pharmaphorum

OCTOBER 3, 2021

Novartis has joined a growing number of companies insisting that its workforce is double vaccinated against COVID-19 if they want to work at one of its sites. The Swiss pharma group had earlier said it would require staff to either be vaccinated or have a negative COVID-19 test result within the last 14 days before visiting one of its facilities, but will now insist on a full primary course of shots or recovery from COVID-19 within the last six months.

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Vaccination Vaccine Pharma Companies Regulation 111

BioSpace

OCTOBER 3, 2021

Sage Therapeutics and Biogen announced positive results from their ongoing clinical trials on the efficacy and safety of zuranolone in treating major depressive disorder and postpartum depression.

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Clinical Trials Clinical Trials Trials 95

JAMA Internal Medicine

OCTOBER 3, 2021

This cohort study examines the incidence and clinical outcomes of acute myocarditis among adults following mRNA vaccination in an integrated health care system in the US.

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Vaccination Vaccine 77

BioSpace

OCTOBER 3, 2021

Once the deal is done, the company will be renamed MoonLake Immunotherapeutics and trade on the Nasdaq under the ticker symbol MLTX.

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Marketing 98

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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 Research

JAMA Internal Medicine

OCTOBER 3, 2021

Several recent case series have described acute myocarditis after COVID-19 messenger RNA (mRNA) vaccination. While the cardiac complications of vaccines are important, discussion has been limited by small sample sizes that lack gender and racial and ethnic diversity. In this issue of JAMA Internal Medicine, Simone et al examine the incidence and outcomes of acute myocarditis following COVID-19 mRNA vaccination in a large community health system.

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RNA Vaccination Vaccine Medicine 70

BioSpace

OCTOBER 3, 2021

Clinical trials have demonstrated that intermittent apomorphine injections provide rapid and effective relief from sudden, unexpected “off” periods brought on by primary Parkinson’s medicine, levodopa.

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Clinical Trials Clinical Trials Medicine Trials 90

BioSpace

OCTOBER 3, 2021

QurAlis' first piece of the puzzle is a protein called stathmin-2, which is encoded by the STMN2 gene.

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Protein Gene 103

NY Times

OCTOBER 3, 2021

President Biden’s Covid adviser also says it is “too soon to tell” if the Delta surge will decline enough to allow safe gatherings around the holidays.

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Vaccination Vaccine Clinical Trials Clinical Trials 64

BioSpace

OCTOBER 3, 2021

The deal has a value of over one billion dollars, with highlights for Xencor including receiving a $100 million upfront payment, a $25 million equity investment, eligibility for plamotamab royalties and potential milestone payments worth up to $1.18 billion.

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Antibody 52

Drug Patent Watch

OCTOBER 3, 2021

Annual Drug Patent Expirations for INNOPRAN+XL Innopran Xl is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. There is one…. The post New patent expiration for Ani Pharms drug INNOPRAN XL appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

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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

Clinical Trials

BioSpace

OCTOBER 3, 2021

Instead of continuing to develop the two different assets, EDP-305 and EDP-297, the company intends to seek an out-licensing deal to focus on infectious respiratory diseases.

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Licensing Licensing Development 52

Druggist

OCTOBER 3, 2021

Yes. The Covishield vaccine has been approved by the UK but with terms and conditions. The world wide acceptance of Covishield, especially the approval by the UK is raising many questions in every person’s mind. The reasons behind delay in approval and acceptance of Covishield in UK The Covishield vaccine has been effective in treating the COVID-19 infection , especially its severe symptoms and death.

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Immune Response Vaccination Vaccine Clinical Trials 40

BioSpace

OCTOBER 3, 2021

Data from the Phase II CYPRESS study presented at the virtual IDWeek (Infectious Disease Week) 2021 showed that the vaccine candidate provided a robust response against the infection.

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Vaccination Vaccine 68

BioTech 365

OCTOBER 3, 2021

SOM Biotech presents positive Phase 2a data with SOM3355 at the 34th ECNP Congress 2021 SOM Biotech presents positive Phase 2a data with SOM3355 at the 34th ECNP Congress 2021 SOM Biotech presents positive Phase 2a data with SOM3355 at … 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.

Clinical Supply

BioSpace

OCTOBER 3, 2021

Four months after collaborating on an experimental atopic dermatitis treatment, Amgen and Kyowa Kirin are seeing the fruits of that deal with positive Phase II data.

