Bio Pharma Dive
JUNE 27, 2022
The regulator suspended testing of Astellas’ Pompe disease treatment after one patient experienced peripheral nerve damage. Both of the pharma’s clinical-stage gene therapies are now on hold.
Pharmaceutical Technology
JUNE 29, 2022
Approximately 75,000 enzymes are thought to exist in the human body as vital catalysts for biochemical reactions or conversions. For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The pharmaceutical industry often relies on enzymes to perform a process known as biocatalysis, which facilitates the cost-effective and sustainable production of small molecule drugs at scale.
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World of DTC Marketing
JUNE 29, 2022
Suppose you’re on Facebook or Instagram, and Meta has determined you may be interested in cancer treatments. In that case, you may have seen an ad for a dangerous cancer treatment, or one of the 20 or so others recently running from the CHIPSA hospital in Mexico near the US border, all of which are publicly listed in Meta’s Ad Library. They are part of a pattern on Facebook of ads that make misleading or false health claims targeted at cancer patients.
pharmaphorum
JUNE 30, 2022
Merck & Co is looking for startup companies applying artificial intelligence , machine-learning and other digital approaches to drug discovery and development for a new accelerator programme. The big pharma – known as MSD outside North America – is initially offering support to 12 companies though the newly-formed Merck Digital Sciences Studio (MDSS) and is now taking applications from would-be participants.
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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
JUNE 27, 2022
Epizyme, which was once worth more than $2 billion, agreed to be bought for $247 million upfront. The biotech has continued to lose money despite winning FDA approval for a drug for rare cancers.
Pharmaceutical Technology
JULY 1, 2022
The latest issue of Pharma Technology Focus is out now. Read it for free on all devices. Some months after the first Covid-19 vaccines became available, the World Health Organization (WHO) set a target of vaccinating 70% of each country’s population by the end of June 2022. Global trends indicate that initially, a slow supply did not allow African countries, in particular, to stay on pace to meet this target, and now vaccination rates have even begun to slow down.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NY Times
JUNE 28, 2022
With Roe v. Wade overturned, states banning abortion are looking to prevent the distribution of abortion medication. Brazil shows the possible consequences.
Bio Pharma Dive
JUNE 30, 2022
Data compiled by BioPharma Dive show a growing gap in the frequency and size of new stock offerings compared to prior years. Some analysts believe as many as a third of public biotechs must “go away” before the sector’s slump ends.
Pharmaceutical Technology
JUNE 29, 2022
The proportion of pharmaceutical companies hiring for AI related positions kept relatively steady in May 2022 compared with the equivalent month last year, with 39.3% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 39% of companies who were hiring for AI related jobs a year ago but a decrease compared to the figure of 43.6% in April 2022.
pharmaphorum
JUNE 27, 2022
An antisense drug in development at GSK has shown further activity against hepatitis B virus (HBV) in a mid-stage trial, setting up a phase 3 assessment next year to see if it could offer a “functional cure” for the widespread disease. Interim results from the phase 2b B-Clear showed that bepirovirsen reduced levels of hepatitis B surface antigen (HBsAg) and HBV DNA after 24 weeks’ treatment to below the lower limit of detection in people with chronic hepatitis B, raising hopes
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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
BioPharma Reporter
JUNE 27, 2022
Australian biotech Skin2Neuronâs new form of cell therapy reversed a dementia-like syndrome in dogs, according to results of a veterinary trial.
Bio Pharma Dive
JUNE 29, 2022
Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.
Pharmaceutical Technology
JULY 1, 2022
Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally. Due to the oral form, the therapy can be prescribed in the early infection stage to avert severe illness.
pharmaphorum
JUNE 30, 2022
The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst. The FDA delivered a blow to Spero’s hopes of bringing the carbapenem to market in a complete response letter (CRL) delivered this week, which said another trial would be required to support approval.
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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.
BioPharma Reporter
JUNE 27, 2022
The European Medicines Agencyâs Committee for Medicinal Products for Human Use (CHMP) made several recommendations for approval of drugs and therapies at its June 2022 meeting.
