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 this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

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European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.

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European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising. billion, and rising.

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European Pharmaceutical Review

APRIL 17, 2024

Roche explained that additional data offered further evidence on the safety profile of OCREVUS SC injection. It was consistent with the safety profile of OCREVUS IV infusion, the findings revealed. No new safety signals were identified for OCREVUS SC.

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European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

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European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

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Pharmaceutical Technology

AUGUST 23, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ocelot Bio’s OCE-205 to treat hepatorenal syndrome. It will analyse the safety and efficacy of OCE-205 in adult HRS-AKI patients having cirrhosis with ascites. It also showed to possess a promising safety profile.

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European Pharmaceutical Review

APRIL 16, 2024

In December 2023, the US Food and Drug Administration (FDA) approved the treatment for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data, Novartis confirmed.

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European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. What recommendations are included in the draft guidance on psychedelic drugs? However, these are still investigational products.

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European Pharmaceutical Review

AUGUST 29, 2023

Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration. The safety and efficacy profile was consistent with the IV formulation.

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Pharmatutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

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European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The approval is also accompanied by labelling with safety warnings.

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MedCity News

NOVEMBER 18, 2022

The group complains that the FDA never studied the safety of the drugs under the labeled conditions of use. .

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Pharmaceutical Technology

APRIL 5, 2023

Shionogi has obtained fast track designation from the US Food and Drug Administration (FDA) for its ensitrelvir fumaric acid, an investigational oral antiviral drug for the treatment of Covid-19. The firm also plans to initiate new studies to further assess the drug.

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European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica.

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European Pharmaceutical Review

DECEMBER 22, 2023

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

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Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

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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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Pharmaceutical Technology

JUNE 14, 2023

The US Food and Drug Administration (FDA) has granted fast track designation for CellCentric’s inobrodib (CCS1477) to treat relapsed or refractory multiple myeloma patients. The therapy can be utilised by patients who have failed to progress on other therapies and along with existing standard-of-care drugs.

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European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection. He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.”

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Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

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European Pharmaceutical Review

JANUARY 9, 2024

Safety of TALZENNA plus XTANDI in the TALAPRO-2 trial was found to be generally consistent with the known safety profile of each medicine. While a key secondary endpoint, favouring TALZENNA plus XTANDI was also observed, these data are immature, Pfizer noted.

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Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

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European Pharmaceutical Review

JANUARY 29, 2024

Overall, the authors summarised that the enhanced sensitivity improves safety assessments for volatiles in medical devices. The paper discussed the detection of volatile extractables released during the clinical use of medical devices.

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European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. In conclusion, it is clear US and UK regulators are working to streamline guidelines to ensure the quality and thus safety of medical devices that are made available.

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European Pharmaceutical Review

OCTOBER 30, 2023

Moreover, no unexpected safety signal for the gene therapy was identified in the LGMD2I/R9 study. The Data Safety Monitoring Board (DSMB) has authorised enrolment of the second dose cohort for this clinical trial in LGMD2I/R9, Atamyo noted.

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European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

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European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. It was investigated both as monotherapy and in combination with phosphate binder therapy.

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European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

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