World of DTC Marketing
AUGUST 8, 2021
SUMMARY: Pharma marketing is in a funk. Somewhere over the last decade, the passionate people who believed that helping patients was the first step in excellent marketing have been replaced with people who want to know the ROI of everything. We need to hire people who have a passion for learning, exploring, and implementing great patient-centered marketing.
BioSpace
AUGUST 8, 2021
The hold is related to a report of a SUSAR of myelodysplastic syndrome in a patient treated with eli-cel, also known as Lenti-D, in a Phase III clinical trial.
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JAMA Internal Medicine
AUGUST 8, 2021
This longitudinal ecological study estimates the associations between prison crowding, community COVID-19 transmission, and prison incidence rates of COVID-19.
BioSpace
AUGUST 8, 2021
Although August is a fairly busy month for PDUFA dates, there were only two on the U.S. FDA’s calendar for this week, and one of those has already been reported. Here’s a look.
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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
Clinical Trial Gurus
AUGUST 8, 2021
Starting a clinical research investigative site requires various forms of insurance coverage. In this video we discuss a few different forms of liability coverage that site owners can purchase.
BioSpace
AUGUST 8, 2021
Voyager’s primary focus will be on developing gene therapies for Huntington’s disease, Amyotrophic Lateral Sclerosis (ALS), and pre-clinical research in spinal muscular atrophy and diseases linked to GBA1 mutations.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
AUGUST 8, 2021
As COVID-19 vaccines near full approval by the U.S. FDA, Dr. Anthony Fauci expects several organizations across the country, including businesses and schools, will issue their own vaccine mandates before people can enter their establishments.
BioTech 365
AUGUST 8, 2021
BioVie Inc. Announces Pricing of Public Offering of Common Stock BioVie Inc. Announces Pricing of Public Offering of Common Stock SANTA MONICA, Calif., Aug. 08, 2021 (GLOBE NEWSWIRE) — BioVie Inc.
BioSpace
AUGUST 8, 2021
Seagen forged an exclusive licensing agreement with China’s RemeGen Co., Ltd, to develop and commercialize disitamab vedotin, a novel HER2-targeted ADC.
BioTech 365
AUGUST 8, 2021
Bavarian Nordic Reports Initial Results from First-in-Human Trial of COVID-19 Vaccine Bavarian Nordic Reports Initial Results from First-in-Human Trial of COVID-19 Vaccine Vaccine was well tolerated across all dose groups with no observed difference in adverse event profile after first … Continue reading →
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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 8, 2021
AbbVie has terminated its license and collaboration deal with Molecular Partners for abicipar pegol, and returned all rights to the Swiss company.
BioTech 365
AUGUST 8, 2021
EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Regulatory Admission 09.08.2021 / 07:00 Acer Therapeutics and Relief Therapeutics Announce Submission of a New Drug Application to the U.S.
BioSpace
AUGUST 8, 2021
Besides making sure you don’t accidentally reply all to that company-wide notice, here are some words to reserve for your texts with friends.
BioTech 365
AUGUST 8, 2021
Epizyme and HUTCHMED Announce Strategic Collaboration to Develop and Commercialize TAZVERIK® (tazemetostat) in Greater China Epizyme and HUTCHMED Announce Strategic Collaboration to Develop and Commercialize TAZVERIK® (tazemetostat) in Greater China Collaboration designed to accelerate global development and investigate TAZVERIK® combinations … Continue reading →
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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 8, 2021
The clinical study compared Enhertu to Kadcyla in HER2+ metastatic breast cancer patients who previously received trastuzumab.
BioTech 365
AUGUST 8, 2021
Infostretch Collaborates with INDIASHIELD to Deliver Citizen-Led COVID Assistance Across India Infostretch Collaborates with INDIASHIELD to Deliver Citizen-Led COVID Assistance Across India SANTA CLARA, Calif.
BioSpace
AUGUST 8, 2021
Called “female Viagra” in the media, Ovoca Bio’s BP-101 (Libicore) nasal spray therapy for low libidos in premenopausal women is undergoing Phase II trials in Australia and New Zealand, and is being reviewed by the Russian Ministry of Health after successful Phase III trials in that country.
BioTech 365
AUGUST 8, 2021
HUTCHMED and Epizyme Announce Strategic Collaboration to Develop and Commercialize TAZVERIK® (tazemetostat) in Greater China HUTCHMED and Epizyme Announce Strategic Collaboration to Develop and Commercialize TAZVERIK® (tazemetostat) in Greater China Collaboration designed to accelerate global development and investigate TAZVERIK® combinations with HUTCHMED’s … Continue reading →
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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
AUGUST 8, 2021
Sanofi has announced that the U.S. FDA approved its new treatment for babies diagnosed with late-onset Pompe disease.
BioTech 365
AUGUST 8, 2021
MedSmart Group Inc. (MSGP) Announces MOU Signed Between Milanion and Ukrainian Armor for Distribution Rights to the AGEMA UGV MedSmart Group Inc.
BioSpace
AUGUST 8, 2021
The acquisition of OtiTopic will boost the company’s new strategy and potentially address a significant unmet medical need in more than 83 million people in the U.S. with myocardial infarction.
BioTech 365
AUGUST 8, 2021
[Ad hoc announcement pursuant to Art.
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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.
BioSpace
AUGUST 8, 2021
Mission Therapeutics and AbbVie announced their DUB inhibitor collaboration back in 2018.
Drug Patent Watch
AUGUST 8, 2021
This chart shows the patent expirations for suspension dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from…. The post Suspension dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
AUGUST 8, 2021
It was a busy week for clinical trial announcements. Take a look.
pharmaphorum
AUGUST 8, 2021
A flurry of new offers by Philip Morris International (PMI) and private equity firm Carlyle has hiked the value of respiratory medicines company Vectura to £1 more than a billion ($1.4 billion), with the tobacco giant leading the bidding at the latest count. Carlyle first broke ground with a 136 pence per share offer that was agreed by Vectura in May, only to be trumped by a 150p bid by PMI a few weeks later.
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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.
BioSpace
AUGUST 8, 2021
The company indicated they plan to meet with the FDA to determine the next course of action.
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