Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Distribution 52

European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Safety Transportation 97

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).

Food and Drug Administration 52

Food and Drug Administration FDA Biopharma Safety 52

pharmaphorum

DECEMBER 9, 2022

Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., This means that enrolment is now completed for the initial target or morphological cohort to form the basis of a Biological License Application (BLA) submission by the end of CY2023 to the US Food and Drug Administration (FDA).

Food and Drug Administration 98

Food and Drug Administration Safety Biopharma Patients 98

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. There have been many cases where people have tried to simply link existing drugs to radioisotopes or have attached new (recently made in scale) radioisotopes on old drugs.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Side effects Doctors 105

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).

Food and Drug Administration 52

Food and Drug Administration Biopharma Sales Food 52

MedCity News

JUNE 12, 2023

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence.

Food and Drug Administration 104

Food and Drug Administration Prescription Government FDA 104

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.

Food and Drug Administration 59

Food and Drug Administration Medicine Biopharma Food 59

Pharmaceutical Technology

OCTOBER 3, 2022

Myovant Sciences has rejected an acquisition offer worth $2.5bn from Sumitovant Biopharma and its wholly-owned subsidiary Sumitomo Pharma, citing it 'significantly undervalues' the company. for each share in cash. Established in 2016, Myovant conducted five successful Phase III clinical trials in oncology and women’s health.

Food and Drug Administration 52

Food and Drug Administration Specialization Biopharma Food 52

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

Food and Drug Administration 52

Food and Drug Administration Biopharma Medical Sales 52

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.

Manufacturing 97

Manufacturing Food and Drug Administration Biopharma Marketing 97

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.

Food and Drug Administration 52

Food and Drug Administration Pharma Side effects FDA 52

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.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

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.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Marketing 52

Clarivate

JUNE 26, 2023

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

Food and Drug Administration 52

Food and Drug Administration Patients Side effects Medicine 52

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.

Marketing 52

Marketing Patients Food and Drug Administration Digital Media 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

Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

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. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

Patients 52

Patients Food and Drug Administration FDA Safety 52

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.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 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. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades. .

Food and Drug Administration 119

Food and Drug Administration Medicine Food Government 119

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Drugs can be now cleared for human trials using non-animal technologies developed over the last 10-15 years. Food and Drug Administration, 2023). Then, of course, there are the ethical considerations.

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Engineering 52

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.

Food and Drug Administration 52

Food and Drug Administration Biopharma FDA Food 52

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.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Biopharma 52

Pharmaceutical Technology

APRIL 4, 2023

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. The biopharma aims to start the study as soon as the IND is cleared by the FDA.

Food and Drug Administration 52

Food and Drug Administration Biopharma FDA Pharmaceutical 52

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. FDA continues to approve the most NASs.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

Clarivate

NOVEMBER 14, 2023

Figure 1: Timeline of GLP-1 RA development [9] , [10] Abbreviations: EMA, European Medicines Agency; US FDA, United States Food and Drug Administration. 9] Food and Drug Administration. Drug approvals and databases. What’s next in diabetes? Reviews in Endocrine and Metabolic Disorders.

Food and Drug Administration 52

Food and Drug Administration Medicine Patients Food 52

Pharmaceutical Technology

MARCH 1, 2023

Sunshine Biopharma has signed an exclusive global licence deal with the University of Arizona for PLpro-based Covid-19 treatment. Since February last year, Sunshine Biopharma has been working along with the University of Arizona on this project. Please check your email to download the Whitepaper.

Biopharma 59

Biopharma Food and Drug Administration Pharmacology Food 59

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.

Biopharma 52

Biopharma Food and Drug Administration Pharmaceutical Sales 52

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.

FDA 52

FDA Food and Drug Administration Patients Marketing 52