Category: Clinical Operations

  • Microsoft’s commitment to compliance in pharma and life sciences

    Over a year has gone by since the beginning of the global pandemic, and it’s clear that the pharmaceutical industry and COVID-19 vaccines are at the center of everyone’s attention. Calls for quick and rigorous development of a COVID-19 vaccine have given way to the equally important demand for rapid distribution. Because of this unprecedented […]

  • Ocugen and Bharat Biotech reach vaccine commercialization agreement for US market

    Ocugen, Inc., a biopharma company, and Bharat Biotech, a vaccines specialist, have entered into a definitive agreement to co-develop, supply and commercialize COVAXIN, Bharat’s Covid-19 vaccine candidate, for the US market. Per the deal, Ocugen will be granted US rights to the vaccine candidate and will be in charge of clinical development, regulatory approval (including emergency use authorization, […]

  • Software and info tech business ink healthcare partnership

    Komodo Health, a software platform company, and IT provider Blue Health Intelligence (BHI) have reached a multi-year agreement to integrate BHI’s patient data into Komodo’s Healthcare Map, which provides a view of patient encounters with the US healthcare system. Together, the combined Komodo database captures the patient journeys of more than 325 million de-identified individuals, […]

  • Remote patient monitoring to sustain impact on healthcare delivery

    Ongoing Covid-19 lockdowns and social distancing requirements have caused healthcare provision and patient monitoring to seek alternatives. Even though remote patient monitoring (RPM) was already being used prior to the start of the pandemic, the uptake of the technology was fairly low, mainly used to ensure better post-acute care and management of chronic conditions, such […]

  • Cure Genetics partners with Boehringer Ingelheim in gene therapy initiative

    Cure Genetics will collaborate with pharma company Boehringer Ingelheim to form novel adeno-associated virus (AAV) vectors, which will use Cure Genetics’ branded VELP platform to develop gene therapies. The new partnership combines Boehringer Ingelheim’s disease biology and gene therapy development experience with Cure Genetics’ AAV knowledge in library construction and in vivo AAV screening. The aim […]

  • EVOQ Therapeutics inks autoimmune partnership

    EVOQ Therapeutics has signed a license and collaboration contract with Amgen around the discovery and development of novel drugs for autoimmune disorders. Under the terms of the agreement, Amgen and EVOQ will team up when it comes to preclinical development, while Amgen will be responsible for clinical development and commercialization. In exchange for exclusive rights […]

  • Sanofi expands immunotherapy portfolio

    Sanofi has acquired Kymab, a biopharma immunotherapy company. Under the deal’s terms, the drug manufacturer will purchase Kymab for an upfront payment of approximately $1.1 billion and up to an additional $350 million for completion of specific milestones. Sanofi will have full global rights to KY1005, a fully human monoclonal antibody that has a novel […]

  • Bayer and CureVac team up on potential vaccine

    Bayer has signed an agreement with CureVac N.V., a biopharma company that manufactures medication based on messenger ribonucleic acid (mRNA). Per the deal, Bayer will help with development, supply and territory operations of CureVac’s Covid-19 vaccine candidate, CVnCoV. As of Dec. 14, the vaccine has been in Phase IIb/III. Bayer will offer its perspective in […]

  • Advanced analytics: Powering pharma’s most critical data mission

    Drug-development efforts are always fraught with  promise and peril. Today, more than half of all investigational drugs in Phase III clinical trials fail 1, due to factors such as flawed design, inappropriate endpoints, safety issues, lack of funding, failure to demonstrate clinical efficacy and under-enrollment. Delays create economic consequences for drugmakers in terms of sunk […]

  • Clues and connections from the real world

    “Encourage your kids to be data scientists,” Jane Quigley, senior VP, digital health, at PRA Health Sciences, offered. Considered one of the “godmothers of real-world data (RWD),” Quigley was underscoring the need today—and great opportunity amid the convergence of technology and accessibility—to surface valuable business- and patient-impacting insights in areas such as clinical trial design, […]

  • Schreiner MediPharm equips Cap-Lock security label with RFID technology

    Schreiner MediPharm, a Germany-based provider of functional labels for the healthcare industry, has augmented its Cap-Lock tamper-evident specialty label with an RFID inlay. Cap-Lock label now equipped with RFID inlay. (Credit: Schreiner MediPharm) Developed to expand digitization initiatives at hospitals, the label-and-cap security concept for prefilled syringes now enables automated inventory and supply chain management, […]

