Drug Discovery World

JUNE 28, 2024

A new Phase II trial, REGENERATE-PD, will study AB-1005, an adeno-associated virus 2 (AAV2) glial cell line-derived neurotrophic factor (GDNF) gene therapy for the treatment of moderate-stage Parkinson’s disease. The trial will include an estimated 87 subjects with study sites located in the US, UK and Europe. In January, AskBio announced that the Phase Ib trial of AB-1005 met its primary endpoint, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putam

Gene Therapy 59

Gene Therapy Gene Trials Development 59

Pharmaceutical Technology

JUNE 28, 2024

On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental GLP-1 receptor antagonist, avexitide, for $35.1m.

Marketing 241

Marketing 241

Bio Pharma Dive

JUNE 28, 2024

Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

Regulation 204

Regulation 204

Pharmaceutical Technology

JUNE 28, 2024

As the largest service provider in the NHS, primary care delivers over 300 million patient consultations annually. In the evolving landscape of clinical research, the data held in primary care Electronic Health Records (EHR) has been recognised for the significant potential it offers in uncovering insights, driving innovation, and enhancing patient care.

Life Science 130

Life Science Clinical Research Research 130

Advertisement

Clinical Supply

Bio Pharma Dive

JUNE 28, 2024

Advisers to the agency unanimously recommended use of Capvaxive in older adults and in certain younger ones, putting it in the same tier as Pfizer's competing Prevnar shot.

Vaccination 167

Vaccination Vaccine 167

Pharmaceutical Technology

JUNE 28, 2024

In this article John McCormack, Executive Director of Research & Life Sciences, explores how unlocking the potential of healthcare technology can enable healthcare teams to work more safely and efficiently to drive improved patient outcomes.

Life Science 130

Life Science Research 130

Pharmaceutical Technology

JUNE 28, 2024

AbbVie has acquired Celsius Therapeutics, a company that focuses on developing new treatments for inflammatory diseases, for $250m in cash.

Development 147

Development 147

Bio Pharma Dive

JUNE 28, 2024

The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.

Gene Therapy 144

Gene Therapy Manufacturing Gene 144

Pharmaceutical Technology

JUNE 28, 2024

The EMA's CHMP has recommended granting marketing authorisation for Pfizer and BioNTech’s Omicron JN.1-adapted Covid-19 vaccine.

Vaccination 147

Vaccination Vaccine Marketing 147

Fierce Pharma

JUNE 28, 2024

After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer an | The recommendation sets up Merck's new pneumococcal disease vaccine to potentially capture some of Pfizer's market share.

Vaccination 97

Vaccination Vaccine Marketing 97

Advertisement

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Pharmaceutical Technology

JUNE 28, 2024

Eisai and Biogen have announced the introduction of LEQEMBI (lecanemab) for the treatment of Alzheimer's disease (AD) in China.

147

147

pharmaphorum

JUNE 28, 2024

The House Ways and Means Committee in the US voted in favour of a new bill which would end a two-decade-long restriction on the coverage of drugs to treat obesity under Medicare.The Treat and Reduce Obesity Act of 2023 (TROA) was originally intended to overturn the restriction completely, but has been hugely scaled back in its scope.

Drugs 83

Drugs 83

Pharmaceutical Technology

JUNE 28, 2024

Hong Kong King-Friend Industrial has acquired worldwide rights to Yusimry, and its subsidiary, Meitheal, will market the therapy in the US.

Marketing 130

Marketing 130

pharmaphorum

JUNE 28, 2024

Amazon’s strategy in telehealth has coalesced around a pay-per-visit and subscription-based model under a new brand – Amazon One Medical.

Branding 94

Branding 94

Advertisement

Clinical Supply

Pharmaceutical Technology

JUNE 28, 2024

Holoclara has secured $16m in a Series A financing to advance new worm-derived therapies targeting allergic and autoimmune diseases.

130

130

Fierce Pharma

JUNE 28, 2024

For the second time in six months, Europe’s CHMP has given a thumbs down to Apellis’ Syfovre for the treatment of patients with geographic atrophy.

Regulation 79

Regulation Drugs 79

Pharmaceutical Technology

JUNE 28, 2024

The US Supreme Court blocked $6bn opioid crisis settlement that would have shielded the Sackler Family in a 5-4 decision.

130

130

Fierce Pharma

JUNE 28, 2024

An antibody-drug conjugate patent arbitration fight that Seagen waged against Daiichi Sankyo has officially ended in a win for the Japanese company. | An antibody-drug conjugate patent arbitration fight that Seagen waged against Daiichi Sankyo has officially ended in a win for the Japanese company.

Antibody 65

Antibody Drugs 65

Advertisement

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

Pharmaceutical Technology

JUNE 28, 2024

Nearly 200 people have been charged with participating in healthcare fraud schemes that resulted in $2.75bn in losses.

130

130

Pharma Times

JUNE 28, 2024

The study found an increase in incidence among young people and people from deprived areas

83

83

Pharmaceutical Technology

JUNE 28, 2024

Though downsized, Alumis still clocked one of the largest IPOs within the biotech sector this year.

130

130

Drug Patent Watch

JUNE 28, 2024

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

Drugs 59

Drugs Branding Marketing 59

Advertisement

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

Pharmaceutical Technology

JUNE 28, 2024

Dr Ian Wood, a GP and clinical director for EMIS, explores how technology could be implemented to drive proactive, preventative care within our healthcare system to reduce health inequalities and improve patient outcomes at a national scale.

100

100

Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for RINVOQ Rinvoq is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. There are thirty-three patents protecting this drug.

Drugs 59

Drugs Marketing 59

Pharma Times

JUNE 28, 2024

The neurodegenerative condition currently affects around 153,000 people in the UK

Development 74

Development Drugs 74

Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for XYWAV Xywav is a drug marketed by Jazz and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug.

Drugs 59

Drugs Marketing 59

Advertisement

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Drug Discovery World

JUNE 28, 2024

News round-up for 24-28 June by DDW Senior Digital Content Editor Diana Spencer. This week has seen some exciting advances in neuroscience drug discovery, including Phase II clinical trials for two potentially game-changing treatments, a synapse-regenerating drug for Alzheimer’s and a gene therapy for Parkinson’s, as well as the launch of DDW’s latest In Focus report.

Gene Therapy 52

Gene Therapy Drugs Clinical Trials Clinical Trials 52

Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for MOVANTIK Movantik is a drug marketed by Valinor and is included in one NDA. It is available from three suppliers.

Drugs 59

Drugs Marketing 59

Drug Channels

JUNE 28, 2024

Today’s guest post comes from Kristina Crockett, VP of Product Management at CoverMyMeds. Kristina discusses challenges patients face accessing, affording, and adhering to prescribed medications. She goes on to describe how manufacturers can overcome these challenges to improve outcomes for both patients and brands. Click here to learn more about CoverMyMeds’ technology solutions.

Branding 52

Branding Manufacturing Production Drugs 52

Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for XYREM Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. It is available from three suppliers.

Drugs 59

Drugs Marketing 59

Advertisement

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply