Biopharma News
Biopharma news
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News Construction underway for Yposkesi's second commercial bioproduction site
The French CDMO is also creating a new global resource for drug developers of ATMPs -
News WuXi XDC and LegoChem sign MoD to make more ADCs accessible to patients
XDC will provide a full range of development and manufacturing services in one centralised region -
News First-of-its-kind Alzheimer’s drug gains US FDA approval
Biogen and Eisai's Aduhelm approved using the accelerated approval pathway after clinical trials demonstrated it reduced amyloid beta plaques by up to 71% -
News Entegris to expand three life sciences manufacturing facilities
The expanded capacity and capabilities include the development of a dedicated Life Sciences Technology Center -
News Pandemic inevitably slows pharma M&A activity but appetite for deals remains
The initial outbreak of the COVID-19 pandemic delayed merger and acquisitions in the pharma sector, but evidence points to an uptick in activity because the rationale for sealing deals hasn’t changed -
News Bacthera secures double nod to tread on "virgin territory"
The specialist CDMO receives manufacturing licenses from Switzerland and Denmark to supply customers with live biotherapeutic medicines -
News Overall benefits of ready-to-administer systems outweigh the initial cost disadvantages, says BD expert
Pre-fillable syringes for intravenous drugs can replace traditional glass vials and ampoules, particularly in the time-sensitive and fast-paced world of emergency care -
News COVID-19 has exacerbated contract manufacturing challenges but industry continues to respond well to crisis: experts
Coronavirus pandemic has exacerbated manufacturing capacity constraints, particularly in injectable dose and viral vector production, CPHI audience told -
News Drug delivery start-ups recognize benefits of contract manufacturing: CPHI panel
Strong and effective partnerships with CDMOs are essential to success due to the complexity of manufacturing processes -
News Europe approves SK Bioscience’s global COVID-19 vaccine plant
CDMO's site becomes the first vaccine production facility in South Korea to obtain EU GMP certification, allowing it to ship to Europe -
News Novasep to expand HPAPI manufacturing capacity to keep pace with demand
The plan includes the creation of more than 30 full-time jobs at the CDMO's Le Mans site -
News Sterling Pharma Solutions signs up to manufacture OncoTEX's ovarian cancer drug
The CDMO's expertise and capabilities a "perfect fit" for overcoming the challenges of manufacturing this complex molecule -
News Catalent buys Belgian CDMO to boost pDNA manufacturing and service offering
New facility at Gosselies site will host commercial scale pDNA manufacturing as Catalent extends its cell and gene therapy footprint -
News Richter-Helm invests €70M to triple its production capacity in Germany
The addition of two new manufacturing trains will support the demand for high-value biopharmaceutical products -
News Moderna to transform Massachusetts site into industrial technology centre
The expansion will support a 50% increase in production of biotech's COVID-19 vaccine at its manufacturing site -
News CPHI Discover: How is the Biden Administration impacting the US pharma market?
Ahead of the session, How will the New Administration Impact the US Pharma Market? at CPHI Discover on Tuesday 18th May – global pharma’s largest ever virtual gathering – we spoke with one of the speakers, Nielsen Hobbs... -
News Clean Biologics buys CDMO Biodextris
Transaction enables ArchiMed-backed biopharmaceutical services group to establish North American presence and expand activities with complementary services -
News Moderna signs agreement with Gavi to supply COVID-19 vaccine
Biotech ties up deal three days after World Health Organization issued an emergency use listing for the mRNA vaccine -
News New Moderna agreement will double vaccine drug substance production at Visp, says Lonza
Three additional drug substance manufacturing lines will be added to existing ones at Swiss site and are expected to be operational in early 2022 -
News Sanofi to provide fill and finish manufacturing support for Moderna vaccine
French company is now providing manufacturing capacity to support three different COVID-19 vaccines -
News The cost of bringing US pharma manufacturing home
What are the major implications of any drive to reshore US pharmaceutical manufacturing, given that current Asian domination is based on cost savings and capacity? We ask the experts... -
News Bharat Biotech scales up Covaxin manufacturing capacity in India
The company will expand multiple facilities in Hyderabad and Bangalore to help reach its target of approximately 700 million doses per year of the COVID-19 vaccine -
News CPHI Discover: Two-Tier Contract Market in China as Top CDMOs Grab all the Growth
Ahead of CPHI Discover (17-28 May, 2021) - global pharma's largest ever virtual gathering - we spoke to CPHI Annual Report expert Vicky Xia, China Head at BioPlan Associates on the biologics trends she is seeing emerging in the contract services sp... -
News AGC Biologics and Rocket Pharma expand LVV manufacturing partnership
The expanded agreement will ensure Rocket Pharma's supply of lentiviral vectors across its pipeline -
News Sartorius expands manufacturing capacities in China and the UK
The expansions will enable the company's local customers to test equipment directly at the manufacturing site -
News Abzena to build US biologics manufacturing plant in North Carolina
