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Pharma TrendsEMA Recommends a Conditional Marketing Authorization for Kidney Transplant Medicine By Pharmaceutical Technology EditorsThe European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant. CHMP Recommends Marketing Authorization for Triple Combination Therapy for Cystic Fibrosis By Pharmaceutical Technology EditorsEMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union. Phase III Trial Results Demonstrate Benefit of AstraZeneca’s Breztri Aerosphere By Pharmaceutical Technology EditorsFull results from the Phase III ETHOS trial have demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations in patients with moderate to very severe COPD after treatment with triple-combination therapy Breztri Aerosphere. More PharmTech eBook SeriesRegulatory Sourcebook and Reference, March 2020The Pharmacopoeia Compliance Series features a description of ways bio/pharma companies can participate in monograph development, a practical approach to pharmacopoeial compliance, and a summary of this 12-part series. Other features include a review of FDA s efforts to maintain the quality of the drug supply during the COVID-19 pandemic, a review of FDA s new cell and gene therapy guidance documents, and recommendations for maintaining data integrity. View eBookIndustry NewsCPhI Worldwide Supports Industry with Digital 2020 Experience Jul 01, 2020As a result of disruptions caused by COVID-19, CPhI Worldwide 2020 in-person event will not be taking place in Milan, Italy, but instead will be a unique digital experience to connect the global pharma industry. EIB and EC Pledge Billions More to Ensure Equitable Access to COVID-19 Treatments Jul 01, 2020The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds. EMA Recommends a Conditional Marketing Authorization for Kidney Transplant Medicine Jul 01, 2020The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant. More Supplier NewsSupplier Operations Status Report Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name. Genomics England Launches Next-Generation Genomics Research Platform Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit—a deep tech company—and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research. Cambrex Names Thomas Loewald as CEO Industry veteran Loewald tapped to head CDMO Cambrex. More Bio/Pharma NewsFDA Issues Complete Response Letter to Allergan, Molecular Partners for Ocular Therapeutic BLA The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio. FDA approves Roche’s Phesgo, a Fixed-Dose Combination Breast Cancer Drug Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer. Genomics England Launches Next-Generation Genomics Research Platform Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit—a deep tech company—and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research. More PharmTech TalkGlobal Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally. FDA Speeds New Guidance Development to Inform Manufacturing and Research During Pandemic FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future. FDA Seeks to Restore Credibility with EUA Revocation for HCQ FDA has revoked its Emergency Use Authorization hydroxychloroquine and chloroquine, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronavirus and raise continued concerns about cardiovascular safety risks. More Drug DevelopmentEMA Recommends a Conditional Marketing Authorization for Kidney Transplant Medicine The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant. Genomics England Launches Next-Generation Genomics Research Platform Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit—a deep tech company—and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research. CHMP Recommends Marketing Authorization for Triple Combination Therapy for Cystic Fibrosis EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union. More COVID-19 UpdateSupplier Operations Status Report Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name. CPhI Worldwide Supports Industry with Digital 2020 Experience As a result of disruptions caused by COVID-19, CPhI Worldwide 2020 in-person event will not be taking place in Milan, Italy, but instead will be a unique digital experience to connect the global pharma industry. EIB and EC Pledge Billions More to Ensure Equitable Access to COVID-19 Treatments The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds. Genomics England Launches Next-Generation Genomics Research Platform Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit—a deep tech company—and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research. More Top NewsuniQure, CSL Behring Collaborate on Hemophilia B Gene Therapy in Over $1.6-Billion Deal Jun 29, 2020The companies are entering into a license agreement to provide CSL Behring with exclusive global rights to etranacogene dezaparvovec, uniQure’s investigational gene therapy for patients with hemophilia B. Sanofi to Expand Collaboration with Translate Bio Jun 23, 2020The companies are expanding their existing collaboration and license agreement to develop mRNA vaccines for infectious diseases. Takeda and Neurocrine to Collaborate on $2-Billion Deal for Pipeline Program Development Jun 18, 2020Neurocrine will develop and commercialize seven of Takeda’s pipeline programs, including three clinical-stage assets for schizophrenia, treatment-resistant depression, and anhedonia. More Bio/Pharma and BrexitMixed Opinions on Post-Brexit Approach to Northern Ireland Protocol The protocol on Northern Ireland (NI) once Brexit has been completed has received mixed opinions in industry, according to various press releases. Industry Responds to UK Government’s Approach to Future Relationship with EU ABPI has issued a statement noting that it shares the ambition of the United Kingdom’s government, as set out in its published approach to the negotiations for the future relationship with the European Union (EU).The Future is Bright for Post-Brexit UK Life Sciences, Notes Poll According to executive search firm Odgers Berndtson, its recent poll has highlighted that senior executives in life sciences believe there is a positive future for the United Kingdom’s sector outside the European Union. More PharmTech Europe NewsCPhI Worldwide Supports Industry with Digital 2020 Experience As a result of disruptions caused by COVID-19, CPhI Worldwide 2020 in-person event will not be taking place in Milan, Italy, but instead will be a unique digital experience to connect the global pharma industry. EIB and EC Pledge Billions More to Ensure Equitable Access to COVID-19 Treatments The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds. EMA Recommends a Conditional Marketing Authorization for Kidney Transplant Medicine The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant. More Peer-Review ResearchApproaches to Alleviating Subcutaneous Injection-Site Pain for Citrate Formulations The authors compare formulations containing citrate with other buffers in reducing subcutaneous injection-site pain and discuss a formulation and excipients selection strategy. Determining the Probability of Passing USP Content Uniformity and Dissolution (Immediate and Extended) Tests with CuDAL-Excel The article reports on the CuDAL-Excel program, a set of MS Excel programs transformed and extended from Bergum’s CuDAL version 2 SAS program, designed for industry practitioners to calculate the USP passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios, and for both immediate release and extended release requirements. Identifying the Structure of an Unknown Impurity in a Topical Gel This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product. More Standards/RegulationsEIB and EC Pledge Billions More to Ensure Equitable Access to COVID-19 Treatments The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds. EMA Recommends a Conditional Marketing Authorization for Kidney Transplant Medicine The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant. Europe and Korea to Share Confidential COVID-19 Information The European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have announced an agreement that will enable the parties to share confidential information on COVID-19 medicines. More Sponsored eBooksStrategies for Accelerating Drug and Process DevelopmentThis eBook offers several approaches to meet these needs, including how to gauge the level and type of polymorph screening needed to minimize risk and how to implement Quality by Design during process development. More eBooksOutsourcingCambrex Expands Flexible Manufacturing Capacity in Sweden Cambrex has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s flexible drug substance manufacturing capacity. Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes. Pulling the Levers of Stability Testing The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in development. More

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