Tessa Therapeutics Receives PRIME Designation from European Medicines Agency for CD30 CAR-T Therapy
BEDMINSTER, N.J. and SINGAPORE, Jan. 18, 2021 -- (Healthcare Sales & Marketing Network) -- Tessa Therapeutics (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, toda... Biopharmaceuticals, Oncology, Regulatory Tessa Therapeutics, CAR-T therapy, Hodgkin Lymphoma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 18, 2021 Category: Pharmaceuticals Source Type: news

The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines, The Lancet
Commentary notes approvals of first COVID-19 vaccines in EU are a key milestone in response to COVID-19, which not only offer hope to control the pandemic but also provide proof of concept for a new approach to vaccine development in response to future emerging health threats. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - January 15, 2021 Category: Consumer Health News Source Type: news

EU regulator is considering Oxford-AstraZeneca vaccine
The European Medicines Agency says AstraZeneca and Oxford University have submitted an application for their COVID-19 vaccine to be licensed across the 27-nation European Union (Source: ABC News: Health)
Source: ABC News: Health - January 12, 2021 Category: Consumer Health News Tags: Health Source Type: news

European Medicines Agency recommends COVID-19 Vaccine Moderna for authorisation in the EU, EMA
The Agency has recommended granting a conditional marketing authorisation for use to prevent Coronavirus disease in people from 18 years of age. It is given as two injections, 28 days apart. Trial in ~30,000 people demonstrated 94.1% efficacy. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - January 8, 2021 Category: Consumer Health News Source Type: news

E.U. Regulators Approve Drawing up To Six Doses From BioNTech-Pfizer Vaccine Vials
(BRUSSELS) — The European Union’s drug agency on Friday approved doctors drawing up to six doses from each vial of the coronavirus vaccine made by BioNTech-Pfizer, a move that could speed up the pace of vaccinations in the 27-nation bloc. The European Medicines Agency said its human medicines committee recommended updating the product information for the vaccine to clarify that each vial contains six doses instead of the five that were advised when it originally greenlighted the Pfizer-BioNTech vaccine on Dec. 21. German Health Ministry spokesman Hanno Kautz told reporters in Berlin that the change would come i...
Source: TIME: Science - January 8, 2021 Category: Science Authors: SAMUEL PETREQUIN and MIKE CORDER/ AP Tags: Uncategorized COVID-19 Londontime wire Source Type: news

EU approves Moderna jab amid tensions over slow rollout of vaccines
Move should ease frustrations over low supplies of Pfizer vaccine and EU ’s longer authorisation processCoronavirus – latest updatesSee all our coronavirus coverageThe European Medicines Agency has approved the Moderna vaccine, making it the second coronavirus shot to be cleared for general use across the EU, as tensions continued to rise over the slow progress of vaccination programmes in the bloc.In a move that should ease frustrations over a shortfall in supplies of the Pfizer/BioNTech jab and the EU ’s longer authorisation process, the Amsterdam-based regulatorsaid on Wednesday it had granted a condit...
Source: Guardian Unlimited Science - January 6, 2021 Category: Science Authors: Jon Henley Europe correspondent Tags: Coronavirus Vaccines and immunisation European Union Health Infectious diseases Medical research Microbiology Science Society World news European commission Netherlands Source Type: news

EU regulators recommend approval of Moderna’s Covid vaccine
Go-ahead from European Medicines Agency comes as infection rates spike across bloc (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - January 6, 2021 Category: Pharmaceuticals Source Type: news

Europe boost in Covid battle as Moderna vaccine approved
Decision follows recommendation from European Medicines Agency amid infections spike (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - January 6, 2021 Category: Pharmaceuticals Source Type: news

AstraZeneca: Full Data Provided for Euro Approval of COVID Shot AstraZeneca: Full Data Provided for Euro Approval of COVID Shot
AstraZeneca has submitted full data to pursue conditional marketing authorization from the European Medicines Agency for its COVID vaccine, but the regulator said more information is needed for approval.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 31, 2020 Category: Consumer Health News Tags: Infectious Diseases News Source Type: news

