European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

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European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

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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.

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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.

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Pharmaceutical Technology

FEBRUARY 28, 2023

Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma and Shenzhen Chipscreen Biosciences’ holding subsidiary Chipscreen NewWay Biosciences have entered an exclusive licensing agreement for YH008, a bispecific antibody. Early R&D projects coverage on Pharmaceutical Technology is supported by Mimotopes.

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European Pharmaceutical Review

OCTOBER 19, 2023

billion deal, in which Eli Lilly agreed to acquire two of POINT Biopharma Global’s late-stage radioligand therapies for oncological indications. These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals.

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Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment.

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PM360

JUNE 24, 2024

This is partly due to the limited market potential for drugs in the space, but also due to the sheer volume of rare diseases: approximately 6,000–8,000 have been identified. This fuels an enormous need for effective patient communication and education as new therapies move through the biopharma pipeline.

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Pharmaceutical Technology

NOVEMBER 24, 2022

Xeris Biopharma and Horizon Therapeutics have sig n ed a research partnership and option agreement for developing a ready-to-use, highly-concentrated, subcutaneous injection of teprotumumab. The US Food and Drug Administration (FDA) has granted approval for teprotumumab to treat thyroid eye disease (TED).

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Pharmaceutical Technology

FEBRUARY 16, 2023

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech ’s proposed biosimilar HLX02 (trastuzumab for injection). Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA.

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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.

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Clarivate

MAY 24, 2023

Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers. Most patients must use a wheelchair by the time they are in their teens.

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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.

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European Pharmaceutical Review

SEPTEMBER 2, 2024

Three anti-hypertensive drugs combined in low doses into a single pill has been shown to be superior to standard care for lowering blood pressure in patients with uncontrolled hypertension. The oral treatment GMRx2 is biopharma George Medicines’ lead drug candidate.

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Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. It targets mismatch repair deficiency, a biomarker seen in 25-30% of patients with endometrial cancer.

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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. clinical experts), and converting regulatory guidance into practical application.

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European Pharmaceutical Review

JANUARY 24, 2023

Takeda has entered into an exclusive licensing agreement with biopharma HUTCHMED, to develop and commercialise t yrosine kinase inhibitor fruquintinib, refractory metastatic colorectal cancer (CRC) for outside of mainland China, Hong Kong and Macau. The agreement is valued up to $1.13 This is planned to be completed in the first half of 2023.

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Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. N) = number of approvals. N) = number of approvals.

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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]

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Pharmaceutical Technology

APRIL 4, 2023

of NSCLC patients with exon 19 and 21 mutations develop resistance mutations at C797S. The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024.

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Pharmaceutical Technology

OCTOBER 13, 2022

Myovant Sciences has rejected an acquisition offer from Sumitovant Biopharma and its wholly owned subsidiary, Sumitomo Pharma. GlobalData believes that Myovant considers its value to be higher mainly because of the company’s drug Myfembree, which has the potential to fulfil significant unmet needs in the endometriosis space.

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Clarivate

SEPTEMBER 26, 2023

One of the critical factors determining the success of a clinical trial is the selection of appropriate clinical sites that have evidenced access to specific patient populations. Patient recruitment accounts for 32% of all trial costs and patient drop out averages 18%, according to Deloitte figures. Food and Drug Administration.

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Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. 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? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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European Pharmaceutical Review

MARCH 7, 2024

Lastly, there is growing prominence and interest in radioligand therapeutics within major pharmaceutical companies, who are increasingly investing in this field, evident through recent acquisitions of Point Biopharma and RayzeBio. Orano Med is now building industrial facilities throughout the world for the commercialisation its drugs.

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PM360

NOVEMBER 12, 2024

They are difficult to diagnose early in a disease, the regulatory endpoints are often unprecedented and challenging, and many drugs struggle to get into the brain. The downside is that it also keeps most potential drug treatments from reaching the brain. But innovation doesn’t stop in the lab.

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Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. as the secondary endpoints. ORR, 81.0%

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MedCity News

JUNE 16, 2023

Investors in 2022 appeared confident that the continued transformation of drug research and development protocols and the overall life sciences industry will not only include digital health solutions, but will even depend on them for data collection, analysis, patient engagement, and even their therapeutic properties.

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PM360

MAY 2, 2023

We are fortunate to work with innovative startup and mid-stage biopharma companies that are developing vaccines and medicines for rare diseases, cancer, specialty therapeutic areas, and other patient needs, as well as partnering with diagnostic and medical device companies.

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European Pharmaceutical Review

APRIL 30, 2024

What are the top three trends that you are seeing in the biopharma manufacturing space? Let’s talk about continuous biopharma manufacturing. Speaking of your biopharma clients, what are you hearing about their main priorities? I believe this is going to be an emerging trend in the market.

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Pharmaceutical Technology

APRIL 24, 2023

These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

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Clarivate

NOVEMBER 14, 2023

Well, it is, but only if it benefits patients. 2] Advances in blood glucose monitoring and in the delivery of insulin through insulin pens and, more recently, pumps have also helped to make diabetes management easier for patients. 6] GLP-1 RAs provide another example of the benefits that incremental innovation can bring to patients.

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