European Pharmaceutical Review

DECEMBER 12, 2023

Yannis Morel, Executive Vice President of product portfolio strategy and business development of Innate Pharma SA, offers insight on engineering antibodies to develop antibody-based NK cell therapeutics. As a biotech, what work does Innate Pharma do in the biopharma industry?

Pharma 107

Pharma Engineering Safety Patients 107

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

Patients 52

Patients Food and Drug Administration FDA Safety 52

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients 98

Patients Healthcare Healthcare Marketing 98

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.

Patients 59

Patients Pharma Education Media 59

Pharmaceutical Technology

MAY 23, 2023

BioCryst Pharmaceuticals has secured marketing authorisation from the Public Health Institute (ISP) of Chile for oral, once-daily ORLADEYO (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) attacks in patients aged 12 years and above.

Marketing 52

Marketing Biopharma Safety Pharma 52

Pharmaceutical Technology

SEPTEMBER 13, 2022

An international team of scientific, regulatory, and safety and compliance (GxP) specialists, PharmaLex is based in Germany. The company provides strategic assistance and regulatory support to biopharma firms across the lifecycle of the product.

Biopharma 52

Biopharma Manufacturing Pharmaceutical manufacturing Consulting 52

pharmaphorum

AUGUST 4, 2022

This is due to the specialist nature of roles and the growth and diversification of biopharma, which requires an increasingly sophisticated and skilled workforce. Furthermore, by simulating real-life scenarios, AR offers the chance for staff in the pharma industry to practice complex operations without the associated risks.

Recruitment 96

Recruitment Pharma Training Pharmaceutical manufacturing 96

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

Patients 52

Patients Food and Drug Administration FDA Safety 52

PM360

DECEMBER 14, 2023

Moderna Joins CEPI Pandemic Preparedness Mission After making its debut in the pharma market during the COVID-19 pandemic, Moderna is preparing for the next pandemic. The pharma company has joined the Coalition for Epidemic Preparedness Innovations (CEPI) in a partnership that aims to shorten vaccine development timelines down to 100 days.

Physicians 52

Physicians Pharma Medical Patients 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

Salesforce

JUNE 11, 2019

Biopharma companies have consistently had to reimagine themselves over the years to confront globalization, the entry of generics and biosimilars, and now the advent of precision medicine and value-based care. Simply put, it’s taking more time and money ($2B+) to get new drugs approved, and the peak sales per drug is declining.

Pharma 52

Pharma Biopharma Recruitment Pharmaceutical 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. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

Medicine 52

Medicine Biopharma Safety Food 52

MedCity News

JUNE 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

FDA 96

FDA Leads Safety Patients 96

pharmaphorum

DECEMBER 20, 2022

The road to the development of treatments for non-alcoholic steatohepatitis (NASH) is littered with failed projects, but US biotech Madrigal Pharma thinks it now has enough evidence for its drug resmetirom to support regulatory filings. Although, so far efforts to bring a therapy to market have failed.

Pharmacology 52

Pharmacology Pharma Marketing Biopharma 52

Pharmaceutical Technology

NOVEMBER 4, 2022

Any reduced availability of medicines has a significant impact on patient care. As visibility diminishes, mismanagement of the supply chain can not only lead to revenue and reputational damage for manufacturers but more importantly, loss of life for patients. The CMO solution.

Biopharma 52

Biopharma Manufacturing Media Pharmaceutical 52

Pharmaceutical Technology

JULY 7, 2022

Cell and gene therapies are currently at the forefront of immunotherapy cancer research, and a few approved therapies are already making a difference to disease outcomes for patients. But getting these drugs to patients requires risky transportation, and safety and success hinges on reliable, temperature-controlled logistics.

Medicine 98

Medicine Transportation Manufacturing Biopharma 98

Clarivate

FEBRUARY 28, 2024

These conditions, affecting small patient populations and characterized by diverse clinical manifestations, demand innovative approaches and cutting-edge technologies to drive research and commercialization forward.

Electronics 59

Electronics Healthcare Healthcare Medicine 59

European Pharmaceutical Review

FEBRUARY 21, 2023

They are there to do a job and ultimately to keep patients safe. This knowledge enables companies [in this sector] to accelerate drug discovery and development programmes, with a significant amount of safety, toxicity and efficacy data already known and on which we can build. There is huge potential for new licensed drugs in the space.

Medicine 129

Medicine Manufacturing Specialization Pharmaceutical 129

Clarivate

APRIL 4, 2024

Greater awareness among clinicians could improve early diagnosis and disease management in patients. Because misdiagnoses are relatively frequent for patients with IMIDs, awareness of racial and ethnic variations in IMIDs could aid early diagnosis and improve disease management,” the paper concluded. You can read about the study here.