ECDC releases COVID-19 vaccination rollout strategies for EU/EEA
(European Centre for Disease Prevention and Control (ECDC)) Following the European Medicines Agency recommendation for authorization of the vaccine Comirnaty, developed by BioNTech and Pfizer, the European Centre for Disease Prevention and Control (ECDC) released the technical report titled 'COVID-19 vaccination and prioritization strategies in the EU/EEA.' (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - December 22, 2020 Category: Infectious Diseases Source Type: news

European Union Greenlights BioNTech-Pfizer COVID-19 Vaccine After Agency Gives Safety Approval
(AMSTERDAM) — The European Union on Monday gave official approval for the coronavirus vaccine developed by BioNTech and Pfizer to be used across the 27-nation bloc, raising hopes that countries can begin administering the first shots to their citizens shortly after Christmas. The EU’s executive commission gave the green light just hours after the European Medicines Agency said the vaccine meets safety and quality standards. Brussels had been expected to take two or three days to endorse the market authorization move. “As we have promised, this vaccine will be available for all EU countries at the same tim...
Source: TIME: Health - December 21, 2020 Category: Consumer Health News Authors: ALEKSANDAR FURTULA and FRANK JORDANS / AP Tags: Uncategorized COVID-19 wire Source Type: news

European Medicines Agency authorizes Pfizer vaccine for use in the EU
Europe's medicines regulator on Monday authorized Pfizer and BioNTech's coronavirus vaccine for conditional use, opening the door to an... (Source: Reuters: Health)
Source: Reuters: Health - December 21, 2020 Category: Consumer Health News Source Type: news

Pfizer and BioNTech receive CHMP positive opinion for their COVID-19 vaccine
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of the Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. (Source: World Pharma News)
Source: World Pharma News - December 21, 2020 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Vaccine data from Pfizer and BioNTech possibly stolen in cyberattack against EU medicine regulation agency
(Natural News) Major pharmaceutical companies Pfizer and BioNTech said that their documents relating to the Wuhan coronavirus (COVID-19) vaccine they have been developing may have been stolen after a major cyberattack on the European Medicines Agency (EMA). The EMA is an arm of the European Union based out of Amsterdam that is responsible for the... (Source: NaturalNews.com)
Source: NaturalNews.com - December 18, 2020 Category: Consumer Health News Source Type: news

EU medicines authority seeks to shorten timeline for Covid vaccine approval
European Medicines Agency aims to review Pfizer/BioNTech shot on December 21 (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - December 15, 2020 Category: Pharmaceuticals Source Type: news

EU regulator brings forward Covid vaccine ruling after German pressure
Ruling on Pfizer/BioNTech vaccine brought forward to 21 DecemberCoronavirus – latest updatesSee all our coronavirus coverageThe EU drug regulator has brought forward its ruling on the Pfizer/BioNTech Covid vaccine after Germany made it clear it wanted approval before Christmas.The Amsterdam-based European Medicines Agency ’s announcement that it will meet on 21 December instead of 29 December to decide whether to authorise the shot followed a growing backlash from desperate EU countries, with the German health minister, Jens Spahn, saying that the agency risked losing the trust of EU citizens if it did not act ...
Source: Guardian Unlimited Science - December 15, 2020 Category: Science Authors: Kate Connolly in Berlin Tags: Germany Vaccines and immunisation Coronavirus Science World news Europe Spain Source Type: news

EXPLAINER: Why is the EU taking so long to OK vaccine?
As Canadians, Britons and Americans begin getting immunized with a German-developed vaccine against the coronavirus, pressure is building on the European Medicines Agency to approve the shot made by Pfizer Inc. and German company BioNTech (Source: ABC News: Health)
Source: ABC News: Health - December 15, 2020 Category: Consumer Health News Tags: Health Source Type: news

The European Medicines Agency says it has moved up its meeting to review the Pfizer-BioNTech vaccine to Dec. 21
(Source: ABC News: Health)
Source: ABC News: Health - December 15, 2020 Category: Consumer Health News Tags: Health Source Type: news

FDA approves Roche ’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis
Basel, 14 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS ® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomised, double-blind ENSEMBLE PLUS study.“More than 170,000 people with MS have been treated with OCREVUS - the only approved B-cell therapy with a twice-yearly dosing schedule - and it is the most prescribed...
Source: Roche Media News - December 14, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis
Basel, 14 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS ® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomised, double-blind ENSEMBLE PLUS study.“More than 170,000 people with MS have been treated with OCREVUS - the only approved B-cell therapy with a twice-yearly dosing schedule - and it is the most prescribed...
Source: Roche Investor Update - December 14, 2020 Category: Pharmaceuticals Source Type: news