New facility will be research partnering company’s sixth global site and will be dedicated to mammalian biologics -
News Lonza and Junshi Biosciences expand biologics manufacturing collaboration
The antibody-based products will be expressed using Lonza's GS Xceed Gene Expression System -
News Sanofi strengthens vaccines manufacturing capacity in Singapore
The company will invest €400 million in a new site to enable it to produce vaccines on a massive scale for Asia -
News Catalent boosts plasmid DNA manufacturing at Rockville with addition of ABEC fermenters
The company's custom single run single-use fermenters supplied on fast-track schedule to support flexible manufacturing of plasmid DNA -
News Bavarian Nordic receives $28 million Ebola vaccine order from J&J
The smallpox vaccine specialist will manufacture and deliver bulk drug substance of MVA-BN Filo vaccine during the second half of this year -
News Moderna and Catalent expand COVID vaccine manufacturing agreement
The extended collaboration comes after reaching the initial milestone of producing 100 million doses -
News Sterling Pharma seals acquisition of bioconjugation specialist ADC
By integrating its HPAPI capabilities with those at ADC Biotechnologies' Deeside facility, small molecule CDMO will be able to offer the development and manufacturing of toxin linkers -
News TCR2 bets on lead candidate with new cell therapy manufacturing facility
The US facility in Rockville is expected to accelerate the company’s commercial-scale manufacturing timelines of gavo-cel -
News Lonza to support Pionyr Immunotherapeutics' oncology drug development
The CDMO will provide cell line development, process development, drug substance and drug product manufacturing for Pionyr’s monoclonal antibody candidate -
News CPHI Webinar Series: Latest Approaches for Large Volume Drug Delivery
Innovation in the design and development of large volume drug delivery devices can solve the challenge of accommodating the increasing trend towards patient self-administration and home care while at the same time ensuring that drugs that require intra... -
News Fujifilm names North Carolina as location for $2 billion large-scale cell manufacturing site
CDMO subsidiary Fujifilm Diosynth Biotechnologies will operate the site which is expected to be operational in 2025 -
News Pfizer to sell Chinese biologics manufacturing facility to WuXi
Multinational makes ‘difficult decision’ to halt presence in Chinese biosimilars market five years after $350 million investment -
News Wuxi Vaccines' Ireland site still on course for 2022 despite COVID challenges
Despite COVID-related challenges and supply chain issues, the CDMO's $240 million new facility is on target to open next year -
News European countries suspend use of AstraZeneca COVID-19 vaccine as regulators investigate blood clot reports
Regulators stress temporary halt is precautionary measure and that there is currently no evidence linking the shot to adverse events -
News Special Podcast: CPHI Outlook Roundtable - Listen Now
In this special roundtable podcast exploring potential opportunities in a post-vaccinated world, we are joined by a panel of three world class experts – Bikash Chatterjee, CEO of Pharmatech Associates; Parrish Galliher, Managing Director, Bi... -
News Clinical Development Success Rates and Contributing Factors 2011-2020: New Report from Informa Pharma Intelligence
Biologic products advance through clinical development with a higher success rate than traditional small molecules, this new analysis of clinical development success from Informa Pharma Intelligence, the Biotechnology Industry Organization and the... -
News Merck agrees to support Johnson & Johnson in vaccine manufacturing deal
Funding from BARDA helps the company to adapt and make available a number of existing manufacturing facilities for the production of SARS-CoV-2 vaccines and medicines -
News WuXi AppTec completes $135 million acquisition of Oxgene
The addition further strengthens WuXi's cell and gene therapy service offerings for global customers and will be Wuxi ATU's first facility in Europe -
News Pharmaron pays $118.7 million for AbbVie UK biomanufacturing site
This transaction complements Pharmaron’s recent acquisition of Absorption Systems in the US for building an integrated cell and gene therapy services platform -
News Catalent takes double action to boost cell and gene therapy services
The company acquires a pDNA CDMO and launches pDNA development and manufacturing services at its Rockville, Maryland facility -
News BMS expands global footprint with new cell therapy manufacturing facility
The new site will be equipped to enable quick ramp-up of capacity for clinical and commercial cell therapy products -
News Catalent secures softgels commercial supply agreement with Aurinia
The CDMO will manufacture recently FDA-approved Lupkynis as a softgel dosage form at its St Petersburg, Florida, facility -
News MaxiVAX and Minaris strike immunotherapy manufacturing partnership deal
The manufacturing agreement includes process development for scale-up and technology transfer with the goal of supplying Phase II and III clinical studies -
News Novavax agrees huge supply deal with Gavi for 1.1 billion doses of COVID-19 vaccine
Biotech will manufacture shots with partner SII for equitable vaccine distribution programme, COVAX -
News Dermapharm expands COVID-19 vaccine production capacity at ex-Merck site
The company's additional production capacities are scheduled to go into operation in May 2021 -
News Catalent secures Trizell cell therapy development and manufacturing contract
