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 29, 2020 Category: Consumer Health News Source Type: news

UK prepares to fast-track coronavirus vaccine and train army of health workers
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

Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19
Basel, 19 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Regeneron (NASDAQ: REGN) announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron ’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and ...
Source: Roche Media News - August 19, 2020 Category: Pharmaceuticals Source Type: news

Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19
Basel, 19 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Regeneron (NASDAQ: REGN) announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron ’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and ...
Source: Roche Investor Update - August 19, 2020 Category: Pharmaceuticals Source Type: news

Africa: New Vaginal Ring to Reduce Risk of HIV Infection in Africa
[Capital FM] Nairobi -- European Medicines Agency (EMA) human medicines committee has adopted a positive opinion for Dapivirine Vaginal Ring (Dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV- 1). (Source: AllAfrica News: HIV-Aids and STDs)
Source: AllAfrica News: HIV-Aids and STDs - July 27, 2020 Category: Infectious Diseases Source Type: news

Phase III data show Roche ’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration
Basel, 22 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from the phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of blindness globally.1 In Archway, 98.4% of PDS patients were able to go six months without needing additional treatment and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections, a current standard of care. In the study, PDS was generally well-tolerated, with a favourable benefit...
Source: Roche Media News - July 22, 2020 Category: Pharmaceuticals Source Type: news

Phase III data show Roche ’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration
Basel, 22 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from the phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of blindness globally.1 In Archway, 98.4% of PDS patients were able to go six months without needing additional treatment and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections, a current standard of care. In the study, PDS was generally well-tolerated, with a favourable benefit...
Source: Roche Investor Update - July 22, 2020 Category: Pharmaceuticals Source Type: news

Interim Six-Month Data of RPGR Gene Therapy Shows Significant Vision Improvement in Patients Living with X-Linked Retinitis Pigmentosa
Click to Access Audio Press ReleaseRARITAN, NJ, July 17, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today six-month data from the ongoing Phase 1/2 trial (NCT03252847) of its investigational gene therapy for the treatment of inherited retinal disease X-linked retinitis pigmentosa (XLRP). The interim data showed that low and intermediate doses of the investigational adeno-associated virus retinitis pigmentosa GTPase regulator (AAV-RPGR) were generally well-tolerated and indicated significant improvement in vision. Initial data on the novel AAV-RPGR asset, jointly developed with Meir...
Source: Johnson and Johnson - July 17, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers
             Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine ’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered ...
Source: Roche Media News - July 14, 2020 Category: Pharmaceuticals Source Type: news

IDELVION(R) Becomes First and Only Factor IX Therapy with 21-Day Prophylactic Dosing
European Medicines Agency Approves 21-Day Dosing Intervals for Adult Haemophilia B Patients HATTERSHEIM, Germany, July 3, 2020 -- (Healthcare Sales & Marketing Network) -- Global biotherapeutics leader CSL Behring announced today that the European Medi... Biopharmaceuticals, Regulatory CSL Behring, IDELVION , albutrepenonacog alfa, Factor IX, haemophilia B (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 3, 2020 Category: Pharmaceuticals Source Type: news

Johnson & Johnson Announces European Commission Approval for Janssen ’s Preventive Ebola Vaccine
Discussions with the U.S. Food and Drug Administration (FDA) have taken place to define the required data set for filing US licensure. About Janssen’s Ebola Vaccine Regimen The Janssen preventive Ebola vaccine regimen, Ad26.ZEBOV and MVA-BN-Filo, utilizes a non-replicating viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response.Janssen’s vac...
Source: Johnson and Johnson - July 1, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Roche ’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder
             Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Japan ’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children. ENSPRYNG demonstrated robust efficacy and s ignificantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to ...
Source: Roche Media News - June 29, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder
             Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Japan ’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children. ENSPRYNG demonstrated robust efficacy and s ignificantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to ...
Source: Roche Investor Update - June 29, 2020 Category: Pharmaceuticals Source Type: news

