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- Total Results: 640
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Avid Bioservices to Serve as Commercial Manufacturer for ADC Therapeutics’ ZYNLONTA™ (Loncastuximab Tesirine-Lpyl)
TUSTIN, Calif., May 25, 2021 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced that it will serve as the commercial manufacturer for the humanized monoclonal antibody portion of ZYNLONTA™ (loncastuximab tesirine-lpyl), a recently approved cancer treatment developed…
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Batavia to develop innovative clinical process for RocketVax’s second generation COVID-19 vaccine
Leiden, 6 July 2021 – Today, Batavia Biosciences announces their collaboration with RocketVax, a subsidiary of Swiss Rockets AG developing vaccines based on breakthrough genetic engineering. Under the agreement, Batavia will develop the clinical process and deliver clinical product of RocketVax’s vaccine candidate against the SARS-CoV-2 virus.
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Swiss Government turns to swissfillon for COVID-19 test kit production
Visp, Switzerland, July 7, 2021: Swissfillon AG, a leading Swiss Drug Product Contract Manufacturing Organisation specializing in the sterile filling of pharmaceuticals, has supplied 0.8 million aseptically filled transport media in syringes for the Swiss Army Pharmacy’s COVID-19 PCR test kit. The project began back in March 2020, when the Swiss Army Pharmacy approached Swissfillon. The mandate to provide testing capabilities for Switzerland’s 8.6 million population was urgent.
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SP Doubles Global Manufacturing Capacity for Fill-Finish and Freeze Dryers to Meet Increasing Demand
SP Scientific Products (SP) announces that to stay ahead of the ever-increasing global demand for its state-of-the-art fill-finish and lyophilization (freeze dryer) equipment, it has more than doubled its worldwide manufacturing capacity. Central to this expansion is the opening of a new large-scale manufacturing facility in Barcelona, Spain, for SP i-Dositecno sterile fill-finish systems. SP is also increasing its manufacturing headcount and streamlining many of its manufacturing processes. These strategic advancements are already ensuring reduced order-to-delivery lead…
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Fertin Pharma and associated companies acquired by Philip Morris International
EQT announced today that it has agreed to sell Fertin Pharma, a specialist contract development and manufacturing organization (CDMO) in innovative oral and intra-oral delivery technologies, to Philip Morris International (PMI) (NYSE: PM). With headquarters in Vejle, Denmark, Fertin Pharma is a leading specialist CDMO in innovative oral and intra-oral delivery technologies to support healthier living. The Company develops and manufactures innovative delivery systems, such as chewing gums, tablets, and powders, used for pharmaceutical and nutraceutical applications.…
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Lupin's Novel Laboratories knocked by FDA for cleanliness, quality issues at New Jersey plant
One warning letter is bad enough, but when citations multiply across a company's sites in just four years, a pattern starts to emerge.
FDA investigators are charging Lupin’s Novel Laboratories with a raft of cleanliness, consistency and quality control problems at a New Jersey factory despite a prior scolding from the regulator in November. Novel Laboratories’ manufacturing flubs are just the latest in a string of parallel offenses by parent company Lupin, the FDA said in a warning letter posted online this week.
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AMRI becomes Curia
Formerly AMRI, Curia is global contract research, development and manufacturing organization dedicated to helping our partners advance from curiosity to cure. With locations in North America, Europe and Asia, Curia’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical Services, API Manufacturing and Drug Product
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BioMed X and Merck KGaA, Darmstadt, Germany launch new research program in oncology
Heidelberg, Germany, July 5, 2021 – BioMed X, a leading independent research institute, announced today the start of its eighth joint research program with Merck KGaA, Darmstadt, Germany. The new program will explore the role of extrachromosomal DNA in cancer and it will complement the research of two ongoing oncology programs at BioMed X in the fields of DNA damage response and RNA…
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Viralgen increases its manufacturing capacity with the opening of a new facility for commercial production
Viralgen has been serving the rapidly expanding gene therapy market with its robust AAV manufacturing platform since 2018, supporting customers in preclinical through phase 2. Viralgen’s new facility, located in the same technology park as Viralgen’s existing manufacturing footprint, expands capacity more than 5-fold and enables full support of customer projects from early pre-clinical through to commercial scale. Equipment validation and facility certification activities will continue throughout 2021 with the first commercial-grade 2,000L batches released by mid-2022. This expansion has been…
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GENEZEN BREAKS GROUND ON CGMP LENTIVIRAL VECTOR PRODUCTION FACILITY
Genezen Laboratories, Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early-phase process development, vector production and analytical testing services, has broken ground on a new multiphase master plan for a 75,000+ square foot cGMP-compliant Lentiviral vector production facility.
