Quality Matters

NOVEMBER 27, 2023

Q&A: Building a More Resilient Medicines Supply Chain In this conversation, US Pharmacopeia (USP) Director of Regulatory and Public Policy Development Amy B. Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium (DM): How do you see the Consortium addressing ongoing drug shortage and drug supply chain issues?

Generic Medicine 105

Generic Medicine Hospitals 105

Express Pharma

MAY 17, 2023

Immuno-oncology (IO) agents have transformed the oncology landscape in the last decade, particularly immune checkpoint inhibitors (ICIs) in solid tumor settings and chimeric antigen receptor (CAR) T-cells in hematological malignancies, with patients who previously had very limited therapeutic options achieving long term remissions and even cure.

Immunity 88

Immunity Immunization Vaccines 88

European Pharmaceutical Review

SEPTEMBER 12, 2023

A T-cell epitope cancer vaccine significantly improved overall survival in non-small cell lung cancer (NSCLC) compared to chemotherapy, Phase III data published in Annals of Oncology has shown. Additionally, post progression survival was found to be significantly greater in length for Tedopi: 7.7 months compared to 4.6

Vaccines 98

Vaccines Chemotherapy Immunity Immunization 98

Pharmaceutical Business Review

MARCH 19, 2024

The acquisition notably includes Fusion’s most advanced programme, FPI-2265, a potential treatment for metastatic castration-resistant prostate cancer (mCRPC) that is currently in a Phase II trial. per share payable upon reaching a specified regulatory milestone. per share payable upon reaching a specified regulatory milestone.

Chemotherapy 59

Chemotherapy 59

Pharmaceutical Technology

OCTOBER 7, 2022

Surrozen and Boehringer Ingelheim have entered a partnership and licence agreement for researching and developing SZN-413 to treat retinal diseases. on meeting development, regulatory and commercial milestones, apart from sales-based royalty payments. Additionally, Surrozen is entitled to get payments totalling up to $586.5m

Compounding 59

Compounding 59

European Pharmaceutical Review

NOVEMBER 16, 2023

In the past couple of months, BeiGene has experienced regulatory progress for two of its oncology assets in clinical development. According to Data Bridge Market Research, the haematology /oncology market will value $14.83 According to Data Bridge Market Research, the haematology /oncology market will value $14.83

Immunity 52

Immunity Immunization 52

LifeProNow

MARCH 10, 2023

Advancing Access to Safe and Effective Medical Products $23 million in additional funds to advance the goal of ending the opioid crisis. Additionally, the budget request assists in advancing the development, evaluation and market authorizations of related digital health medical devices. standard of care. standard of care.

Labelling 130

Labelling Packaging Controlled Substances 130

Pharmaceutical Technology

DECEMBER 23, 2022

As per the deal, Merck will receive exclusive international licences from Kelun-Biotech for carrying out the research, development, production and marketing of these ADC therapies. Kelun-Biotech is entitled to get payments of up to $9.3bn in the future on meeting development, regulatory and sales milestones.

Research Laboratories 52

Research Laboratories 52

European Pharmaceutical Review

OCTOBER 21, 2022

billion in target nomination, option fees and development, regulatory and commercial milestones related to developing treatments for cancers such as acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). Both companies also plan to work together on two bispecific research programmes in the future.

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European Pharmaceutical Review

JUNE 15, 2023

Particularly, advances in synthetic biologic and biocatalysis are facilitating efficient and sustainable production of small molecules. Accelerating advancement of research and technology in biopharma are generating opportunities for the industry to develop innovative small molecule drugs.

Compounding 52

Compounding Drug Development 52

Pharmaceutical Technology

AUGUST 17, 2022

These programmes will include therapies and vaccines in infectious disease and oncology areas. Preclinical data showed the potential of oRNA expression and delivery as a method for advanced development in various areas, including vaccines and oncology treatments.