Partnering with the European Union and Global Regulators on COVID-19
The FDA and the European Commission (EC) and its European Medicines Agency (EMA) are collaborating on many scientific and regulatory fronts as part of our COVID-19 response. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 25, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Roche ’s Tecentriq in combination with chemotherapy (including Abraxane) meets primary endpoint of improved pathological complete response, regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer
Basel, 18 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion031 study, evaluating Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chem otherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression.“Tripl...
Source: Roche Media News - June 18, 2020 Category: Pharmaceuticals Source Type: news

Roche announces 2-year risdiplam data from SUNFISH and new data from JEWELFISH in infants, children and adults with spinal muscular atrophy (SMA)
Basel, 12 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented two-year data from Part 1 of its pivotal SUNFISH trial in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA) at the virtual Cure SMA Annual Conference, 8-12 June, 2020. The results of an exploratory efficacy analysis show risdiplam significantly improved motor function after 24 months of treatment compared to natural history data. In addition, preliminary 12 month data from JEWELFISH, a trial in people with all types of SMA aged 6 months to 60 years previously treated with other SMA therapies, showed that treatment with risdiplam le...
Source: Roche Media News - June 12, 2020 Category: Pharmaceuticals Source Type: news

NIDCR's Summer 2020 E-Newsletter
Having trouble viewing this email? View it as a Web page. NIDCR's Summer 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 infrastruc...
Source: NIDCR Science News - June 4, 2020 Category: Dentistry Source Type: news

AstraZeneca-Merck Lynparza gets EMA's positive recommendation
Drugmakers AstraZeneca Plc and Merck& Co Inc said on Monday their blockbluster cancer drug, Lynparza, has received positive recommendation from the European Medicines Agency (EMA) as a maintenance treatment for a form of pancreatic cancer. (Source: Reuters: Health)
Source: Reuters: Health - June 1, 2020 Category: Consumer Health News Tags: healthNews Source Type: news

Johnson & Johnson Receives Positive CHMP Opinion for Janssen ’s Investigational Preventive Ebola Vaccine Regimen
Discussions with the FDA are ongoing to define the required data set for filing Janssen’s Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway. About Janssen’s Ebola Vaccine Regimen The Janssen investigational preventive Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) utilizes a viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors are modified to safely carry the genetic code of an Ebola virus protein in order...
Source: Johnson and Johnson - May 29, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

CHMP recommends EU approval of Roche ’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer
      ·Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, and could become Roche ’s first tumour-agnostic therapy in EuropeBasel, 29 May 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 adopted a positive opinion under conditional marketing authorisation for Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrop...
Source: Roche Media News - May 29, 2020 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer
Basel, 29 May 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 adopted a positive opinion under conditional marketing authorisation for Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine r eceptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who h...
Source: Roche Investor Update - May 29, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s OCREVUS (ocrelizumab) shorter 2-hour infusion time approved in Europe
             Basel, 28 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS ® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).“The approval of a shorter, two-hour infusion time for OCREVUS in Europe, dosed twice yearly, will further improve the treatment experience for patients while als...
Source: Roche Media News - May 28, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s OCREVUS (ocrelizumab) shorter 2-hour infusion time approved in Europe
             Basel, 28 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS ® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).“The approval of a shorter, two-hour infusion time for OCREVUS in Europe, dosed twice yearly, will further improve the treatment experience for patients while als...
Source: Roche Investor Update - May 28, 2020 Category: Pharmaceuticals Source Type: news

U.S. FDA Approves New Pediatric Formulation of SIRTURO ® (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis
NEW BRUNSWICK, NJ, May 27, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of SIRTURO® (bedaquiline). SIRTURO® is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis (MDR‑TB). In the U.S., the medicine should be reserved for use when an effective treatment regimen cannot otherwise be provided. This indication received acceler...
Source: Johnson and Johnson - May 27, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Roche ’s Port Delivery System with ranibizumab shows positive phase III results in neovascular age-related macular degeneration
Basel, 27 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the phase III Archway study, evaluating Port Delivery System with ranibizumab (PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD). PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customised formulation of ranibizumab over a period of months. The Archway trial met its primary endpoint, demonstrating that patient s with PDS who received refills every six months achieved visual acuity outcomes equivalent to tho...
Source: Roche Media News - May 27, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Port Delivery System with ranibizumab shows positive phase III results in neovascular age-related macular degeneration
Basel, 27 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the phase III Archway study, evaluating Port Delivery System with ranibizumab (PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD). PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customised formulation of ranibizumab over a period of months. The Archway trial met its primary endpoint, demonstrating that patient s with PDS who received refills every six months achieved visual acuity outcomes equivalent to tho...
Source: Roche Investor Update - May 27, 2020 Category: Pharmaceuticals Source Type: news

