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Category: Research and Development


Manufacturing, Research and Development

CPHI Annual Report Predicts AI Transformation of All Drug Development Processes by 2026

September 15, 2023

Via: Biopharm International

A recent publishing of the first part of the CPHI Annual Report predicts substantial progress ahead for artificial intelligence (AI)’s use in pharma, despite the uproar surrounding ChatGPT and other AI programs. According to a press release, the implications go […]


FDA, Manufacturing, Regulations, Research and Development

FDA boosts collaboration with manufacturers to overcome ongoing cancer drug shortages

September 15, 2023

Via: PMLiVE

The US is currently experiencing a shortage of 15 cancer drugs as a result of manufacturing and supply chain issues. Three of these drugs – cisplatin, carboplatin and methotrexate – have been staples of cancer treatment for decades, but their […]


Clinical Trials, Industry, Pharma, Research and Development

Clinical Trials and their Impact on the Pharma Industry

September 1, 2023

Via: Biopharm International

Clinical trials are essential for establishing the efficacy of new drugs, observing patients’ reactions to treatments, and representing populations of people that may not always be discussed in everyday conversation. Although there are many diseases and disorders that are waiting […]


Clinical Trials, Research and Development

FDA Halts Clinical Trial Enrollment for Gilead’s Magrolimab in AML Studies

August 21, 2023

Via: Biopharm International

On Aug. 21, 2023, Gilead Sciences announced that FDA has placed a partial clinical hold on the company initiating new patients into US studies for magrolimab, an investigational anti-CD47 immunotherapy, to treat acute myeloid leukemia (AML). FDA’s decision follows a […]


Manufacturing, Research and Development

Drug Digest: Accelerating Biopharma Development and Manufacturing through CDMOs and CGT

August 9, 2023

Via: Biopharm International

The biopharmaceutical industry has seen a lot of change in recent years, between new collaborations with supplier and contract development and manufacturing organizations (CDMOs) and accelerated drug delivery times. According to recent research, biopharmaceutical figures are already using digital and […]


Clinical Trials, Research and Development

How the right technology and tools can accelerate progress in rare disease clinical trials

August 7, 2023

Via: Biopharma Dive

Although diseases such as Ehlers-Danlos syndrome, Sanfilippo syndrome and Hemophilia are considered rare, their impact looms large. Rare diseases, defined as occurring in fewer than one in 2,000 individuals, affect more than 300 million people across the globe, and most […]


Clinical Trials, Research and Development

EMA reports actions to improve EU clinical trials conducted during health emergencies

July 26, 2023

Via: PMLiVE

The report presents EU-level actions to address the challenges that were experienced during the COVID-19 pandemic and the outbreak of mpox disease in setting up adequately sized clinical trials across multiple member states. Organised in June 2023, with participation from […]


Clinical Trials, Research and Development

BridgeBio claims success in heart drug trial, rebounding from earlier failure

July 17, 2023

Via: Biopharma Dive

An experimental medicine benefited patients with a deadly heart condition in a closely watched Phase 3 trial, lifting the fortunes of its developer, BridgeBio Pharma, and clearing the way for the biotechnology company to seek U.S. approval. Trial results showed […]


Clinical Trials, Research and Development

Positive data for Caribou Biosciences’ CB-010 candidate

July 14, 2023

Via: Pharma Times

Caribou Biosciences – a company focused on genome-editing – has announced follow-up data from the dose escalation element of its ongoing ANTLER phase 1 trial. This new data set includes all 16 patients treated in dose escalation with the CB-010 […]


Clinical Trials, Research and Development

Large Clinical Trial Supports Alzheimer Drug Full Approval

July 11, 2023

Via: Biopharm International

FDA recently granted full, or traditional, approval to Eisai Pharmaceutical’s Alzheimer’s treatment Leqembi, converting an earlier conditional approval status with further data from a multi-regional study of nearly 1800 patients. Results indicated that the drug slows the rate of cognitive […]


Manufacturing, Research and Development

Lonza and Vertex work Co-invest in a New Production Plant

June 30, 2023

Via: Contract Pharma

Vertex Pharmaceuticals and Lonza are partnering in the production of a new facility. Both companies are working together to manufacture and support the production of Vertex’s experimental cell therapy VX-880 for Type 1 diabetes and a second candidate VX-264. The […]


Clinical Trials, Research and Development

10 clinical trials to watch in the second half of 2023

June 28, 2023

Via: Biopharma Dive

The next six months will be full of dramatic moments for the biotechnology industry. The Food and Drug Administration will either be validated or undermined for its decision to grant an early approval to the first gene therapy for Duchenne […]


Clinical Trials, Research and Development

New Competitor to Wegovy, Retatrutide, Shows Promise in Clinical Trials

June 27, 2023

Via: Drugs.com

An experimental drug appears to outperform the trendy medications Wegovy and Ozempic for both weight loss and diabetes control, a pair of early clinical trials shows. Retatrutide helped people with obesity drop about one-quarter of their starting weight, on average, […]


Manufacturing, Research and Development

Andelyn Biosciences Opens New CGT Manufacturing Headquarters

June 22, 2023

Via: Biopharm International

On June 22, 2023, Andelyn Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization, announced the opening of its newly constructed manufacturing headquarters in Columbus, Ohio. According to a company press release, the 180,000-ft2 facility is intended […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Mendus and NorthXBiologics Enter Cell Therapy Manufacturing Alliance

June 15, 2023

Via: Biopharm International

Mendus, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, and NorthX Biologics, a contract development and manufacturing organization that serves as the National Swedish Innovation Hub for the good manufacturing practice (GMP) manufacture of biologics used in vaccines, gene […]


Clinical Trials, Research and Development

Decentralized clinical trials (DCTs): protect your data to reduce risk

June 12, 2023

Via: Biopharma Dive

Many professionals in the life sciences industry are excited about the benefits decentralized clinical trials (DCTs) bring to the clinical research process and specifically to patients. The use of wearables, electronic consent forms, digital outcomes assessments, and other DCT technologies […]


Clinical Trials, FDA, Regulations, Research and Development

FDA announces additional steps to modernize clinical trials

June 6, 2023

Via: World Pharma News

Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data […]


Clinical Trials, Research and Development

Biogen scraps late-stage study for Parkinson’s drug

June 5, 2023

Via: Biopharma Dive

Biogen has disclosed plans to stop a late-stage clinical trial testing one of its drugs as a potential treatment for Parkinson’s disease. According to a Monday announcement, the decision is due to several factors, including the trial’s complexity and run […]


Manufacturing, Research and Development

Nexcella Begins Production of CAR-T Cell Therapy Engineering Batches at US Manufacturing Site

May 31, 2023

Via: Biopharm International

Nexcella, a subsidiary of US-based Immix Biopharma and a clinical-stage biopharmaceutical company, announced on May 26, 2023 that it has begun producing engineering batches of NXC-201, its lead candidate and a chimeric antigen receptor T cell (CAR-T) therapy, at its […]


Manufacturing, Research and Development

Scaling Manufacturing Processes Using Single-Use Technologies

May 30, 2023

Via: Biopharm International

Since biological drugs first became available, their demand has been increasing—with the biologic market being valued at approximately US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound annual growth rate of 9.06% (1). With […]