European Pharmaceutical Review

MARCH 8, 2024

Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. Therefore, to achieve this, quality by design offers a systematic approach to development, the authors stated.

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European Pharmaceutical Review

SEPTEMBER 25, 2023

The post Achieving pharmaceutical drug traceability compliance appeared first on European Pharmaceutical Review.

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eMediWrite

JULY 13, 2023

Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceutical production process. They play a crucial role in assuring the efficacy and safety of products given to patients. A company’s systems transparency may also be shown by such data.

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European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. We are grateful to Friedreich’s ataxia patients, investigators, US regulators, and our scientists and employees who made this approval possible. “As

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MedCity News

APRIL 11, 2023

Risk-based quality management, or RBQM, is the process by which pharmaceutical organizations monitor and manage quality throughout clinical trials.

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pharmaphorum

JULY 6, 2022

And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better?

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European Pharmaceutical Review

NOVEMBER 1, 2022

The Phase III open-label, randomised trial ( NCT03682536 ) evaluated the efficacy and safety of Reblozyl versus epoetin alfa. The safety results for the trial were consistent with previous studies. The safety results for the trial were consistent with previous studies. No new safety issues were reported. in November 2021.

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European Pharmaceutical Review

OCTOBER 20, 2022

Apogenix , a biopharmaceutical company developing next generation immunotherapeutics, announced that asunercept showed statistically significant benefits for hospitalised COVID-19 patients in the ASUNCTIS trial. The Phase II trial investigated efficacy and safety of asunercept in 435 patients with moderate to severe COVID-19 disease.

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Pharmaceutical Technology

JUNE 15, 2023

Chugai Pharmaceutical has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for crovalimab to treat paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disorder in which parts of the immune system attack and damage red blood cells and platelets.

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Pharma Marketing Network

JULY 19, 2023

Sponsorships can be a powerful tool for pharmaceutical companies to engage with their target audience, build relationships with key stakeholders, and promote their brand in a meaningful way. Provide care to patients? This can help to improve the lives of patients and make a real difference in the world. Fund research?

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Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Acadia Pharmaceuticals CEO Steve Davis said: “Today marks an important milestone for the Rett community and Acadia.

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Pharma Marketing Network

JULY 19, 2023

For pharmaceutical companies, this means aligning sponsorships with causes that are related to health and wellness. This could include sponsoring research into new drugs and treatments, providing educational resources about health conditions, or supporting patient care programs.

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PharmaVoice

OCTOBER 26, 2022

The VP of regulatory affairs and global patient safety explains why her line of work lets her do “a little of everything,” and the company’s plans to score a new approval for its blockbuster drug.

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European Pharmaceutical Review

DECEMBER 4, 2023

The (bio)pharmaceutical industry is currently facing numerous hurdles in its path to high-efficiency production that are more complex and pressing than ever before. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety. principles.

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PM360

SEPTEMBER 7, 2023

However, Keri McDonough, Head, Patient Voice Consortium & Vice President, Medical and Scientific Strategy, Syneos Health , says that AI will only help so much in alleviating the “ burnout ” 3 or “ moral injury ” 4 many HCPs face. “To Of course, AI can also be used to help marketers better understand and serve patients.

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Pharma Marketing Network

JULY 27, 2022

The patient care team supplies an abundance of information, although sifting through brochures and online resources can be daunting for the patient and their caregiver. 1 The marketer’s goal is to design easy-to-follow patient guidelines while conforming to med-legal language. Meeting Patients Where They Are.

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eMediWrite

JUNE 22, 2023

The process of giving a pharmaceutical product a unique identity on the market is called pharmaceutical product positioning. Your pharmaceutical firm can gain a competitive edge, boost sales, and develop brand loyalty by using effective product positioning.

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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.

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Pharma Marketing Network

OCTOBER 16, 2023

The pharmaceutical industry is increasingly turning to social media to reach patients, healthcare professionals, and other stakeholders. In this article, we’ll explore the power of social media in pharmaceutical marketing, and how to develop a successful strategy.

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European Pharmaceutical Review

AUGUST 16, 2022

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia.

