Bio Pharma Dive
SEPTEMBER 3, 2021
A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field.
XTalks
SEPTEMBER 3, 2021
As part of a rebrand, leading contract Development and Manufacturing Organization (CDMO) Albany Molecular Research, Inc. (AMRI) has changed its name to Curia. AMRI says the name change reflects and emphasizes the company’s strategic positioning as an end-to-end global CDMO that offers scientific expertise and capabilities that range from research and development (R&D) through to commercial manufacturing.
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Bio Pharma Dive
SEPTEMBER 3, 2021
The U.K.-based drugmaker fell behind on its promise to supply 300 million doses by the end of June to countries in the trading bloc. Now, it's set to reach that target by March 2022.
XTalks
SEPTEMBER 3, 2021
Compound Foods, a food technology company, raised $4.5 million to make synthetic coffee. The company has raised a total of $5.3 million to date with investors from a Seed funding round, including Lowercarbon Capital, SVLC, Humboldt Fund, Collaborative Fund, Maple VC, Petri Bio and angel investors. The startup uses synthetic biology to recreate the molecular structure of coffee in order to reduce and eliminate the use of coffee beans. .
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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
Pharma Times
SEPTEMBER 3, 2021
The monoclonal antibody is designed to block IL-17A, a molecule involved in the psoriasis inflammatory response
pharmaphorum
SEPTEMBER 3, 2021
The internationally recognised composer, peace worker and musical therapy pioneer tells pharmaphorum how his emerging field stands at an important threshold. History provides a wealth of commentary on the emotional value of music. One of the earliest came from Plato, who concluded that “rhythm and harmony find their way into the inward places of the soul”.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
SEPTEMBER 3, 2021
The European Commission and AstraZeneca have settled their dispute over the supply of COVID-19 vaccine, Vaxzevriav, in a move that will see the EU receive 200 million doses of the drug makerâs shot by March 2022.
Pharma Times
SEPTEMBER 3, 2021
Trial showed ‘robust antibody responses’ against Delta variant
pharmaphorum
SEPTEMBER 3, 2021
Novartis hopes of improving on tacrolimus as the standard drug for preventing organ rejection in transplant patients have been dashed after its iscalimab candidate failed a mid-phase trial. An interim analysis of data from the CIRRUS-1 trial suggested that iscalimab (CFZ533) was less effective than tacrolimus at preventing rejection in kidney transplant patients when both drugs were added to standard immunosuppressive therapies like mycophenolate mofetil and corticosteroids.
Pharma Times
SEPTEMBER 3, 2021
Deal worth $20m plus potential $250m in milestone payments
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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
Drug Patent Watch
SEPTEMBER 3, 2021
Annual Drug Patent Expirations for QUILLICHEW+ER Quillichew Er is a drug marketed by Nextwave Pharms and is included in one NDA. It is available from two suppliers. There are seven…. The post New patent for Nextwave Pharms drug QUILLICHEW ER appeared first on DrugPatentWatch - Make Better Decisions.
Delveinsight
SEPTEMBER 3, 2021
Charcot-Marie-Tooth (CMT) disease is a rare, chronic and sensory neuropathy that causes weakness of the limbs and progresses gradually over time. It can lead to atrophy, sensory loss and complete limb dysfunction. However, rare, the condition is the most common inherited disorder that damages peripheral nerves with an estimated global prevalence of 2.6 million people worldwide (NINDS).
Drug Patent Watch
SEPTEMBER 3, 2021
Annual Drug Patent Expirations for MINOLIRA Minolira is a drug marketed by Epi Hlth and is included in one NDA. The generic ingredient in MINOLIRA is minocycline hydrochloride. Additional details…. The post New patent for Epi Hlth drug MINOLIRA appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
SEPTEMBER 3, 2021
AstraZeneca’s legal dispute with the European Commission over a shortfall in the supply of COVID-19 vaccines promised by the company earlier this year has been settled in advance of court proceedings. Under the terms, AZ has agreed to deliver 60 million doses of its Vaxzevria vaccine to the EU by the end of this month, rising to 200 million doses by the end of March 2022.
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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.
