EU medicines agency to support coronavirus vaccine, drug development
The European Medicines Agency (EMA) said it was taking steps to speed up the development of vaccines and treatments to combat the new coronavirus that has killed more than 400 people. (Source: Reuters: Health)
Source: Reuters: Health - February 4, 2020 Category: Consumer Health News Tags: healthNews Source Type: news

EMA Panel Backs First Treatment for Acute Hepatic Porphyria EMA Panel Backs First Treatment for Acute Hepatic Porphyria
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for the first treatment for acute hepatic porphyria.International Approvals (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - February 1, 2020 Category: Gastroenterology Tags: Gastroenterology News Alert Source Type: news

EU Panel Backs Cholera Vaccine Vaxchora for Adults, Children EU Panel Backs Cholera Vaccine Vaxchora for Adults, Children
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for Vaxchora recombinant, live, oral cholera vaccine.International Approvals (Source: Medscape Pediatrics Headlines)
Source: Medscape Pediatrics Headlines - January 31, 2020 Category: Pediatrics Tags: Infectious Diseases News Alert Source Type: news

Roche announces CHMP recommendation for EU approval of Venclyxto plus Gazyvaro for people with untreated chronic lymphocytic leukaemia
Basel, 31 January 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with Gazyvaro® (obinutuzumab) for the treatment of adults with previously untreated chronic lymphocytic leukaemia (CLL).“Despite advances in treating chronic lymphocytic leukaemia, many patients cannot tolerate the side effects of chemotherapy-containing regimens,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product ...
Source: Roche Investor Update - January 31, 2020 Category: Pharmaceuticals Source Type: news

23.01.20: Not intended for U.S. and UK Media
Bayer submits application to European Medicines Agency for pre-filled syringe to administer eye medication Eylea®mehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - January 23, 2020 Category: Pharmaceuticals Source Type: news

Bayer submits application to European Medicines Agency for pre-filled syringe to administer eye medication Eylea ® (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - January 23, 2020 Category: Pharmaceuticals Source Type: news

EU Panel Confirms 4-Week Limit on High-Strength Estradiol Creams EU Panel Confirms 4-Week Limit on High-Strength Estradiol Creams
The decision marks the third time the European Medicines Agency's safety committee has issued the controversial recommendation.News Alerts (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - January 17, 2020 Category: Cancer & Oncology Tags: Ob/Gyn & Women ' s Health News Alert Source Type: news

Risk Management Plans: GVP Module V Revision 2 and Its Local Impact in...
Risk management plans in the EU have undergone significant changes to address the European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) Module V Revision 2. In this free...(PRWeb January 16, 2020)Read the full story at https://www.prweb.com/releases/risk_management_plans_gvp_module_v_revision_2_and_its_local_impact_in_the_eu_upcoming_webinar_hosted_by_xtalks/prweb16840423.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - January 16, 2020 Category: Pharmaceuticals Source Type: news

A statement in support of EMA ’s clinical study report transparency policy
Cochrane supports EMA ’s policy to make drug regulatory documents publicly available, which is currently the subject of a legal challenge.The European Medicines Agency (EMA) is awaiting a ruling from the European Court of Justice regarding whether they are legally allowed to grant public access to clinical study reports (CSRs).CSRs are detailed documents that pharmaceutical companies submit to regulators as part of the drug authorisation process. They are often the single most comprehensive source of information on a clinical trial, giving details of the design and methods used, as well as results for under-reported ...
Source: Cochrane News and Events - January 13, 2020 Category: Information Technology Authors: Lydia Parsonson Source Type: news

European Medicines Agency Validates BioMarin's Marketing Authorization Application for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A
Potential 1st Gene Therapy in Europe Directed at Any Type of Hemophilia Application to be Reviewed Under Accelerated Assessment SAN RAFAEL, Calif., Dec. 23, 2019 -- (Healthcare Sales & Marketing Network) -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN... Biopharmaceuticals, Regulatory BioMarin Pharmaceutical, valoctocogene roxaparvovec, hemophilia A, gene therapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 23, 2019 Category: Pharmaceuticals Source Type: news

Pfizer's rare disease drug gets EMA's positive recommendation
Pfizer Inc said on Friday the European Medicines Agency granted the company a positive recommendation for approval of its treatment for a rare disorder that occurs in patients with cardiomyopathy. (Source: Reuters: Health)
Source: Reuters: Health - December 13, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Roche announces positive Phase III study results for Tecentriq plus Cotellic and Zelboraf in people with previously untreated BRAF V600 mutation-positive advanced melanoma
             Basel, 13 December 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the Phase III IMspire150 study, in people with previously untreated BRAF V600 mutation-positive advanced melanoma, met its primary endpoint of progression-free survival (PFS). The study showed adding Tecentriq ® (atezolizumab) to Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf. A significant and clinically meaningful improvement in PFS was demonstrated in the study. The safety ...
Source: Roche Investor Update - December 13, 2019 Category: Pharmaceuticals Source Type: news

