FDA: Mercury Risk Means Certain People Should Not Get Amalgam Dental Fillings
FRIDAY, Sept. 25, 2020 -- Certain people are at higher risk for health problems from mercury-containing amalgam dental fillings and should avoid them if possible, a new U.S. Food and Drug Administration recommendation says. Groups that may be at... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 25, 2020 Category: Pharmaceuticals Source Type: news

Wood Ear Mushrooms Linked to Salmonella Outbreak
FRIDAY, Sept. 25, 2020 -- Recalled wood ear mushrooms imported by Wismettac Asian Foods Inc., of Santa Fe Springs, California, and sold to restaurants may be linked to a multistate Salmonella outbreak, the U.S. Food and Drug Administration said... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 25, 2020 Category: Pharmaceuticals Source Type: news

FDA revokes Va. facility's mammography accreditation
The U.S. Food and Drug Administration (FDA) The U.S. Food and Drug Administration...Read more on AuntMinnie.comRelated Reading: FDA document outlines new mammo appeals process Okla. hospital resolves mammography issue FDA updates mammo facility guidance for COVID-19 FDA posts warning for Florida mammography center Va. mammography center gets certificate reinstated (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 25, 2020 Category: Radiology Source Type: news

Recalled Mushrooms, Possibly Served At Mass. Restaurants, Linked To Salmonella Outbreak
(CNN) — At least 41 people are sick in 10 different states after a salmonella outbreak that has been linked to dried wood ear mushrooms, the Centers for Disease Control and Prevention said. The cases started between January 21 to August 26, the agency reported Thursday. Of the 41 infected, four hospitalizations were reported. The infected people range in age from two to 74 years old. The mushrooms, distributed by Wismettac Asian Foods, Inc. in Sante Fe Springs, California, were sold only to restaurants and not directly to consumers. The recalled mushrooms (Image credit: CDC via CNN) The company voluntarily recalled t...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - September 25, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Syndicated CBSN Boston CNN Recall Source Type: news

Popular Dental Filling Could Cause Health Problems For Some Patients
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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - September 25, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Syndicated CBSN Boston CNN FDA Source Type: news

Benadryl Warning: FDA Investigates Reports Of Teen Injuries, Deaths Linked To TikTok Challenge
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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - September 25, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Syndicated CBSN Boston Benadryl CNN FDA TikTok Source Type: news

FDA Approves Nucala (mepolizumab) as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)
London UK 25 September 2020 -- GlaxoSmithKline plc (GSK) today announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

Zydus Cadila gets US health regulator nod for multiple sclerosis treatment drug
Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Dimethyl Fumarate delayed release capsules, (Tecfidera) in the strengths of 120 mg and 240 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 25, 2020 Category: Pharmaceuticals Source Type: news

FDA Warns of Danger From'Benadryl Challenge,' Asks TikTok to Remove Videos
THURSDAY, Sept. 24, 2020 -- Parents and other caregivers need to be more aware of the potentially lethal " Benadryl Challenge " circulating on social media, the U.S. Food and Drug Administration warned Thursday. The new internet dare, broadcast... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - September 24, 2020 Category: General Medicine Source Type: news

FDA Requiring Labeling Changes to Benzodiazepine Prescribing Information
THURSDAY, Sept. 24, 2020 -- In response to reports of misuse and abuse of benzodiazepines, the U.S. Food and Drug Administration is now requiring class-wide labeling changes to the prescribing information, the agency announced yesterday. The Boxed... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 24, 2020 Category: Pharmaceuticals Source Type: news

ADC Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
LAUSANNE, Switzerland--(BUSINESS WIRE)-- September 24, 2020 -- ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 24, 2020 Category: Drugs & Pharmacology Source Type: news

Trump attacks FDA plan for tougher standards on emergency vaccine approval as a ‘political move’
The president warned he may reject the proposal, hours after the Food and Drug Administration chief told senators that a vaccine decision will be free of political interference. (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - September 24, 2020 Category: Consumer Health News Authors: Amy Goldstein Source Type: news