BioTech 365
SEPTEMBER 3, 2021
New Australian Hearing Aid Broker Offers Discounted Invisible Hearing Aid Brands New Australian Hearing Aid Broker Offers Discounted Invisible Hearing Aid Brands Ear Deals Pty Ltd (1300 010 064), an independent hearing aid broker based in Brisbane, has updated its … Continue reading →
pharmaphorum
SEPTEMBER 3, 2021
NICE has recommended broadening NHS use of Novartis’ IL-17 inhibitor Cosentyx to include children aged six to 17 with severe plaque psoriasis. The cost-effectiveness agency says in draft guidance that Cosentyx (secukinumab) should be offered as an option to patients in this age bracket who either don’t respond to or cannot tolerate other systemic treatments.
Pharma Times
SEPTEMBER 3, 2021
Pevonedistat plus azacitidine did not meet primary endpoint of EFS
Clinical Trial Gurus
SEPTEMBER 3, 2021
Update: She got the job! Former CRC Academy standout student shares her journey in clinical research and what type of skillset she has cultivated.
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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.
BioTech 365
SEPTEMBER 3, 2021
Avicanna Announces Filing of Annual Financial Statements For Year Ended December 31, 2020 Avicanna Announces Filing of Annual Financial Statements For Year Ended December 31, 2020 /NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED … Continue reading →
Drug Patent Watch
SEPTEMBER 3, 2021
This chart shows the pharmaceutical companies with the most patents in Poland. 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 Poland? appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
SEPTEMBER 3, 2021
Dr. Reddy’s Laboratories enters into definitive agreement with Citius Pharmaceuticals, Inc. to sell its rights to anti-cancer agent E7777 (denileukin diftitox) Dr. Reddy’s Laboratories enters into definitive agreement with Citius Pharmaceuticals, Inc.
pharmaphorum
SEPTEMBER 3, 2021
Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. The first of an anticipated 30,000 subjects have been vaccinated in Pfizer’s phase 3 RENOIR trial of its vaccine, just behind GSK and J&J started their own late-stage trials in May and July, respectively.
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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.
BioTech 365
SEPTEMBER 3, 2021
CARDIOGENICS HOLDINGS INC. ANNOUNCES LICENSE AGREEMENT AND DIVIDEND DISTRIBUTION CARDIOGENICS HOLDINGS INC. ANNOUNCES LICENSE AGREEMENT AND DIVIDEND DISTRIBUTION Caledon, Ontario, Sept. 03, 2021 (GLOBE NEWSWIRE) — CardioGenics Holdings Inc. (OTC PINK: CGNH) (the “Company”)announced today that its subsidiary, CardioGenics Inc.
BioTech 365
SEPTEMBER 3, 2021
Association of American Physicians and Surgeons (AAPS) Asks Pima County Supervisors to Reject COVID-19 Vaccine Mandate Association of American Physicians and Surgeons (AAPS) Asks Pima County Supervisors to Reject COVID-19 Vaccine Mandate TUCSON, Ariz., Sept.
BioTech 365
SEPTEMBER 3, 2021
atai Life Sciences to Participate in Upcoming September Investor Conferences atai Life Sciences to Participate in Upcoming September Investor Conferences BERLIN, Sept. 03, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V.
BioTech 365
SEPTEMBER 3, 2021
Alpha Cognition Reports Second Quarter of Fiscal 2021 Results Alpha Cognition Reports Second Quarter of Fiscal 2021 Results VANCOUVER, B.C.–(BUSINESS WIRE)–$ACOG—Alpha Cognition Inc.
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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.
BioTech 365
SEPTEMBER 3, 2021
Worldwide Medical Device and Diagnostics Contract Research Organization Industry to 2028 – Featuring Qserve Group, IQVIA and Proxima Clinical Research Among Others – ResearchAndMarkets.
BioTech 365
SEPTEMBER 3, 2021
Scopus BioPharma’s Subsidiary — Duet Therapeutics — to Present at the 14th Annual RNA Consortium Meeting Scopus BioPharma’s Subsidiary — Duet Therapeutics — to Present at the 14th Annual RNA Consortium Meeting Alan Horsager, Ph.D.
BioTech 365
SEPTEMBER 3, 2021
Monthly information related to total number of voting rights and shares composing the share capital – August 31, 2021 Monthly information related to total number of voting rights and shares composing the share capital – August 31, 2021 Monthly … Continue reading →
BioTech 365
SEPTEMBER 3, 2021
Iba – Acquisition of Own Shares – 20210903 Iba – Acquisition of Own Shares – 20210903 Immediate Release – September 3rd, 2021 Louvain-la-Neuve, Belgium, September 3rd, 2021 – In accordance with article 8:4 of the Royal Decree of 29 April … 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.
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