Bio Pharma Dive
JULY 27, 2021
The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease.
Camargo
JULY 27, 2021
How and When to Incorporate PK Design into Your Gene Therapy Development Plan. Gene therapy, which was in its infancy around 30 years ago, is now becoming a more prominent treatment method in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19. When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dos
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Bio Pharma Dive
JULY 27, 2021
After screening 650,000 people, Regeneron unearthed a mutation associated with lower weight. AstraZeneca aims to help the biotech make a drug based on its findings.
Pharma Times
JULY 27, 2021
Study in adolescents met it primary endpoint, successfully bridging immune responses to those observed in an efficacy study in adults
Bio Pharma Dive
JULY 27, 2021
The companies said that patients treated with their experimental drug BIIB080 had reductions in a protein called tau, which research indicates is tied to Alzheimer's but isn't yet proven to impact the course of the disease.
BioPharma Reporter
JULY 27, 2021
BioNTech aims to develop the first mRNA-based malaria vaccine, hoping to reach clinical trials by 2022. Meanwhile, it is also exploring possibilities to set up mRNA manufacturing facilities on the African continent â which could potentially be used for vaccines against a wide range of diseases.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JULY 27, 2021
Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. Illinois-headquartered Apar – which makes inhalers, syringe components, eye drop bottles and other delivery systems for pharmaceuticals, cosmetics and other sectors – is paying €8.70 per share in the initial deal, which will give it a 64.6% stake in the company.
Pharma Times
JULY 27, 2021
A traumatic injury includes any injury that requires admission to hospital at the time of injury, according to NICE
Outsourcing Pharma
JULY 27, 2021
A recent check-in with several biopharma and CRO companies, conducted by Life Science Strategy Group, indicates adjustment to pandemic-related challenges.
BioSpace
JULY 27, 2021
Three companies, including two biotech companies and one drug discovery company, announced yesterday the successful closing of Series A financing, with IMIDomics taking the lead.
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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
pharmaphorum
JULY 27, 2021
Flushed with the success of its COVID-19 vaccine, BioNTech has pressed the accelerator on the development of shots for other infectious diseases, and now plans to take malaria and tuberculosis candidates into the clinic next year. Human testing of the malaria shot should get underway by the end of 2022, according to the German biotech, which says it is working with the World Health Organization (WHO), European Commission and other organisations on the malaria project.
XTalks
JULY 27, 2021
Despite rising commodity costs, Unilever managed to record five percent underlying sales growth in its second-quarter results. The company recorded 6.8 percent underlying sales growth in its food and refreshments sector, ahead of beauty and personal care (up 4.2 percent) and home care (up 3.2 percent). So how did the owner of Ben & Jerry’s, Marmite and Hellmann’s maintain positive growth and what lies ahead for the consumer goods giant?
pharmaphorum
JULY 27, 2021
Boehringer Ingelheim’s latecomer antibody therapy for COVID-19 has been side-lined, as the company focuses its attention on its thrombolytic drug alteplase, heading into a phase 3 programme later this year. The decision to discontinue development of BI 767551, an inhaled antibody, has been taken because of the “evolving landscape” in managing the pandemic including the success of vaccination programmes, the availability of multiple antibody therapies and the emergence of SARS-C
XTalks
JULY 27, 2021
The Alzheimer’s Association International Conference (AAIC) 2021 is being held this week and the controversial approval of Biogen’s Aduhelm (aducanumab) is among the topics front and center at the largely virtual meeting this year. To kick start the Aduhelm discussions, an expert Alzheimer’s disease panel has unveiled the first set of published recommendations for use of the drug.
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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
BioSpace
JULY 27, 2021
"For the first time in history, medicine has become information." That's the groundbreaking connection AI-driven RNA therapeutics has given us, according to Deep Genomics Founder and CEO Brendan Frey.
XTalks
JULY 27, 2021
Dole has introduced a new functional line of juices and fruit bowls that move towards their promise of eliminating added sugars from all of their products by 2025. The Dole Promise includes giving one billion people access to their food, moving towards zero fruit loss and zero fossil-based plastics use by 2025, along with achieving net-zero carbon emissions by 2030.
BioSpace
JULY 27, 2021
?A breakthrough study has found that altering the genetic makeup of malaria-carrying mosquito species could be the key to stopping the spread of the malaria virus and finally eradicating the disease.
Pharma Times
JULY 27, 2021
Organon will license the global development, manufacturing and commercial rights to investigational treatment ebopiprant
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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.
BioSpace
JULY 27, 2021
Deerfield Management and ARCH Venture Partners have partnered with venture capital firm Section 32 to sponsor DA32 Life Science Tech Acquisition Corp, a blank check company that is today priced for $200 million in an initial public offering (IPO).
BioPharma Reporter
JULY 27, 2021
AC Immune will acquire Affirisâ portfolio of therapeutics targeting alpha-synuclein (a-syn), which includes a vaccine candidate for the treatment of Parkinsonâs disease.
BioSpace
JULY 27, 2021
There has been a flurry of expansion activity in the life sciences industry as biopharma and diagnostic companies expand manufacturing sites. Here’s a look.
Outsourcing Pharma
JULY 27, 2021
The two pharma firms will partner to study the efficacy of Opdivo, paired with a SHP2 inhibitor, to treat non-small cell lung cancer with KRAS mutations.
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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 27, 2021
Clinical trial for first vaccine candidate is planned for the end of 2022
BioSpace
JULY 27, 2021
The extension will see a new investment of nearly $1 billion, which AbbVie and Calico will split down the middle.
pharmaphorum
JULY 27, 2021
We’ve all got used to hailing healthcare staff as heroes over the past year. Of course they deserve every ounce of admiration, even though many are uncomfortable with the adulation. But the bigger question is whether this heroic status really represents a healthy situation? Someone once advised me that, when conducting due diligence on a business, it’s important to find the hero.
BioSpace
JULY 27, 2021
More than ever, the current global health crisis has increased the demand for health professionals. The coronavirus disease (COVID-19) pandemic that has ravaged across the globe has demanded more experts in microbiology, particularly jobs in virology.
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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.
NY Times
JULY 27, 2021
If approved by a judge next month, the plan would resolve thousands of lawsuits and set in motion the release of $4.5 billion to help cover costs from the opioid epidemic.
BioSpace
JULY 27, 2021
A quick overview of life science companies scooping up some summer spending money this week.
BioPharma Reporter
JULY 27, 2021
Absci Corp, a Vancouver, Washington headquartered synthetic biology company developing technologies to accelerate drug discovery, has gone public.
Pharma Business Blog
JULY 27, 2021
Switzerland and the EU did not reach a consensus on the negotiations of the Institutional Framework Agreement. As a consequence, the Mutual Recognition Agreement (MRA) between the EU and Switzerland and related provisions for medical devices were not updated and, therefore, ceased to apply on 26 May 2021. With that, as of now Switzerland is considered as a ‘third country’ and Swiss MedTech companies lost their previously barrier-free access to the EU market and vice versa.
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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.
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