring, side effect reporting, and communication, with one click on their device and smartphone. The FDA 510(k) submission is expected to take place in Quarter 3 2023. Orbita Outreach. Patty Riskind.

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Prescription Medical Side effects Patients 105

pharmaphorum

SEPTEMBER 8, 2022

The problem with this form of treatment is that it is not targeted and, as a result, there are a number of short- and long-term side effects which can impact patients’ lives. One such company is Clarity Pharmaceuticals, an Australian company, which is developing radiopharmaceutical-based ‘theranostics’.

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Manufacturing Pharma Side effects Patients 95

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs.

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Medical Electronics Patients Healthcare 105

Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. The trial has confirmed its safety and efficacy for the treatment of pain and fever in the targeted patients. All but one patient in the trial received a single dose of Caldolor.

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Food and Drug Administration FDA Side effects Safety 98

European Pharmaceutical Review

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age. However, babies are at highest risk for getting pertussis and having serious complications from it.”.

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FDA Food and Drug Administration Side effects Food 102

Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. The trial is designed to analyse the safety and efficacy of Hemgenix.

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Food and Drug Administration FDA Side effects Food 105

European Pharmaceutical Review

DECEMBER 18, 2023

Treatment-related side effects included nausea and headache but were generally mild. “As In terms of safety, they noted that being a part of the group calmed their fears and increased their sense of preparedness to engage in therapy. Participants described generally positive experiences.

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Food and Drug Administration Patients Side effects Safety 109

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.

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FDA Food and Drug Administration Side effects Safety 83

Pharmaceutical Technology

FEBRUARY 26, 2023

This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. with placebo.

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Safety FDA Medicine Side effects 111

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.

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Food and Drug Administration Food FDA Safety 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.

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Food and Drug Administration Safety Patients Leads 77

European Pharmaceutical Review

DECEMBER 27, 2023

In other words, the apheresis centres must become an integral part of the pharmaceutical production line with identical quality assurance and regulations, which is new and unpreceded for both sides. FDA; 2022 [cited 2023 Mar]. Overview of approved car‐t therapies, ongoing clinical trials, and its impact on clinical practice.

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Manufacturing Food and Drug Administration Patients Pharma 83

Pharmaceutical Technology

OCTOBER 10, 2022

The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds. In 2015, the FDA approved Sprout Pharmaceuticals’s Addyi, also known under the generic name flibanserin, for use by pre-menopausal women with hypoactive sexual desire disorder (HSDD). It is a condition.

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Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. Major pharmaceutical acquisitions have taken place in recent months in the rare disease space, as the number of orphan drug approvals continues to grow. GlobalData is the parent company of Pharmaceutical Technology.

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FDA Safety Pharmaceutical Patients 126