Fierce Pharma

OCTOBER 5, 2023

Five weeks removed from slashing 25% of its workforce amid problems wi | Five weeks removed from slashing 25% of its workforce amid problems with its groundbreaking geographic atrophy drug, Apellis is making progress in re-accelerating the launch of Syfovre. Ahead of its quarterly earnings presentation, Apellis estimated sales of approximately $74 million for the third quarter for Syfovre and a rekindling of demand in recent weeks as doctors get a better handle on the risk of vascular retinitis.

Drugs 84

Drugs Doctors Doctor Sales 84

Bio Pharma Dive

OCTOBER 5, 2023

Kyowa will pay nearly $400 million to acquire Orchard, which sells the gene therapy Libmeldy in Europe but has struggled to find paths to market for other experimental treatments.

Gene Therapy 264

Gene Therapy Gene Marketing 264

Pharmaceutical Technology

OCTOBER 5, 2023

Lumicell co-founder, Moungi Bawendi, has been awarded the accolade alongside two others for his research into quantum dots.

Research 258

Research 258

Bio Pharma Dive

OCTOBER 5, 2023

The company says Syfovre prescriptions accelerated again in August after a rocky summer of side effect probes.

Sales 264

Sales Drugs 264

Advertisement

Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 5, 2023

Milk teas – a variety of sweet drinks including bubble tea – have become phenomenally popular in China and other parts of Asia in recent years, and a new study has highlighted some worrying links between the beverage and mental health issues.

Research 189

Research Clinical Trials Clinical Trials Clinical Research 189

Bio Pharma Dive

OCTOBER 5, 2023

The company exercised an option to buy Mitokinin, a Pfizer-backed drugmaker built on work by scientific co-founders Nicholas Hertz and Kevan Shokat.

Drugs 177

Drugs 177

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 5, 2023

Advanced, portable and intuitive diagnostic tools are considerably benefiting the Indian healthcare to tackle diseases such as dengue and malaria. Easily transportable and convenient diagnostics systems are invaluable in remote areas, aiding timely diagnosis and patient care.

Clinical Trials 153

Clinical Trials Clinical Trials Clinical Research Trials 153

Bio Pharma Dive

OCTOBER 5, 2023

All told, the biotech said it will discontinue more than half of its research and technology projects, including a Parkinson’s disease treatment.

Research 148

Research 148

Pharmaceutical Technology

OCTOBER 5, 2023

Orchard's portfolio includes Libmeldy, which has been approved for a rare genetic disorder, metachromatic leukodystrophy.

Gene Therapy 162

Gene Therapy Gene Genetics 162

Bio Pharma Dive

OCTOBER 5, 2023

Precede has used the money to develop a platform that reveals the activity of genes and pathways.

Gene 148

Gene Development 148

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

OCTOBER 5, 2023

The US FDA has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders.

Development 147

Development Drugs 147

Pharmaceutical Commerce

OCTOBER 5, 2023

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.

124

124

Pharmaceutical Technology

OCTOBER 5, 2023

Antibody-drug conjugates (ADCs) saw a 400% growth in total licensing agreement deal value from 2017 to 2022 and reached a peak of $16.6bn.

Licensing 130

Licensing Licensing Antibody Drugs 130

Pharma Times

OCTOBER 5, 2023

The research approach will help small- to mid-sized organisations to advance their clinical studies - News - PharmaTimes

Research 129

Research 129

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

OCTOBER 5, 2023

Shorla Oncology has received $35m in Series B funding to boost the oncology portfolio growth by advancing its pipeline of drug candidates.

Drugs 130

Drugs 130

Pharma Times

OCTOBER 5, 2023

It will be the company’s first platform to be installed in an external scientific setting - News - PharmaTimes

DNA 128

DNA Development 128

Pharmaceutical Technology

OCTOBER 5, 2023

IMIDomics and WuXi Biologics have signed an agreement to advance the development and manufacturing of the humanised antibody, IMB1001

Antibody 130

Antibody Development Manufacturing 130

BioSpace

OCTOBER 5, 2023

After finally getting the green light from the Federal Trade Commission last month, Amgen has completed the buyout and expects to provide updated fiscal year 2023 guidance during its third-quarter earnings call.

109

109

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

OCTOBER 5, 2023

Advanz Pharma has signed an agreement to licence Dimerix’s DMX-200 for marketing in the UK, Australia and New Zealand among others.

Licensing 130

Licensing Licensing Drugs Marketing 130

Fierce Pharma

OCTOBER 5, 2023

Merck’s Keytruda is riding a winning streak in bladder cancer. | Merck’s Keytruda is riding a winning streak in bladder cancer. Following FDA approvals in the metastatic and non-muscle invasive settings, the anti-PD-1 therapy has delivered a positive readout in muscle-invasive urothelial carcinoma.

FDA Approval 106

FDA Approval Trials 106

Pharmaceutical Technology

OCTOBER 5, 2023

Forxiga has approval for adult use in 122 countries and in the EU to treat paediatric patients for T2D above the age of ten.

130

130

BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

Manufacturing 105

Manufacturing Pharma Packaging Packaging Packaging 105

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

Pharmaceutical Technology

OCTOBER 5, 2023

The initiative was created in partnership with Medicines Discovery Catapult, the Medical Research Council, and Innovate UK.

Medicine 130

Medicine Drugs Research 130

BioPharma Reporter

OCTOBER 5, 2023

CellProthera is moving forward with its cell therapy which regenerates damaged tissue following a severe heart attack, restoring cardiac function and effectively mending a broken heart.

Development 105

Development 105

Pharmaceutical Technology

OCTOBER 5, 2023

EMA gives positive opinion for granting Calliditas Therapeutics’ Alport syndrome drug an orphan designation.

Drugs 130

Drugs 130

Fierce Pharma

OCTOBER 5, 2023

Mirati Therapeutics enjoyed a stock-price spike Thursday after rumors started swirling about a potential buyout by French drug giant Sanofi. | Mirati Therapeutics saw its stock price spike Thursday at the possibility of a buyout from Sanofi. The French pharma has been evaluating a potential acquisition of the KRAS drug developer, Bloomberg reports, citing unnamed sources.

Drugs 104

Drugs Development 104

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

Pharmaceutical Technology

OCTOBER 5, 2023

Inhibikase is planning a Phase II trial to investigate its Abelson Tyrosine Kinase inhibitor in MSA.

Drugs 130

Drugs Trials 130

Fierce Pharma

OCTOBER 5, 2023

The abrupt departure of Lonza’s CEO last month clearly hasn’t dampened the Swiss CDMO’s dealmaking prowess. | Lonza has extended a long-term collaboration with an unnamed “major global biopharmaceutical partner” to crank up commercial supply of antibody-drug conjugates at its site in Visp, Switzerland. The deal is set to boost Lonza’s current bioconjugation capacity fourfold, thanks to the addition of two new bioconjugation suites.

Antibody 101

Antibody Production Drugs 101

BioSpace

OCTOBER 5, 2023

Keytruda’s winning streak in bladder continues with positive data from the Phase III AMBASSADOR study, showing significantly better disease-free survival in muscle-invasive urothelial carcinoma.

101

101

BioPharma Reporter

OCTOBER 5, 2023

Modernaâs combination vaccine targeting Covid and the flu is moving to a final stage trial after demonstrating positive results in an earlier study.

Vaccination 105

Vaccination Vaccine Trials Development 105

Advertisement

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply