Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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FDA Side effects Pharmacology Patients 115

pharmaphorum

AUGUST 3, 2022

It is, however, the first that can be substituted across all Lucentis’ five indications and to be fully interchangeable – which means it is considered to have no clinically meaningful difference compared to the reference drug in safety, purity, or potency and can be substituted for it without any prescriber intervention.

FDA 59

FDA Safety Sales Competition 59

Impetus Digital

AUGUST 2, 2024

Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported. In 2022, the AI-fuelled pipeline reportedly expanded at an annual rate of almost 40%.

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Pharmaceutical Technology

MAY 31, 2023

The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. SNIPR001 consists of four CRISPR-edited phages targeting E.Coli.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects FDA 98

Clarivate

JULY 31, 2023

Following the acquisition of Dialog Solutions as part of the ProQuest M&A in December 2021, Dialog Solutions products and services will be folded into the Clarivate portfolio of offerings for Life Sciences & Healthcare. Today, the Dialog Solutions brand has been integrated into Clarivate.

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Healthcare Healthcare Safety Competition 52

Pharmaceutical Technology

JANUARY 22, 2023

Dr. Jerry Mendell, MD, professor of paediatrics and neurology at the Ohio State University College of Medicine, is optimistic for its approval and says the drug has a good safety profile. However, before the drug can receive an approval, Santhera will have to overcome doubts about vamorolone’s safety. compared to 38.5% on placebo.

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FDA Safety Pharmaceutical Patients 126

Integrity Solutions

MAY 26, 2022

According to the 2021 Global Business Ethics Survey® , around 1 in 5 U.S. One of those concerns is “psychological safety,” creating psychologically safe environments for employees to speak their minds. Clearly, how (and whether) companies deliver on that core value promise varies dramatically.

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Ethics Sales Training Specialization 130

Copyright Clearance Center

FEBRUARY 22, 2023

If you don’t think a single source to access all this data is crucial, consider this: a 2021 study from Qatalog and Cornell University’s Ellis Idea Lab says 43% of respondents report spending too much time switching between different online tools. This is done using enabled vocabularies including MeSH, ChEMBL, and SciBite VOCabs.

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Food Competition Safety Pharmaceutical 98

European Pharmaceutical Review

NOVEMBER 8, 2022

Pharmaceutical manufacturers have submitted Citizen Petitions raising safety or efficacy concerns about proposed competing generic and biosimilar products, and such submissions often delay FDA approval of the proposed products while the FDA resolves the pending petitions. 2(1)(B)(i) (2021), [link] senate-bill/562/text.

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Food and Drug Administration Pharma Manufacturing Prescription 52

Pharmaceutical Technology

JUNE 20, 2023

This comes after an independent data monitoring committee confirmed the safety and tolerability profile of ARGX-117 was consistent with results from an earlier Phase I study. In addition to assessing the safety and efficacy of ARGX-117, it will populate a PK/PD model to inform Phase III study dose selection.

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Safety Patients Prospecting Marketing 98

European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. The Impact of Biosimilar Competition in Europe, IQVIA, December 2021. Guidance on the licensing of biosimilar products, May 2021. Lausuntopalvelu.fi.

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Medicine Biopharma Safety Food 52

Pharmaceutical Technology

OCTOBER 28, 2022

The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy. In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Competition in an increasingly heated market.

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Training Marketing Competition FDA 64

European Pharmaceutical Review

FEBRUARY 7, 2023

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. However, a delicate balance will need to be struck between the need for affordable and accessible medicinal products and the desire to foster innovation and competitiveness in the EU.

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Medical Government Marketing Medicine 117

Pharma Marketing Network

NOVEMBER 11, 2020

Chief Executive Officer of Arteric, Hans Kaspersetz presented how AI can help develop your competitive edge. Some of the many reasons people currently prefer telehealth over in-person doctor visits include convenience, flexibility, less wait time, safety, and easier routine follow-ups. Rea ching HCP’s When Your Sales Force Can’t.

Marketing 52

Marketing Pharma Competition Doctors 52

PM360

DECEMBER 20, 2023

It was the first $1bn quarter since 2021 which does suggest that biotech’s IPO window is opening once more. This allows for a complementary portfolio fit without the kind of competitive overlap that comes under regulatory scrutiny from the FTC. Eight companies floated in the third quarter of 2023, raising $1.3

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Pharmaceutical Technology

FEBRUARY 13, 2023

By this same virtue, PROTACs are able to degrade previously undruggable targets, which provides a major competitive advantage for this modality if shown to be true. Moreover, off-target effects from conventional BTKis result in a suboptimal safety profile, which the enhanced selectivity of PROTACs can help mitigate.

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Competition Safety Patients Pharmaceutical 59

Pharmaceutical Technology

APRIL 11, 2023

In Trial 7, a multicentre 24-week, open-label study safety in 46 patients between the ages of one and two, Orkambi’s safety profile was found to be similar to that in a similar Phase III trial (NCT03125395) for patients of ages two and older. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

Medicine 98

Medicine Patients Safety Prospecting 98

Pharmaceutical Technology

JUNE 7, 2023

The study was stopped after a recommendation from the independent Data and Safety Monitoring Board (DSMB) following a planned interim assessment of efficacy. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Free Report How is the Biopharmaceutical industry evolving?

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Prospecting Patients Marketing Competition 105

Pharmaceutical Technology

MAY 30, 2023

Launched back in 2021, AION Labs was formed as an alliance between AstraZeneca , Merck , Pfizer and Teva , as well as Amazon and the Israel Biotech Fund. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. This is the sixth call for applications that AION has launched.

