This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Combatting the pandemic has highlighted the importance of the partnership between biopharma organizations and the contractmanufacturing organizations (CMOs) that must flexibly handle outsourced production, which can come suddenly and often must quickly be ramped up.
Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families. | In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR.
The global pharma industry experienced a 9% rise in social media posts on orphan designated drugs in Q1 2023 compared with the previous quarter, with the highest share accounted for Teva Pharmaceutical Industries, according to GlobalData’s analysis of social media posts.
The success of COVID-19 vaccines paved the path for mRNA-based drug products. However, synthesis and manufacturing of mRNA is fraught with several challenges as the production of such biomolecules is complex, cost intensive, requires specialized expertise and dedicated equipment.
The global pharmaceutical industry experienced an 18% drop in company filings mentions of orphan designated drugs in Q1 2023 compared with the previous quarter, with the highest share accounted for by Horizon Therapeutics with 50% year-on-year increase, according to GlobalData’s analysis of over 182 pharmaceutical company filings.
Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. This will improve accessibility to services for AAV-mediated gene therapy programmes.
4th Edition Market Study into Small Molecule Drug Product ContractManufacturer Quality – ResearchAndMarkets.com 4th Edition Market Study into Small Molecule Drug Product ContractManufacturer Quality – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Small Molecule Drug Product ContractManufacturer Quality Benchmarking (..)
Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. As a result, biopharmaceutical contractmanufacturing has picked up pace in the recent years. The same is true for the biopharmaceutical contract services market.
Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. As a result, biopharmaceutical contractmanufacturing has picked up pace in the recent years. The same is true for the biopharmaceutical contract services market.
The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. In 2023, there will be opportunities for a wider range of CMOs that can offer services for less innovative drugs requiring reformulation or biosimilar production.
Although biopharmaceuticals offer significant profit margins and have demonstrated the potential to treat a myriad of disease indications, they are generally associated with high costs of development and complex manufacturing protocols. Advanced and complex technologies are required for manufacturing, as well as testing of biopharmaceuticals.
Pharmaceutical companies often outsource different parts of the manufacturing process, including the production of small molecule active pharmaceutical ingredients (APIs) and parenteral packaging, to contractmanufacturing organizations (CMOs). Procos SpA and Regis Technologies are contracted to produce the small molecule API.
WuXi Vaccines launched its first standalone vaccine contractmanufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development.
Symbiosis Pharmaceutical Services Ltd (Symbiosis), a fast-growing contractmanufacturing organisation (CMO) specialising in sterile global manufacture of pharmaceuticals, vaccines and biopharmaceuticals including Advanced Therapeutical Medicinal Products (ATMPs), has announced the completion of a £1.3
Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.
Global Pharmaceutical ContractManufacturing Market 2021-2026: Increasing Focus on Specialty Drugs and Attractive Nuclear Medicine Sector – ResearchAndMarkets.com Global Pharmaceutical ContractManufacturing Market 2021-2026: Increasing Focus on Specialty Drugs and Attractive Nuclear Medicine Sector – ResearchAndMarkets.com DUBLIN–(BUSINESS (..)
In the last year, well-known contractmanufacturing organisations (CMOs) such as Agilent Technologies (Santa Clara, California) and Abzena (Cambridge, UK) have expanded their continuous manufacturing capabilities. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals.
In preparation for this, drugmanufacturing will begin later this year and will be outsourced to external contractmanufacturing organisations (CMOs). The most common marketed drugs in this space aim to address the hyperammonaemia caused by the defective genes in this disorder.
The current landscape consists of more than 95 players that claim to offer oligonucleotide contractmanufacturing services for research, diagnostic and therapeutic applications. These contract service providers are actively entering into strategic collaborations to augment their existing portfolios. Our Social Media Platform.
Amid a corporate review of AstraZeneca’s global manufacturing and supply network, the company’s Indian subsidiary is planning to close up shop at the “beating heart” of its India operations in Bang | AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing.
You may also be interested in the following titles: Live Biotherapeutic Products and Microbiome Manufacturing Marke t Next Generation Complement Therapeutics Market Intranasal Therapeutics and Drug Delivery Systems Market. Our Social Media Platform. Web: [link]. LinkedIn: [link]. Twitter: [link]. Medium: [link]. Pinterest: [link].
Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. To re ad the previous editions in this series, click here , here and here.
After laying out a goal to launch four new drugs in 2023, Eli Lilly has run into yet another regulatory snag. | The FDA has rejected Lilly’s investigational atopic dermatitis treatment lebrikizumab over findings uncovered during the inspection of a third-party contractmanufacturing organization.
Gilead has filed its COVID-19 drug remdesivir with the FDA, to treat patients with severe disease, under the brand name Veklury. The drug is currently available to US patients under an Emergency Use Authorisation for treatment of hospitalised patients with severe COVID-19. Feature image courtesy of Rocky Mountain Laboratories/NIH.
US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt. Moreover, as an orally-active drug merimepodib could also have found a role outside the hospital setting.
Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.
There is a lower threshold for people from south Asian, Chinese, and Black African or Caribbean family backgrounds, who can experience more serious health implications from obesity, typically allowing treatment with drug if the BMI is 2.5 The post Novo Nordisk gets NICE okay for obesity drug Wegovy appeared first on. kg/m2 lower.
Bisphosphonates are drugs that slow the progression of bone loss. EffRx has received several European regulatory approvals for drugs in its portfolio. Alkindi is one of EffRx’s three marketed drugs. In Italy, Abiogen began distributing its bisphosphonates in 2014 and has since seen some successful drug approvals.
An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC). The post Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs appeared first on.
Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contractmanufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.
Ozempic has been plagued by a shortage fueled by demand, and Wegovy has had contract-manufacturing-related supply chain issues, but that hasn’t prevented Novo’s GLP-1 franchise from achieving overall sales growth of 44% for the first nine months of the year.
Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contractmanufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).
Catalent, one of the largest contractmanufacturers in the pharmaceutical industry, was cited by the U.S. Food and Drug Administration for a series of quality control failures at a facility in Bloomington, Ind., the same plant where the company helps produce two Covid-19 vaccines.
Meanwhile, the EC has also reached an agreement with Gilead Sciences to secure “rapid and equitable” access to its antiviral drug Veklury (remdesivir) – just as there are reports of shortages emerging around the world. It’s ramped up production capacity internally and through a series of agreements with contractmanufacturing partners.
Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. Find the leading pharmaceutical solid dose manufacturing companies in contract marketing.
Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.
Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contractmanufacturer Lonza to make sure it can meet demand. They looked at safety as well as carrying out a futility analysis to gauge whether the drug was working as expected.
In a move set to transform drug discovery, CRO NovAliX has partnered with Bruker, a leader in scientific instruments, through a strategic investment aimed at enhancing drug development success rates.
Pfizer has signed a multi-year agreement with Gilead to manufacture and supply the COVID-19 antiviral remdesivir, which is also being tested in combination with other drugs in an effort to fight the pandemic. Pfizer will provide contractmanufacturing services at its facility in McPherson, Kansas, to supply the drug to Gilead.
With over 18 years of experience, Alexander Dragitsch is a commercial customer service contractmanufacturing (CSCM) manager at Baxter’s Halle/Westfalen facility in Germany. The Halle customer service team is a “one-stop-shop” for client requests when it comes to commercial drug product manufacturing,” explains Dragitsch.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content