EMA Panel Endorses Approval of Five New Cancer Drugs EMA Panel Endorses Approval of Five New Cancer Drugs
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization or has given a positive opinion regarding several cancer therapies.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 14, 2020 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Biocon, Mylan's diabetic drug receives positive opinion from European Medicines Agency
Biocon said the CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected early next year. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 14, 2020 Category: Pharmaceuticals Source Type: news

Data From Pfizer/BioNTech, Moderna for COVID-19 Vaccines'Very Robust': EMA Data From Pfizer/BioNTech, Moderna for COVID-19 Vaccines'Very Robust': EMA
The data submitted to the European Medicines Agency by Pfizer/BioNTech and Moderna for their COVID-19 vaccine candidates is'very robust', its executive director said on Thursday.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - December 11, 2020 Category: Intensive Care Tags: Infectious Diseases News Source Type: news

Pfizer/BioNTech vaccine docs hacked from European Medicines Agency
The EMA, which is assessing two Covid-19 vaccines, launches a "full investigation" after the attack. (Source: Reuters: Health)
Source: Reuters: Health - December 9, 2020 Category: Consumer Health News Source Type: news

VAX ATTACKS: The new mRNA coronavirus vaccines will likely cause immune cells to attack placenta cells, causing female infertility, miscarriage or birth defects
(Natural News) Two brave doctors, Dr. Wolfgang Wodarg and Dr. Michael Yeadon, have issued a motion for administrative and regulatory action to the European Medicines Agency (EMA) regarding the new mRNA coronavirus vaccines developed by Pfizer/BioNTech. They warn that the vaccines can attack placenta cells, causing female infertility. The doctors petition for regulatory action that... (Source: NaturalNews.com)
Source: NaturalNews.com - December 7, 2020 Category: Consumer Health News Source Type: news

Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma
December 5, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today longer-term results from the combined Phase 1b/2 CARTITUDE-1 study (NCT03548207) 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, for the treatment of patients with relapsed and/or refractory multiple myeloma. These data, presented as an oral presentation at the American Society of Hematology (ASH) 2020 Annual Meeting (Abstract #177), continued to demonstrate a very hig...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

How vaccine approval compares between the UK, Europe and the US
The regulatory fast-tracking of the Covid vaccine in Britain by MHRA has led some to question its methodsCoronavirus – latest updatesSee all our coronavirus coverageThe Medicines and Healthcare Products Regulatory Authority (MHRA) in the UK has not had a round of applause from anyone other than the UK ’s politicians and the vaccine companies. It gave temporary authorisation to the Pfizer/BioNTech vaccine on Wednesday and within hours, the European Medicines Agency (EMA) put out a stiff statement implying more work was needed than the UK regulator had done. Its own decision could come as late as 29 December. It ...
Source: Guardian Unlimited Science - December 4, 2020 Category: Science Authors: Sarah Boseley Health Editor Tags: Coronavirus Vaccines and immunisation Medical research Regulators US news UK news Science Source Type: news

Johnson & Johnson announces initiation of rolling submission for its single-dose Janssen COVID-19 vaccine candidate with the European Medicines Agency
Janssen-Cilag International N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has initiated a rolling submission with the European Medicines Agency (EMA) for its investigational single-dose vaccine candidate for the prevention of COVID-19. The EMA's Committee for Medicinal Products for Human Use (CHMP) enabled a rolling review of the investigational single-dose Janssen COVID-19 vaccine candidate based principally on positive non-clinical data showing that the vaccine candidate elicits a robust immune response, as demonstrated by neutralizing antibodies. (Source: World Pharma News)
Source: World Pharma News - December 4, 2020 Category: Pharmaceuticals Tags: Featured Johnson & Business and Industry Source Type: news