The agreement allows the CDMO to "stay on the forefront of emerging indications and cell types" -
News Clinical knowledge deficits to slow biotech development, warns Europital
The CRO predicts investment communities will come to the rescue of small and medium companies looking to advance their candidates -
News Argonaut Manufacturing Services opens custom controls & standards facility
The CMO has designed the new service to alleviate manufacturing challenges associated with positive controls and nucleic acid templates -
News EU delivers export threat after AstraZeneca cuts Q1 vaccine supply
European Commission pressures pharma firm over reduced shipments amid criticism for slow vaccine rollout across block -
News Emergent to manufacture Humanigen COVID-19 therapeutic
The CDMO gears up for rapid deployment of its clinical-to-commercial manufacturing operations for its seventh collaboration to help deliver COVID-19 treatments -
News Sartorius and RoosterBio partner to advance scale-up of hMSC manufacturing
The collaboration aims to accelerate the development and commercialization of groundbreaking cell-based regenerative cures -
News Thermo Fisher buys Novasep viral vector manufacturing business
Expanded global capacity addresses growing demand for cell and gene therapy -
News Merck KGaA expands its mRNA capabilities through AmpTec acquisition
AmpTec's differentiated PCR-based technology has shown to have advantages compared with other technologies for mRNA manufacturing -
News Baxter BioPharma Solutions to manufacture Novavax COVID-19 vaccine
Manufacturing at Baxter's Halle/Westfalen, Germany facility will help increase commercial production and promote access in UK and European markets -
News Abzena to open new biologics GMP manufacturing site in the US
The new facility will house up to 12 X 2000-L bioreactors and will be equipped to handle existing and new advances in manufacturing -
News Bavarian Nordic to supply smallpox vaccines to three European countries
The company hopes its newly built fill and finish facility will assume commercial manufacturing this year -
News Fujifilm Diosynth Biotechnologies to establish new viral vector manufacturing facility in Boston
The $40 million investment marks the company's third viral vector manufacturing site -
News AGC Biologics becomes first manufacturer of newly approved Libmeldy
The CDMO will use its gene and cell therapy commercial expertise to bring "remarkable innovation" to young eligible patients -
News Wuxi agrees €150 million deal to buy Wuppertal drug substance facility from Bayer
Acquisition will extend the Chinese CDMO’s European footprint and will complement Leverkusen drug product site -
News Lonza to expand bioconjugation capabilities at Visp site
CDMO will add two production suites for clinical and commercial supply and extend lab space to double analytical and process development capacity -
News Spanish CDMO Reig Jofre to manufacture Janssen COVID-19 vaccine candidate
The company will be responsible for the formulation, filling, and packaging of Ad26.COV2-S at its new €30 million injectable products plant in Barcelona -
News Thermo Fisher boosts clinical supply chain and distribution services in Europe
Two new facilities in Germany will provide clinical supply and cold chain services to support growing demand -
News Lilly nabs gene therapy company Prevail Therapeutics
Through the acquisition, Lilly will establish a gene therapy program via Prevail's gain clinical-stage and preclinical neuroscience assets -
News AstraZeneca taps Halix for commercial drug substance manufacture of COVID-19 vaccine
Dutch CDMO will expand with two additional viral vector production lines to meet the increased demand -
News Catalent starts manufacture of Passage Bio's lead gene therapy products
The CDMO will provide packaging, labeling and distribution services through its FastChain demand-led supply offering -
News CPHI Online Report - Pharma Market Trends 2021
Twelve pharma market trends we anticipate across 2021 for the drug development, manufacturing and outsourcing sectors. -
News AZ and Oxford COVID-19 vaccine brings end of pandemic a little closer
AZD1222 is 90% effective, cheap to produce and easy to store, distribute and administer -
News Alvotech and Yangtze River forge biosimilar deal for Chinese market
The partnership will focus on commercializing eight biosimilar medicines in China for the domestic market -
News Early trial results hail Moderna's COVID-19 vaccine as 94.5% effective
Data also show that mRNA-1273 remains stable at 2–8°, the temperature of a standard home or medical refrigerator, for 30 days. -
News Seqirus to build $800m influenza vaccine manufacturing facility in Australia
The facility will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere. -
News European Commission wraps up CureVac COVID-19 vaccine supply deal
Europeans set to benefit from the EC's authorization of COVID-19 candidate vaccine supply agreement, securing up to 405 million doses of CVnCoV -
News Vibalogics establishes US presence with virotherapy facility in Boston
The specialist CDMO's $150 million 3-year investment plan will provide a complete suite of virotherapy services to support drug developers and their most "revolutionary" products. -
News Pharmapack Podcast: The opportunities and challenges of bringing connected devices to market in the drug delivery sector
Smart, connected devices are revolutionizing drug delivery in the ways they can gather, order and transmit crucial patient data to physicians -
News Who are BioNTech?
