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CHMP recommends EU approval of Ronapreve to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease
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 the antibody combination, Ronapreve™ (casirivimab and imdevimab), for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms (pre- or post-exposure prophylaxis). (Source: World Pharma News)
Source: World Pharma News - November 11, 2021 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

Moderna Seeks EU Authorization for COVID-19 Vaccine in Young Kids Moderna Seeks EU Authorization for COVID-19 Vaccine in Young Kids
Moderna on Tuesday sought conditional marketing authorization with the European Medicines Agency for use of its COVID-19 vaccine in children in the age-group of 6-11 years.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 10, 2021 Category: Consumer Health News Tags: Infectious Diseases News Source Type: news

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

EMA filing acceptance and validation for spesolimab
Boehringer Ingelheim announces European Medicines Agency ’s filing acceptance and validation of marketing authorization application for spesolimab in generalized pustular psoriasis The marketing authorization application (MAA) package includes results from the pivotal Effisayil-1 global trial (Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - October 28, 2021 Category: Research Source Type: news

Merck Will Allow Other Drug Manufacturers to Produce Its COVID-19 Pill
(LONDON) —Pharmaceutical company Merck agreed to allow other drug makers to produce its COVID-19 pill, in a move aimed at helping millions of people in poorer countries get access to the potentially life-saving drug, a United Nations-backed public health organization said on Wednesday. The Medicines Patent Pool said in a statement that it had signed a voluntary licensing agreement for molnupiravir with Merck and its partner Ridgeback Biotherapeutics. The agreement will allow the Medicines Patent Pool to grant further licenses to qualified companies who are approved to make the drug. Neither drug maker will receive ro...
Source: TIME: Health - October 27, 2021 Category: Consumer Health News Authors: Associated Press Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

European Medicines Agency's Committee for Medicinal Products for Human Use starts rolling review of molnupiravir for treatment of COVID-19 in adults, EMA
Decision to start rolling review of this oral antiviral medicine is based on preliminary results from lab and clinical studies suggesting it may reduce ability of SARS CoV 2 to multiply in the body, thereby preventing hospitalisation or death in patients with COVID-19. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - October 27, 2021 Category: Consumer Health News Source Type: news

European Medicines Agency's Committee for Medicinal Products for Human Use recommends booster dose of Moderna's COVID-19 vaccine, Spikevax , EMA
This follows data showing that a booster, consisting of half the dose used for primary vaccination, given 6 to 8 months after 2nd dose, led to a rise in antibody levels in adults whose antibody levels were waning, with a pattern of side effects similar to that after 2nd dose. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - October 27, 2021 Category: Consumer Health News Source Type: news

EU drug regulator OKs booster doses of Moderna's COVID shot
The European Medicines Agency said a booster dose of Moderna’s coronavirus vaccine “can be considered” in people aged 18 and above (Source: ABC News: Health)
Source: ABC News: Health - October 25, 2021 Category: Consumer Health News Tags: Health Source Type: news

Merck asks EU regulator to authorize pill that treats COVID
Pharmaceutical company Merck has asked the European Medicines Agency to authorize its COVID-19 antiviral treatment (Source: ABC News: Health)
Source: ABC News: Health - October 25, 2021 Category: Consumer Health News Tags: Health Source Type: news

European Medicines Agency starts rolling review of Evusheld (tixagevimab and cilgavimab) for prevention of Covid-19 in adults, EMA
Tixagevimab and cilgavimab are monoclonal antibodies that attach to the spike protein of SARS-CoV-2 and stop the virus from entering the body ' s cells and causing infection. The decision to start the rolling review was based on preliminary results from clinical studies. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - October 18, 2021 Category: Consumer Health News Source Type: news

EU Panel Likes Two Cancer Drugs, Drops One EU Panel Likes Two Cancer Drugs, Drops One
Two new cancer drugs were recommended for approval, and one had its marketing authorization withdrawn at the October meeting of the European Medicines Agency ' s advisory panel.International Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - October 15, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

The Latest: Europe Medicines Agency looking at antibody drug
The European Medicines Agency has started an expedited licensing process for an antibody combination drug aimed at preventing the coronavirus, made by AstraZeneca (Source: ABC News: Health)
Source: ABC News: Health - October 14, 2021 Category: Consumer Health News Tags: Health Source Type: news

Roche ’s Gazyvaro shorter 90-minute infusion time approved in Europe for people with previously treated or untreated follicular lymphoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro ® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL). (Source: Roche Investor Update)
Source: Roche Investor Update - October 14, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s Gazyvaro shorter 90-minute infusion time approved in Europe for people with previously treated or untreated follicular lymphoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro ® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL). (Source: Roche Media News)
Source: Roche Media News - October 14, 2021 Category: Pharmaceuticals Source Type: news

Covid vaccine side effects: Stay 'alert' to three new side effects - EMA issues warning
THE SIDE effects of the Covid vaccines continue to be monitored stringently as booster programmes get underway. The European Medicines Agency today has issued instructions to healthcare professionals administering the Janssen vaccine, which is approved for UK use. The EMA urges professionals to stay "alert" to three serious side effects following vaccination. (Source: Daily Express - Health)
Source: Daily Express - Health - October 13, 2021 Category: Consumer Health News Source Type: news