The UK Just Approved the Pfizer Covid Vaccine. What Happens Next?
When early results from the final trials began to roll in, scientists were well prepared. Now, they face the logistical challenge of putting the vaccine to work. (Source: NYT Health)
Source: NYT Health - December 2, 2020 Category: Consumer Health News Authors: Benjamin Mueller Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Nursing Homes BioNTech SE Pfizer Inc National Health Service Belgium Great Britain European Medicines Agency Source Type: news

How the U.K. Approved Pfizer ’s COVID-19 Vaccine Faster Than the U.S. and Europe
The U.K. became the first western country to authorize the use of a COVID-19 vaccine on Dec. 1, when its medicines regulator gave the greenlight to the vaccine produced by Pfizer and BioNTech. The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the authorization at record speed, just three weeks after Pfizer published the first data from the final stage of its clinical trial. Later results showed the vaccine to be 95% effective in preventing illness from COVID-19. The announcement raises expectations for the impending decisions by regulators in the U.S. and the E.U., who are still poring over ...
Source: TIME: Health - December 2, 2020 Category: Consumer Health News Authors: Ciara Nugent Tags: Uncategorized Source Type: news

BioNTech, Pfizer ask Europe to quickly approve virus vaccine
The German pharmaceutical company BioNTech and its U.S. partner Pfizer say they have submitted an application for speeded-up, conditional approval of their coronavirus vaccine with the European Medicines Agency. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 1, 2020 Category: Pharmaceuticals Source Type: news

SeQuent Scientific launches veterinary medicine in 19 European countries
The product had recently received approval from European Medicines Agency (EMA) through its Spanish subsidiary Laboratorios Karizoo, S A, the company added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 1, 2020 Category: Pharmaceuticals Source Type: news

COVID-19: A data challenge and a catalyst for new insights
  One of the key issues that arose during the pandemic, and arguably a factor that has led to more deaths, has been one of healthcare systems, public health and governments having insufficient or no relevant data on which to base critical decisions. The right data are not in the right place to answer the right questions at the right time. Yet, in the midst of this we have also seen remarkable collaboration on the scientific response to the pandemic, from diagnostics to therapeutic and vaccine research and development. We have learned a lot about the virus since its genome was shared by Chinese researchers in Jan...
Source: EyeForPharma - November 24, 2020 Category: Pharmaceuticals Authors: Andrew Stone Source Type: news

Late-Breaking 12-Month Data of Investigational RPGR Gene Therapy Shows Statistically Significant and Continued Vision Improvement in Patients with X-Linked Retinitis Pigmentosa
RARITAN, N.J., November 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new 12-month data from the ongoing Phase 1/2 trial (NCT03252847) of its investigational gene therapy for inherited retinal disease X-linked retinitis pigmentosa (XLRP). The data showed that low and intermediate doses were well-tolerated and continued to demonstrate statistically significant sustained or increased vision improvement across multiple metrics (mean sensitivity, volumetric and pointwise) and modalities (full-field static perimetry and microperimetry). Data on the novel adeno-associated virus re...
Source: Johnson and Johnson - November 13, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Roche ’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
             Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changin...
Source: Roche Media News - October 29, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
             Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changin...
Source: Roche Investor Update - October 29, 2020 Category: Pharmaceuticals Source Type: news

EU Medicine Agency Could Approve COVID-19 Vaccines Early Next Year: Report EU Medicine Agency Could Approve COVID-19 Vaccines Early Next Year: Report
The European Medicines Agency could approve three COVID-19 vaccines early next year, its Executive Director Guido Rasi said on Friday, according to a report by Italian news agency ANSA.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - October 19, 2020 Category: Intensive Care Tags: Infectious Diseases News Source Type: news

Akero Therapeutics Receives European Medicines Agency Priority Medicines (PRIME) Designation for Efruxifermin (EFX) in NASH
Designation highlights EFX's potential to treat NASH and its related comorbidities SOUTH SAN FRANCISCO, Calif., Oct. 16, 2020 -- (Healthcare Sales & Marketing Network) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic non-alcoholic steatoh... Biopharmaceuticals, Mergers & Acquisitions Akero Therapeutics, non-alcoholic steatohepatitis, efruxifermin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 16, 2020 Category: Pharmaceuticals Source Type: news

BioNTech and Pfizer initiate rolling submission to European Medicines Agency for SARS-CoV-2 vaccine candidate BNT162b2
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies' vaccine development program against COVID-19. The EMA's decision to start a rolling review follows the encouraging preliminary results from pre-clinical and early clinical studies in adults, (Source: World Pharma News)
Source: World Pharma News - October 6, 2020 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