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PerkinElmer Agrees to Acquire Viral Vector Gene Delivery Leader SIRION Biotech
WALTHAM, Mass.–(BUSINESS WIRE)–Jun. 22, 2021– PerkinElmer, Inc. (NYSE: PKI) (“PerkinElmer”) is pleased to announce it has entered into an agreement to acquire SIRION Biotech GmbH, a leading, global provider of viral vector-based technologies that drive improved delivery performancefor cell and gene therapies. The acquisition is expected to close during the third quarter of 2021.Headquartered in Munich, Germany, privately held SIRION has approximately 50 employees based in Germany, the U.S. and France. The company has…
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French biopharma company Ipsen invests €25m Dublin plant
Investment aimed at boosting capacity of plant to produce ‘transformative medicine’
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Ortec, Inc breaks ground in Newcastle West, Ireland
Newcastle West, May 14, 2021, Ortec, Inc., a leading supplier of contract formulation and manufacturing services to the life science industry, has announced that construction has begun on its European Headquarters, Manufacturing and Operations Centre in Newcastle West, Co. Limerick. The privately-owned company communicated its intention to establish its European HQ at Newcastle West in 2016 and is now pleased to progress the development.
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Entegris Expands Life Sciences Production Capacity and Capabilities
Billerica, MA – Entegris, Inc. (NASDAQ: ENTG), a world-class supplier of advanced materials and process solutions for the semiconductor and other high-technology industries, today announced the expansion of its Life Sciences manufacturing facilities located in Billerica, MA; Bloomington, MN; and Logan, UT.
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Ocugen Secures Manufacturing Partnership for US Production of COVID-19 Vaccine Candidate, COVAXIN®
MALVERN, PA, June 15, 2021 - Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it has entered into an agreement with Jubilant HollisterStier of Spokane, Washington for manufacturing of vaccine candidate COVAXIN® for the US and Canadian markets.
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Cellenkos® Selects Cryoport to Support On-Demand, Flexible COVID-19 Therapy Shipments to Patients in Need
NASHVILLE, Tenn., June 22, 2021 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or "the Company"), a global leader in temperature-controlled supply chain solutions for the life sciences industry, today announced that Cellenkos®, Inc., a privately held, clinical-stage biotechnology company, has selected Cryoport to provide a staged, on-demand, logistics solution for COVID-19 therapy shipments for patients in need.
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AbCellera to Build Antibody Manufacturing Facility in Canada
VANCOUVER, British Columbia, -- AbCellera (Nasdaq: ABCL) today announced it has secured a site in Vancouver for the construction of a Good Manufacturing Practices (GMP) manufacturing facility for the production of therapeutic antibodies, which will be the first of its kind in Canada. The 130,000-square-foot facility will expand AbCellera’s capabilities in bringing new antibody therapies to clinical trials, supporting Canada’s efforts to respond quickly and effectively to future pandemics and providing AbCellera’s partners with a full solution for accelerating their programs…
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WHO voices concerns over Sputnik V Covid vaccine plant
WHO reports issues with quality control data and test results as Slovakia announces it is offloading 160k doses
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Horizon Therapeutics plc Announces Purchase of Irish Manufacturing Facility
DUBLIN--(BUSINESS WIRE)--Jun. 17, 2021-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that it has reached an agreement to purchase a drug product manufacturing facility from EirGen Pharma, an OPKO Health Company (Nasdaq: OPK) in Waterford, Ireland. The facility, which is located in an IDA Ireland business park, includes a filling line and lyophiliser, or freeze dryer, that can be used for both Horizon’s commercial medicines, including its rare disease biologics…
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Curevac shares slump as Covid vaccine reports 47% efficacy
Nasdaq-traded shares in Tübingen-based firm collapsed by almost half following admission
Hopes for Germany’s second Covid-19 vaccine are fading after pharmaceuticals company Curevac admitted its much-delayed mRNA jab has an efficacy rate of only 47 per centNasdaq-traded shares in the Tübingen-based firm collapsed by almost half in late trading after the company’s admission that their jab, developed in partnership with Bayer, does “not meet prespecified statistical success criteria”.