F.D.A. Requires Stronger Warning Label for Xanax and Similar Drugs
Benzodiazepines — commonly prescribed for anxiety, insomnia, seizures and panic disorders — are highly addictive and come with health risks, especially when combined with other drugs. (Source: NYT Health)
Source: NYT Health - September 24, 2020 Category: Consumer Health News Authors: Sheila Kaplan Tags: Drug Abuse and Traffic Drugs (Pharmaceuticals) Mental Health and Disorders Opioids and Opiates Food and Drug Administration your-feed-healthcare Source Type: news

Massachusetts Man Dies From Eating Too Much Black Licorice
(AP) – A Massachusetts construction worker’s love of black licorice wound up costing him his life. Eating a bag and a half every day for a few weeks threw his nutrients out of whack and caused the 54-year-old man’s heart to stop, doctors reported Wednesday. “Even a small amount of licorice you eat can increase your blood pressure a little bit,” said Dr. Neel Butala, a cardiologist at Massachusetts General Hospital who described the case in the New England Journal of Medicine. The problem is glycyrrhizic acid, found in black licorice and in many other foods and dietary supplements containing li...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - September 23, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Featured Health Syndicated CBSN Boston Mass General Hospital Source Type: news

FDA Requiring Labeling Changes for Benzodiazepines
September 23, 2020 -- The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring an update to the Boxed Warning, the agency’s most prominent safety warning, and requiring class-wide... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 23, 2020 Category: Pharmaceuticals Source Type: news

Stricter Vaccine Approval Rules Coming From FDA
WEDNESDAY, Sept. 23, 2020 -- Stricter guidelines for emergency authorization use of a vaccine against the new coronavirus could soon be issued by the U.S. Food and Drug Administration. The guidelines would outline more specific criteria for... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 23, 2020 Category: Pharmaceuticals Source Type: news

NeuroRx seeks emergency use authorization for its experimental Covid-19 therapy
NeuroRx said Wednesday it has submitted an emergency use authorization request with the Food and Drug Administration for the company's Covid-19 treatment in patients who have exhausted all approved treatments. NeuroRx is based in Wilmington and has its clinical operations in Radnor. The emergency use authorization would cover the use of RLF-100, which NeuroRx is developing in a partnership with Relief Therapeutic Holdings of Geneva, Switzerland. RLF-100 is a patented formulation of synthetic human… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 23, 2020 Category: Pharmaceuticals Authors: John George Source Type: news

Johnson & Johnson ’ s Coronavirus Vaccine Enters Phase 3 Trial With Beth Israel
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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - September 23, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Covid-19 Boston, MA Health Healthcare Status Beth Israel Deacones Medical Center Coronavirus Johnson & Johnson Source Type: news

Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen ’s COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online i...
Source: Johnson and Johnson - September 23, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

F.D.A. to Release Stricter Guidelines for Emergency Vaccine Authorization
The new guidelines underscore the fact that a vaccine is highly unlikely before the election. (Source: NYT Health)
Source: NYT Health - September 23, 2020 Category: Consumer Health News Authors: Noah Weiland and Sharon LaFraniere Tags: United States Politics and Government Clinical Trials Vaccination and Immunization Coronavirus (2019-nCoV) Trump, Donald J Food and Drug Administration your-feed-healthcare Source Type: news

Pfizer is on track to be first to find out if its Covid vaccine works
A wide range of symptoms and severity makes the evaluation of Covid-19 vaccines tricky. The U.S. Food and Drug Administration has said that to be approved, vaccines should cut the number of symptomatic cases by half. Yet documents released by the drugmakers show each has its own approach to defining which symptoms count, and when to count them. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 23, 2020 Category: Pharmaceuticals Source Type: news

COVID-19: Analysis reveals heart-related side effects of hydroxychloroquine, chloroquine
In the analysis of real-world data from the Food and Drug Administration Adverse Events Reporting System, a global database of post-marketing safety reports, hydroxychloroquine and chloroquine were associated with higher rates of various cardiovascular problems, including life-threatening heart rhythm events, heart failure, and damage to the heart muscle itself (termed cardiomyopathy). (Source: The Economic Times)
Source: The Economic Times - September 23, 2020 Category: Consumer Health News Source Type: news

