pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

Side effects 77

Side effects Safety Biopharma Recruitment 77

European Pharmaceutical Review

AUGUST 23, 2023

Retevmo’s potential in oncology The Phase III study LIBRETTO-531 enrolled 291 patients and is the first randomised trial to compare the safety and efficacy of a highly selective RET -kinase inhibitor with multikinase inhibitors in this patient population. Both biopharma companies have lead assets focusing on obesity and diabetes.

Biopharma 94

Biopharma Safety Medical Patients 94

European Pharmaceutical Review

NOVEMBER 16, 2022

Engineering or redesigning facilities without due consideration of what is needed, of what may be superfluous, or of how systems and processes will be validated over time, could lead to costly remedial action and delays in getting important and premium new products to market. Embracing the spirit rather than the letter of regulations.

Manufacturing 113

Manufacturing Pharma Biopharma Management 113

Clarivate

OCTOBER 25, 2021

This year, Clarivate acquired Bioinfogate , a leading provider of analytics solutions in the life sciences and producer of the OFF-X portal. The move further expands and integrates drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle.

Safety 110

Safety Biopharma Competition Management 110

MedCity News

MARCH 20, 2023

BioNTech is expanding its cancer immunotherapy scope by partnering with OncoC4 on clinical testing of its lead drug. The antibody was designed to offer a safety edge over other CTLA-4-blocking drugs it’s on track for a Phase 3 test in non-small cell lung cancer.

Safety 82

Safety Leads Biopharma Pharma 82

Pharmaceutical Technology

MAY 23, 2023

The safety and effectiveness of the drug prophylaxis for acute HAE attacks are yet to be proved. Extra doses of ORLADEYO above 150mg once daily are not suggested as this could lead to prolongation of the QT [a measure of the heart’s electrical activity].

Marketing 52

Marketing Biopharma Safety Pharma 52

pharmaphorum

JULY 4, 2022

Two weeks after reporting disappointing results for its lead coeliac disease therapy, 9 Meters Biopharma will draw some comfort from a mid-stage trial of its candidate for short bowel syndrome (SBS), although its share price remains under pressure. Some children are born with an abnormally short small intestine.

Biopharma 82

Biopharma Leads Food Safety 82

European Pharmaceutical Review

AUGUST 22, 2022

However, the biopharma industries realised that traditional vaccine development and manufacturing techniques, which take around five to 10 years for initial development to large-scale distribution, 1 were inadequate to meet the growing demand for COVID-19 vaccines. Novel biotechnology platforms for vaccine development.

Manufacturing 90

Manufacturing Biopharma Engineering Safety 90

PM360

DECEMBER 20, 2023

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. Evaluate’s VC data show quarter-over-quarter drops in the number of biopharma companies raising private cash and in the amount of money raised.

Biopharma 111

Biopharma Pharma Marketing Management 111

European Pharmaceutical Review

JUNE 13, 2023

Novartis has entered into an acquisition agreement with biopharma Chinook Therapeutics for a value up to £2.5 In addition, atrasentan revealed a significant reduction in proteinuria versus baseline in a Phase II study, with good tolerability, including liver safety profile. These immune complexes trigger inflammation and kidney damage.

Biopharma 52

Biopharma Safety Leads Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 19, 2022

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

Medicine 52

Medicine Biopharma Safety Food 52

pharmaphorum

JANUARY 6, 2023

a Los Angeles area-based, late-stage clinical biopharma, with additional operations in the San Francisco Bay area, has announced it is acquiring privately held ValenzaBio – which develops therapies for autoimmune and inflammatory diseases – in an all-stock transaction. ACELYRIN, Inc.,

Biopharma 57

Biopharma Marketing Patients Leads 57

pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease.

Sales 102

Sales Biopharma Medicine Patients 102

pharmaphorum

OCTOBER 18, 2022

It will create a Nasdaq-listed biopharmaceutical company under the name “Oculis Holding SA”, placing Oculis in position to become a leading global ophthalmic biopharma, with product candidates to address areas of significant medical needs affecting a growing number of patient populations.

Biopharma 57

Biopharma Management Specialization Physicians 57

Pharmaceutical Technology

AUGUST 10, 2022

But there are several key factors companies should consider when selecting a CMO or else potentially run the risk of supply chain failure, reputational damage, and inadequate patient safety measures to name a few. Major hurdles include not anticipating long lead times for equipment and components. Material data safety sheet (MSDS)????

Biopharma 52

Biopharma Manufacturing Safety Pharmaceutical 52

Pharmaceutical Technology

NOVEMBER 4, 2022

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 expertise in procurement for new projects is a definite advantage with choosing a CMO like Baxter BioPharma Solutions.

Biopharma 52

Biopharma Manufacturing Media Pharmaceutical 52

Clarivate

JULY 31, 2023

In product applications, key solutions, e.g. the Dialog platform and Drug Safety Triager will be developed and marketed under the Clarivate brand. Clarivate continues to evolve to best serve our customers through the lens of their industry, their pain points and challenges, and their own customers.

Healthcare 52

Healthcare Healthcare Safety Competition 52

PM360

DECEMBER 14, 2023

A New Online Destination for HCPs HealthCentral Corporation , operator of leading digital platforms that serve patients living with chronic illness, their care partners, and health professionals, has announced the newest addition to its suite of HCP support sites: MedCentral.

