European Pharmaceutical Review

NOVEMBER 2, 2023

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” Like Stelara, the most serious known side effect of Wezlana is infection.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

Pharmaceutical Technology

NOVEMBER 14, 2022

Such developments, including a 2021 approval of AstraZeneca’s Saphnelo (anifrolumab) , prompted The Lancet Rheumatology to posit that 2022 could be a “banner year” for the condition. The CAR-T therapies for conditions like lupus continue to look promising, but their safety is a concern, says Gilkeson. MSCs and CAR-Ts for lupus.

Side effects 144

Side effects Patients Manufacturing Safety 144

pharmaphorum

SEPTEMBER 16, 2022

Findings presented at EADVC 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.

Management 100

Management Side effects Patients Safety 100

European Pharmaceutical Review

JULY 20, 2022

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Supporting regulators. It focused on data from France, Germany and the UK.

Medicine 97

Medicine Safety Side effects Electronics 97

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They detail the medication’s intended use, proper administration, potential side effects and precautions. percent as EU average with some Member States as high as 25 percent).

Healthcare 98

Healthcare Healthcare Safety Electronics 98

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. In conclusion, navigating the regulatory environment of pharmaceutical marketing requires a delicate balance between patient safety and industry innovation.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

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. Back in April 2022, the microbiome-focused biotech Kaleido Therapeutics folded due to financial and regulatory setbacks.

Safety 111

Safety FDA Medicine Side effects 111

European Pharmaceutical Review

OCTOBER 20, 2022

These are all diseases that are highly prevalent in the population and are generally treated with drugs that are broadly immunosuppressive; while some of these drugs are beneficial and do ameliorate some symptoms, these patients experience side effects including increased susceptibility to infections. 5 Aug 2022. Gene Therapy.

Engineering 140

Engineering Side effects Manufacturing Patients 140

European Pharmaceutical Review

AUGUST 25, 2022

IN 2022, treating glioblastoma (GBM) remains an uphill battle. the promise of leveraging oncolytic viruses stands out because of their excellent safety profile, minimal predicted side effects and potent ability to kill cancer cells while leaving healthy cells unscathed2. 3 Because current treatment options are so time?

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Side effects Safety Patients Engineering 111

European Pharmaceutical Review

OCTOBER 17, 2024

Additionally, EURneffy could alleviate the risk of accidental needle-related side effects (such as injection into the blood vessel and hand) 3 and it has the attributes of being smaller in size, has better temperature sensitivity, and is less complex to use compared to needle-based injectors. 2022 ; 17(11). Hand (N Y).

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

European Pharmaceutical Review

JUNE 12, 2024

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. 2022; 7(12):1083-1091. percent for MBK-01 and 4.26 J Clin Microbiol.

Safety 111

Safety Patients Side effects Healthcare 111

European Pharmaceutical Review

JUNE 16, 2023

According to Maximize Market Research , new technologies are expected to boost the clinical trials market between 2022 to 2029, especially as the industry and patients are shifting towards digitalisation approaches and personalised medicines.

Safety 111

Safety Electronics Recruitment Patients 111

PM360

MAY 25, 2023

above pre-pandemic levels by Q2 2022. This is different from clinical trials which are really designed to look at efficacy and safety in a very controlled environment, so controlled trials are very good at answering those two questions. They’re wonderful medications, blockbuster sales, but real side effects.

Side effects 95

Side effects Medical Patients Networking 95

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Cradle to grave. cited Dec2023].

Medicine 116

Medicine Safety Competition Medical 116

pharmaphorum

SEPTEMBER 11, 2022

Health-related quality of life scores were also higher in patients treated with TIL than Yervoy, said Haanen, and no new safety issues were found with the cell therapy, which can be hard to tolerate with grade 3 or higher adverse events occurring in all patients treated.

Side effects 105

Side effects Patients Engineering Management 105

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.

Marketing 52

Marketing Side effects Safety Patients 52

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. This included the EC’s approval of Roctavian in August 2022, which was the first gene therapy for haemophilia A.

Consulting 74

Consulting Manufacturing Side effects Safety 74

Impetus Digital

AUGUST 2, 2024

In 2022, the AI-fuelled pipeline reportedly expanded at an annual rate of almost 40%. In theory, this will allow for highly tailored, personalized therapy plans with superior efficacy and minimal side effects. Looking back at 2023 , AI for drug discovery saw both wins and losses.

Pharma 94

Pharma Manufacturing Medicine Marketing 94

pharmaphorum

SEPTEMBER 11, 2022

All told, 7% of patients treated with SpringWorks’ therapy had a complete response to treatment, and 95% of side effects liked to the drug were mild (grade 1 or 2), most commonly diarrhoea, rash, and elevated levels of phosphate in the blood. Oncology (@myESMO) September 10, 2022. link] #rarecancer.

Side effects 52

Side effects Leads Safety Patients 52

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.