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BioTech 365

OCTOBER 3, 2021

Addex to Present at the 10th International Meeting on Metabotropic Glutamate Receptors Addex to Present at the 10th International Meeting on Metabotropic Glutamate Receptors Geneva, Switzerland, October 4, 2021 – Addex Therapeutics (SIX: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based … Continue reading →

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BioSpace

OCTOBER 3, 2021

It was a busy week for clinical trial news. Here’s a look.

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Clinical Trials Clinical Trials Trials 97

BioTech 365

OCTOBER 3, 2021

Galapagos announces completion of patient enrollment for DIVERSITY Phase 3 study with filgotinib in Crohn’s Disease Galapagos announces completion of patient enrollment for DIVERSITY Phase 3 study with filgotinib in Crohn’s Disease 1,374 patients enrolled into the phase 3 study across … 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.

Clinical Trials

BioSpace

OCTOBER 3, 2021

Johnson & Johnson is expected to ask the U.S. Food and Drug Administration to authorize a booster for its one-shot COVID-19 vaccine this week.

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Vaccination Vaccine Drugs 68

BioTech 365

OCTOBER 3, 2021

Cassiopea S.p.A. / Key word(s): Offer 04-Oct-2021 / 07:00 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art.

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BioSpace

OCTOBER 3, 2021

The U.S. FDA is kicking off the month of October with a number of PDUFA dates and an advisory committee meeting. Read on for more details.

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BioTech 365

OCTOBER 3, 2021

Cosmo Pharmaceuticals N.V. / Key word(s): Offer 04-Oct-2021 / 06:00 GMT/BST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. 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.

Clinical Supply

BioSpace

OCTOBER 3, 2021

?The FDA granted the latest designation based on the Phase III DESTINY-Breast03 trial on adult patients diagnosed with unresectable or metastatic HER2-positive breast cancer.

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Trials 43

BioTech 365

OCTOBER 3, 2021

‘Medicine Miles’ Becoming a Concern for European Patients ‘Medicine Miles’ Becoming a Concern for European Patients Research shows the origin of medicines becomes more important AMSTERDAM–(BUSINESS WIRE)–The pandemic has triggered a greater interest among patients about Europe’s role in medicine … Continue reading →

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Medicine Research 52

Drug Patent Watch

OCTOBER 3, 2021

This chart shows the pharmaceutical companies with the most solution dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most solution dosed drugs…. The post Which pharmaceutical companies have the most solution dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 97

BioTech 365

OCTOBER 3, 2021

ENHERTU® Granted Breakthrough Therapy Designation in U.S. for Patients with HER2 Positive Metastatic Breast Cancer Treated with One or More Prior Anti-HER2-Based Regimens ENHERTU® Granted Breakthrough Therapy Designation in U.S.

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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.

Clinical Trials

BioTech 365

OCTOBER 3, 2021

Active Biotech: Tasquinimod clinical development in multiple myeloma advances into combination therapy following completion of the initial phase of the ongoing trial in the US Active Biotech: Tasquinimod clinical development in multiple myeloma advances into combination therapy following completion of … Continue reading →

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Clinical Development Development Trials 40

BioTech 365

OCTOBER 3, 2021

Xenon Pharmaceuticals Announces Conference Call and Webcast to Discuss Topline Results from Phase 2b ‘X-TOLE’ Clinical Trial of XEN1101 Xenon Pharmaceuticals Announces Conference Call and Webcast to Discuss Topline Results from Phase 2b ‘X-TOLE’ Clinical Trial of XEN1101 BURNABY, British … Continue reading →

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Clinical Trials Clinical Trials Trials 40

BioTech 365

OCTOBER 3, 2021

Scholar Rock to Present Apitegromab TOPAZ Phase 2 Pharmacologic Data at the 2021 World Congress of Neurology Scholar Rock to Present Apitegromab TOPAZ Phase 2 Pharmacologic Data at the 2021 World Congress of Neurology CAMBRIDGE, Mass.

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BioTech 365

OCTOBER 3, 2021

Celltrion Healthcare Showcases Positive Data on Switching and Monotherapy With Remsima® SC in Patients With Inflammatory Bowel Disease at UEG Week Virtual 2021 Celltrion Healthcare Showcases Positive Data on Switching and Monotherapy With Remsima® SC in Patients With Inflammatory Bowel … Continue reading →

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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.

Clinical Trials