Physicians 52

Physicians Pharma Medical Patients 52

pharmaphorum

DECEMBER 20, 2022

The condition is largely associated with obesity and an unhealthy diet and lifestyle, and is on the rise in industrialised nations, leading to estimates it could present a market opportunity worth tens of billions of dollars worldwide.

Pharmacology 52

Pharmacology Pharma Marketing Biopharma 52

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. For cell and gene therapy, a “big issue” she stated, was the complexity of manufacturing.

Consulting 60

Consulting Side effects Manufacturing Safety 60

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects).

Networking 59

Networking Consulting Safety Side effects 59

Clarivate

OCTOBER 25, 2023

Expect some provider practices to research using alternative treatments not subject to price negotiations for their new patients, assuming comparable efficacy, safety, and tolerability (e.g., Providers therefore could find their buy and bill operations are in the red.

Prescription 52

Prescription Physicians Manufacturing Healthcare 52

Clarivate

MARCH 14, 2024

Research is raising concerns about PFAS use Similarly, PFAS (per- and polyfluoroalkyl substances) in pharmaceutical packaging have recently come under scrutiny, leading to significant regulatory changes. With Europe taking the lead in introducing draft regulations on PFAS, will other countries and regions implement their own regulations?

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

Clarivate

NOVEMBER 13, 2023

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. The work, said lead investigator Brett King, Associate Professor at Yale Dermatology, “helped change the landscape of alopecia areata forever.”

Patients 52

Patients Food and Drug Administration FDA Safety 52

European Pharmaceutical Review

FEBRUARY 21, 2023

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. Prior to leading the firm McKinsey, Arthur was an M&A investment banker at Lazard. He founded Celadon in 2018.

Medicine 130

Medicine Manufacturing Specialization Pharmaceutical 130

Clarivate

NOVEMBER 10, 2022

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. The work, said lead investigator Brett King, Associate Professor at Yale Dermatology, “helped change the landscape of alopecia areata forever.”. The regulatory landscape around COAs is fast evolving.

Patients 52

Patients Food and Drug Administration FDA Safety 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. For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches.

Recruitment 86

Recruitment Pharma Training Pharmaceutical manufacturing 86

Pharmaceutical Technology

DECEMBER 20, 2022

Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. The collaborative spirit arising between pharmaceutical and biotechnology companies is leading to a new rapport with regulators, as well. Free Whitepaper.

Biopharma 52

Biopharma Manufacturing FDA Pharmaceutical 52

PM360

SEPTEMBER 15, 2022

Quantitative survey results can often lead to a false sense of security around pre-selected response options, therefore missing critical contextual information that helps someone truly understand the patient’s perspective. This sub-set of office personnel is valuable and often leads to rich insights if marketers can spend the time/money.

Patients 98

Patients Healthcare Healthcare Marketing 98

Clarivate

OCTOBER 10, 2022

Fruquintinib was well-tolerated, with a safety profile consistent with that previously reported in other studies. The question of which KRAS inhibitor is most effective remains elusive, although being first to market in addition to strong efficacy and safety data could differentiate the more competitive agent. Market impact.

Marketing 52

Marketing Safety Patients Competition 52

pharmaphorum

JANUARY 6, 2023

Veeva’s industry experts share their predictions about how breaking down silos across clinical, regulatory, safety, and quality teams will benefit patients. With an early view of market viability, leading companies will be able to monetise new products quickly and at scale across Europe.”.

Safety 100

Safety Management Patients Biopharma 100

PM360

SEPTEMBER 28, 2022

At Roche at the time, his job was to lead a task force which was given the objective of planning a strategy to preserve and protect the companies billion-dollar originator biologics franchises as well as build a plan which would counter the introduction and use of biosimilars. Now, as the President of Accord BioPharma , the U.S.

Competition 98

Competition Marketing Biopharma Manufacturing 98

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.

Biopharma 52

Biopharma Side effects Consulting Pharmaceutical products 52

pharmaphorum

SEPTEMBER 28, 2022

Pheon’s lead ADC PHN-010 is directed at a novel, undisclosed cancer antigen that it says is highly expressed in a broad range of solid tumours. ” The company says its ADC platform is designed to balance safety and efficacy for each target, and is already attracting interest from big pharma partners. billion in 2020.

Biopharma 52

Biopharma Pharma Leads Safety 52

PM360

JULY 13, 2023

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. What Other Developments Within Oncology Excite You? What Is Your Company Currently Working On?

Patients 98

Patients Engineering Side effects Leads 98

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]). million for Hemgenix [AAV5-hFIX-Padua]). This enhances the commercial viability of USP.

Manufacturing 86

Manufacturing Safety Patients Competition 86

pharmaphorum

SEPTEMBER 12, 2022

Dr Prasanth Reddy, head of oncology at LabCorp, tells us how the company works with cancer care teams, biopharma partners, and patients as an integral part of the patient journey from testing to treatment. The oncology sector has transformed over the past several decades thanks to the rise of technological advances. About the interviewee.

Patients 95

Patients Medicine FDA Healthcare 95