Vaccines 59

Vaccines Research Laboratories Packaging 59

pharmaphorum

MARCH 22, 2021

AstraZeneca is mourning the loss of one of its top scientists after eminent cancer researcher José Baselga passed away at the age of just 61. . News reports suggest that Baselga succumbed to Creutzfeldt-Jakob disease (CJD), a rare and progressive neurodegenerative disorder that tends to appear late in life and advances quickly.

Drug Development 111

Drug Development 111

PharmaShots

APRIL 3, 2023

Shots: Innate will receive $5M up front, ~$410M upon achievement of development, regulatory & commercial milestones along with royalties on net sales of any commercial product Takeda gets an exclusive right globally to research & develop ADC using a panel of selected Innate Abs against an undisclosed target with an initial focus on Celiac disease. (..)

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European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work.

Drug Development 80

Drug Development Communication Dosage Chemotherapy 80

European Pharmaceutical Review

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Research published in Annals of Oncology in May 2023 showed comparable levels of Tecentriq in the blood when administered subcutaneously.

Immunity 83

Immunity Immunization 83

European Pharmaceutical Review

AUGUST 18, 2022

Merck (MSD outside of the US and Canada) has entered into a collaboration agreement with Orna Therapeutics to discover, develop and commercialise multiple programmes of engineered circular RNA (oRNA) therapies, including vaccines and therapeutics in the areas of infectious disease and oncology.

Vaccines 87

Vaccines Research Laboratories Packaging 87

European Pharmaceutical Review

JANUARY 18, 2024

An attractive destination for ATMP clinical trials Based on the Cell and Gene Therapy Catapult (CGT Catapult)’s recently published UK 2023 Advanced Therapy Medicinal Product (ATMP) Clinical Trials Database , the UK is an attractive location for ATMP clinical trials.

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Pharmaceutical Technology

JANUARY 12, 2023

The National Medical Products Administration (NMPA) of China has approved Takeda ’s Exkivity (mobocertinib) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients. The regulatory approval is based on the data obtained from the Phase I/II trial of the therapy.

Adverse Reactions 52

Adverse Reactions Chemotherapy 52

pharmaphorum

JULY 6, 2022

A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a median of 241 days. The past decade has seen huge advances in cancer therapy, with a swathe of first-in-class or breakthrough therapies being developed.

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Express Pharma

DECEMBER 7, 2023

We need collaborative strategies that will fuel innovation and value-led growth The keynote speaker, K Raja Bhanu, Deputy Director & Joint Director (FAC), Drugs Control Administration, Visakhapatnam Region of Andhra Pradesh shared his insights for the progress of the pharma industry from a regulatory perspective.

Packaging 89

Packaging Biosimilars 89

pharmaphorum

JANUARY 21, 2022

First-line standard of care is currently a chemotherapy regimen of gemcitabine and the powerful intravenous drug cisplatin However, there are no globally accepted standards of care for locally advanced or metastatic biliary tract cancer (BTC) if first-line chemotherapy fails. This type of cancer is known as epithelial adenocarcinoma.

Chemotherapy 64

Chemotherapy 64

European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Pooled with this new regulatory text, the product will undoubtedly be categorised as drug in all European countries. coli strains in the gut”.

Immunity 98

Immunity Immunization Chemotherapy Vaccines 98

European Pharmaceutical Review

AUGUST 17, 2022

The approval of Advanced Accelerator Applications (AAA)’s Pluvicto is based on the alternate primary endpoint results from the randomised, open-label, international, multi-centre, Phase III VISION trial, where patients with progressive PSMA positive mCRPC treated with at least one AR pathway inhibitor and one or two taxane regimens.

Chemotherapy 111

Chemotherapy Compounding Labelling 111

PharmaShots

FEBRUARY 17, 2023

Difficile Infection Date: Feb 15, 2023 | Tags: Seres Therapeutics, SER-109, Recurrent C. to go Public via Austin Biosciences SPAC Merger for ~$166.3M to go Public via Austin Biosciences SPAC Merger for ~$166.3M

Biosimilars 40

Biosimilars Vaccines 40

Pharmaceutical Technology

MAY 3, 2023

CBMG will receive $245m in an upfront payment and will also be entitled to potential development, regulatory filing, commercialisation and sales milestones along with tiered royalty payments on net trade sales. The transaction is anticipated to be completed in the second quarter of 2023.