CPHI lifts the lid on the relatively little known German biotech and partner of Pfizer behind the most promising COVID19 vaccine candidate -
News Biomanufacturing: a future shaped by evolving markets, technology and global events
Gareth Macdonald
The coronavirus pandemic has impacted biopharmaceutical manufacturing and is likely to continue to do so for years to come. But the pandemic is not the only thing changing how the industry goes about making medicines. -
News Stelis starts next phase of investment into its biologics manufacturing facility
This phase sees the CDMO start work on installing two 2,000-L single-use bioreactor trains in its mammalian cGMP facility. -
News Pfizer and BioNTech COVID vaccine proves 90% effective
Results from a Phase III clinical study found Pfizer and BioNTech's mRNA-based vaccine candidate, BNT162b2, is more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection, the companies announced Monday... -
News Altimmune signs up Lonza to manufacture intranasal COVID-19 vaccine
Altimmune adds Lonza as a manufacturing partner for supply of AdCOVID, its single-dose intranasal vaccine candidate for COVID-19. -
News It’s time for the pharmaceutical sector to do the smart thing
For many years, well before the arrival of COVID-19, the pharmaceutical sector has faced increasing pressures, with challenges such as fake goods and grey market diversion. There is also increased emphasis on how to ensure patient adherence, as this di... -
News The challenges of innovating in packaging and drug delivery
In this interview with Pharmapack, Arnaud Steiner, R&D Packaging Manager at Virbac shares his thoughts on trending issues in the packaging market such as patient centricity and eco-design, the challenges of managing the development of new packaging and... -
News Nostrum Laboratories recalls lots of metformin tablets after nitrosamine detection
Company is the latest in a lengthening list of pharma companies recalling the diabetes medicine over unacceptable levels of NDMA -
News Minaris Regenerative Medicine to expand its cell & gene therapy manufacturing capacity
The expansion will entail building two new facilities - one in Germany, the other in Japan. -
News Sanofi and GSK to support COVAX with 200 million doses of COVID-19 vaccine
The companies anticipate first results of Phase I/II in early December 2020, to support the initiation of a pivotal Phase III study before the end of the year. -
News Russia submits Sputnik V emergency use and prequalification application to WHO
The Russian Federation has become one of the first countries to apply to the WHO for prequalification of its vaccine, Sputnik V, against the novel coronavirus infection. -
News Vaccine manufacturing demand has had limited effect on regenerative medicine sector, panel tells CPHI audience
The ramping up of vaccine manufacturing demand amid the COVID-19 pandemic had an initial impact on cell and gene therapy production but the regenerative medicine sector has largely weathered the storm, according to senior industry figures in a recent p... -
News The future of bacterial manufacturing is now
By Duncan Emerton, PhD; Director, Custom Intelligence, Informa Pharma Intelligence -
News RedHill Biopharma secures expanded manufacturing for COVID-19 therapeutic candidate
The biopharma company collaborates with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing. -
News Synthesis Theta
The recipe for efficiency by Universal Pack -
News Company Profile
MPA Technical Devices Srl is an Italian company specializing in designing and manufacturing top quality and accurate dosing systems. -
News Company introduction – Cyclolab Cyclodextrin Research and Development Ltd
CycloLab Cyclodextrin Research and Development Ltd. is a private SME with the focus on cyclodextrin research and development for over 30 years. We are working in the fields of pharmaceutical, cosmetic and food industry, agrochemical, environmental and ... -
News Streamlining biologics and biosimilars drug development process through a single source
The increasing number of complex and sensitive biologics and the administration shift from hospitals to patients' homes are two of today’s main biopharmaceutical industry challenges. Complex drugs and self-administration require an appropriat... -
News Biologics & biosimilars: Drug delivery innovation is finally here
Pushpa Vijayaraghavan Director, Healthcare & Lifesciences Practice, Sathguru Management Consultants -
News Trends in autoinjectors and pre-filled syringes
