Bio Pharma Dive
AUGUST 4, 2021
Acting FDA head Janet Woodcock asked for an investigation of the agency's decision to approve Biogen's Alzheimer's drug, but the inspector general's planned review appears to be more broadly aimed.
World of DTC Marketing
AUGUST 4, 2021
SUMMARY: People are going online more and more to sarch for health information after seeing a DTC pharma TV spot. Pharma websites are not consdiered a top resource for infromation on new products. Cost is not that big of an issue for people who have health insurance. It’s more about weighing the benefit against the potential side effects. TV spots are the number one way people learn about new pharma products.
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Bio Pharma Dive
AUGUST 4, 2021
Vividion Therapeutics was headed toward an IPO earlier this year, but a company executive said Bayer’s $1.5B offer ended up being a more attractive option.
pharmaphorum
AUGUST 4, 2021
Spinal Muscular Atrophy (SMA) is a rare disease affecting the motor nerve cells in the spinal cord. It’s a debilitating condition that affects 1 per 8,000 to 10,000 people worldwide , impacting their ability to walk, eat, and breathe. SMA Type 1 represents an estimated 50% of all cases, for which life expectancy is less than 18 months without treatment. .
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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
AUGUST 4, 2021
The biotech is also constructing a new factory in Ohio and, between the two, expects to investment nearly $1 billion over the next few years.
XTalks
AUGUST 4, 2021
The search to find talent in the life sciences isn’t always an easy pursuit. It requires ongoing strategies for attracting, retaining and developing the right candidates. Talent acquisition and employment practices are constantly changing in the pharma industry. This is why employers must stay up to date with the latest hiring trends. Popular online job platforms (such as Indeed, ZipRecruiter and other broader job posting websites) are optimized for unemployed job seekers.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
AUGUST 4, 2021
Sativex is a complex botanical formulation that contains the principal cannabinoids THC and CBD
pharmaphorum
AUGUST 4, 2021
Fresenius has launched a virtual reality based training programme for people undergoing home dialysis in Germany, its home market, ahead of a rollout in other countries later this year. The VR system – called stay•safe MyTraining VR – is designed for use in patients undergoing peritoneal dialysis, which uses the peritoneum in a person’s abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood.
BioSpace
AUGUST 4, 2021
Top-line results from the Phase II REPAIR trial show a gold nanocrystal suspension, CNM-Au8®, significantly improved brain energetic metabolism in patients with Parkinson’s disease and multiple sclerosis.
pharmaphorum
AUGUST 4, 2021
Eli Lilly and Incyte have another rival in the rear-view mirror for Olumiant in alopecia areata after Pfizer reported that its ritlecitinib improved scalp hair regrowth in a late-stage trial. In the phase 2b/3 ALLEGRO trial, JAK inhibitor ritlecitinib hit its primary objective of improving the area of scalp covered by hair in people with this autoimmune form of hair loss, giving Pfizer a positive readout in the first of two trials that will form the basis of regulatory filings for the drug.
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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
AUGUST 4, 2021
A United Kingdom watchdog organization has accused Pfizer and Flynn Pharma of violating antitrust rules and overcharging that country’s National Health Services for anti-epilepsy treatments.
pharmaphorum
AUGUST 4, 2021
The need for automated metadata management software has never been greater. The number of global clinical trials being run is increasing every year. And, they are becoming increasingly complex to manage. There’s a vast amount of data that needs to be collected and analyzed. There are more regulations in place than ever before and industry standards are constantly being updated.
BioSpace
AUGUST 4, 2021
Gilead Sciences’ Kite Pharma has entered into a collaboration and licensing agreement with biotech startup Appia Bio, which will focus on the joint research and development of allogeneic cell therapies for cancer.
pharmaphorum
AUGUST 4, 2021
Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. Istodax (romidepsin) – originally developed by Celgene – is the latest in a string of cancer drugs originally given accelerated approval based on mid-stage data to be withdrawn because a follow-up confirmatory trial missed the mark.
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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.
BioSpace
AUGUST 4, 2021
CytoDyn files a lawsuit against the activist group led by Rosenbaum and Patterson, alleging that they are "waging an illegal proxy contest to take over control of the Company's Board of Directors.
Delveinsight
AUGUST 4, 2021
Neurological Disorders are one of the most leading causes of injuries, death, and disability. Over more than 600 Neurological Disorders are believed to affect millions of people worldwide. These disorders have a deep impact on the patients, their families, and society at large. As per the systematic analysis for the “Global Burden of Disease Study 2016” by Prof Valery L Feigin, et. al., “Neurological Disorders contribute to around 11·6% of global DALYs and are the causes of 16·5% of deaths, over
pharmaphorum
AUGUST 4, 2021
Identifying the most important & active digital experts in your space is just the first step of the engagement planning cycle. Because even within a therapy area, digital KOLs (DOLs) have very different online characteristics – those who tend to initiate online conversations, those that tend to create new content, those that tend to propagate existing data, etc., and by engaging with those experts in a way that is aligned with their unique characteristics and personal positioning, you can po
BioSpace
AUGUST 4, 2021
As the spread of the Delta variant exacerbates the COVID-19 pandemic, companies are increasingly moving toward requiring staffers to be vaccinated. Here’s a look at those stories and more.
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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.
BioPharma Reporter
AUGUST 4, 2021
An industry study from the producer of CPhI North America shows the pandemic and other factors are contributing to a very dynamic pharmaceutical market.
BioSpace
AUGUST 4, 2021
Tadataka “Tachi” Yamada, a former GlaxoSmithKline and Takeda Pharmaceutical executive, early gene therapy backer, and philanthropist, passed away on Wednesday of natural causes at the age of 76.
Pharma Times
AUGUST 4, 2021
Less than one in 20 children had symptoms for more than four weeks
BioSpace
AUGUST 4, 2021
The Phase III trial shows that PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved OS compared with chemotherapy alone with locally advanced NSCLC.
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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.
Pharma Times
AUGUST 4, 2021
Phase III trials did not demonstrate sufficient clinical benefit.
BioSpace
AUGUST 4, 2021
RNA caught the public’s imagination in the form of mRNA vaccines against COVID-19, but RNA can be used in other ways, too, to make therapeutic proteins.
Pharma Times
AUGUST 4, 2021
First treatment to be approved for UK MPM patients for more than 15 years
BioSpace
AUGUST 4, 2021
Under the terms of the agreement, Bayer is paying $1.5 billion upfront and up to $500 million in various milestone payments.
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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
AUGUST 4, 2021
Amgen will build a new multi-product drug substance manufacturing facility in Holly Springs, North Carolina.
BioSpace
AUGUST 4, 2021
Legal firms are lining up to lead litigation against the company on behalf of shareholders who saw their stock dive.
XTalks
AUGUST 4, 2021
PepsiCo announced yesterday it would be selling Tropicana, Naked and other North American juice brands to private equity firm PAI Partners in a $3.3 billion deal. The beverage giant will keep a 39 percent non-controlling stake in a newly formed joint venture in the deal with PAI, meaning it will retain a minority ownership with no control over decisions.
BioSpace
AUGUST 4, 2021
Biopharma and life sciences companies from across the globe provide updates to their pipelines and businesses.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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