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Vicore Pharma’s C21 med shows promise in COVID-19 study

Vicore Pharma’s lead candidate drug C21 has scored some promising results in a study evaluating the medicine in hospitalised COVID-19 patients. The ATTRACT study recruited a total of 106 hospitalised patients with a confirmed COVID-19 diagnosis and signs of an acute respiratory infection without the need for mechanical ventilation. The patients were randomised to receive either oral treatment with C21 or placebo for seven days, on top of standard-of-care. In an expanded data analysis of this study, the data showed a restoration of lung function in COVID-19 patients treated with C21. In a statement, Vicore said that these results suggest “C21 can become an important complement to vaccines to combat the COVID-19 pandemic”. In a subgroup analysis of patients requiring supplemental oxygen, C21 also produced a greater reduction of C-reactive protein (CRP) compared to the placebo arm. In previously reported results, C21 treatment reduced the number of patients needing mechanical ...
- Source: drugdu
- 469
- December 23, 2020
Covid-19
Aimmune’s peanut allergy med Palforzia wins EU approval

The European Commission (EC) has approved Aimmune Therapeutics’ Palforzia, making it the first treatment for peanut allergy in the EU, according to the firm. Following the EC approval, Palforzia will be available to patients aged four to 17 years with a confirmed diagnosis of peanut allergy. It is not, however, indicated for the treatment of allergic reactions – including anaphylaxis – and must be used in conjunction with a peanut-avoidant diet. The drug can also be continued in patients aged 18 years or older, Aimmune added in a statement. The EC approval was based on a data package including two phase III clinical trials – PALISADE and ARTEMIS. Across both studies, Palforzia treatment led to a significant increase in the amount of peanut protein tolerated in participants with peanut allergy, compared to placebo. “Today’s approval is a historic moment for the millions of people living with potentially life-threatening peanut allergy, ...
- Source: drugdu
- 358
- December 22, 2020
Peanut allergy
Albireo submits rare liver disease med odevixibat to FDA and EMA

Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). The US-based biopharmaceutical company has previously received fast track, rare paediatric disease and orphan drug designations for odevixibat in the US for PFIC. The drug also has orphan drug designations for the treatment for Alagille Syndrome, biliary atresia and primary biliary cholangitis. Odevixibat is a one-daily non-systemic ileal bile acid transport inhibitor (IBATi) currently being developed for the treatment of a number of rare paediatric liver diseases, such as PFIC, biliary atresia and Alagille syndrome. In a phase III trial evaluating the efficacy and safety of odevixibat in PFIC, the drug met two primary endpoints, demonstrating the ability to reduce serum bile acid responses and improve pruritus assessments with a single digit diarrhoea rate. “With randomised, placebo-controlled PEDFIC data, ...
- Source: drugdu
- 212
- December 13, 2020
Albireo
CRUK researchers develop new early-stage rectal cancer treatment

Cancer Research UK (CRUK) researchers have developed a new treatment for early-stage rectal cancer which they say could provide patients with an improved quality of life. In a pilot study of the new treatment option, which combines local keyhole surgery and radiotherapy, researchers found that they could prevent debilitating side effects such as diarrhoea and the need for a permanent colostomy bag. This study, dubbed TREC, enrolled 123 patients with early-stage rectal cancer, with 61 patients receiving the newly-developed treatment approach. In addition, 55 patients were randomised to two treatment approaches – 28 received major surgery and 27 received the new organ preserving treatment. Within the patient population who received the new treatment, 70% were treated successfully, meaning their tumour was removed while preserving the rest of their rectum and the cancer did not return during the three to five-year follow-up period. Patients who received the new treatment also reported ...
- Source: drugdu
- 571
- December 12, 2020
cancer
Janssen eyes US approval for EGFR-targeting NSCLC therapy

4th December 2020 Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab. Amivantamab is a bispecific antibody designed to target EGFR and mesenchymal epithelial transition factor (MET) mutated tumours. The FDA submission is based on results from the monotherapy arm of Janssen’s phase I CHRYSALIS study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a third generation EGFR tyrosine kinase inhibitor (TKI). An overall response rate (ORR) of 36% was observed in all NSCLC patients and 41% in patients with previously treated with platinum-based chemotherapy. In addition, the median duration of response for all evaluable patients was ten months and seven months for patients previously treated with platinum-based chemoterhapy. The median progression-free survival was 8.3 months for all patients and ...
- Source: drugdu
- 221
- December 11, 2020
NSCLC therapy
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
- 496
- 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
- 267
- December 4, 2020
SARS-CoV-2 external control kit

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