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.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

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.

Medicine 52

Medicine Biopharma Safety Food 52

Clarivate

OCTOBER 7, 2021

As part of our Drugs to Watch series, which reviews therapies expected to have significant impact on healthcare markets, Clarivate oncology experts sifted through the more than 2,800 abstracts that were accepted for presentation at the ESMO 2021 Virtual Conference and selected their top picks. Context: In August 2021, Merck & Co.

Patients 91

Patients Safety Marketing Physicians 91

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.

Training 64

Training Marketing Competition FDA 64

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

Biopharma 111

Biopharma Pharma Marketing Management 111

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.

Media 52

Media Marketing Pharma Safety 52

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

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.

Media 69

Media Pharma Networking Safety 69

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.

Pharmaceutical 52

Pharmaceutical Medicine Government Side effects 52

European Pharmaceutical Review

JANUARY 10, 2024

This dynamic microbial interaction includes competition for nutrients, cross-feeding and genetic exchange, among other interactions, contributing to the fluctuation in microbiome composition and functionality. 2021 May 18;9(1). References Kamada N, Kim YG , Sham HP, et al. frontiersin.org. Microbiome. 2020 [cited 2023 Dec] 4;1–16.

Medicine 52

Medicine Manufacturing Leads Networking 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.”

Government 95

Government Marketing Management Education 95

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.

Ethics 52

Ethics Sales Training Specialization 52

European Pharmaceutical Review

JANUARY 16, 2023

Rykindo ® was approved for marketing in China in 2021 for the treatment of schizophrenia. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. Promising schizophrenia drug faces tough competition.

Food and Drug Administration 116

Food and Drug Administration FDA Competition Pharma 116

Clarivate

DECEMBER 1, 2021

Clarivate experts share takeaways from the 2021 American Heart Association Scientific Sessions (AHA21) , with insights on how findings may impact patient care. Milvexian displayed better efficacy and matching safety compared with current SoC, subcutaneous enoxaparin, following knee arthroplasty. Circulation 2021; 144(suppl1): LBS.05.

Safety 52

Safety Patients Management Marketing 52

PM360

APRIL 25, 2023

Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. The increase, from ASP plus 6% to ASP plus 8%, will last for five years, and may help increase access to and utilization of biosimilars and promote competition in the marketplace.

Marketing 97

Marketing Competition Government Manufacturing 97

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 57

FDA Safety Sales Competition 57

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 98

Medical Food and Drug Administration Healthcare Healthcare 98

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.

Competition 59

Competition Safety Patients Pharmaceutical 59

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. million for Hemgenix [AAV5-hFIX-Padua]). Proprietary cell lines also allow companies to attain IP and build brand recognition.

Manufacturing 85

Manufacturing Safety Patients Competition 85

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.

Food 97

Food Competition Safety Pharmaceutical 97

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.

Government 95

Government Medical Medicine Marketing 95

Pharmaceutical Technology

FEBRUARY 3, 2023

After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting. This way, producer cells can be successfully grown to required volumes, achieving yields very much competitive with those obtained via transient transfection.

Medicine 97

Medicine Manufacturing Safety Management 97

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

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.

Pharma 84

Pharma Pharmaceutical Manufacturing Distribution 84

European Pharmaceutical Review

JULY 1, 2022

Health and safety – the COVID-19 pandemic has thrown into sharp relief the significance of safe working environments, including the importance of employee mental health and wellbeing.

Government 86

Government Pharmaceutical Safety Consulting 86

Evolve Your Success

MAY 2, 2023

She offers tips and insights on how to write a winning medical sales resume that will help you stand out from the competition and land your dream job. Did I help increase safety numbers and decrease falls? 2020 to 2021.” They’ve got a lot of competition out there. What did I do? How much did I participate in?

Medical sales 98

Medical sales Medical Sales Management 98

Healthcare Success

AUGUST 29, 2022

Better fitness Creative at-home offerings like Peloton, Mirror, and Tonal saw unprecedented growth in 2020 and 2021 as people tried to maintain physical activity during the pandemic. only, Tweets from March 1, 2021 - March 2022). Men and women aged 18-34 are the most likely to seek out healthier food options (e.g.,

Marketing 52

Marketing Ethics Media Engineering 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

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.

FDA 115

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

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