FDA introduces digital health center of excellence
The U.S. Food and Drug Administration (FDA) has introduced what it is calling...Read more on AuntMinnie.comRelated Reading: FDA clears Nous Imaging's MRI software RadLogics secures FDA clearance for chest x-ray AI Intelligent Ultrasound seeks FDA clearance for new system Vida receives FDA clearance for AI lung software GE gets FDA nod to package Clariscan in polymer bottle (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 22, 2020 Category: Radiology Source Type: news

Perrigo Asthma Inhalers Recalled Due to Clog Risk
TUESDAY, Sept. 22, 2020 -- Perrigo inhalers have been recalled because they could clog and not provide patients with any or enough medication, the U.S. Food and Drug Administration says. The retail recall is for all unexpired albuterol sulfate... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 22, 2020 Category: Pharmaceuticals Source Type: news

FDA clears Nous Imaging's MRI software
Nous Imaging has received clearance from the U.S. Food and Drug Administration...Read more on AuntMinnie.comRelated Reading: Nous Imaging appoints new CEO Nous Imaging software targets brain MR troubles (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 22, 2020 Category: Radiology Source Type: news

NanoVibronix UroShield(R) Receives U.S. Food and Drug Administration Authorization for Entry into the U.S.
ELMSFORD, N.Y., Sept. 22, 2020 -- (Healthcare Sales & Marketing Network) -- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic... Devices, FDA NanoVibronix, UroShield, PainShield, WoundShield, Surface Acoustic Wave (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 22, 2020 Category: Pharmaceuticals Source Type: news

What Your Blood Tells You About Cancer
Blood tests can tell us a lot about what’s going on in our bodies—from whether we’re eating too much sugar to whether we’re harboring any infectious diseases. Scientists lately have been working on ways to use similar diagnostic tools for cancer, which have the potential to dramatically increase the amount of information doctors use to figure out the best treatments for their patients. Called liquid biopsies, these tests are designed to pick up genetic material shed by cancer tumors into the blood, which lets doctors avoid the invasive procedures needed to extract samples directly from tumors. That ...
Source: TIME: Health - September 22, 2020 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized Source Type: news

Strides Pharma Science arm gets USFDA nod for tension headache tablets
Strides Pharma Global Pte Ltd, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine tablets USP in the strengths of 50 mg/325 mg/40 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 22, 2020 Category: Pharmaceuticals Source Type: news

FDA Alerts of Perrigo's voluntary albuterol inhaler recall
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Bill Gates turns on CDC and FDA, insists they can't be trusted with Trump in charge
(Natural News) Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) can no longer be trusted, according to billionaire eugenicist Bill Gates, because President Trump is not overseeing these agencies the way Gates would like. During a recent interview, Gates whined about how Trump is supposedly engaged in... (Source: NaturalNews.com)
Source: NaturalNews.com - September 21, 2020 Category: Consumer Health News Source Type: news

In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.
Experts said the memo would make it more difficult for the F.D.A. to issue new rules, but it ’s unclear how it would affect the vetting of coronavirus vaccines. (Source: NYT Health)
Source: NYT Health - September 20, 2020 Category: Consumer Health News Authors: Sheila Kaplan Tags: Coronavirus (2019-nCoV) Regulation and Deregulation of Industry United States Politics and Government Food and Drug Administration Centers for Medicare and Medicaid Services Centers for Disease Control and Prevention Source Type: news

We Need a COVID-19 Vaccine. We Also Need Transparency About Its Development
The authorization of an effective vaccine will mark perhaps the biggest turning point in the battle against coronavirus, but only if enough people are willing to get vaccinated. There have been substantial declines in public willingness to get vaccinated against COVID-19, despite immense, unprecedented public investments in vaccine development. In one survey, barely half of Americans said they would get the vaccine as soon as it was available, numbers that will undermine the benefits of even a highly effective vaccine. It is no mystery why trust in a potential vaccine has plummeted. Operation Warp Speed, the Trump Administ...
Source: TIME: Health - September 18, 2020 Category: Consumer Health News Authors: Dr. Ashish K. Jha Tags: Uncategorized COVID-19 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

Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys ® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response.1 Specifically, the test targets antibodies which are directed against the ...
Source: Roche Media News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys ® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response.1 Specifically, the test targets antibodies which are directed against the ...
Source: Roche Investor Update - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra ®/RoActemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo...
Source: Roche Media News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra ®/RoActemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo...
Source: Roche Investor Update - September 18, 2020 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets American health regulator's approval to market mineral supplement
Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Potassium Chloride extended release tablets in the strengths of 10 mEq (750 mg) and 20 mEq (1,500 mg), Zydus Cadila, part of Cadila Healthcare group. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 18, 2020 Category: Pharmaceuticals Source Type: news

John Najarian, Pioneering Transplant Surgeon, Dies at 92
He was known for taking on difficult cases, many involving children. An anti-rejection drug he developed led to a scandal, but he was vindicated. (Source: NYT Health)
Source: NYT Health - September 17, 2020 Category: Consumer Health News Authors: Neil Genzlinger Tags: Transplants Surgery and Surgeons Deaths (Obituaries) Food and Drug Administration University of Minnesota Najarian, John S. Source Type: news

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020
Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq® (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek® STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to re...
Source: Roche Media News - September 17, 2020 Category: Pharmaceuticals Source Type: news

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020
Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq® (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek® STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to re...
Source: Roche Investor Update - September 17, 2020 Category: Pharmaceuticals Source Type: news

US FDA's Hahn Plans'Significant' Work With AstraZeneca in COVID-19 Trial Inquiry US FDA's Hahn Plans'Significant' Work With AstraZeneca in COVID-19 Trial Inquiry
The top US Food and Drug Administration official on Tuesday confirmed AstraZeneca's US COVID-19 vaccine trial is on hold.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - September 16, 2020 Category: Intensive Care Tags: Infectious Diseases News Source Type: news

Federal Government Outlines Plan To Make Coronavirus Vaccine Free To All
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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - September 16, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Covid-19 Boston, MA Health Healthcare Status Syndicated CBSN Boston Coronavirus Source Type: news

Paused AstraZeneca Trials Emphasize Need For Vaccine Transparency
AstraZeneca, and all the other companies under Food and Drug Administration purview, are developing vaccines for Covid-19. In the midst of current trials across the globe, they paused operation when a participant in the United Kingdom developed symptoms of a spinal inflammatory disease. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - September 16, 2020 Category: Pharmaceuticals Authors: William A. Haseltine, Contributor Tags: Healthcare /healthcare Innovation /innovation Coronavirus business pharma & Source Type: news

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer
Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec®PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtecPLUS Cytology to triage positive results from the cobas ® HPV Test run on the fully integrated, automated and high-thr...
Source: Roche Media News - September 16, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer
Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec®PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtecPLUS Cytology to triage positive results from the cobas ® HPV Test run on the fully integrated, automated and high-thr...
Source: Roche Investor Update - September 16, 2020 Category: Pharmaceuticals Source Type: news

FDA clears ControlRad Trace for OEC C-arms
ControlRad has received 510(k) clearance from the U.S. Food and Drug Administration...Read more on AuntMinnie.comRelated Reading: ControlRad announces executive appointments ControlRad secures $15M in funding FDA OKs ControlRad's fluoro dose-reduction technology ControlRad touts radiation reductions in fluoro study ControlRad adds former GE CEO to board (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 15, 2020 Category: Radiology Source Type: news

GE gets FDA nod to package Clariscan in polymer bottle
GE Healthcare has received U.S. Food and Drug Administration (FDA) clearance...Read more on AuntMinnie.comRelated Reading: GE brings Critical Care Suite to Canada GE unveils cardiac ultrasound package at ESC GE launches 7T MRI scanner at ISMRM 2020 GE, Osprey announce distribution deal FDA clears GE's Clariscan macrocyclic GBCA (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 15, 2020 Category: Radiology Source Type: news

NIH 'very concerned' about serious side effect in AstraZeneca coronavirus vaccine trial
The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case. (Source: CNN.com - Health)
Source: CNN.com - Health - September 15, 2020 Category: Consumer Health News Source Type: news