Bio Pharma Dive
OCTOBER 14, 2021
But the committee members remain opposed to broad use of boosters in healthy young adults, for whom the benefits of an additional shot are less clear.
Camargo
OCTOBER 14, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Discusses Focus Areas for PDUFA VII During Public Meeting. Following the August publication of the proposed PDUFA VII commitment letter negotiated with industry, the FDA held its corresponding required public meeting on September 28.
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Bio Pharma Dive
OCTOBER 14, 2021
The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however.
pharmaphorum
OCTOBER 14, 2021
UK-based Big Health has passed a digital health milestone after Scotland became the first country to make anxiety and insomnia digital therapeutics available on a national basis. NHS Scotland will offer the digital health firm’s Sleepio and Daylight, and the cognitive behavioural therapy they provide, to all adults via their GP or online self-referral greatly expanding their previous availability.
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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
XTalks
OCTOBER 14, 2021
The US Food and Drug Administration (FDA) announced new sodium guidelines on Wednesday that provide voluntary sodium reduction targets for a multitude of foods. While the guidelines are aimed at reducing the amount of salt Americans consume, the agency did not lower sodium levels recommended for cutting the risk of heart attack and stroke. “This guidance is intended to provide measurable voluntary short-term (2.5-year) goals for sodium content in commercially processed, packaged, and prepared fo
BioSpace
OCTOBER 14, 2021
Merck is getting its chance at participating in the pandemic. The FDA has announced an outside expert panel will meet on November 30 to deliberate on Merck’s COVID-19 pill.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 14, 2021
On Thursday, Tentarix Biotherapeutics announced that it earned $50 million in a Series A financing round, which was co-led by Versant Ventures and Samsara BioCapital.
BioPharma Reporter
OCTOBER 14, 2021
Avid Bioservices, Inc. is expanding its CDMO service offering into the cell and gene therapy market: constructing a purpose-built 53,000 sq. ft. viral vector development and CGMP manufacturing facility in Costa Mesa, CA.
BioSpace
OCTOBER 14, 2021
The 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ran from October 13 to 15, with companies globally presenting cutting-edge studies on MS.
Pharma Times
OCTOBER 14, 2021
The ATTC is coordinated as part of the Cell and Gene Therapy Catapult, and operates within the NHS framework
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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
OCTOBER 14, 2021
?The project will be one of the largest construction projects in North Carolina, with about 2 million sq. ft. of space. It is expected to bring in 725 new jobs in Wake County over the next five years.
Pharma Times
OCTOBER 14, 2021
Keytruda plus chemotherapy demonstrated superior overall survival rate in this patient population in the KEYNOTE-826 trial
BioSpace
OCTOBER 14, 2021
?The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date.
Scienmag
OCTOBER 14, 2021
To fully grasp and plan for climate impacts under any scenario, researchers and policymakers must look well beyond the 2100 benchmark. Unless CO2 emissions drop significantly, global warming by 2500 will make the Amazon barren, the American Midwest tropical, and India too hot to live in, according to a team of international scientists. Credit: James […].
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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
OCTOBER 14, 2021
Genomics veteran Bob Ragusa is taking over GRAIL, a newly-acquired business unit of Illumina, Inc. He is taking over as CEO Hans Bishop steps down from his role.
BioPharma Reporter
OCTOBER 14, 2021
Merck KGgA and subsidiary MilliporeSigma have completed work on their second Carlsbad, California-based facility.
BioSpace
OCTOBER 14, 2021
CT38 is being studied in myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), as well as in fibromyalgia and chronic Lyme disease.
BioPharma Reporter
OCTOBER 14, 2021
PTC Therapeutics is celebrating the opening of a new gene therapy manufacturing facility in Hopewell, N.J.
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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
OCTOBER 14, 2021
Read about TFF Pharmaceuticals and Augmenta Bioworks' dry powder COVID-19 antibody formula, the world's first gene editing clinical trial for PKU, Bayer's COVID-19 vaccine and other key developments in life sciences research.
Pharma Times
OCTOBER 14, 2021
26 experts have been appointed to join the Scientific Advisory Group on the Origins of Novel Pathogens (Sago)
BioSpace
OCTOBER 14, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
NY Times
OCTOBER 14, 2021
Those eligible for the extra shot would include adults over 65 and others at high risk — the same groups now eligible for a Pfizer-BioNTech boost.
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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.
Outsourcing Pharma
OCTOBER 14, 2021
The company has deployed with several healthcare firms, emerged from stealth, named a chief commercial officer, and landed investors backing the technology.
NY Times
OCTOBER 14, 2021
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines are voting on this week? This scorecard may help.
BioSpace
OCTOBER 14, 2021
Facing thousands of lawsuits related to its talc-based products, life sciences giant Johnson & Johnson is launching a separate subsidiary dubbed LTL Management LLC that will take the brunt of potential legal liabilities.
Outsourcing Pharma
OCTOBER 14, 2021
A leader from the pharmaceutical firm talks about some of the most impactful technologies and shares a number of notable advancements made by the company.
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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.
Pharma Times
OCTOBER 14, 2021
Entry closes on 22nd October – so don’t miss out on your chance to enter now
BioSpace
OCTOBER 14, 2021
The news of a unanimous decision by the adcom came just two days after the agency issued a 45-page document that contained vague comments on the drug.
Pharma Times
OCTOBER 14, 2021
The measures include a £250m ‘winter access fund’ from NHS England
pharmaphorum
OCTOBER 14, 2021
Multiple sclerosis drug Kesimpta has shown promising safety data for patients who are exposed to it for extended periods. Novartis announced the findings at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), revealing that mean immunoglobulin G (IgG) levels in patients treated with Kesimpta (ofatumumab) remained stable, and there was no apparent association between decreased IgG levels and the risk of serious infections.
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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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