Bio Pharma Dive
JULY 9, 2021
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.
World of DTC Marketing
JULY 8, 2021
SUMMARY: TV continues to be the dominant channel for DTC advertising. Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. TV ads only drive awareness as the first step for online health seekers. More conversations are happening on social media, and pharma seems to be immune to the conversations.
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pharmaphorum
JULY 6, 2021
The UK’s biotechnology sector is going through a purple patch, attracting almost £1.6 billion ($2.2 billion) in financing in the three months to end-May – which is a record for the industry. The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for UK biotech and life sciences companies, headlined by DNA sequencing company Oxford Nanopore’s £195 million raise in May that was just shy of the £205 million re
Pharma Times
JULY 7, 2021
Eli Lilly and Boehringer Ingelheim have revealed positive results from a Phase III study of Jardiance in HFpEF patients
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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
Bio Pharma Dive
JULY 7, 2021
Hoos, who led cancer R&D at GSK, will take over as head of Scorpion Therapeutics, a new biotech company that's raised $270 million in venture funding since launching last October.
World of DTC Marketing
JULY 9, 2021
SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. From 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period.” From 2016 to 2020, compensation for the 14 companies’ top executives totaled $3.2 billion.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JULY 6, 2021
Vaccine will be evaluated in 13 HIV-negative adults aged 18-65 years old
Bio Pharma Dive
JULY 8, 2021
Treatments from Bluebird bio and CRISPR Therapeutics have shown considerable promise and could soon be nearing regulatory review. A full pipeline is growing behind them.
NY Times
JULY 5, 2021
The World Bank said the financial crisis could rank among the world’s three worst since the mid-1800s. The currency has lost more than 90 percent of its value and unemployment has skyrocketed.
pharmaphorum
JULY 9, 2021
Takeda’s Adam Zaeske discusses how cross-sector collaboration is shaping a brighter future for rare disease diagnosis. Diagnosis can sometimes be the most difficult part of a rare disease patient’s journey, and it’s with good reason that the process is often referred to as an ‘odyssey’ in these communities. “We’re dealing with very small populations of patients, on top of small populations of specialist physicians who are able to diagnose them,” says Adam Zaeske, formerly head of Rare Diseases,
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
JULY 8, 2021
Acting commissioner of the U.S. FDA asked the independent Office of the Inspector General to investigate how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s Aduhelm (aducanumab) for Alzheimer’s disease.
Bio Pharma Dive
JULY 8, 2021
The approval of Aduhelm last month, already highly controversial, was made more so by the agency's decision to clear the drug for an exceptionally broad group of patients. New prescribing information more closely matches clinical testing.
BioPharma Reporter
JULY 5, 2021
The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.
pharmaphorum
JULY 6, 2021
A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response or better, compared to 29% of patients given only chemo.
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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.
BioSpace
JULY 7, 2021
Ivermectin has become a contentious issue as to whether it effectively prevents and treats COVID-19. Several studies suggest it is effective, while others have indicated it is not.
Bio Pharma Dive
JULY 9, 2021
Janet Woodcock, the agency's acting head, asked the HHS inspector general to investigate contacts between Biogen executives and FDA staff as criticism mounts of the regulator's handling of the controversial approval.
Outsourcing Pharma
JULY 8, 2021
The immunotherapy firm is conducting a Phase III trial centered on an innovative approach to treating recurrent glioblastoma, an aggressive brain cancer.
pharmaphorum
JULY 8, 2021
Artificial intelligence-based drug discovery company Exscientia is stepping up its search for new COVID-19 medicines, thanks to an award by the Bill & Melinda Gates Foundation. . The $1.5 million grant will be used to develop a new class of small-molecule inhibitors of M pro , a protease enzyme essential for the replication of the SARS-CoV-2 virus.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharma Times
JULY 8, 2021
Company is aiming to transform the discovery of therapeutics focused on enzyme inhibition
Bio Pharma Dive
JULY 6, 2021
The results are a potentially significant finding that could help change how heart failure patients with preserved ejection fraction are treated, and will support the companies' application for the drug's approval.
BioPharma Reporter
JULY 7, 2021
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
pharmaphorum
JULY 9, 2021
The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation. . According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis with the shots.
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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.
Pharma Times
JULY 8, 2021
Collaboration will focus on the development of smart neurostimulators for the treatment of severe chronic diseases
Bio Pharma Dive
JULY 6, 2021
The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs.
BioSpace
JULY 7, 2021
Agenus, an immuno-oncology company based out of Lexington, Mass., has purchased a 120-acre plot of land near Genentech’s manufacturing facility in Vacaville, Cali.
pharmaphorum
JULY 9, 2021
Orchard Therapeutics’ gene therapy for rare childhood disease metachromatic leukodystrophy (MLD) Libmeldy has been rejected for NHS use by NICE in draft guidance. The agency said that while there was evidence of a short-term benefit with Libmeldy (atidarsagene autotemcel or OTL-200 ), assumptions about its long-term effects are uncertain, making it unclear whether it will offer value for money to the NHS.
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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.
Pharma Times
JULY 8, 2021
COVID-19 infection rates were three times lower in fully vaccinated people compared to unvaccinated people
Bio Pharma Dive
JULY 7, 2021
Having proved mRNA's might in COVID-19, the biotech company aims to develop similar vaccines for other respiratory illnesses caused by influenza, RSV and metapneumovirus.
BioSpace
JULY 7, 2021
“The Great Resignation” is a term that’s been coined to describe the wave of people leaving their jobs for other opportunities or exiting the workforce altogether.
pharmaphorum
JULY 8, 2021
GlaxoSmithKline’s head of oncology Axel Hoos has resigned from the company, and will take up a new role as chief executive of US biotech Scorpion Therapeutics. . Hoos is leaving GSK after nine years, a period that saw a complete revamp of the unit including the wholesale divestment of cancer drugs to Novartis in a $16 billion deal announced in 2014 – which completed as he took over the division.
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