PRAC Starts Safety Review of Remdesivir PRAC Starts Safety Review of Remdesivir
A'safety signal'of acute kidney injury in patients with COVID-19 taking remdesivir prompts the European Medicines Agency to launch a review.News Alerts (Source: Medscape Infectious Diseases Headlines)
Source: Medscape Infectious Diseases Headlines - October 2, 2020 Category: Infectious Diseases Tags: Nephrology News Alert Source Type: news

EU regulator starts safety review of coronavirus drug
The European Medicines Agency says it has started a safety review after some patients taking the coronavirus drug remdesivir reported serious kidney problems (Source: ABC News: Health)
Source: ABC News: Health - October 2, 2020 Category: Consumer Health News Tags: Health Source Type: news

EU agency starts 'rolling review' to speed OK for vaccine
The European Medicines Agency has begun its first review process for the COVID-19 vaccine being developed by Oxford University and AstraZeneca (Source: ABC News: Health)
Source: ABC News: Health - October 1, 2020 Category: Consumer Health News Tags: Health Source Type: news

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi ™ (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) showed that they continued to improve and achieve motor milestones. This exploratory analysis showed that an estimated 88% of infants were alive and required no permanent ventilation at two years. In addition, at two years, 59% (10/17 vs. 7/17 at 1-year) of infants were able to sit without support...
Source: Roche Media News - September 28, 2020 Category: Pharmaceuticals Source Type: news

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi ™ (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) showed that they continued to improve and achieve motor milestones. This exploratory analysis showed that an estimated 88% of infants were alive and required no permanent ventilation at two years. In addition, at two years, 59% (10/17 vs. 7/17 at 1-year) of infants were able to sit without support...
Source: Roche Investor Update - September 28, 2020 Category: Pharmaceuticals Source Type: news

European Medicines Agency endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation, EMA
Based on a review of RECOVERY trial, dexamethasone is recommended as an option in adults and adolescents (>12 years;> 40 kg) who require supplemental oxygen therapy. The recommended dose, administered orally or by injection/infusion is 6 milligrams once a day for up to 10 days. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - September 22, 2020 Category: Consumer Health News Source Type: news

Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 18 September 2020 - 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 Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemi c therapy. Based on this recommendation, a final decision regarding approval of Tecentriq in combination with Avastin in this disease setting, along with the full details of the approved indication, is expe...
Source: Roche Media News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 18 September 2020 - 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 Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemi c therapy. Based on this recommendation, a final decision regarding approval of Tecentriq in combination with Avastin in this disease setting, along with the full details of the approved indication, is expe...
Source: Roche Investor Update - September 18, 2020 Category: Pharmaceuticals Source Type: news

Orfadin(R) (nitisinone) receives positive opinion from CHMP for treatment of AKU
STOCKHOLM, Sept. 18, 2020 -- (Healthcare Sales & Marketing Network) -- Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive ... Biopharmaceuticals, Regulatory Swedish Orphan Biovitrum, Orfadin, nitisinone, alkaptonuria (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 18, 2020 Category: Pharmaceuticals Source Type: news

NIDCR's Fall 2020 E-Newsletter
Having trouble viewing this email? View it as a Web page. NIDCR's Fall 2020 E-Newsletter In this issue: NIDCR News Funding Opportunities NIH/HHS News Funding Notices Science Advances Subscribe to NICDR News Grantee News   NIDCR News NIDCR Announces Availability of COVID-19 Research Funding On May 5, NIDCR issued two Notices of Special Interest highlighting the urgent need for research on coronavirus disease 2019. This research may be conducted either via the National Dental PBRN infrastructu...
Source: NIDCR Science News - September 1, 2020 Category: Dentistry Source Type: news

Thousands of physiotherapists, dentists and even vets will be trained to give Covid-19 injections
Drugs regulator the Medicines and Healthcare products Regulatory Agency (MHRA) will be given powers to approve a vaccine without the go-ahead from the European Medicines Agency. (Source: the Mail online | Health)
Source: the Mail online | Health - August 28, 2020 Category: Consumer Health News Source Type: news