pharmaphorum

DECEMBER 28, 2022

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. But what steps can the smaller companies at the cutting edge take to make them acquisition-ready and maximise their value during this process?

Compliance 119

Compliance Regulation Manufacturing Licensing 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

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

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. Veeva is equally ‘super excited’.

Life Science 98

Life Science Pharma Companies Sales Marketing 98

pharmaphorum

JANUARY 7, 2021

The California-based company has signed a non-exclusive license with Pfizer to supply its 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients.

Doctors 53

Doctors Doctor Immune Response Pharma Companies 53

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

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

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. Andrew is also an expert on GDPR.

Production 115

Production Medicine Marketing Regulation 115

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 102

Vaccination Vaccine Doctors Doctor 102

pharmaphorum

MAY 14, 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. The post How will NICE fare in a post-Brexit world? appeared first on.

Marketing 59

Marketing Regulation Medicine Life Science 59

pharmaphorum

MAY 14, 2021

Merck KGaA had been developing the drug with partner Avillion and van Amstel’s team got in touch as soon as they heard the German pharma was considering selling it as part of a pipeline rethink. Licensed in from Ablynx in 2013 five years before a merger with Sanofi, German Merck recognised its potential.

Licensing 62

Licensing Licensing Drugs Marketing 62

Drug Discovery World

MAY 6, 2024

The transfer of technologies from the lab to the market, is no longer purely via IP out licensing, but rather via start-up M&A deals – start-ups being the de-risking vehicle for large corporates. As companies move through the phases of development, they benefit from a long-established ecosystem of competency in clinical regulation.

Drugs 59

Drugs Life Science Gene Editing Gene 59

XTalks

DECEMBER 29, 2022

In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. It has also been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the US regulator for both SCD and TDT.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

Drug Discovery World

MARCH 29, 2023

The commission is looking to put more pressure on pharma companies to report such shortages, and to offer a drug’s marketing authorisation to another company before withdrawing it from the market. She also does not believe that the problems with Europe’s medicines can be solved with regulation.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,

Packaging 52

Packaging Packaging Drugs Containment 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.

Bioinformatics 116

Bioinformatics Drugs Development Scientist 116

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).

Development 98

Development Drugs Clinical Trials Clinical Trials 98

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. For example, price regulations are becoming more common in Latin America, often being based on models such as NICE’s.

Marketing 103

Marketing Regulation Production Medicine 103

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

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

DECEMBER 8, 2020

Its approach involves licensing rights to the antibodies to other pharma companies, rather than bringing its own candidates through development.

Drugs 104

Drugs Antibody FDA Approval Pharma Companies 104

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 99

Drugs Clinical Trials Clinical Trials Pharma Companies 99

The Pharma Data

NOVEMBER 5, 2020

The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect,” says Anna Ljung, CEO of Moberg Pharma. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 CET on November 6, 2020.

Marketing 40

Marketing Production Regulation Containment 40

pharmaphorum

SEPTEMBER 1, 2020

.” This public-spirited industry still required greater oversight, however, and government regulations on medicines increased on both sides of the Atlantic. Thalidomide and the development of drug safety regulation and monitoring. George Merck on the cover of Time magazine.

Medicine 145

Medicine Insulin Pharmacy Drugs 145

pharmaphorum

MAY 21, 2021

It builds on the company’s four partnership projects: two with the generics and biosimilars firm Hikma, one with US biotech Inhibrix and another with an unnamed biosimilars partner. Regulators may not require the large phase 3 trials needed to approve completely new drugs, as safety is proven.

Insulin 52

Insulin Drugs Production Marketing 52

XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. To address cultural considerations, it is essential that pharma companies work together with healthcare providers to promote trust in vaccines.

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

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.

Life Science 97

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

XTalks

FEBRUARY 15, 2024

US Senator Bernie Sanders, who chairs the Health, Education, Labor, and Pensions (HELP) Committee, managed to bring CEOs of major American pharma companies to a committee hearing to discuss exorbitant US drug pricing.

Drugs 52

Drugs Pharma Companies Pharmacy Regulation 52

The Pharma Data

DECEMBER 16, 2020

Recombinant monoclonal antibodies are designed to enhance the immune system’s ability to regulate cell functions. More Vaccine Development : In France, specialty vaccine company Valneva SE announced it was launching a Phase I/II study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. government in September.

Vaccination 52

Vaccination Vaccine DNA Antibody 52