  • Catalent to acquire cell therapy manufacturing facility in Belgium

    Catalent has signed an agreement with Bone Therapeutics to acquire its cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support SA, including all of its assets located in Gosselies, Belgium. The transaction is expected to close in November. The Skeletal Cell Therapy Support manufacturing facility in Gosselies, Belgium. (Image courtesy of Catalent) Under the terms of […]

  • US biopharmaceutical supply chain resilient and effective during early Covid-19 response

    A new report published by the Healthcare Distribution Alliance (HDA) Research Foundation and Deloitte Consulting LLP found that during the first 90 days of the Covid-19 pandemic, the biopharmaceutical finished goods industry adapted and adjusted to deliver medicines safely and efficiently to patients with only minimal disruptions. In the report titled, The First 90 Days: […]

  • TFF Pharmaceuticals expands its cGMP manufacturing capabilities

    TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has expanded its engagement with contract manufacturing organization (CMO) Experic, LLC to install its patented thin film freezing (TFF) processing line and associated capabilities at the CMO’s cGMP facility in Cranbury, NJ. Installation of the custom-designed equipment is expected to be completed in early Q2 2021. It will […]

  • West Pharma’s vial to IV bag admixture device cleared by FDA for drug transfer

    West Pharmaceutical Services, Inc. has received FDA 510(k) clearance of its Vial2Bag Advanced 20mm Admixture Device, which enables reconstitution and transfer of a drug between a vial and an IV bag. The needle-free device is suited for immediate use and can optimize pharmacy cleanroom time, while assisting in standardizing admixture systems to maximize the efficiency […]

  • New business options aim to ease clinical budget headaches

    Strategikon Pharma is expanding its Clinical Maestro business operations platform for biopharmaceutical participants with two new offerings, a full-service model and an operator model. The company provides a Software as a Service (SaaS) product license for clinical trial RFP planning and budgeting, which includes implementation and training. The Clinical Maestro cloud-based platform enables participants in […]

  • UNICEF to stockpile more than a half billion syringes by year end

    In anticipation of forthcoming Covid-19 vaccine approvals, the United Nations Children’s Fund (UNICEF) announced plans to stockpile 520 million syringes in its warehouses, part of a larger plan to have a billion syringes ready for use through 2021 in order to guarantee initial supply and help ensure that syringes arrive before vaccines are distributed. To […]

  • TurboFil introduces module for automated syringe filling and assembly

    TurboFil Packaging Machines LLC, a company specializing in design and development of liquid filling and assembly machines, has introduced a module offering automated, simplified production for a range of syringe formats. TurboFil’s SimpliFil Syringe Filling & Assembly System Employing a setup that fills syringes via ceramic piston, peristaltic pump or direct draw from a reservoir […]

  • LabVantage to supply lab information management system to Walter Reed unit

    The Walter Reed Army Institute of Research has awarded LabVantage Solutions, Inc. a contract to supply its LabVantage Pharma laboratory information management system (LIMS) to support Covid-19 and other vaccine production programs at the institute’s pilot bioproduction facility. The web-based system provides out-of-the box workflows and functionality to manage pharmaceutical manufacturing, including batch management, stability […]

  • IQVIA: Biosimilars on track to reduce drug costs by $100b over next five years

    Biosimilar medicine availability and use are growing and on track to reduce drug costs by $100 billion over the next five years, according to a new report from the IQVIA Institute for Human Data Science. The development and approvals of biosimilars have been accelerating in the U.S. over the past two years, bringing a total […]

  • Abzena invests $60 million to expand cGMP manufacturing capacity

    Abzena, a contract provider of integrated services for biologics and bioconjugates, has invested $60 million into a new facility for late phase and commercial current good manufacturing practice (cGMP) production. The new 50,000 square foot ‘Lusk’ facility at the company’s site in San Diego houses a process development laboratory and two new cGMP manufacturing cleanrooms for […]

  • Omnicell rebrands unit with mission to raise quality at lower cost for providers and payers

