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. Topic sponsors are not involved in the creation of editorial content.

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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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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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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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European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date.

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PM360

AUGUST 26, 2024

Now, precision medicine needs an overhaul. During the period from 2008 through 2020, the number of precision medicines in the US increased from 5 to 285. Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers.

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European Pharmaceutical Review

DECEMBER 18, 2023

Treatment-related side effects included nausea and headache but were generally mild. “As Classified as a Schedule I drug—defined as having no accepted medical use and a high potential for abuse— psilocybin is currently not approved by the US Food and Drug Administration (FDA) for clinical use.

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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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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. During the two-year project, the companies will assess the mental health side effects of the asthma drug, montelukast.

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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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European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). EURneffy was determined by the European Medicines Agency (EMA) to be interchangeable with injection products given it provides the comparable exposures to epinephrine (adrenaline) and pharmacodynamic response as approved injection products.

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Pharmaceutical Technology

FEBRUARY 26, 2023

While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. with placebo.

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European Pharmaceutical Review

OCTOBER 18, 2024

This new treatment could decrease long-term side effects including second cancers later in life and heart and lung conditions, according to the researchers. The goal of this study was to improve the cure rate while also minimising side effects and long-term toxicities—and that’s what makes this an unprecedented clinical trial.”

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pharmaphorum

AUGUST 5, 2022

SAR444245, meanwhile, is a long-acting IL-2 that blocks off part of the molecule that engages with alpha receptors, designed to maintain the anticancer efficacy of the molecule while preventing side effects. It is being tested in a wide range of solid tumours and lymphoma, alone and in combination with other drugs.

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pharmaphorum

AUGUST 11, 2022

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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Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

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European Pharmaceutical Review

OCTOBER 19, 2023

This has been instrumental in having the medical oncology community look at radiopharmaceuticals as alternative medicines for the treatment of late-stage cancers where they are available. He has over 20 years of research and business development experience in Nuclear Medicine.

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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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Impetus Digital

AUGUST 2, 2024

Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported. Despite new partnerships and increasing traction, there were some setbacks.

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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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Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. The study of ketamine’s antidepressant effects has inspired research for different conditions, says Dr. Gerard Sanacora, director of the Depression Research Program at Yale School of Medicine, Connecticut. Generally, side effects are present in high doses, he explains.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. Cisplatin has multiple side effects including loss of appetite, nausea, and ototoxicity (hearing loss).

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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.

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Contrarian Sales Techniques

FEBRUARY 25, 2023

This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication. This includes potential side effects or adverse reactions to medications.

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European Pharmaceutical Review

JULY 20, 2023

The Alliance for Regenerative Medicine (ARM) stated in a 2022 report that adeno-associated viral vector (AAV) is the primary vector in ongoing gene therapy trials. More recently, the FDA granted approval of Roctavian in June 2023. Batty discussed some of the capabilities of haemophilia gene therapies in 2023.

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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. References: 1.

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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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PM360

AUGUST 9, 2022

The Modern Medicine Cabinet and Remote Therapy Monitoring Platform. KEEP’s Modern Medicine Cabinet and Remote Therapy Monitoring Platform provides real-time visibility into daily dosing events, informing proactive, data-driven interventions that connect patients to support when they need it most. References: 1. Jeff Wandzura, RPh.

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pharmaphorum

OCTOBER 13, 2022

Gene therapies and research into them have grown immensely in recent years, offering more novel tools in regenerative medicine to fight disease, including rare diseases and genetic disorders. 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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European Pharmaceutical Review

OCTOBER 24, 2024

The biologic treatment was granted approval as Kisunla (donanemab-azbt) in the US by the Food and Drug Administration (FDA) in July 2024. The cost-effectiveness estimate for donanemab is five to six times above what NICE normally considers an acceptable use of NHS resources,” explained Helen Knight, Director of medicines evaluation at NICE.

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European Pharmaceutical Review

DECEMBER 27, 2023

Lessons learned The process of establishing point-of-care CAR T manufacturing was a learning curve, not just in managing the toxicities and side effects, but also in understanding the important difference between emerging CAR T-cell adoptive immunotherapy and traditional stem cell transplantation. FDA; 2022 [cited 2023 Mar].

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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. How can data itself play a larger role in addressing adherence? Jason Burum.

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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).

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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).

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European Pharmaceutical Review

JANUARY 3, 2023

Sensorion, a biotechnology company has announced that the first patient has been enrolled in its NOTOXIS Phase IIa proof of concept clinical trial of SENS-401 (Arazasetron) in cancer patients experiencing cisplatin-induced ototoxicity (permanent hearing loss), a serious side effect of key chemotherapeutic agent cisplatin.

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Silver Line CRM

MARCH 22, 2021

Patient-focused medicine. What side effects are they talking about? . But how medicines get delivered in the real world matters in terms of the patient experience. As you map out the patient journey, you may have goals at certain points, whether it’s for data collection, patient interaction, or medicine usage.

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Pharma Marketing Network

JANUARY 9, 2025

Precision Medicine Marketing: Drugs like Keytruda , designed for specific genetic profiles, have revolutionized treatment approaches. FDA and EMA Updates: Regularly monitor guidelines from agencies like the FDA (U.S.) Disclosing side effects and potential risks builds credibility.

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