pharmaphorum

MARCH 26, 2021

The UK Government and EU Commission trumpeted their Brexit trade deal, struck at the end of December, as ‘comprehensive’, the ‘biggest yet’ But a closer inspection of the EU-UK Trade and Cooperation Agreement (TCA) renders these statements largely illusory for the pharma sector. Medical devices do not feature at all.

Production 119

Production Medicine Marketing Regulation 119

pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. Pharma companies are looking at whether blocking TIGIT as well as PD-1/PD-L1 can improve the efficacy of cancer immunotherapy.

Drugs 98

Drugs Antibody Pharma Companies Development 98

pharmaphorum

JULY 5, 2021

Parexel has been a champion of the concept for years, but while adoption was fairly slow pre-COVID, it has accelerated at a fast pace since the crisis, aided by the increasing willingness of regulators to accept decentralised trial data in marketing applications.

Clinical Trials 64

Clinical Trials Clinical Trials Regulation Trials 64

pharmaphorum

NOVEMBER 30, 2022

The biggest gathering of pharma companies in Europe right now on the commercial side, the Veeva Systems Summit permits the sharing of best practices and of new ideas. Facts that they gleaned included: Across Europe, only 52% of HCPs will accept a visit from a pharma company (i.e.

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Life Science Pharma Companies Sales Marketing 98

pharmaphorum

MAY 14, 2021

This article appears in our digital magazine, Deep Dive: Market Access 2021. Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA. appeared first on.

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Marketing Regulation Medicine Life Science 59

Drug Discovery World

MAY 6, 2024

During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8% for the top five European Union markets and 5.6% for the US market 2. So, in this way there is a cross fertilisation from the bigger companies to newer ones.

Drugs 57

Drugs Life Science Gene Editing Gene 57

pharmaphorum

OCTOBER 28, 2020

Identifying, recruiting, retaining and monitoring patients during this part of the cycle is estimated to cost pharma US$19 billion a year as companies seek to harvest patient experiences. Once a drug is licensed and launched, however, there is a deafening silence. 72% do not feel listened to by pharmaceutical companies.

Medicine 119

Medicine Pharma Companies Vaccination Vaccine 119

pharmaphorum

DECEMBER 16, 2022

There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations. The industry has so far resisted demands for the sharing of intellectual property (IP) around products developed to counter the pandemic.

Vaccination 96

Vaccination Vaccine Production Licensing 96

pharmaphorum

JANUARY 7, 2021

ImaginAb has signed a deal with Pfizer, which it hopes will help it to gather information necessary for approval of its tumour imaging agent as a medical device in markets in the US and other countries.

Doctors 53

Doctors Doctor Immune Response Pharma Companies 53

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

pharmaphorum

MAY 14, 2021

In an interview with pharmaphorum’s news editor Richard Staines, chief operating officer Arnout Ploos van Amstel revealed how the biotech and its “mystery CEO” managed to swoop for the drug ahead of big pharma rivals. Licensed in from Ablynx in 2013 five years before a merger with Sanofi, German Merck recognised its potential.

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Licensing Licensing Drugs Marketing 66

XTalks

DECEMBER 29, 2022

This highlights potentially new marketing trends that life science companies may have to start looking into if they haven’t already. In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. 4. Social Media Marketing.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

pharmaphorum

DECEMBER 21, 2020

A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

Vaccination 111

Vaccination Vaccine Doctors Doctor 111

pharmaphorum

DECEMBER 7, 2020

Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region.

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Marketing Regulation Production Medicine 109

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

pharmaphorum

APRIL 1, 2021

In the past couple of years, Turbine worked with a number of big pharma companies, including Bayer, and has also started building its own pipeline, including a target delivering new biological insight in PARP inhibitor resistance. “We There’s not really a well-developed ecosystem of biotech funding and spin-out companies.

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Bioinformatics Drugs Development Scientist 123

XTalks

MARCH 22, 2023

While not a record-breaking deal at $17 billion, the buyout strengthened Pfizer’s injectables business unit with the company reporting an 11 percent increase in revenue the following year. In 2022, this number increased by 64 percent to a total of 37 new drug approvals.

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Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

DECEMBER 30, 2020

The reason for this is still not understood and many regulators may want it to be explained before authorizing it for broader use. In short, the advisory committee did not vote to recommend the drug to the agency, which has a PDUFA date of March 7, 2021 to decide whether to approve the aducanumab Biologics License Application (BLA).

Vaccination 52

Vaccination Vaccine Gene Therapy Trials 52

Drug Discovery World

APRIL 20, 2023

Regulators are therefore used to seeing cognitive data as primary or secondary outcomes in clinical trials, and are familiar with the instruments and methodological nuances of such data. These may provide an opportunity for treatment for post-Covid-19 cognitive impairment. depression).

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Development Drugs Clinical Trials Clinical Trials 98

The Pharma Data

NOVEMBER 5, 2020

By a separate press release, the Company has today announced its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021. Other expenses for the Company’s operations.

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Pharmaceutical Technology

AUGUST 12, 2022

In principle, the deal could create new opportunities for British pharma companies – not least the chance to work under a more supportive regulatory framework. Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs.

Medicine 290

Medicine Production Generic Drugs Regulation 290

pharmaphorum

MAY 26, 2022

While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go. A risk-benefit approach underpins the decision-making process to evaluate human drugs, drug/device combinations and advanced therapy medicinal products for licensing of human medicines.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Medicine 143

pharmaphorum

SEPTEMBER 1, 2020

Previously a centre of the trade in textiles and dyes, Swiss manufacturers gradually began to realise their dyestuffs had antiseptic and other properties and began to market them as pharmaceuticals, in contrast to the origin in pharmacies of other enterprises. Thalidomide and the development of drug safety regulation and monitoring.

Medicine 145

Medicine Insulin Pharmacy Drugs 145

pharmaphorum

AUGUST 4, 2020

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. The company’s shares were valued as high as 95p on the London Stock Exchange following the announcement, the highest they had been since 2015.

Drugs 109

Drugs Clinical Trials Clinical Trials Pharma Companies 109

pharmaphorum

DECEMBER 8, 2020

The company says in its IPO prospectus that it plans to list its shares on the Nasdaq Global Market under the ABCL ticker. Its approach involves licensing rights to the antibodies to other pharma companies, rather than bringing its own candidates through development.

Drugs 111

Drugs Antibody FDA Approval Pharma Companies 111

pharmaphorum

MAY 21, 2021

Arecor Therapeutics is planning to float on the London stock market, to raise funding and awareness for its developmental portfolio of biologic drugs, which are based on already-marketed drugs reformulated to provide extra benefits for patients. . We have been well known within pharma with the tech platform that can deliver. “We

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Insulin Drugs Production Marketing 52