Bio Pharma Dive
JUNE 29, 2022
The Swiss pharma confirmed it will cut as many as 1,400 jobs in Switzerland and thousands more globally under a reorganization plan first announced in early April.
Pharmaceutical Technology
JUNE 29, 2022
Terumo Blood and Cell Technologies and BioBridge Global subsidiary, GenCure, have entered a new partnership agreement to expand and integrate cell and gene therapy manufacturing solutions. In a bid to meet the growing demand for automated and closed smart systems across the cell and gene therapy (CGT) industry, the companies entered the deal to merge technologies and capabilities.
pharmaphorum
JUNE 29, 2022
Bayer has stepped up the digital capabilities of its radiology business with the launch of artificial intelligence-based apps for X-ray, MRI and CT imaging. The cloud-hosted platform – called Calantic Digital Solutions – has tools to help radiologists detect and quantify disease lesions in medical images and select patients for treatment in order of priority, improving their productivity.
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
JUNE 29, 2022
AVA6000 is a novel form of doxorubicin that has been modified using Avacta’s delivery platform to improve safety
Bio Pharma Dive
JUNE 28, 2022
Positive results for the treatment, which was developed by U.K. biotech MeiraGTx, could rebuild expectations after another gene therapy from Biogen failed in the retinal disease.
Pharmaceutical Technology
JUNE 28, 2022
Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). An iADC merges an antibody with a small molecule compound that elicits immunogenic cell death, and an immune-activating molecule. It can potentially enhance the anti-cancer effect.
pharmaphorum
JUNE 27, 2022
Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. The analysis – from a dataset that spans more than half a million patients – reveals once again the lack of inclusivity in clinical research, which undermines the ability of clinical trials to generate results that reflect the real-world situation in US cancer treatmen
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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.
Drug Patent Watch
JULY 1, 2022
Annual Drug Patent Expirations for AIRDUO+RESPICLICK Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from four suppliers. There are sixteen…. The post New patent for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
Bio Pharma Dive
JUNE 30, 2022
Converting Paxlovid’s emergency authorization to a standard clearance could further broaden its use. But the drug may not meaningfully help people who are vaccinated, and concerns about its potency against emerging variants are growing.
Pharmaceutical Technology
JUNE 27, 2022
Last Friday, the World Health Organization (WHO) launched updated guidelines for the treatment of hepatitis C , calling for testing and treatment to be delivered in peripheral and community-based facilities and integrating these with available care services. While some countries are making progress in eliminating hepatitis C, many remain challenged in reaching those affected, Dr Philippa Easterbrook, Senior Scientist at WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infection
pharmaphorum
JUNE 27, 2022
The revamp of French drugmaker Ipsen has continued with a takeover agreement for US counterpart Epizyme and its cancer therapy Tazverik, in a deal valued at a little under $250 million. Ipsen is offering $1.45 per share for Cambridge, Massachusetts-based Epizyme – valuing the US company at around $247 million – and is also promising a further contingent value right (CVR) payment of up to $1 per share if Tazverik (tazemetostat) achieves certain development and sales targets.
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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.
Drug Patent Watch
JULY 1, 2022
Annual Drug Patent Expirations for LICART Licart is a drug marketed by Ibsa Inst Bio and is included in one NDA. The generic ingredient in LICART is diclofenac epolamine. Additional…. The post New patent for Ibsa Inst drug LICART appeared first on DrugPatentWatch - Make Better Decisions.
Bio Pharma Dive
JUNE 29, 2022
The two drugmakers joined a long list of investors, including Pfizer and Sanofi, that have been funding the startup’s plan to develop a new type of lipid nanoparticle technology.
Pharmaceutical Technology
JUNE 27, 2022
Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for its CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory large B-cell lymphoma (LBCL) in adult patients. Breyanzi is given as a defined composition for reducing the variability of the CD8 and CD4 component dose.
pharmaphorum
JUNE 28, 2022
Astellas has agreed a $1.36 billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. The alliance includes an upfront payment of $90 million, backed by $422.5 million in possible milestone payments apiece for up to three development programmes based on Sutro’s immunostimulatory antibody-drug conjugate (iADC) technology.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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