CHMP Backs Oral Siponimod (Mayzent) for Multiple Sclerosis CHMP Backs Oral Siponimod (Mayzent) for Multiple Sclerosis
The European Medicines Agency panel recommends siponimod for the treatment of adults with secondary progressive MS with active disease evidenced by relapses or imaging features of inflammatory activity.International Approvals (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - November 15, 2019 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news

Confusion as EU Advice on Vaginal Estradiol Differs from US Confusion as EU Advice on Vaginal Estradiol Differs from US
The European Medicines Agency recommends restricting use of"high-strength" estradiol creams to 4 weeks; the US FDA requires a boxed warning on all estradiol label.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - November 15, 2019 Category: Endocrinology Tags: Ob/Gyn & Women ' s Health News Source Type: news

Jazz Pharma's sleep disorder drug gets European panel backing
Jazz Pharmaceuticals Plc's treatment for a form of sleep disorder has been recommended for approval in Europe by a panel of the European Medicines Agency (EMA), the regulator said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - November 15, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

CHMP recommends EU approval of Roche ’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy. (Source: Roche Media News)
Source: Roche Media News - November 15, 2019 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy. (Source: Roche Investor Update)
Source: Roche Investor Update - November 15, 2019 Category: Pharmaceuticals Source Type: news

Johnson & Johnson Announces Submission of European Marketing Authorisation Applications for Janssen ’s Investigational Ebola Vaccine Regimen
Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated Assessment by European Medicines Agency (Source: Johnson and Johnson)
Source: Johnson and Johnson - November 7, 2019 Category: Pharmaceuticals Source Type: news

The Future Is Now: EMA Qualification Favors Clinical Trial eSource...
The European Medicines Agency (EMA)’s qualification opinion on the use of eSource technology in clinical trials has the potential to change industry practices. Now, with both the US Food and Drug...(PRWeb November 04, 2019)Read the full story at https://www.prweb.com/releases/the_future_is_now_ema_qualification_favors_clinical_trial_esource_solutions_over_outdated_processes_upcoming_webinar_hosted_by_xtalks/prweb16694215.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - November 4, 2019 Category: Pharmaceuticals Source Type: news

European agency highlights blood clot risks from Pfizer's arthritis drug
Pfizer Inc's rheumatoid arthritis drug Xeljanz could increase the risk of blood clots in the lungs and in deep veins, the European Medicines Agency (EMA) said on Thursday. (Source: Reuters: Health)
Source: Reuters: Health - October 31, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Roche ’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA
Roche announced today that the European Medicines Agency (EMA) has validated the company ’s Marketing Authorisation Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it Accelerated Assessment. Validation confirms that the submission is complete and signifies the MAA is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The U.S. Food and Drug Administration (FDA) has also accepted the company’s Biologics License Application (BLA) for satralizumab. The CHMP recommendation and the F...
Source: Roche Media News - October 30, 2019 Category: Pharmaceuticals Source Type: news

Roche ’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA
Roche announced today that the European Medicines Agency (EMA) has validated the company ’s Marketing Authorisation Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it Accelerated Assessment. Validation confirms that the submission is complete and signifies the MAA is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The U.S. Food and Drug Administration (FDA) has also accepted the company’s Biologics License Application (BLA) for satralizumab. The CHMP recommendation and the F...
Source: Roche Investor Update - October 30, 2019 Category: Pharmaceuticals Source Type: news

Cochrane advocates for clinical trial transparency at EU Parliament event
Cochrane recently joined policymakers, civil society organizations and academics at the European Parliament for a roundtable event on clinical trial transparency.Under the European Commission ’s Clinical Trial Regulation, which came into force in July 2014, trial sponsors must post summary results within one year of a study ending, or six months for paediatric trials. However, there has been a lack of commitment towards implementation.The event, which took place on 17 October, called for further action to ensure greater transparency of clinical trial data. It was organized by Health Action International and Transpari...
Source: Cochrane News and Events - October 25, 2019 Category: Information Technology Authors: Lydia Parsonson Source Type: news

European Commission Approves Astellas' XOSPATA(TM) (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
Approval follows accelerated assessment, orphan designation by European Medicines Agency TOKYO, Oct. 25, 2019 -- (Healthcare Sales & Marketing Network) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") ... Biopharmaceuticals, Oncology, Regulatory Astellas Pharma, XOSPATA, gilteritinib, acute myeloid leukemia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 25, 2019 Category: Pharmaceuticals Source Type: news

