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Janssen buys rights to Hemera’s eye disease gene therapy candidate

3rd December 2020 Johnson & Johnson’s pharmaceuticals division Janssen has purchased rights to acquire an investigational gene therapy asset for geographic atrophy from Hemera Biosciences. Geographic atrophy is an advance and severe form of age-related macular degeneration (AMD) which affects five million people globally. Hemera’s investigational gene therapy, HMR59, is administered as a one-time intravitreal injection to aid vision preservation in patients with geographic atrophy. HMR59 is designed to increase the ability of retina cells to produce a soluble form of CD59, a protein that protects the retina from damage. Patients with wet AMD often have low levels of this protein, which is an essential component of the body’s natural immune response. “Geographic atrophy is a devastating form of AMD that impacts the ability to accomplish everyday tasks, such as reading, driving, cooking, or even seeing faces,” said James List, global therapeutic area head, cardiovascular & metabolism, Janssen Research & ...
- Source: drugdu
- 298
- December 9, 2020
Gene therapy
Genentech’s Gavreto scores US approval for RET thyroid cancer

4th December 2020 Roche’s Genentech division and its partner Blueprint Medicines have scored a new approval for Gavreto in the US for the treatment of RET-altered thyroid cancer. The US Food and Drug Administration (FDA) has cleared Gavreto (pralsetinib) for the treatment of adult and paediatric patients with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancer. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations. This newest approval is based on results from the phase I/II ARROW study, in which treatment with Gavreto led to an overall response rate (ORR) of 60% in 55 people with previously-treated RET-mutant metastatic medullary thyroid cancer (MTC). In addition, Gavreto treatment led to an ORR of 66% in 29 people with RET-mutant advanced MTC who had not been previously treated with cabozantinib and vandetanib. Around 10-20% of people with papillary thyroid cancer have RET-fusion positive ...
- Source: drugdu
- 267
- December 8, 2020
RET thyroid cancer
How are Vaccines Stored?

Many vaccines have highly specific storage requirements that if not met can reduce their potency significantly, even rendering them completely ineffective. Vaccines must be stored correctly from the moment they are manufactured until they are ultimately administered, and this is the shared responsibility of the manufacturer, distributor, and healthcare provider. What are the most common storage conditions? The vast majority of vaccines should be stored at between 2-8⁰C in a refrigerator, with a preferred average of 5⁰C, though some should remain frozen in a range between -15 to -50⁰C. Additionally, many should be protected from light and are packaged appropriately, as UV-light can damage them. Many live-virus vaccines can tolerate freezing temperatures and rapidly deteriorate once defrosted, while inactivated vaccines more commonly require stable temperatures of 2-8⁰C and are damaged at temperature extremes. The commonly administered measles, mumps, rubella (MMR) vaccine can be stored either frozen or refrigerated, while the MMRV vaccine ...
- Source: drugdu
- 495
- December 6, 2020
vaccine
Why do Vaccines need to be Refrigerated?

Vaccines must be stored in specific conditions to avoid degradation, usually defined specifically by the manufacturer. Across the stages of manufacture, distribution, storage, and ultimately administration, these conditions must be adhered to, and this process is known as the cold chain. Should the cold chain be broken at any point during transport or storage, via exposure to temperate extremes, then the potency of the vaccine risks being reduced, or the vaccine is even rendered completely ineffective. The vast majority of vaccines must be refrigerated at between 2-8⁰C, with a preferred average of 5⁰C with minimal fluctuations. Specially designed lab refrigerators are usually used for this purpose, which has comparatively minimal temperature fluctuation across days and seasons, do not present any temperature extremes on any interior surface, and may bear an external temperature display that automatically logs the internal temperature at particular time intervals. Many live vaccines tolerate freezing, and depending on the ...
- Source: drugdu
- 562
- December 5, 2020
vaccine
ATCC introduces new product segment with launch of SARS-CoV-2 external control kit