Pharma 84

Pharma Prospecting Government Education 84

Pharmaceutical Technology

APRIL 25, 2023

In October 2021, the World Health Organization recommended the use of GSK’s recombinant protein-based vaccine Mosquirix (RTS,S/AS01) for children at risk of contracting the infectious disease. Storage in other conditions can cause damage to the antigen or adjuvant and reduce the vaccine’s safety or efficacy.

Food and Drug Administration 69

Food and Drug Administration Prospecting Government Food 69

European Pharmaceutical Review

AUGUST 31, 2023

A flexible attitude, together with careful and knowledgeable customisation, enables us to design innovative, automated lines that will process injectable products (eg, vaccines, oncology drugs) at high speeds and in total safety. All our machines feature a robust balcony structure and are designed with the operator in mind.

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Pharma Pharmaceutical Manufacturing Distribution 104

eMediWrite

MAY 10, 2022

The pharma market is expected to be fiercely competitive in 2021 due to a rise in the number of people who require medication. ENSURE SAFETY. Make use of social media to promote safety and make people feel safe. EXPLAINED: 5 KEY STRATEGIES TO IMPROVE PHARMA SOCIAL MEDIA MARKETING.

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Media Marketing Pharma Safety 52

PM360

OCTOBER 13, 2023

If you are a challenger brand in the midst of defining yourself, leap-frogging your competition, and cementing yourself as king of the jungle, this is the type of opportunity that comes around, once, maybe twice in a career. Reddit has also improved its brand safety protocol, while daily user activity is up 58% since 2020.

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Media Pharma Networking Safety 69

Medico Reach

OCTOBER 17, 2022

billion in 2021, with a compounded annual growth rate (CAGR) of 3.1% From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. The potential increase in industry competition could also spell trouble for some. from 2022 to 2030.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Clarivate

AUGUST 27, 2024

European marketing approval) for its Farapulse system in 2021, where it had been used in more than 40,000 procedures before gaining U.S. In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients. Boston Scientific Corp. received CE mark (i.e., in December 2023.

Marketing 52

Marketing FDA Competition Medical 52

PM360

JULY 26, 2023

Even top AI developers from Google and OpenAI co-signed a statement at the end of May from non-profit the Center for AI Safety that said, “Mitigating the risk of extinction from AI should be a global priority alongside other societal-scale risks such as pandemics and nuclear war.”

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Government Marketing Management Education 95

Rep-Lite

JULY 27, 2023

Moreover, we’ll shed light on the evolution of medical sales techniques and strategies, the impact of technology, and the importance of talent acquisition to thrive in this competitive domain. Navigating Regulatory Changes and Compliance The medical device industry operates under strict regulations to ensure patient safety.

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Sales Medical Medical sales Sales Strategy 52

Pharmaceutical Technology

MAY 4, 2023

The approval comes after an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted in support of Arexvy’s effectiveness and safety. The study will continue for three RSV seasons to test the duration of effectiveness and the safety and effectiveness of repeat vaccination.

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FDA Safety Medicine Prescription 64

Pharmaceutical Representative Training

OCTOBER 9, 2024

In the competitive world of pharmaceutical sales, effectively handling customer objections is crucial for success. 3 By actively listening to providers and addressing their objections with tailored solutions, sales professionals can cultivate strong relationships that lead to success in this competitive field. 2021, December 17).

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Sales Pharma Pharmaceutical Sales Prospecting 52

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prospecting 52

Contrarian Sales Techniques

FEBRUARY 26, 2023

Pharmaceutical experts have spoken about four aspects that generic manufacturers must take into account when purchasing active pharmaceutical ingredients, such as cost, quality, availability, quality control, and safety. Indian and Chinese companies that produce high-quality generic medicines and export them around the world are competing.

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Pharmaceutical Medicine Government Manufacturing 52

Pharmaceutical Representative Training

JANUARY 8, 2025

Without this information, providers cant ensure the safety or efficacy of the medications they prescribe. 1] How can mastering pharmacology give sales reps a competitive advantage when meeting with prospective HCPs? link] How can mastering pharmacology give sales reps a competitive advantage when meeting with prospective HCPs?

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Pharmacology Pharma sales reps Sales Pharma 52

Pharmaceutical Technology

MAY 30, 2023

Launched back in 2021, AION Labs was formed as an alliance between AstraZeneca , Merck , Pfizer and Teva , as well as Amazon and the Israel Biotech Fund. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. This is the sixth call for applications that AION has launched.

Pharma 52

Pharma Prospecting Government Education 52

Pharmaceutical Technology

MARCH 23, 2023

Florham Park, New Jersey-based Exeltis Pharmaceuticals is currently running a Phase III study (EudraCT-2021-002178-17) with LPRI-421, a fixed dose combination of dienogest, a synthetic progesterone, and ethinylestradiol, a synthetic estrogen. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

Medical 52

Medical Management Patients Transportation 52

Pharmaceutical Technology

MAY 30, 2023

The safety data was consistent with the previous updates, with the majority of adverse events (AEs) being grade 1 and 2, with no grade 4 AEs reported. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. months, versus 1.87 months on standard of care (SOC) (HR 0.518; 95% CI: 0.216-1.165).

Patients 59

Patients Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

MAY 23, 2023

Saurabh Saha said, “We believe SerpinPC has the potential to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with haemophilia B, subject to review and approval.” 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

FDA 59

FDA Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

FEBRUARY 6, 2023

In an email , a Pliant spokesperson told Pharmaceutical Technology , “As currently approved therapies are not well tolerated, a new agent with a favorable safety profile and demonstrated efficacy would be a welcome addition to the IPF treatment armamentarium”. In the US, the annual cost for Esbriet is $113,193 and $112,357 for Ofev.

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