Electronics 52

Electronics Patients Medical FDA 52

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances. References.

Food and Drug Administration 109

Food and Drug Administration Medicine Food Government 109

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. That leaves three years for pharma companies to prepare. asked panel chair Ipsita Smolinski, MD of consultancy Capitol Street.

FDA 52

FDA Prescription Medicine Biopharma 52

Clarivate

OCTOBER 25, 2023

The biggest impacts are likely to be felt by patients with PDPs that use coinsurance, which most plans do for specialty drugs. Impact for patients taking the diabetes drugs and blood thinners might be less noticeable since these drugs tend to receive coverage as preferred brand tiers with copays.

Prescription 52

Prescription Physicians Manufacturing Healthcare 52

Clarivate

OCTOBER 10, 2022

Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients. Positive outcomes in a key patient segment could broaden TRODELVY’s uptake in metastatic breast cancer. Market impact.

Marketing 52

Marketing Safety Patients Competition 52

European Pharmaceutical Review

DECEMBER 7, 2022

Biopharma Akeso Inc. state the therapy could help reduce side effects and safety concerns. At the American Society of Clinical Oncology (ASCO) 2022, Phase II study results showed ivonescimab demonstrated an overall response rate (ORR) for patients with NSCLC who failed EGFR-TKI’s of 68.4 Under the agreement, Akeso Inc.

Pharma 95

Pharma Side effects Safety Biopharma 95

PM360

SEPTEMBER 28, 2022

Now, as the President of Accord BioPharma , the U.S. The entire premise was that because biosimilars were so new, and there was not a lot of information on the safety and efficacy of those products, customers should be a bit leery prior to jumping on the biosimilar bandwagon. specialty division of Intas Pharmaceuticals, Ltd.,

Competition 98

Competition Marketing Biopharma Manufacturing 98

Clarivate

MARCH 14, 2024

Future research could focus on developing PFAS-free packaging materials that meet regulatory standards without compromising safety. A chance to innovate: Global health impacts our world and there are various stakeholders making choices, from manufacturers to healthcare providers and patients.

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

Clarivate

MARCH 12, 2024

For the approximately 10% of biopharma candidates that actually manage to make it to clinical trials, many fail to achieve enough revenue once they reach the market to justify the R&D effort. In fact, one-third of drugs launched over a recent 10-year period fell short of sales expectations.

Government 52

Government Physicians Marketing Biopharma 52

World of DTC Marketing

JUNE 8, 2021

The Financial Times said , “Michael Carome, director of the health research group at Public Citizen, said, “these costs to patients, to their families, are just not justified based upon what we know about this drug”. There are no efficacy data to clearly demonstrate this drug helps patients. Nowhere to be seen.

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FDA Food and Drug Administration Patients Biopharma 207

Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? The health of pregnant people and their fetuses can be compromised if the dose/dosing regimen, safety, and efficacy of treatments used during pregnancy are not established.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

pharmaphorum

SEPTEMBER 28, 2022

It is being led by chief executive Bertrand Damour (pictured above), a biopharma entrepreneur who previously held the top job at Swiss biotech NBE-Therapeutics , another ADC specialist that was acquired by Boehringer Ingelheim for $1.4 It is expected to be ready for clinical testing within the next 18 months, according to a company statement.

Biopharma 52

Biopharma Pharma Leads Safety 52

pharmaphorum

SEPTEMBER 28, 2022

In recent years, the biopharma market has become progressively complex. Payers must take into consideration not only the clinical efficacy of a drug, but also its safety profile, side effects, and cost-effectiveness, among other factors. Scientific advice is a mechanism to reduce that challenge—so take it.”.

Biopharma 52

Biopharma Side effects Consulting Pharmaceutical products 52

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. What’s new from AHA21: In this subanalysis of the EMPEROR-Preserved trial, empagliflozin was shown to be effective in patients with preserved LVEF of ?

Safety 52

Safety Patients Management Marketing 52

Pharmaceutical Technology

AUGUST 26, 2008

“The inherent advantages of biopharma are that it allows you to pursue therapies against targets that are not small molecule therapies, for example by targeting protein-protein interactions and targeting GPCRs (G-protein coupled receptors),” he says. “Biotechnology has exploded across the industry. ”

Manufacturing 52

Manufacturing Pharmaceutical Biopharma Medicine 52

Clarivate

JULY 6, 2023

Precision medicine The biopharma industry is increasingly moving towards a precision medicine approach that enables patients to be treated at an earlier stage of disease for better outcomes. This process provides crucial spatial context to molecular data, enhancing our understanding of diseases and informing clinical decision-making.

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Consulting Medicine Biopharma Patients 52