European Pharmaceutical Review

APRIL 20, 2023

This is according to results from a preliminary study, of which the abstract will be presented at the American Academy of Neurology’s 75th Annual Meeting held between April 22-27 2023. Dr Pozo-Rosich added that more research will be needed to assess the long-term efficacy and safety of atogepant.

Side effects 98

Side effects Safety Medical Pharmaceutical 98

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

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.

Patients 96

Patients Food and Drug Administration Side effects Food 96

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. As of October 2023, 62.93

Medicine 116

Medicine Safety Competition Medical 116

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. Derived from IQVIA Claims Data, 2023.

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. Donor of stools for MBK-01 were screened for pathogens and viruses to ensure safety. Safety and quality of life of the patients participating in the study were also assessed. percent for MBK-01 and 4.26

Safety 111

Safety Patients Side effects Healthcare 111

Pharmaceutical Technology

JULY 28, 2022

The TLR9 agonist is currently being investigated in the Phase III CONCLUDE trial (NCT04985968), with an expected study completion date of August 2023. Data from the QUASAR induction study demonstrated positive efficacy and safety results. Abivax is developing obefazimod, another agent with a first-in-class mechanism.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects Marketing 98

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. In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. with placebo.

Safety 111

Safety FDA Medicine Side effects 111

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

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.

Food and Drug Administration 115

Food and Drug Administration Side effects Pharmaceutical Leads 115

Pharmaceutical Technology

MAY 26, 2023

It follows a March 2023 FDA Advisory Committee meeting where panelists voted 16-1 in favour of the drug’s approval. In response to the approval news, some pointed concerns about long-term safety. Paxlovid’s most common side effect is diarrhoea.

Food and Drug Administration 59

Food and Drug Administration FDA Side effects Safety 59

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. More recently, the FDA granted approval of Roctavian in June 2023.

Consulting 74

Consulting Manufacturing Side effects Safety 74

European Pharmaceutical Review

MARCH 14, 2024

Individuals who receive corticosteroids may experience limited efficacy, alongside significant side effects. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. cited 2024Mar]. Internet] Vera Therapeutics. cited 2024Mar]. cited 2024Mar].

Food and Drug Administration 98

Food and Drug Administration Patients Leads Side effects 98

European Pharmaceutical Review

MARCH 14, 2024

Individuals who receive corticosteroids may experience limited efficacy, alongside significant side effects. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. cited 2024Mar]. Internet] Vera Therapeutics. cited 2024Mar]. cited 2024Mar].

Food and Drug Administration 98

Food and Drug Administration Patients Leads Side effects 98

PM360

AUGUST 24, 2023

A patient-first approach enables biosimilar brands to define their ideal audience and timing based on real-world care milestones, such as knowing a patient is experiencing side effects with the biologic reference product or knowing a patient has changed to an insurance where the biosimilar product is preferred and more affordable for the patient.

Marketing 97

Marketing Physicians Electronics Patients 97

Impetus Digital

AUGUST 2, 2024

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

Pharma 94

Pharma Manufacturing Medicine Marketing 94

pharmaphorum

AUGUST 5, 2022

Also covered by the pact is a dual M1/M4 agonist and a selective M1 agonist, which are scheduled to start clinical trials in 2023 and would trigger additional payments. The latest milestone payment has been triggered by FDA approval to start a phase 2 trial of the drug in schizophrenia, said Sosei Heptares this morning.

Side effects 52

Side effects Safety FDA 52

Pharma Leaders

MAY 18, 2023

The biopharmaceutical company expects XPHOZAH to be commercially available in Q4 2023 after an approval from the regulatory body. Diarrhea was the most common side effect with XPHOZAH. The regulatory agency has determined that the NDA is a class 2 review , which leads to a six-month review period from the date of resubmission.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 52

PM360

JULY 13, 2023

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. Preliminary data are expected in 2023. What Is Your Company Currently Working On?

Patients 98

Patients Engineering Side effects Leads 98

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. ANeuroTech CEO Erik Buntinx ANeuroTech will enrol the first patient in its Phase IIIb trial of ANT01 in MDD in Q4 2023, said Buntinx.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

Pharmaceutical Technology

JUNE 1, 2023

For context, in January 2023, the FDA accepted Intercept’s resubmission of its NDA for OCA as a Class 2 resubmission (which has a six-month review period in NASH) and set a Prescription Drug User Fee Act (PDUFA) date of 22 June 2023. risk reduction compared with placebo). risk reduction compared with placebo).

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FDA Side effects Prescription Patients 52

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

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.

Prescription 105

Prescription Medical Patients Side effects 105

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. 2023 AD/PD Conference.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

pharmaphorum

SEPTEMBER 12, 2022

If Amgen can secure full approval for Lumakras ahead of the FDA’s 14 December decision date for Mirati’s drug, it could close off that route to market and force the company to wait for its own phase 3 trial, due to read out in August 2023.

Side effects 52

Side effects FDA Patients Safety 52

PM360

JULY 13, 2023

Launched in April 2023, BrightInsight’s PSP+ Companion App, built on the compliant BrightInsight Platform, connects patients to the resources they need to complete prior authorization, register for financial assistance, understand and track their therapies, and much more. But outdated manual processes are complex and leave many patients out.

Education 89

Education Medical Patients Media 89

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

Are you intrigued to know what technologies will rule the pharma market and how they can benefit your business in 2023? I anticipate this trend will only continue in 2023.” The Emergence of the Pharmacovigilance Market Medicines and vaccines often have unwanted and severe side effects. from 2023 to 2030.

Pharma 52

Pharma Medicine Marketing Prospecting 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

AUGUST 30, 2022

The promise of the new class is that inhibiting Factor XIa seems to provide the same anticoagulant properties of current anticoagulants, without raising the risk of bleeding side effects. On safety, the incidence of major bleeding was low and similar to placebo.

Safety 98

Safety Side effects Patients 98

European Pharmaceutical Review

OCTOBER 12, 2022

The safety data from the trial was consistent with earlier trial data. This is promising when side effects such as ARIAs are often detected in magnetic resonance imaging brain scans of patients who are given the antibodies. TauRx intends to submit its anti-tau therapy for regulatory approval in the US and Canada in 2023.

Side effects 98

Side effects Safety Patients Sales 98

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

Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). 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. Neither Addyi nor Vyleesi is approved by the EMA.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Nixon Gwilt Law

NOVEMBER 5, 2021

Extension in Coverage for Category 3 Telehealth Services CMS finalized the proposed extended timeframe for reimbursement of temporary, Category 3 telehealth services until the end of 2023. CMS will evaluate such requests and propose any additions in the 2023 Proposed Medicare Physician Fee Schedule.

Physicians 52

Physicians Professional Services Medical Side effects 52

Pharmaceutical Technology

JANUARY 22, 2023

More therapies to meet unmet needs GlobalData predicts that at least 35 US regulatory decisions on drugs for rare diseases are on the horizon for 2023. In 2023, Sarepta Therapeutics has a PDUFA date for the first gene transfer DMD therapy, delandistrogene moxeparvovec (SRP 9001), on May 29. In clinical trials, the drug showed a 3.8-point

FDA 126

FDA Safety Pharmaceutical Patients 126

Pharmaceutical Technology

JUNE 5, 2023

With a higher expression of PD-1 and VEGF in tumour tissue and the tumour microenvironment, Summit claims that ivonescimab can more effectively target tumour tissue to provide safer treatment with fewer side effects. The treatment had an acceptable safety profile in combination with chemotherapy.

Side effects 52

Side effects Patients Leads Prospecting 52