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?

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Patients Healthcare Healthcare Marketing 98

European Pharmaceutical Review

JANUARY 8, 2024

The European Commission (EC) has now granted a marketing authorisation for biopharma company UCB’s treatment, as an add-on to standard therapy in patients who have this rare autoimmune condition. It is indicated as a subcutaneous, add-on to standard therapy in these patients.

Biopharma 97

Biopharma Medicine Healthcare Healthcare 97

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. More than 800 patients from 16 countries were included in the trial.

Biopharma 97

Biopharma Safety Medical Patients 97

European Pharmaceutical Review

NOVEMBER 18, 2022

The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. Upstaza is administered through a minimally invasive neurosurgical stereotactic procedure used to treat several neurological disorders in paediatric and adult patients. Upstaza clinical trials.

Side effects 126

Side effects Biopharma Safety Patients 126

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

Pharmaceutical Technology

FEBRUARY 15, 2023

Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA). Kinnate Biopharma expects to receive initial dose escalation data in the second half of this year.

Food and Drug Administration 52

Food and Drug Administration FDA Biopharma Safety 52

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

European Pharmaceutical Review

DECEMBER 20, 2022

FINTEPLA ® ▼ (fenfluramine) oral solution has been recommended for marketing authorisation by the Committee for Medicinal Products for Human Use (CHMP) for treating seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients over two years old in the European Union (EU).

Safety 91

Safety Medicine Biopharma Patients 91

European Pharmaceutical Review

DECEMBER 14, 2023

I’m happy to see…that my patients will soon have this new nonhormonal treatment option available to better control their moderate to severe VMS,” commented Prof. These studies (SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4) enrolled some 3,000 patients across Europe, the United States and Canada.

Food and Drug Administration 82

Food and Drug Administration Biopharma Medicine Food 82

European Pharmaceutical Review

NOVEMBER 20, 2023

. “This state-of-the-art parenteral site with the latest technology will enable us to continue to deliver medicines with safety first and quality always around the world,” stated Edgardo Hernandez, Executive Vice President and President of Eli Lilly’s manufacturing operations.

Manufacturing 92

Manufacturing Medicine Biopharma Engineering 92

Pharmaceutical Technology

FEBRUARY 16, 2023

Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA. It is now approved in more than 30 countries and benefitted more than 100,000 Chinese patients. More importantly, we prioritise the needs of patients.”

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Food and Drug Administration FDA Safety Biopharma 52

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

pharmaphorum

AUGUST 23, 2022

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease.

Safety 104

Safety Biopharma Patients 104

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

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.

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Biopharma Pharma Marketing Management 111

European Pharmaceutical Review

NOVEMBER 23, 2022

Patients with severe Haemophilia B typically need routine intravenous (IV) infusions of Factor IX replacement products to sustain sufficient clotting factor levels to prevent bleeding episodes. Patients should be monitored for adverse infusion reactions and transaminitis in their blood. Haemophilia B clinical trial.

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FDA Food and Drug Administration Biopharma Food 128

MedCity News

OCTOBER 20, 2022

Gene therapy can offer hope to patients with previously untreatable diseases, but there’s more work to be done to improve both the safety and efficacy of this therapeutic modality.

Safety 109

Safety Patients Biopharma 109

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.

Side effects 100

Side effects Biopharma Patients Competition 100

pharmaphorum

DECEMBER 9, 2022

Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., has announced that the pivotal phase 2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukaemia (ALL) patients has met its primary endpoint of overall remission rate (ORR) at interim analysis.

Food and Drug Administration 79

Food and Drug Administration Safety Biopharma Patients 79

European Pharmaceutical Review

NOVEMBER 16, 2022

Beyond adapting existing sites or engineering new facilities geared to modern drug production, biopharma companies also need to be more cost-conscious than ever before, in how they run and monitor their manufacturing and supply chain operations. Embracing the spirit rather than the letter of regulations.

Manufacturing 117

Manufacturing Pharma Biopharma Management 117

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

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. billion or more.

Sales 102

Sales Biopharma Medicine Patients 102

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.

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FDA Leads Safety Patients 103

Pharmaceutical Technology

APRIL 13, 2023

The agreement between PharmaLex and Cpharm also creates an opportunity to provide end-to-end solutions for biopharma clients in Australia and New Zealand. The merger plan will enable the delivery of complementary services and widen the service portfolio of both firms.

Biopharma 52

Biopharma Medical Safety Management 52

Pharmaceutical Technology

OCTOBER 19, 2022

Syncromune and Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma have entered an exclusive global licence agreement for OX40 antibody YH002 and two other active ingredients. . A co-stimulating molecule for the OX40 target, YH002 has shown favourable safety and anti-tumour activity against solid tumours.

Biopharma 52

Biopharma Safety Pharmaceutical Marketing 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

European Pharmaceutical Review

JUNE 13, 2023

Novartis has entered into an acquisition agreement with biopharma Chinook Therapeutics for a value up to £2.5 According to the CEO of Novartis, Dr Vas Narasimhan, the company is excited by the potential for bringing “additional much-needed treatment options to patients”.

Biopharma 52

Biopharma Safety Leads Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 12, 2023

As a biotech, what work does Innate Pharma do in the biopharma industry? IPH5201 is being investigated in a Phase II trial, MATISSE, in combination with durvalumab (anti-PD-L1) and chemotherapy, in patients with resectable early-stage NSCLC. A favorable safety profile was also observed. An ORR of 46.4 percent in the blood.

Pharma 115

Pharma Engineering Safety Patients 115

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

Veeva

APRIL 22, 2024

A robust pharmacovigilance and safety strategy is crucial, regardless of a company’s scale. Solutions like Veeva Vault Safety enable life sciences companies to bring management of safety processes in-house, with global end-to-end adverse event management on a unified platform, enabling access to real-time information.

Safety 52

Safety Management Biopharma Patients 52

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

SEPTEMBER 8, 2022

Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time.

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Specialization Leads Pharma Side effects 45

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

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

pharmaphorum

SEPTEMBER 20, 2022

The phase 1/3 ROSALIA study showed that the copycat denosumab matched Amgen’s brand on multiple pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity measures in postmenopausal women with osteoporosis, said Sandoz in a statement. billion TNF inhibitor Enbrel (etanercept) and $2.25

Medicine 52

Medicine Safety Marketing Biopharma 52

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. Material data safety sheet (MSDS)???? Proven results??. Key elements of a robust RFP include:????.

Biopharma 52

Biopharma Manufacturing Safety Pharmaceutical 52

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.

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Electronics Patients Medical FDA 52