Regulatory approval of Pfizer/BioNTech vaccine for COVID-19, MHRA (updated 24th December 2021)
Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine. 24 December 2021Information for Healthcare Professionals and UK recipients on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174) was updated 22 December 2021Added HTML document for Summary of product characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection
Source: Current Awareness Service for Health (CASH) - December 24, 2021 Category: Consumer Health News Source Type: news

Hemorrhoids, Skin Tags and All Things Perianal Hemorrhoids, Skin Tags and All Things Perianal
Review recent advances in management of common benign anorectal diseases including hemorrhoids, anal fissure, and anal fistula.Current Opinion in Gastroenterology
Source: Medscape Today Headlines - December 23, 2021 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Johnson & Johnson Statement on its COVID-19 Vaccine Following CDC ACIP Meeting
NEW BRUNSWICK, N.J., December 16, 2021 – Johnson & Johnson remains confident in the overall positive benefit-risk profile of its COVID-19 vaccine. Studies have shown that the Johnson & Johnson COVID-19 vaccine generates strong antibody and cellular immune responses [i] and long-lasting immune memory[ii] and breadth of protection across variants. In addition, a growing body of evidence is revealing the strength of protection of our vaccine as a booster to either the Janssen COVID-19 vaccine or a different authorized or approved COVID-19 vaccine, both in terms of its efficacy and durability.[iii], [iv], [v], [vi], ...
Source: Johnson and Johnson - December 16, 2021 Category: Pharmaceuticals Source Type: news

Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine
NEW BRUNSWICK, N.J., December 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for use of the Company’s COVID-19 vaccine as a booster for adults aged 18 and older at least two months after primary vaccination with a single-shot of the Johnson & Johnson COVID-19 vaccine, and as a ‘mix and match’ booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting). “We are pleased with today’s Positiv...
Source: Johnson and Johnson - December 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
The objective responsive rate observed in this study suggests a potential benefit for many patients with triple-class exposed disease with an off-the-shelf therapy.”As of September 2021, 165 patients were treated with teclistamab at the SC 1.5 mg/kg dose across both Phase 1 and Phase 2 of MajesTEC-1.1 The primary objectives of the MajesTEC-1 Phase 1 study (NCT03145181) were to identify the recommended SC RP2D (part 1) and characterize the safety and tolerability of teclistamab at the RP2D (part 2). The primary objective of the MajesTEC-1 Phase 2 study (NCT04557098) was to evaluate the efficacy of teclistamab at the RP2D,...
Source: Johnson and Johnson - December 13, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Data from CARTITUDE-1 Study Show Continued Deep and Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
ATLANTA, Ga., December 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today longer-term results from the Phase 1b/2 CARTITUDE-1 study evaluating the efficacy and safety of ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy administered as a single infusion, in the treatment of patients with relapsed and/or refractory multiple myeloma. The data, featured as an oral presentation at the American Society of Hematology (ASH) 2021 Annual Meeting (Abstract #549) and selected as part of the Highli...
Source: Johnson and Johnson - December 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma
ATLANTA, Ga., December 11, 2021– The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of talquetamab (NCT03399799). Talquetamab is the only investigational off-the-shelf T cell redirecting bispecific antibody in clinical development targeting both GPRC5D, a novel multiple myeloma target, and CD3 on T cells.[1] Results from the study show that no new safety signals were observed with longer follow-up.1 Heavily pretreated patients with multiple myeloma treated with talquetamab at the recommended subcutaneous (SC) Pha...
Source: Johnson and Johnson - December 11, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster
NEW BRUNSWICK, N.J., December 9, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the interim recommendation by the Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) supporting the use of the Johnson & Johnson COVID-19 vaccine as a booster shot in persons aged 18 years and above. The WHO recommend the booster shot should be administered two to six months after the primary vaccination. SAGE advises WHO on global vaccine and immunization policies, and its recommendations provide guidance on the use of vaccines supplied through the COVAX Facility, a ...
Source: Johnson and Johnson - December 9, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses
NEW BRUNSWICK, N.J., DECEMBER 5, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting (mix-and-match). T...
Source: Johnson and Johnson - December 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Protective measures for holiday or after-school clubs and other out-of-school settings for children during the coronavirus (COVID-19) outbreak, DforE (updated 2nd December 2021)
Protective measures for providers of community activities, holiday or after-school clubs, tuition and other out-of-school settings offering provision to children during the coronavirus (COVID-19) outbreak. 2 December 2021Converted to HTML to improve accessibility and add clarification on the use of face visors and face shields by those who are exempt from wearing face coverings. 29 November 2021Updated information about isolation, vaccinations for under 18 year olds, face coverings and international education visits.
Source: Current Awareness Service for Health (CASH) - December 2, 2021 Category: Consumer Health News Source Type: news

Higher education providers: coronavirus (COVID-19), DforE (updated 2nd December 2021)
Coronavirus (COVID-19) operational guidance for higher education providers. 2 December 2021Converted to HTML to improve accessibility. Added clarification on the use of face visors and face shields by those who are exempt from wearing face coverings and what guidance students and staff must follow when traveling to England from abroad. 29 November 2021Updated guidance on face coverings, travel and quarantine to reflect new measures announced on 27 November 2021.
Source: Current Awareness Service for Health (CASH) - December 2, 2021 Category: Consumer Health News Source Type: news

Actions for schools during the coronavirus outbreak, DforE (updated 2nd December 2021)
What all schools will need to do during the coronavirus (COVID-19) pandemic. 2 December 2021Converted to HTML to improve accessibility. Added clarification on the use of face visors and face shields by those who are exempt from wearing face coverings and what guidance children and staff must follow when travelling to England from abroad. 29 November 2021Updated guidance on contact tracing and isolation, travel and quarantine, face coverings and vaccination of under 18 year olds to reflect new measures announced on 27 November 2021.
Source: Current Awareness Service for Health (CASH) - December 2, 2021 Category: Consumer Health News Source Type: news

Janssen Seeks Approval of IMBRUVICA ®(ibrutinib) in a Fixed-Duration Regimen for Patients with Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, 30 November 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new treatment option for IMBRUVICA® (ibrutinib) as a fixed-duration combination with venetoclax (I+V) for adult patients with previously untreated chronic lymphocytic leukaemia (CLL)."Ibrutinib was the first approved Bruton’s tyrosine kinase inhibitor and over the past seven years has become a key treatment for CLL and some other B-cell malignancies, treating more than 250,000 patients globally,�...
Source: Johnson and Johnson - November 30, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson to Evaluate Its COVID-19 Vaccine Against New Omicron COVID-19 Variant
Since the emergence of the COVID-19 pandemic, Johnson & Johnson (the Company) has been closely monitoring newly emerging COVID-19 variants. In collaboration with academic groups in South Africa and around the world, the Company has been evaluating the effectiveness of its COVID-19 vaccine across variants, including now the new and rapidly spreading Omicron variant. The Company is testing blood serum from participants in completed and ongoing booster studies to look for neutralizing activity against the Omicron variant. In addition, the Company is pursuing an Omicron-specific variant vaccine and will progress it as need...
Source: Johnson and Johnson - November 29, 2021 Category: Pharmaceuticals Source Type: news

Shoppers are buying from resale retailers more than ever. Here's why
The market for secondhand and new-with-tags items is booming as consumer habits change and they seek out hard-to-find luxury items. #resaleretailers
Source: Reuters: Health - November 28, 2021 Category: Consumer Health News Source Type: news

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