BioSpace
OCTOBER 17, 2021
Products getting regulatory approval and hitting the market doesn’t always spell success for companies, especially during a global pandemic. Michigan-based Esperion has learned that lesson all too well.
NY Times
OCTOBER 17, 2021
Merck has taken a step to make its antiviral pill available in poor nations, but many obstacles remain for broad access to coronavirus drugs.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
BioSpace
OCTOBER 17, 2021
Omeros Corporation shares were down in premarket trading after the company received a CRL for its experimental hematopoietic stem cell transplant-associated thrombotic microangiopathy treatment.
BioTech 365
OCTOBER 17, 2021
Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001 Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001 VLA2001 successfully met both co-primary endpoints Superior neutralizing antibody titer levels compared to active … Continue reading →
Advertisement
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
OCTOBER 17, 2021
Phathom announced positive results from its Phase III trial, PHALCON-EE, comparing vonoprazan against lansoprazole in patients with moderate to severe erosive esophagitis.
pharmaphorum
OCTOBER 17, 2021
A hospital trust has become the first in the UK to deploy a gaming system developed by Swiss company MindMaze that is intended to help patients suffering a stroke to repair their brains. The MindPod interactive game is being installed at the Royal Buckinghamshire Hospital (RBH) in Aylesbury and requires players to use upper body movements to control an animated dolphin called Bandit on a screen, directing it to explore the ocean environment and catch fish using movement tracking technology.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
OCTOBER 17, 2021
People who had received a first dose of the Oxford-AstraZeneca COVID-19 vaccine and received an mRNA vaccine for their second dose had a lower risk of infection compared to people who had received both doses of the Oxford-AstraZeneca vaccine. This is shown in a nationwide study performed by researchers at Umeå University, Sweden. Credit: Mattias […].
BioSpace
OCTOBER 17, 2021
?It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.
Clinical Trial Gurus
OCTOBER 17, 2021
Clinical research coordinator is the most important role in any clinical trial. In this video we discuss the top mistakes that all coordinators make and how to potentially avoid these issues. Our CRC Academy focuses a lot of the curriculum around avoiding making serious errors as a clinical research coordinator.
BioSpace
OCTOBER 17, 2021
Biogen announced topline results from the Phase III VALOR trial of tofersen for superoxide dismutase 1 amyotrophic lateral sclerosis.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
FDA Law Blog
OCTOBER 17, 2021
By Deborah L. Livornese — Many of us have been waiting not-so patiently for FDA to begin implementing the over-the-counter (OTC) monograph reform provisions of the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here ). While we are aware that behind the scenes the Office of Nonprescription Drugs has been busy hiring, training, reorganizing and otherwise working on implementation, apart from setting the amount of the new fees and related actions (see our b
BioSpace
OCTOBER 17, 2021
The U.S. Food and Drug Administration has a few PDUFA dates on its calendar for this week. Here’s a look.
BioTech 365
OCTOBER 17, 2021
Ipsen Adds Another Program Into Its Pre-Clinical R&D Oncology Pipeline Through an Exclusive Worldwide Collaboration With Accent Therapeutics, Targeting the RNA Modifying Protein, METTL3 Ipsen Adds Another Program Into Its Pre-Clinical R&D Oncology Pipeline Through an Exclusive Worldwide Collaboration With … Continue reading →
BioSpace
OCTOBER 17, 2021
The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Advertisement
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.
BioTech 365
OCTOBER 17, 2021
Philips delivers Q3 sales of EUR 4.2 billion, with a 7.6% comparable sales decline due to headwinds; income from continuing operations increases to EUR 442 million, and Adjusted EBITA margin amounts to 12.3% Philips delivers Q3 sales of EUR 4.
BioSpace
OCTOBER 17, 2021
?The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.
BioTech 365
OCTOBER 17, 2021
SOM Biotech granted Orphan Drug Designation by the FDA for SOM3355 SOM Biotech granted Orphan Drug Designation by the FDA for SOM3355 SOM Biotech granted Orphan Drug Designation by the FDA for SOM3355 ~SOM3355 has potential to be an alternative … Continue reading →
BioSpace
OCTOBER 17, 2021
It was yet another busy week for clinical trial announcements. Take a look.
Advertisement
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.
BioTech 365
OCTOBER 17, 2021
Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS In the Phase 3 VALOR study, the primary endpoint as … Continue reading →
Drug Patent Watch
OCTOBER 17, 2021
This chart shows the pharmaceutical companies with the most patents in Germany. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Germany? appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
OCTOBER 17, 2021
DGAP-News: Vivoryon Therapeutics N.V. / Key word(s): Study 18.10.2021 / 07:00 The issuer is solely responsible for the content of this announcement.
Scienmag
OCTOBER 17, 2021
AUGUSTA, Ga. (Oct. 18, 2021) – Another difference between females and males appears to be a key mechanism in how they become hypertensive, scientists say, and consequently which antihypertensives should be most effective for them. Credit: Michael Holahan, Augusta University AUGUSTA, Ga. (Oct. 18, 2021) – Another difference between females and males appears to be a key […].
Advertisement
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.
pharmaphorum
OCTOBER 17, 2021
With rumours growing that that ex-FDA head Robert Califf looks set to receive President Joe Biden’s nomination to be the next FDA commissioner, at least one analyst thinks the appointment would be a positive for the biopharma industry. Califf was appointed to the helm of the FDA under the Obama administration in 2016, and picked up a reputation for cracking down on manufacturing and safety, as well as defending the agency’s independence, before the change in administration saw his ti
Expert insights. Personalized for you.
98 
Let's personalize your content