ATCC, the world’s premier biological materials management, and standards organization, today announced the introduction of its new SARS-CoV-2 External Control Kit for clinical laboratories and test manufacturers. Image Credit: ATCC The ready-to-run kit provides controls in the rapidly changing COVID-19 testing landscape as a workflow-optimized kit with complete genome coverage that’s widely compatible with most commercial and laboratory-developed tests. Federal regulation requires that clinical laboratories assess the performance of their testing applications. This new ATCC kit is a practical, kitted solution clinical laboratories can use to meet this requirement. Validated, convenient, and ready-to-use, it offers a universal, full-process positive control (a heat-inactivated virus) and negative control (human cell line) that allow clinical laboratories to easily and accurately verify and assess the quality of their molecular diagnostic assays. The SARS-CoV-2 External Control Kit is compatible with most molecular diagnostic tests being used today. This broad compatibility is critical as surveys from the ...
- Source: drugdu
- 266
- December 4, 2020
SARS-CoV-2 external control kit
UK medicines regulator gives approval for first UK COVID-19 vaccine

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020. This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, ...
- Source: drugdu
- 380
- December 3, 2020
Covid-19 vaccine
Closing In On The Cause Of Alzheimer’s Disease

The unpredictability of Alzheimer’s disease may be partly caused by changes in star-shaped cells in the brain called astrocytes, find scientists from South Korea. AsianScientist (Dec. 1, 2020) – Despite decades of scientific research, Alzheimer’s disease and its causes still largely remain a mystery. Now, scientists from South Korea have identified a key indicator associated with neurodegeneration in Alzheimer’s. Their findings was published in Nature Neuroscience. Poignantly depicted in Hollywood films like The Notebook and Still Alice, Alzheimer’s disease is a brain disorder that accounts for a majority of cases of dementia, the progressive loss of memory and other cognitive abilities. Over the years, numerous hypotheses regarding the cause of Alzheimer’s have been presented. Perhaps the most prominent is the amyloid hypothesis, which pins the progression of Alzheimer’s on the build-up of beta-amyloid (Aβ) plaques in the brain. These plaques block cell signalling—potentially triggering inflammation and leading to brain cell ...
- Source: drugdu
- 404
- December 2, 2020
Alzheimer's disease
Moderna’s Phase 3 COVE study for its COVID-19 vaccine

30 November 2020 The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has ...
- Source: drugdu
- 161
- December 1, 2020
Covid-19 vaccine
Novel cannabis plant extracts could protect against COVID-19

Researchers in Canada have conducted a study suggesting that novel Cannabis sativaextracts may decrease levels of the host cell receptor that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses to gain viral entry to target tissues. SARS-CoV-2 is the agent responsible for the current coronavirus disease 2019 (COVID-19) pandemic that continues to sweep the globe threatening public health and the worldwide economy. The team – from the University of Lethbridge and Pathway Rx Inc., Lethbridge – developed hundreds of new C. sativa cultivars and tested 23 extracts in artificial 3D human models of the oral, airway and intestinal tissues. As recently reported in the journal Aging, 13 of the extracts downregulated expression of the SARS-CoV-2 host cell receptor angiotensin-converting enzyme 2 (ACE2). “The observed down-regulation of ACE2 gene expression by several tested extracts of new C. sativa cultivars is a novel and crucial finding,” say the researchers. “While our most effective extracts require further large-scale validation, ...
- Source: drugdu
- 471
- November 30, 2020
Covid-19
Subscribe to our FREE newsletter Subscribe New EU pharma strategy looks to future-proof healthcare sector, stimulate innovation and boost access to biosimilars and generics

The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and rare diseases. It is also aiming to bolster the competitiveness and the innovative capacity of the EU’s pharma industry. Enhancing crisis preparedness and response mechanisms, and addressing security of supply, drawing lessons from the COVID-19 crisis, are also namechecked as top policy priorities in the strategy, as well as a need to guarantee a strong EU voice on the global stage by promoting a high level of quality, efficacy and safety standards. “The COVID-19 pandemic has, and continues to have, a very serious impact on Europe. Though Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines or the availability ...
- Source: drugdu
- 201
- November 29, 2020
pharma

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