WHO Suspends Study of Hydroxychloroquine as COVID-19 Treatment to Review Safety Concerns
(GENEVA) — The World Health Organization said Monday that it will temporarily drop hydroxychloroquine — the anti-malarial drug U.S. President Trump says he is taking — from its global study into experimental COVID-19 treatments, saying that its experts need to review all available evidence to date. In a press briefing, WHO director-general Tedros Adhanom Ghebreyesus said that in light of a paper published last week in the Lancet that showed people taking hydroxychloroquine were at higher risk of death and heart problems, there would be “a temporary pause” on the hydroxychloroquine arm of its g...
Source: TIME: Health - May 25, 2020 Category: Consumer Health News Authors: Maria Cheng and Jamey Keaten / AP Tags: Uncategorized COVID-19 News Desk overnight wire Source Type: news

Global regulators commit to cooperate on observational research in the context of COVID-19, European Medicines Agency
Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19: pregnancy, medicines used in clinical practice and vaccine safety and effectiveness monitoring. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - May 22, 2020 Category: Consumer Health News Source Type: news

Cochrane Centres call for transparency of COVID-19 clinical studies
Representatives of four Cochrane Centres in Europe have signed an open letter to the European Medicines Agency (EMA) initiated by the German Institute for Quality and Efficiency in Health Care (IQWIG).The letter – which Cochrane Austria, Cochrane France, Cochrane Germany and Cochrane Ireland have signed – calls on the EMA to publish clinical study reports on all drugs and vaccines for COVID-19 in full and immediately on the date of marketing authorisation.Clinical study reports (CSRs) are detailed study documents that pharmaceutical companies provide to regulators such as the EMA as part of the drug approval pr...
Source: Cochrane News and Events - May 20, 2020 Category: Information Technology Authors: Lydia Parsonson Source Type: news

Janssen ’s BCMA CAR-T Therapy JNJ-4528 Showed Early, Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
RARITAN, NJ, May 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ-4528, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in the treatment of patients with relapsed or refractory multiple myeloma. Longer-term follow-up results from the Phase 1b portion of the study (n=29), to be shared in an oral presentation at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (Abstract #8505), show t...
Source: Johnson and Johnson - May 14, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

EMA recommends expanding compassionate use of Gilead's COVID-19 drug
The European Medicines Agency (EMA) on Monday recommended that Gilead Sciences Inc's experimental drug for the new coronavirus be given under compassionate use to patients other than those undergoing invasive mechanical ventilation. (Source: Reuters: Health)
Source: Reuters: Health - May 11, 2020 Category: Consumer Health News Tags: healthNews Source Type: news

COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines, EMA
The European Medicines Agency has published this overview of how it will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - May 6, 2020 Category: Consumer Health News Source Type: news

Medivir Receives Positive Opinion on Orphan Medicinal Drug Designation by the European Medicines Agency for MIV-818
STOCKHOLM, April 30, 2020 -- (Healthcare Sales & Marketing Network) -- Medivir AB (Nasdaq Stockholm: MVIR) today announced that it has received positive opinion from the Committee for Orphan Medicinal Products on orphan medicinal product designation in t... Biopharmaceuticals, Oncology, Regulatory Medivir, hepatocellular carcinoma, liver cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 30, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s risdiplam shows significant improvement in survival and motor milestones in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented 1-year data from FIREFISH Part 2, a pivotal global study evaluating risdiplam in infants aged 1 – 7 months old with symptomatic Type 1 spinal muscular atrophy (SMA). The study met its primary endpoint with 29% of infants (12/41; p
Source: Roche Media News - April 28, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s risdiplam shows significant improvement in survival and motor milestones in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented 1-year data from FIREFISH Part 2, a pivotal global study evaluating risdiplam in infants aged 1 – 7 months old with symptomatic Type 1 spinal muscular atrophy (SMA). The study met its primary endpoint with 29% of infants (12/41; p
Source: Roche Investor Update - April 28, 2020 Category: Pharmaceuticals Source Type: news