Prescription 105

Prescription Medical Patients Side effects 105

European Pharmaceutical Review

DECEMBER 27, 2023

4 Manufacturing of CAR T-cell therapies: an overview In addition, multi-disciplinary teams must be established for in-house CAR T-cell therapy programmes to ensure maximum success and safety. FDA; 2022 [cited 2023 Mar]. After this incident CAR-related toxicity scales and guidelines were established to prevent adverse reactions.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

SEPTEMBER 22, 2023

While new positive clinical data with anti-Abeta mAbs signal tremendous advancement and proof‑of-concept for the whole field, it is believed that the observed effects could still be improved and optimised in terms of greater clinical benefits, lower side effects and enhanced treatment convenience. References Hendrix S.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

Pharmaceutical Technology

JANUARY 25, 2023

By selectively degrading these proteins, PROTACs have the potential to effectively treat a range of diseases with potentially fewer side effects compared to traditional approaches. This was presented at the Targeted Protein Degradation (TPD) Conference in Boston, October 2022.

Side effects 52

Side effects Leads Safety Manufacturing 52

European Pharmaceutical Review

AUGUST 15, 2024

BTKis, oral drugs given as continuous monotherapy, have revolutionised the treatment of CLL, with the first generation BTKi ibrutinib receiving European Medicines Agency (EMA) approval in 2014; however, side-effects (such as cardiovascular toxicities 2 ) have limited its suitability. for all-comers; HR=0.52

Safety 52

Safety Patients Medical Medicine 52

pharmaphorum

SEPTEMBER 12, 2022

There were fewer serious adverse events with the KRAS inhibitor, and overall a more favourable safety profile than docetaxel treatment, according to the abstract figures. Liver enzyme elevations were seen with the drug in around 10% of patients, although that also seems to be an issue with adagrasib based on its phase 2 data.

Side effects 52

Side effects FDA Patients Safety 52

European Pharmaceutical Review

JULY 18, 2024

1 As they can be highly targeted in their action, they could become the treatment of choice for clinicians and patients due to the reduced risk of side effects. Because ADCs offer a good way to specifically deliver an effective treatment to tumour systems, this could be an improvement on the systemic impact of chemotherapy.

Food and Drug Administration 59

Food and Drug Administration Engineering Pharmacology Side effects 59

Medico Reach

FEBRUARY 8, 2023

from 2022 to 2030, the pharma industry will reach USD 9,241.34 The Emergence of the Pharmacovigilance Market Medicines and vaccines often have unwanted and severe side effects. Such results call for stringent vigilance on the medicines quality and after-effects, nudging the emergence of the pharmacovigilance market.

Pharma 52

Pharma Medicine Marketing Prospecting 52

PM360

JULY 13, 2023

Feb-May 2022. Alliance by Aspen RxHealth , which debuted in October 2022, is its latest solution. In fact, after learning about prescription medications on Healthline Media’s website, 69% of visitors say they are extremely or very likely to refill their current prescription. 1 References: 1.

Education 89

Education Medical Patients Media 89

PM360

OCTOBER 13, 2023

“They are effective but too expensive for the majority of patients, even with insurance coverage,” said one primary care physician (PCP). 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.

Healthcare 59

Healthcare Healthcare Doctors Pharma 59

PM360

JUNE 11, 2022

Then, the MRL team and the influencer must align on where there is flexibility within messaging while still abiding to brand safety guidelines, as you don’t want to lose the authenticity that the influencer brings. For example, everyone must be steeped in both FDA and FTC guidelines. Rishi Kadiwar.

Patients 59

Patients Pharma Education Media 59

pharmaphorum

JULY 6, 2022

— President Biden (@POTUS) July 7, 2022. Ahead of the changes, the American Medical Association (AMA) had warned that the pharmacy-based clinic component of the test-to-treat scheme “flaunts patient safety and risks significant negative health outcomes,” not least because Paxlovid “has six pages of drug interactions.”

FDA 118

FDA Doctors Side effects Patients 118

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. It was another exciting year on the regulatory front as three new therapies were approved in 2022 with four more cell and gene therapies slated later this year.

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Patients Safety Marketing Side effects 111

European Pharmaceutical Review

DECEMBER 7, 2022

state the therapy could help reduce side effects and safety concerns. At the American Society of Clinical Oncology (ASCO) 2022, Phase II study results showed ivonescimab demonstrated an overall response rate (ORR) for patients with NSCLC who failed EGFR-TKI’s of 68.4 A $5 billion collaboration.

Pharma 98

Pharma Side effects Safety Patients 98

European Pharmaceutical Review

OCTOBER 3, 2024

It is highly selective and has shown an excellent safety and tolerability profile to date. Advancements in oral small molecule drug development can be attributed to significant technological improvements, particularly in screening methodologies, including AI -driven approaches, which help identify and profile drugs more effectively.

Safety 52

Safety Patients Pharmaceutical Side effects 52

Nixon Gwilt Law

NOVEMBER 5, 2021

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) finalized the Medicare Physician Fee Schedule for Calendar Year 2022 (the “Final 2022 MPFS” or the “Final Rule”). This means that, even if the PHE ends in 2022, providers may bill for Category 3 telehealth services until the close of the following year.

Physicians 52

Physicians Professional Services Medical Side effects 52

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. In clinical trials, the drug showed a 3.8-point point improvement (unadjusted means) and a 3.2-point

FDA 126

FDA Safety Pharmaceutical Patients 126