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pharmaphorum

NOVEMBER 6, 2020

Accelerate the Bench to Bedside Development of Novel CAR Immunotherapies for Safe, Effective & Affordable Advanced Therapies. Provide a mechanistic rationale for combination therapies with Agenus & Ziopharm Oncology. Discuss ‘gold standards’ and innovations in assay development GlaxoSmithKline & bluebird bio.

Drug Development 65

Drug Development 65

pharmaphorum

SEPTEMBER 29, 2020

The pharmaceutical industry is one of the most scientifically innovative and competitive industries, particularly in oncology. Pre-competitive collaborations, often in basic and preclinical research, can reduce the barrier of competition and drive benefits for all stakeholders, most notably, the patient.

Drug Development 122

Drug Development Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 122

pharmaphorum

APRIL 14, 2022

Advancements in extra-hepatic delivery of oligonucleotides. The Oligonucleotide Therapeutics and Delivery conference reveals the latest in oligonucleotide discovery and delivery, with presentations on targeted delivery mechanisms, oligonucleotide chemistries and important clinical advances. Website: www.oligonucleotide.co.uk/pharmaphorum.

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PharmaShots

MAY 5, 2023

Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive EC’s Marketing Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease Date: May 05, 2023 | Tags: Chiesi Global Rare Diseases, Protalix BioTherapeutics, PRX-102, pegunigalsidase alfa, Fabry Disease, Regulatory, EC, Marketing Authorization Kinoxis Therapeutics (..)

Biosimilars 40

Biosimilars 40

European Pharmaceutical Review

MARCH 4, 2024

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. Their small size also allows them to cross the blood-brain barrier, which is a vibrant field of research, especially in diseases of the central nervous system (CNS).

Vaccines 88

Vaccines Immunity Immunization Compounding 88

PharmaShots

MAY 26, 2023

Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer Date: May 26, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Regulatory, Priority Review, US, FDA Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19 Date: (..)

Biosimilars 40

Biosimilars 40

pharmaphorum

OCTOBER 28, 2021

The two companies have been working together since 2017, with Takeda pledging $100 million to help GammaDelta advance its cell therapy platform as part of a “build-to-buy” arrangement. The Abingworth-backed biotech is developing therapies based on the unique properties of gamma delta (??) He added that ??T

Immunity 96

Immunity Immunization 96

pharmaphorum

MAY 17, 2022

AbbVie and Cugene have teamed up to research autoimmune diseases and cancer in an exclusive worldwide agreement. million, and the company will be eligible to receive development and regulatory milestones and a license option exercise payment if AbbVie exercises the option.

Immunity 59

Immunity Immunization 59

Pharma Marketing Network

APRIL 27, 2021

Rod joined Pfizer in Sandwich, UK as a Research Scientist and conducted medicinal chemistry research in the cardiovascular, GI, Sexual Health, Urology and Allergy & Respiratory diseases. Rod is the co-inventor of darifenacin (Enablex ).

Hospitals 52

Hospitals 52

PharmaShots

JUNE 20, 2023

John Orwin: Our collaboration with Xencor, signed in 2020, is focused on researching, developing and commercializing T cell engaging bispecific antibodies as potential therapeutics in oncology. Each company will lead development, regulatory and commercialization activities for one of the joint programs.

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pharmaphorum

AUGUST 16, 2022

The US company said it is paying $280 million upfront to acquire rights to the drug in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia, with another $175 million tied to the achievement of regulatory and commercial objectives in those territories.

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pharmaphorum

JANUARY 12, 2022

Only a regulatory framework that “embraces a culture of excellence and innovation” will make Europe a world leader in life sciences and ensure people can reap the benefits of life-changing new treatments. Researchers and developers are working on a raft of cutting-edge therapies, all of which have huge potential. Ensuring access.

Vaccines 96

Vaccines 96