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European Pharmaceutical Review

OCTOBER 1, 2022

A Phase III trial from Shanghai Henlius Biotech is the first study to suggest that the programmed cell death (PD) 1 receptor immune checkpoint inhibitor Hansizhuang (serplulimab) plus chemotherapy can markedly improve survival for extensive-stage small cell lung cancer (ES-SCLC) patients. A follow-up after 12.3

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European Pharmaceutical Review

JUNE 29, 2022

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. How are regulatory guidelines adapting to this trend? References.

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European Pharmaceutical Review

APRIL 18, 2024

percent success rates in patients with uncomplicated urogenital gonorrhoea (GC). EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in uncomplicated urogenital gonorrhoea.

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European Pharmaceutical Review

OCTOBER 6, 2022

The approval redefines the pool of patients to be optioned for Enhertu (fam-trastuzumab deruxtecan-nxki), a modified HER2-directed antibody drug conjugate (ADC). Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes.”. Every year 2.3

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Pharmaceutical Technology

JULY 25, 2022

Digitalization is now in full swing as medical care integrates with ICT to take the patient experience to the next level. There are already opportunities for patients to track their health through smart medical devices sending reports directly to their healthcare provider.

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Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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pharmaphorum

NOVEMBER 30, 2022

X4 Pharmaceuticals has announced positive top-line results from a Phase 3 study of its lead investigational therapy, mavorixafor, in people with warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome. Dubbed 4WHIM, the trial was initially designed to enrol 18-28 patients.

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Pharmaceutical Technology

JUNE 14, 2023

Senju Pharmaceutical and Novaliq have closed a licence agreement for NOV03 (perfluorohexyloctane ophthalmic solution) to treat dry eye disease in Japan. Senju Pharmaceutical president Shuhei Yoshida stated: “We are thrilled to collaborate with Novaliq as a pioneer for cutting-edge water-free eye drop technology. “On

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Contrarian Sales Techniques

JANUARY 25, 2023

When I first started working as a pharmaceutical sales representative, I didn't fully understand the importance of compliance with regulatory requirements. Regulatory requirements such as HIPAA and FDA regulations are put in place to protect patient's safety and ensure that all sales and marketing efforts are compliant.

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Pharmaceutical Commerce

JULY 20, 2022

If there’s anything we learned from the pandemic, it’s the critical need to analyze patient outcome data in real time to stay informed on the safety and efficacy of treatments in the real world.

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Safety Patients 52

European Pharmaceutical Review

OCTOBER 28, 2022

revealed the first patient to be dosed with OTX-2002, the first programmable mRNA therapeutic for c-Myc (MYC) oncogene overexpression, which targets cancer cells while sparing healthy cells. Biotech firm Omega Therapeutics, Inc. The investigation is expected to enrol around 190 volunteers in the US, Asia and Europe.

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European Pharmaceutical Review

APRIL 26, 2024

The Phase IIIb/IV LEVEL UP study evaluated the efficacy and safety of these drugs in individuals 12 years old and older with moderate-to-severe atopic dermatitis. The trial assessed patients who had an inadequate response to systemic therapy or when using these therapies was inadvisable. percent vs 8.9 percent vs 8.9 percent vs 22.5

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Pharmaceutical Technology

JANUARY 6, 2023

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

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Pharma Marketing Network

MAY 15, 2023

Big data has become an increasingly important tool for businesses across various industries, and the pharmaceutical industry is no exception. However, the use of big data in pharmaceutical marketing also poses significant challenges that must be considered. One of the biggest challenges is ensuring that patient privacy is protected.

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Pharmaceutical Technology

JANUARY 19, 2023

Sun Pharmaceutical Industries has signed a definitive agreement to buy all outstanding shares of Concert Pharmaceuticals, in a deal valued at $576m. Deuruxolitinib’s safety and efficacy was assessed in moderate to severe Alopecia Areata adult patients in the THRIVE-AA Phase III clinical programme.

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Pharmaceutical Technology

NOVEMBER 30, 2022

While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options. Currently, only Roche’s Ocrevus (ocrelizumab) is available for this patient population and its efficacy is limited.

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