Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. This approval marks a major milestone in the fight against Alzheimer’s, which is the sixth leading cause of death in the United States and affects over 5 million people.

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Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

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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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Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. NAS approval times have improved but still differ.

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European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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Pharmaceutical Technology

MARCH 29, 2023

In September 2021, Bristol Myers Squibb in-licensed the first programme, EVT8683, after the successful filing of an investigative new drug (IND) application with the Food and Drug Administration (FDA). This programme has now proceeded into a Phase I clinical trial.

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Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. since April, 2021 for treatment of endometrial cancer and certain solid tumors. ADCs and bispecifics aren’t new.

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pharmaphorum

NOVEMBER 2, 2022

The most common solutions today for pain relief are non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, meaning that standard treatments have not changed for a number of years. This leads to psychological harm becoming a significant factor in chronic pain, alongside the physical symptoms. The potential for a digital solution.

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Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

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Pharmaceutical Technology

MARCH 3, 2023

Albireo’s pipeline includes its lead asset, Bylvay (odevixibat), a potent, once-a-day, oral, non-systemic, ileal bile acid transport inhibitor (IBATi). In 2021, it secured regulatory approvals in the US to treat pruritus in progressive familial intrahepatic cholestasis (PFIC) in patients aged three months and above.

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European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Pharmaceutical Technology

APRIL 27, 2023

Pompe Disease, also known as glycogen storage type II, is a rare inherited lysosomal disorder caused by a deficiency of enzyme acid alpha-glucosidase (GAA) leading to the accumulation of glycogen in skeletal and cardiac muscles. The recommendation follows Pombilit’s EC approval in March 2023.

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European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). This could lead to significant research waste.

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European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

This follows the US Food and Drug Administration's (FDA) recent approval, in January this year, of Roche’s Vabysmo (faricimab) for DME, coupled with the anticipated approval of pipeline therapies in the forecast period from 2021 to 2031, which are expected to drive the growth of the DME market in the 7MM.

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European Pharmaceutical Review

NOVEMBER 4, 2022

Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. tumour effects. The importance of taxanes in oncology.

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European Pharmaceutical Review

AUGUST 11, 2022

The study compared outcomes for 110 patients treated with remdesivir and dexamethasone and 81 treated with both those medications plus baricitinib at Saint Peter’s University Hospital in New Jersey, USA, between June 2020 and June 2021. .

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Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.

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European Pharmaceutical Review

AUGUST 10, 2022

It was approved by the US Food and Drug Administration in October 2021 as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA-associated vasculitis), in combination with standard therapy.

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PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. and is one of the leading causes of kidney failure. Throughout the remainder of that year, screenings went back up, but started to decline again in 2021.

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European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. 1 ranking in 2021.

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Pharmaceutical Technology

JULY 29, 2022

In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs). This leads to hyperammonaemia, which causes symptoms such as vomiting, mental confusion, and lethargy. A nitrogen-binding drug, its global sales were $292m in 2021, as per GlobalData.

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Pharmaceutical Technology

JULY 28, 2022

The frequency of administration associated with a therapy is a critical factor that companies in this space focus on to fine-tune their chances of success in the wAMD market. Lower frequency of administration represents a significant alleviation of treatment burden and lower cost of treatment compared with standard of care.

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PM360

OCTOBER 25, 2023

Between May 1, 2016, and May 31, 2021, 42% of all U.S. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. When 1+1 ≠ 2 In theory, combining two or more branded agents can lead to a price that exceeds SoC monotherapy. References: 1. Benjamin, Alexander Xu, Mark P.

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Legacy MEDSearch

DECEMBER 6, 2022

Activ Surgical is on the leading edge when it comes to enhancing surgical vision and significantly reducing unintended medical errors, and I am confident that ActivSight will improve surgical outcomes.”. Activ Surgical received 501(k)-clearance for ActivSight by the Food and Drug Administration (FDA) in the United States in 2021.

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European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Pharmaceutical Technology

APRIL 25, 2023

After missing the previous Q1 deadline, bluebird bio has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its sickle cell disease gene therapy lovo-cel, based on an April 24 company announcement. This hold was lifted a year later.

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European Pharmaceutical Review

MAY 4, 2023

Martin Vogel, Janssen’s Therapeutic Area Lead Oncology for the Europe, Middle-East and Africa (EMEA) region shared with EPR what makes the BsMAb promising for treating this indication. Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication? What are the current trends in antibody therapeutics?

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European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015.

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Legacy MEDSearch

JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

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Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The first AdCom was critical of the study’s robustness.

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European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

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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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Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). More than half of stroke survivors aged 65 and older experience reduced mobility, and stroke has become a leading cause of long-term disability. The burden on patient functioning is also profound. MedRhythms is headquartered in Portland, Maine.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. Clarify launched its real-world evidence on health disparities in 2021. However, another study found that 0.1%

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