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FDA Takes Steps to Increase Availability of COVID-19 Vaccine
Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available. The agency is announcing today that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. Before making this decision, the FDA conducted a thorough…
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Long-suffering Dendreon finds new avatar as contract manufacturer for cell therapy partners
Filing for bankruptcy in 2014 might have seemed the end for Dendreon. But seven years later—and three rounds of being bought and sold—the company has resurfaced. This week, Dendreon revealed plans to establish a CMO division offering end-to-end manufacturing of complex…
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Yposkesi launches construction of its second bioproduction site.
Corbeil-Essonnes (near Paris), France, June 14, 2021 – Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies, today announces the launch of project SKY, the construction of Yposkesi’s second commercial cell and gene therapy facility and new global resource for drug developers of biologics, also called ATMPs (Advanced Therapy M
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Exelead Helps Manufacture Pfizer-BioNTech Covid-19 Vaccine
INDIANAPOLIS — Exelead, Inc., a contract development and manufacturing company providing complex medicines to customers and their patients, delivered its first vaccine precursor batch manufactured at its facility, as part of an agreement with Pfizer for the Pfizer-BioNTech COVID-19 Vaccine. In its recently expanded, state-of-the-art facilities, Exelead is supporting production of the vaccine by dedicating a portion of its manufacturing capacity to this effort. “We are extremely proud to be part of the manufacture…
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Revolo and Northway Biotech Enter Manufacturing Partnership
To manufacture novel binding immunoglobulin protein, ‘1805, to support phase 2 trials in rheumatoid arthritis and uveitis.
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WuXi Biologics, WuXi STA Establish WuXi XDC JV
To provide contract development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs).
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Moderna Announces New Drug Substance Production Agreement with Lonza in the Netherlands
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 2, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has entered into an additional agreement with Lonza (SIX: LONN) to support drug substance manufacturing for its global supply chain. The agreement will establish a new production line at Lonza’s Geleen site in the Netherlands, contributing to the supply of an additional 300 million doses of Moderna’s updated booster variant vaccine candidate,…
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AGC Biologics’ Heidelberg Facility to Further Supply Plasmid DNA for COVID-19 Vaccine
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced its partnership with BioNTech SE (Nasdaq BNTX) to further supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGC’s Heidelberg, Germany facility.
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Merck Accelerates Scale Up of Lipids to Meet Covid-19 Demand
To meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics, Merck, a leading science and technology company, has launched a new, high-purity synthetic cholesterol product, nine months ahead of schedule “Tapping into two decades’ experience of developing and manufacturing high-quality lipids, we designed a proprietary process to bring our new SAFC® synthetic cholesterol product to market nearly a year early,” said Andrew Bulpin, head of Process Solutions, Life Science, at Merck. “With the introduction…
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Onyx’s capabilities bolstered with commercial API manufacturing license
Onyx Scientific, a small molecule API contract development and manufacturing organisation has received a commercial API license for its UK facility.
The license, granted by the Medicines and Healthcare Products Regulatory Agency (MHRA), allows Onyx to support API projects from pre-clinical studies to low volume commercial manufacture.