The rise of specialty and biologics has meant that one of the fastest growing segments by value today are Injectables demonstrating a 5-Year CAGR of 10%. This growth of course has implications and creates pressures across various areas such as treatmen... -
News Biosimilars as market drivers for autoinjector technology
Charbel Tengroth, Managing Director, Tengroth Consulting -
News CPHI Festival of Pharma Blog
With the Festival of Pharma now well and truly upon us, keep abreast of all that is happening and when over the ten days of this vast virtual event. -
News Patient-centric medicines the way forward during COVID-19 crisis, say CPHI panel
Festival of Pharma roundtable discusses how drug delivery formulation and development is focused on hospital-to-home care setting -
News Abzena invests $60m into cGMP manufacturing capacity
The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects. -
News MHRA approves second of two GMP manufacturing suites for COVID-19 vaccine candidate
The two suites, established with VMIC equipment and operated by Oxford Biomedica, will be operating at 1000-L scale. -
News HPNE introduces defined tubing routing for single-use facilities
Flexible support system simplifies and secures tubing paths for biopharmaceutical manufacturers. -
News Purification specialist BIA Separations to become part of Sartorius
BIA Separations will be Sartorius's center of excellence for purification of cell and gene therapeutics. -
News Cobra Biologics to manufacture plasmids for COVID-19 vaccine trial
Scancell’s DNA vaccine could provide long-lasting immunity against COVID-19 by generating protection against this and new strains of coronavirus. -
News Novel customizable and flexible single-use assembly solution
Hugh Purity New England's solution can utilize other vendors' components and can be implemented directly into any process. -
News New thin film technology to revolutionize vaccine storage and distribution
Up to 500 doses of vaccine to be placed on a single wafer-thin and stored for extended periods of time. -
News Ingredients and Formulation - evolving opportunities and challenges
Ingredients are the lifeblood of the pharmaceutical and nutraceutical industries. They connect today’s cutting-edge medicine and consumer products makers with their origins in the chemicals sector of the late nineteenth century. While ingredients... -
News Alvotech and DKSH extend biosimilar partnership in Asia
The companies will commercialize six new biosimilar candidates addressing multiple therapeutic areas. -
News Micreos initiates trial to evaluate world's first endolysin-drug as a therapy for atopic dermatitis
The targeted removal of one particular bacterial species from the skin microbiome, while preserving the beneficial ones, represents a new way to treat atopic dermatitis. -
News Tackling Issue of Pharmaceuticals in the Environment from Manufacturing Emissions
The second in a quarterly series of blog posts about responsible supply chain management from the PSCI Chair, Caroline O'Brien -
News T-knife and Catalent sign tech transfer and manufacturing agreement
Catalent to manufacture clinical batches of T-knife's platform process for TCR-based cell therapy at its site in Gosselies, Belgium, for European trials in 2021. -
News TESSA technology for robust and reproducible AAV manufacture at scale
Novel, plasmid-free manufacturing system reduces the cost of goods and improves AAV quality to enable development of safer gene therapies. -
News Humanigen and Lonza collaborate to expand manufacturing of COVID-19 therapeutic candidate
Humanigen's proprietary monoclonal antibody may prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19. -
News Univercells Technologies introduces new upstream platform for virus manufacturing
The NevoLine Upstream platform has been designed to address the needs of gene therapy and vaccine innovators and CDMOs for robust and cost-effective upstream viral vectors manufacturing. -
News Pharmapack 2021 opens entries for Patient-Centric Design Awards
The global pandemic continues to impact lots of industries and slow down business, but the pharma and packaging industries are striving to tackle new challenges to bring more faster and safer solutions to deliver medication to patients. The Pharmapack ... -
News The latest patient-centric packaging & drug delivery solutions revealed in Pharmapack 2020 Innovation Gallery
Pharmapack Europe, the leading conference & exhibition in pharma packaging & drug delivery business traded the successful 2020 edition at the beginning of February. The innovation gallery, as the key feature of this event, has gathered the most recent ...
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