Rep-Lite

JULY 27, 2023

Leveraging data and analytics empowers sales representatives to identify trends, optimize their efforts, and focus on high-value prospects, thereby enhancing overall productivity. 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

European Pharmaceutical Review

AUGUST 12, 2022

Key secondary endpoints include progression-free survival (PFS), duration of response (DoR) and safety. Analysis data cut-off: 27 August 2021. The safety profile of Tagrisso plus savolitinib was consistent with the known profiles of the combination and each treatment alone. No new safety signals were identified.

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Safety Patients Prospecting Medical 88

European Pharmaceutical Review

AUGUST 10, 2022

The prospective, open-label, single-arm, Phase II TUXEDO-1 study enrolled 14 women and one man with human epidermal growth factor receptor 2 (HER2)-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy. Two patients (13.3

Patients 92

Patients Medicine Prospecting Safety 92

European Pharmaceutical Review

NOVEMBER 11, 2022

The trial evaluated the safety, tolerability and efficacy of NTLA-2001 in 12 participants. These results indicate that IV NTLA-2001 is a potential new treatment option… However, further research is needed to establish [its] long-term safety.”. Study safety results. August 2021. References. Gheorghiade M et al.

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Safety Medical Patients Transportation 101

Pharmaceutical Technology

OCTOBER 1, 2022

This news came after the pharma giant halted islatravir studies for the prevention and treatment of HIV infections in December 2021 on grounds of safety. In March 2021, MSD and Gilead announced the joint development and commercialisation of the combined treatment, with a focus on oral and injectable formulations.

Safety 72

Safety Healthcare Healthcare Leads 72

pharmaphorum

JANUARY 19, 2023

Prospects for Johnson & Johnson’s HIV vaccine effort have looked shaky since one of its shots failed to protect women in sub-Saharan Africa against infection with the virus in a phase 2b trial reported in 2021, and the company has now abandoned the programme altogether after a phase 3 readout.

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Prospecting Safety 52

Clarivate

SEPTEMBER 1, 2022

This can disproportionately affect girls’ educational prospects and, as is often the case in stressful environments and during times of crisis, puts women at increased risk of domestic violence. Many of the 2021 recipients of our Highly Cited Researchers program have tackled this important problem from a variety of angles.

Education 124

Education Healthcare Healthcare Prospecting 124

European Pharmaceutical Review

JULY 25, 2022

This means falsified medicines may contain the wrong ingredients or low levels of the active ingredient – a terrifying prospect for a global consumer base reliant on medical treatments. These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. Supply-chain visibility.

Pharmaceutical 83

Pharmaceutical Medicine Pharmaceutical manufacturing Manufacturing 83

pharmaphorum

JANUARY 16, 2023

US regulators cleared the single-shot J&J vaccine for use back in February 2021 and health authorities held high hopes for it, not least because it carried fewer cold-chain storage requirements than competing shots. J&J is also currently engaged in arbitration with Merck & Co.,

Manufacturing 109

Manufacturing Government Prospecting Safety 109

Nixon Gwilt Law

NOVEMBER 5, 2021

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) finalized the Medicare Physician Fee Schedule for Calendar Year 2022 (the “Final 2022 MPFS” or the “Final Rule”). We predict that the PHE will be extended beyond 2021, and that remote direct supervision will be permissible until at least December 31, 2022.

Physicians 52

Physicians Professional Services Side effects Medical 52

Pharmaceutical Technology

APRIL 12, 2023

In 2021, they accounted for 0.2% However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

Pharma 98

Pharma Food and Drug Administration Safety Medicine 98

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

Salesforce

APRIL 7, 2021

The four critical uncertainties we proposed are also still useful for tracking the potential outcomes, but many new developments have changed the upside and downside prospects, both for the world as a whole and across regions. While difficult to scale, that keeps the prospect of herd immunity within reach. Citizens across the U.S.,

Prospecting 52

Prospecting Management Government Marketing 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.

Safety 98

Safety Patients Prospecting Marketing 98

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

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 Government Prospecting Food 69

Pharmaceutical Technology

MARCH 6, 2023

Based on preclinical research for their impact on aging, well-known drugs like metformin and rapamycin are already being considered for off-label usage, due to their accepted safety profile and cost-effectiveness. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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FDA Pharmaceutical Prospecting Medicine 145

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

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

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 Government Prospecting Education 84

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

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?

Prospecting 105

Prospecting Patients Competition Marketing 105

Pharmaceutical Technology

JUNE 21, 2023

The FDA also granted the drug approval in 2021 to treat adults living with heart failure with reduced ejection fraction. This latest approval is based on results from the Phase III DINAMO trial (NCT03429543) that investigated the safety and efficacy of both drugs. reduction in haemoglobin A1c compared to an average increase of 0.7%

Medicine 59

Medicine FDA Food and Drug Administration Sales 59

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.

FDA 64

FDA Safety Medicine Prescription 64

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

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 Government Prospecting Education 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

JUNE 6, 2023

Ellipses reported preliminary efficacy and safety data for the 109 patients enrolled in the trial. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.

Pharma 52

Pharma Patients Prospecting Competition 52

Pharmaceutical Technology

MAY 31, 2023

The document would include the drug/biological product name, side effects, directions for use, safety information, and a concise summary of indications and uses. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Free Report How is the Biopharmaceutical industry evolving?

Prescription 52

Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

MAY 1, 2023

Communication is important as well for letting people become comfortable and understand the vaccine’s safety and necessity. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. You also need to look at the supply chain that is needed to deliver vaccines to those countries and then distribute it.

Food and Drug Administration 52

Food and Drug Administration Medicine Pharmaceutical Marketing 52

Pharmaceutical Technology

JUNE 22, 2023

There, the European Commissioner for Health and Food Safety, Stella Kyriakides, stated that incentives need to be used to fuel innovation needed to bring new antimicrobials to the market. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Free Report How is the Biopharmaceutical industry evolving?

Pharma 52

Pharma Pharmaceutical Government Marketing 52

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.

Marketing 59

Marketing Pharmaceutical FDA Prospecting 59

Pharmaceutical Technology

MARCH 16, 2023

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. As these drugs are not licensed for the specific indication of gender-affirming care, collecting safety data on off-label use is not viewed as a priority.

Ethics 144

Ethics Prescription Safety Healthcare 144

Pharmaceutical Technology

JUNE 5, 2023

The treatment had an acceptable safety profile in combination with chemotherapy. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.

Side effects 52

Side effects Patients Leads Prospecting 52

Pharmaceutical Technology

JUNE 16, 2023

Clinical-stage cell therapy company Tessa Therapeutics have announced positive safety and efficacy data from the trial (NCT04288726 of TT11X, its off-the-shelf CD30.CAR-modified The company claimed that early trials have demonstrated a strong safety profile and efficacy. GlobalData is the parent company of Pharmaceutical Technology.

Safety 52

Safety Engineering Prospecting Patients 52

Pharmaceutical Technology

MAY 25, 2023

According to the companies report, the BT-001 single agent treatment was completed in 18 patients and no safety concerns were reported. The independent Safety Review Committee has now approved initiation of the combination part of the trial with pembrolizumab. Free Report How is the Biopharmaceutical industry evolving?

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Safety Patients Prospecting Marketing 52