C-Path receives letter of support from EMA on type 1 diabetes biomarker initiative
(Critical Path Institute (C-Path)) The Critical Path Institute today announced that its Type 1 Diabetes (T1D) Consortium has received a letter of support from the European Medicines Agency to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to diagnose T1D: insulin autoantibodies, glutamic acid decarboxylase 65, and insulinoma antigen-2 autoantibodies as enrichment biomarkers for T1D clinical trials. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 28, 2020 Category: International Medicine & Public Health Source Type: news

CARsgen Therapeutics Receives Positive EMA Opinion on Orphan Drug Designation for Fully Human Anti-BCMA CAR-T Cells (CT053) for the Treatment of Multiple Myeloma
SHANGHAI, April 27, 2020 -- (Healthcare Sales & Marketing Network) -- CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted a ... Biopharmaceuticals, Oncology, Regulatory CARsgen Therapeutics, CAR-T, cell therapy, multiple myeloma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 27, 2020 Category: Pharmaceuticals Source Type: news

European Medicines Agency update to guidance on regulatory expectations in the context of COVID-19 pandemic, EMA (updated 20th April 2020)
The updated guidance states validity of GMP certificates and time-limited manufacturing/import authorisations, as well as validity of GDP certificates and time-limited wholesale authorisations will be extended until end of 2021 in order to mitigate impact of supply disruptions. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 22, 2020 Category: Consumer Health News Source Type: news

EU Panel Review Supports Decision to Pull Picato From Market EU Panel Review Supports Decision to Pull Picato From Market
A European Medicines Agency safety committee concluded that the risks for skin cancer from the topical gel used to treat actinic keratosis outweigh the benefits.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 20, 2020 Category: Consumer Health News Tags: Dermatology News Alert Source Type: news

US FDA and EMA accept applications for Roche ’s OCREVUS (ocrelizumab) shorter 2-hour infusion time
             Basel, 20 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the application for a two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS).“With more than 150,000 people treated with OCREVUS, the twice-yearly dosing schedule has benefited many MS patients and their physi...
Source: Roche Media News - April 20, 2020 Category: Pharmaceuticals Source Type: news

US FDA and EMA accept applications for Roche ’s OCREVUS (ocrelizumab) shorter 2-hour infusion time
Basel, 20 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the application for a two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS).“With more than 150,000 people treated with OCREVUS, the twice-yearly dosing schedule has benefited many MS patients and their physicians, as indicated by more than 90 percent* of patients continuing with treat...
Source: Roche Investor Update - April 20, 2020 Category: Pharmaceuticals Source Type: news

NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options
The National Institutes of Health and the Foundation for the NIH (FNIH) are bringing together more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and the European Medicines Agency to develop an international strategy for a coordinated research response to the COVID-19 pandemic. (Source: World Pharma News)
Source: World Pharma News - April 17, 2020 Category: Pharmaceuticals Tags: Featured Development Research and Development Source Type: news

European Medicines Agency (EMA) establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
The EMA has published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which assists Member States and the European Commission in dealing with development, authorisation and safety monitoring of COVID-19 therapeutics and vaccines. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 14, 2020 Category: Consumer Health News Source Type: news

Global regulators stress need for robust evidence on COVID-19 treatments, European Medicines Agency
The report presents the outcomes of a regulatory workshop on COVID-19 therapeutic medicine development. It emphasises that no medicine has yet clearly demonstrated efficacy in treating COVID-19, and that RCTs with an appropriate control are needed to generate the necessary data. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 14, 2020 Category: Consumer Health News Source Type: news

Johnson & Johnson Reports 2020 First-Quarter Results:
New Brunswick, N.J. (April 14, 2020) – Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2020. The Company also announced earlier today that its Board of Directors declared a 6.3% increase in the quarterly dividend rate, from $0.95 per share to $1.01 per share. At the new rate, the indicated dividend on an annual basis is $4.04 per share compared to the previous rate of $3.80 per share. “With Johnson & Johnson’s century-plus history of leading in times of great challenge, we are mobilizing our resources across the Company in the fight against the COVID-19 pandemic,” sai...
Source: Johnson and Johnson - April 14, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news