    Omnicell, Inc. is rebranding its Population Health Solutions division into EnlivenHealth, a unit dedicated to enabling retail pharmacies and health plans to improve patient outcomes while reducing costs through software-as-a-service technology. The newly named division serves nearly 30,000 retail pharmacies across the country, delivering patient engagement and personalized communications tools to pharmacists. Technology services offered […]

  • Sandoz launches its first RFID-tagged critical injectable medicines

    Sandoz Inc.’s first two injectable medicines featuring Radio Frequency Identification (RFID) tags will become available to U.S. hospitals beginning this month through a collaborative effort with automated medication management company Kit Check, Inc. The medicines include Anectine 200 mg/10mL and Rocuronium 50mg/5mL and 10mg/5mL (paralytics to relax muscles during surgery or other medical procedures). The […]

  • Cryoport completes MVE and CryoPDP acquisitions

    Cryoport, Inc. has completed the acquisitions of MVE Biological Solutions, a global supplier of manufactured vacuum insulated products and cryogenic freezer systems, and CryoPDP, a provider of temperature-controlled logistics for the clinical research, pharmaceutical and cell and gene therapy markets. In 2019, MVE generated revenue of approximately $84 million and CryoPDP generated approximately $47 million […]

  • Cryoport gobbles up MVE Biological Solutions, extending its deep-frozen scope

    On the heels of what would normally be considered a major acquisition by a relatively small company—Cryoport’s purchase of Paris-based CryoPDP—the company is now leaping ahead with a new acquisition: the life sciences business, MVE Biological Solutions, of Chart Industries. The purchase price is $320 million, which Cryoport is swinging by combining its own cash […]

  • Digital pills, aka ‘ingestible sensors’, are at a crossroads

    EtecctRx, one of a handful of companies pursuing what has variously been called “digital medicine,” “digital pills” and “ingestible sensors,” has appointed Valerie Sullivan, an executive experienced in patient support functions, and is going forward with its IDCap technology for monitoring patients taking oral drugs. Meanwhile, over the summer, a dramatic confrontation has played out […]

  • Cryoport acquires CryoPDP for specialized temperature-controlled shipping

    Cryoport, whose business a few years ago was mostly around providing metal containers (dewars) for cryogenic shipping of life sciences materials, has now become a global player with a focus on the rapidly evolving cell and gene therapy (CGT) field. It opened a service center in the Netherlands in 2019 along with a European-based partnership. […]

  • Pandemic spotlights the rise of mobile research nursing

    The impact of the COVID-19 pandemic on clinical trials has been well chronicled in recent months, with new and ongoing studies targeting a number of diseases, particularly chronic conditions, being hit hard by reductions in patient participation.  Juliet Hulse Jules Moritz This has shifted fundamental approaches in clinical operations, with some pharma sponsors turning to digital and […]

  • Adverse event reporting: NLP’s new niche?

    Getting critical treatments approved and delivered to market is no easy feat. Currently, only 15%1 of drugs successfully make it from clinical trials to U.S. FDA approval—with nearly 75% of failures attributed to safety and efficacy concerns. Once drugs do make it to market, keeping them there requires in-depth pharmacovigilance (PV) practices. Adverse event (AE) […]

  • The investment gold rush continues for regenerative medicines

    The latest sector report from the Alliance for Regenerative Medicine (ARM), covering the first half of 2020, has a surprising finding: Despite the arrival of a global pandemic at the beginning of the year, new investment in cellular and genetic therapies (CGTs) and tissue engineering topped $10.7 billion globally—more than all of 2019. ARM expects […]

  • Clinical trial data-gathering for Covid-19: new technology, new collaborations

    So many research projects are underway for vaccines or therapies for SARS-CoV-2 that there are concerns over getting suitable trial patients; it seems foreordained that there will be duplicative efforts and perhaps contradictory findings. A further complication, much commented on in the research arena for trials generally, is that travel and movement restrictions have made […]

  • Innovative Solutions to Overcome eSource Challenges

    eSource (defined as data initially recorded in an electronic format) formats have provided excellent opportunities to not only streamline clinical research securely, but to increase data quality and trustworthiness. As these methods are continually reviewed for newer and better processes to be leveraged, challenges arise. In effect, many cutting-edge technologies have been developed as the […]