Provention Bio Announces PRV-031 (Teplizumab) Granted PRIME Designation by the European Medicines Agency
OLDWICK, N.J., Oct. 24, 2019 -- (Healthcare Sales & Marketing Network) -- Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the European Medic... Biopharmaceuticals, Endocrinology, Regulatory Provention Bio, teplizumab, diabetes (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 24, 2019 Category: Pharmaceuticals Source Type: news

EMA Recommends Upadacitinib for Rheumatoid Arthritis EMA Recommends Upadacitinib for Rheumatoid Arthritis
A European Medicines Agency advisory panel recommended marketing authorization for upadacitinib for the treatment of patients with rheumatoid arthritis.International Approvals (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - October 19, 2019 Category: Drugs & Pharmacology Tags: Rheumatology News Alert Source Type: news

EU Committee Backs Delafloxacin for ABSSSI EU Committee Backs Delafloxacin for ABSSSI
A European Medicines Agency advisory panel recommended delafloxacin for acute bacterial skin and skin structure infections in adults when other commonly used antibacterial drugs are inappropriate.International Approvals (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - October 19, 2019 Category: Internal Medicine Tags: Infectious Diseases News Alert Source Type: news

J & J's depression drug Spravato wins European panel vote
Johnson& Johnson's nasal spray for depression won recommendation for approval from a European Medicines Agency (EMA) panel, the regulatory body said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - October 18, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Medical Device Management in the World of Personalized Medicine
Medical device manufacturers can now supply patients with devices that are tailored specifically to their physiology. As the nature of patient care evolves, so do global regulations governing the manufacture and supply chain for these personalized medical devices. These devices require more consistent monitoring and service and thus demand greater traceability. In the current complex environment, medical device organizations are turning to cloud Enterprise Resource Planning (ERP) solutions to enable them to better manage their devices. The ability to maintain visibility at a global scale requires a solution that has the ca...
Source: MDDI - October 7, 2019 Category: Medical Devices Authors: Michael Kolias Tags: Digital Health Source Type: news

EU Panel: Don't Use Estradiol Creams for Longer Than 4 Weeks EU Panel: Don't Use Estradiol Creams for Longer Than 4 Weeks
A European Medicines Agency committee warns against using certain estradiol creams for longer than a single period of 4 weeks to reduce the risk for adverse health effects.International Approvals (Source: Medscape PublicHealth Headlines)
Source: Medscape PublicHealth Headlines - October 7, 2019 Category: Primary Care Tags: Ob/Gyn & Women ' s Health News Alert Source Type: news

Study Finds High Number of European Cancer Drug Trials at Risk for Bias
Half of the cancer drug trials that led to approvals by the European Medicines Agency may have been associated with a high risk for bias. (Source: CancerNetwork)
Source: CancerNetwork - October 4, 2019 Category: Cancer & Oncology Authors: Seth Augenstein Source Type: news

CHMP Issues Positive Opinion to Expand Trulicity(R) (dulaglutide) Label to Include Results from REWIND Cardiovascular Outcomes Trial
INDIANAPOLIS, Sept. 20, 2019 -- (Healthcare Sales & Marketing Network) -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a... Biopharmaceuticals, Endocrinology, Cardiology, Regulatory Eli Lilly, Trulicity, dulaglutide (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 20, 2019 Category: Pharmaceuticals Source Type: news

Zantac Has Low Levels of a Cancer-Causing Chemical, the F.D.A. Says
The chemical, NDMA, is the same one found in the blood pressure drug valsartan, which led to widespread recalls last year. (Source: NYT)
Source: NYT - September 14, 2019 Category: American Health Authors: Katie Thomas and Sheila Kaplan Tags: Drugs (Pharmaceuticals) Heartburn Product Tests Food and Drug Administration European Medicines Agency carcinogen Zantac your-feed-healthcare Source Type: news

More bad news for Novavax ’s RSV vaccine, this time in Europe
Novavax Inc. has suffered yet another major setback in its quest to get its respiratory syncytial virus vaccine to market: European regulators aren ’t on board. The Gaithersburg company expects to receive notice that the European Medicines Agency won’t be granting RSV vaccine ResVax a conditional marketing authorization pathway in the European Union, “based on the data package provided under the scientific advice request,” Novavax (NAS DAQ: NVAX) disclosed in Securities and Exchange Commission… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 10, 2019 Category: Biotechnology Authors: Sara Gilgore Source Type: news

EU Panel Starts Safety Review of Ingenol Mebutate (Picato) Gel EU Panel Starts Safety Review of Ingenol Mebutate (Picato) Gel
A European Medicines Agency safety committee is reviewing data on cases of skin cancer in patients who use topical ingenol mebutate to treat actinic keratosis.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 6, 2019 Category: Consumer Health News Tags: Dermatology News Alert Source Type: news