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AstraZeneca breast cancer drug reduces recurrence rates, data shows
Lynparza may be effective medication for patients with BRCA genetic mutation
Results from the OlympiA Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
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Samsung Biologics Expands Vaccine Manufacturing Capabilities
Samsung Biologics, a global CDMO providing end-to-end contract development and manufacturing services, unveiled plans to add mRNA vaccine drug substance (DS) manufacturing capability to the current facility in Songdo, ready for cGMP operations within the earlier part of the year in 2022. mRNA has been the technology of choice for many COVID-19 vaccines due to its characteristics of safety and fast scalability in manufacturing.
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CPL Completes Successful Virtual Health Canada Audit
June 2, 2021, Mississauga, Ontario, Canada— Contract Pharmaceuticals Limited Canada (CPL), a Health Canada and US FDA inspected manufacturer of liquid and semi-solid prescription and regulated OTC products, has successfully completed a virtual cGMP audit of its manufacturing facility by Health Canada. Since the onset of the global pandemic, CPL has focused on keeping our employees safe while also continuing to deliver product for our customers. One innovation was to create a 360° virtual tour that “walks” our customers and regulators…
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VIVEbiotech Increases Viral Vector manufacturing capacity
VIVEbiotech’s production capacity will increase by 400%, with an increase in average batch size per year from 20 in 2020 to 80 in 2022.
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Ori and Vineti Partner for Manufacturing and Supply Chain Solutions in CGT
LONDON and SAN FRANCISCO, May 26, 2021 (GLOBE NEWSWIRE) — Ori Biotech, an innovator in cell and gene therapy manufacturing, and Vineti, a provider of leading digital enterprise platforms for cell and gene therapy supply chains, today announces that the companies will partner to produce a fully pre-integrated solution to modernize, fast-track, and streamline the manufacture and delivery of cell and gene therapies (CGTs).
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Humanigen Selects Chime Biologics as Manufacturing Partner
Humanigen, Inc. (Nasdaq:HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, and Chime Biologics (“Chime”), a world-class contract development and manufacturing organization (CDMO), today announced that they have entered into a manufacturing services agreement to produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the United…
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Resilience Bolsters Canadian Biomanufacturing Site
SAN DIEGO & BOSTON--(BUSINESS WIRE)--National Resilience, Inc. (Resilience), a company building the world’s most advanced biopharmaceutical manufacturing ecosystem, announced that the Government of Canada will invest CAD 199.2 million ($163.8 million), through the Strategic Innovation Fund, in the company’s Ontario-based subsidiary Resilience Biotechnologies Inc. (RBI) to modernize and expand production capacity.
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Pfizer to start producing Covid-19 vaccine in Ireland by end of the year
Pfizer is to start producing supplies of its Covid-19 vaccine from its Grange Castle plant in Dublin as part of a new $40 million investment locally, the company confirmed on Wednesday. The Grange Castle facility will produce the mRNA drug substance, making it only the second plant outside of Pfizer’s flagship factory in Andover, Massachusetts to do so. Drug substance is the essential active ingredient in the vaccine. The new multimillion-euro investment is on top of a €300 million programme of investment announced for three of Pfizer’s Irish plants…
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Covid vaccine packaging group doubles Waterford staff
US pharma group makes stoppers for vials of Covid-19 vaccine. West Pharmaceuticals has doubled its Waterford workforce to meet demand for Covid-19 medical supplies. West specialises in packaging for injectible drugs. That includes stoppers for vials of Covid-19 vaccines. The company says it is involved with more than 90 per cent of the companies that have Covid-19 vaccines or vaccine candidates in phase-three trials. That has seen the US group scale up operations and working schedules at the Waterford plant that it opened in 2018 in response to a surge in customer demand…
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Eli Lilly appoints 3 Indian Pharma Companies —Cipla, Lupin and Sun Pharma to bolster supply of COVID-19 drug baricitinib
INDIANAPOLIS, May 4, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution…
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- Total Results: 640
- Total Pages: 16
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