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Pfizer Booster Can Be Given After 6 Months, European Drug Agency Says
The E.U. ’s main drug regulator also said that extra doses of the Moderna and Pfizer-BioNTech vaccines can be given to those with underlying health conditions as early as 28 days after the second dose. (Source: NYT)
Source: NYT - October 4, 2021 Category: American Health Authors: Monika Pronczuk Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) European Medicines Agency Source Type: news

Pfizer and BioNTech receive CHMP positive opinion for COVID-19 vaccine booster in the European Union
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older. (Source: World Pharma News)
Source: World Pharma News - October 4, 2021 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Roche presents new data at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders
Basel, 24 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from across its growing neuromuscular portfolio at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to six weeks of age and data supporting the continued clinical investig ation of gene therapy, SRP-9001, in Duchenne muscular dystrophy (DMD).“These new data for Evrysdi may help extend the potential benefits of th...
Source: Roche Investor Update - September 24, 2021 Category: Pharmaceuticals Source Type: news

Roche presents new data at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders
Basel, 24 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from across its growing neuromuscular portfolio at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to six weeks of age and data supporting the continued clinical investig ation of gene therapy, SRP-9001, in Duchenne muscular dystrophy (DMD).“These new data for Evrysdi may help extend the potential benefits of th...
Source: Roche Media News - September 24, 2021 Category: Pharmaceuticals Source Type: news

Flurry of Cancer Drug Endorsements From EU Panel Flurry of Cancer Drug Endorsements From EU Panel
The European Medicines Agency panel recommended for approval three new cancer drugs and additional indications for two other already marketed immunotherapies.International Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - September 17, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

Roche receives positive CHMP opinion for Gavreto ® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
Basel, 17 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gavreto® (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated w ith a RET inhibitor. (Source: Roche Media News)
Source: Roche Media News - September 17, 2021 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Gavreto ® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
Basel, 17 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gavreto® (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated w ith a RET inhibitor. (Source: Roche Investor Update)
Source: Roche Investor Update - September 17, 2021 Category: Pharmaceuticals Source Type: news

Ivermectin: Cochrane ’s most talked about review so far, ever. Why?
In this author interview with Stephanie Weibel and Maria Popp, we find out more about their Cochrane review, Ivermectin for treating and preventing COVID-19. The review currently has an Altmetric Attention Score of more than 7000, which makes it the most talked-about review in the history of the Cochrane Library.Briefly, what is Ivermectin?Ivermectin is a medicine used to kill parasites, such as intestinal worms (helminths) in animals or scabies in humans. It is inexpensive and it is widely used in regions of the world where parasitic infestations are common, such as in parts of Asia and South America. Ivermectin has few u...
Source: Cochrane News and Events - September 14, 2021 Category: Information Technology Authors: Lydia Parsonson Source Type: news

EMA issues 'warning' about new 'serious' side effect of the AstraZeneca Covid vaccine
THE EUROPEAN Medicines Agency has added a rare but serious condition to its product information for the AstraZeneca Covid vaccine. The regulatory body has issued a warning that a "causal relationship" to the vaccine is a "reasonable possibility". (Source: Daily Express - Health)
Source: Daily Express - Health - September 10, 2021 Category: Consumer Health News Source Type: news

AstraZeneca's Covid jab can trigger nerve disorder Guillain-Barre syndrome, EU says
The European Medicines Agency said they considered it to be 'at least a reasonable possibility' that the AstraZeneca jab could trigger the condition in 'very rare' cases. (Source: the Mail online | Health)
Source: the Mail online | Health - September 9, 2021 Category: Consumer Health News Source Type: news

Pfizer and BioNTech submit a variation to EMA with the data in support of a booster dose of COMIRNATY ®
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. (Source: World Pharma News)
Source: World Pharma News - September 9, 2021 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

AstraZeneca vaccine side effects: Four new side effects reported - EMA issues major update
THE UNPRECEDENTED scale and speed of the global vaccination effort has required health bodies to constantly monitor for vaccine side effects. On Tuesday, the European Medicines Agency added four new side effects to the product information for the AstraZeneca Covid vaccine. A causal link has not been specified, however. (Source: Daily Express - Health)
Source: Daily Express - Health - September 8, 2021 Category: Consumer Health News Source Type: news

EU regulator evaluating if COVID vaccine booster is needed
The European Medicines Agency says it has started an expedited evaluation on whether to recommend use of a booster dose of the coronavirus vaccine made by Pfizer-BioNTech (Source: ABC News: Health)
Source: ABC News: Health - September 6, 2021 Category: Consumer Health News Tags: Health Source Type: news

European Centre for Disease Prevention and Control (CDC) and European Medicines Agency (EMA) issue joint update for additional and booster doses of COVID-19 vaccines, EMA (published 2nd September 2021)
Based on current evidence, there is no urgent need for administration of booster doses of vaccines to fully vaccinated individuals. The report notes additional doses should already be considered for those with severely weakened immune systems as part of their primary vaccination (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - September 3, 2021 Category: Consumer Health News Source Type: news

Johnson & Johnson Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine
NEW BRUNSWICK, N.J., August 25, 2021 – Johnson & Johnson today announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine. In July, the Company reported interim Phase 1/2a data published in the New England Journal of Medicine that demonstrated neutralizing antibody responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization. In anticipation of the potential need for boosters, the Company conducted two Phase 1/2a studies in individuals pre...
Source: Johnson and Johnson - August 25, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news