EMA Panel Recommends Ibalizumab for Multidrug-Resistant HIV-1 EMA Panel Recommends Ibalizumab for Multidrug-Resistant HIV-1
A European Medicines Agency advisory panel recommended marketing authorization for ibalizumab (Trogarzo, Theratechnologies International) for the treatment of patients with multidrug-resistant HIV-1 infection.International Approvals (Source: Medscape Med Students Headlines)
Source: Medscape Med Students Headlines - July 29, 2019 Category: Universities & Medical Training Tags: HIV/AIDS News Alert Source Type: news

European panel okays GW Pharma cannabis drug for epilepsy
GW Pharmaceuticals' marijuana-based treatment Epidyolex has won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel on Friday for use as an additional treatment for two types of seizures. (Source: Reuters: Health)
Source: Reuters: Health - July 26, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), for the initial (first-line) treatment of adults with metastatic no n-squamous non-small cell lung cancer (NSCLC). (Source: Roche Media News)
Source: Roche Media News - July 26, 2019 Category: Pharmaceuticals Source Type: news

Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), for the initial (first-line) treatment of adults with metastatic no n-squamous non-small cell lung cancer (NSCLC). (Source: Roche Investor Update)
Source: Roche Investor Update - July 26, 2019 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). (Source: Roche Media News)
Source: Roche Media News - July 26, 2019 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). (Source: Roche Investor Update)
Source: Roche Investor Update - July 26, 2019 Category: Pharmaceuticals Source Type: news

Halozyme Announces Janssen Submits Extension Application To European Medicines Agency For Subcutaneous Formulation Of DARZALEX(R) Utilizing ENHANZE(R) Technology
SAN DIEGO, July 19, 2019 -- (Healthcare Sales & Marketing Network) -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Janssen-Cilag International NV (Janssen) ... Biopharmaceuticals, Oncology, Drug Delivery, Regulatory Halozyme Therapeutics, Janssen, DARZALEX, daratumumab, multiple myeloma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 19, 2019 Category: Pharmaceuticals Source Type: news

Aridis Pharmaceuticals Receives Orphan Drug Designation From the European Medicines Agency for AR-501
SAN JOSE, Calif., July 19, 2019 -- (Healthcare Sales & Marketing Network) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation to AR-501, the Company's inhaled formulat... Biopharmaceuticals, Regulatory Aridis Pharmaceuticals, gallium citrate, cystic fibrosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 19, 2019 Category: Pharmaceuticals Source Type: news

Cochrane supports European regulators as they urge clinical trial sponsors to share their results
Cochrane ’s Editor in Chief supportsan open letter recently co-authored by the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), reminding clinical trial sponsors of their obligation to make their results public.Cochrane has long recognised that clinical trials are key to improvements in patient care and disease prevention and that access to information from these trials is essential for patients, practitioners, policy makers and other stakeholders to be able to make well-informed decisions about healthcare and medical research. Yet an unacceptable number of spon...
Source: Cochrane News and Events - July 10, 2019 Category: Information Technology Authors: Lydia Parsonson Source Type: news

EU approves type 2 diabetes drug for children
The Committee for Medicinal Products for Human Use of the European Medicines Agency has approved the GLP-1 agonist, liraglutide, for the treatment of children and adolescents with type 2 diabetes.Medscape (Source: Society for Endocrinology)
Source: Society for Endocrinology - July 4, 2019 Category: Endocrinology Source Type: news

CHMP recommends EU approval of Roche ’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose t umours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease. (Source: Roche Media News)
Source: Roche Media News - June 28, 2019 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose t umours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease. (Source: Roche Investor Update)
Source: Roche Investor Update - June 28, 2019 Category: Pharmaceuticals Source Type: news

Amgen and UCB Provide Regulatory Update on Status of EVENITY ™ (romosozumab) in the EU
THOUSAND OAKS, Calif. and BRUSSELS, June 27, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the companies have been informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application for EVENITYTM (romosozumab) for the treatment of severe osteoporosis. The companies intend to submit a written notice for a re-examination by the CHMP. "After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,1 a...
Source: Amgen News Release - June 28, 2019 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

How depression pills can wreck your sex life
The European Medicines Agency has announced that some depression pills should carry warnings about the risk of longer term enduring sexual dysfunction. (Source: the Mail online | Health)
Source: the Mail online | Health - June 10, 2019 Category: Consumer Health News Source Type: news

AAA receives positive CHMP opinion for LysaKare
(Advanced Accelerator Applications) Advanced Accelerator Applications S.A. (AAA), a Novartis company, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization of LysaKare ® 25g/25g (arginine hydrochloride/lysine hydrochloride) solution for reduction of renal (kidney) radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide (Lutathera ® ) in adults. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - June 5, 2019 Category: Cancer & Oncology Source Type: news