News
Game on: Pfizer, BioNTech prepare to put COVID-19 shot distribution plan to the test after interim readout
Game on: Pfizer, BioNTech prepare to put COVID-19 shot distribution plan to the test after interim readout kblankenship Tue, 11/10/2020 – 09:46
Success at a glance: call center scheduling
The manual process for fielding scheduling calls isn’t an easy one. Calls can take up to 20 minutes, and call center agents may have to […]
CAMPAING 2020 – 2022 HEALTHY WORKPLACES , LIGHTEN THE LOAD
CAMPAING 2020 – 2022 HEALTHY WORKPLACES , LIGHTEN THE LOAD 27/11/2020 Zaragoza Spain
Health in 2 Point 00, Episode 165 | Centene, Koa Health, Eko and Medically Home
Today on Health in 2 Point 00, there is so much to talk about between the election, the Affordable Care Act, and Pfizer’s COVID vaccine […]
Nartex Laboratorios Homeopaticos S.A. de C.V. – 608540 – 11/04/2020
CGMP/Finished Pharmaceuticals/Adulterated
Eagles Song Health and Wellness LLC – 609733 – 10/28/2020
New Drug/Misbranded
World Nutrition, Inc. – 610003 – 10/27/2020
New Drug/Misbranded
Natural Sprout Co. LLC – 610151 – 10/29/2020
New Drug/Misbranded
Croda strikes deal with Pfizer to supply COVID-19 vaccine additives
The contract with Pfizer runs for five years and awards Croda an initial supply contract for four component excipients used in the production of the […]
Campaign 2020 – 2022 Healthy Workplaces Lighten the Load
Campaign 2020 – 2022 Healthy Workplaces Lighten the Load 27/11/2020 Zaragoza Spain
Aurobindo Pharma Ltd- Opportunity for Internship -Formulation R&D-Apply Now
Aurobindo Pharma Ltd- Opportunity for Internship- Formulation R&D-Apply Now Aurobindo Pharma Ltd- Opportunity for Internship -Formulation R&D-Apply Now
Despite the fine print, we can still feel optimistic about a Covid vaccine | Charlotte Summers
Pfizer’s preliminary results are a huge development, although hurdles still lie ahead Dr Charlotte Summers is a lecturer in intensive care medicine at the University […]
Teva Pharmaceuticals-Hiring M.Sc/ M.Pharm/ B.Pharm for Regulatory Affairs Associate I
Teva Pharmaceuticals-Hiring M.Sc/ M.Pharm/ B.Pharm for Regulatory Affairs Associate I Job Description Compiling of annual report and ensuring it is submitted prior to the commitment […]
HHS secretary anticipating ‘general vaccination’ programs by spring
Health and Human Services (HHS) Secretary Alex Azar said early Tuesday that a COVID-19 vaccine could be widely available to the general public by the […]
In Brief: New Meningococcal Serogroup B Vaccination Recommendations
Date: November 30, 2020 Issue #: 1612 Summary: The Advisory Committee on Immunization Practices (ACIP) has issued new recommendations for meningococcal vaccination. Booster vaccination against […]
Ofatumumab (Kesimpta) for MS
Date: December 28, 2020 Issue #: 1614 Summary: The FDA has approved a subcutaneous formulation of the recombinant human anti-CD20 antibody ofatumumab (Kesimpta – Novartis) […]
IV Amisulpride (Barhemsys) for Postoperative Nausea and Vomiting
Date: December 28, 2020 Issue #: 1614 Summary: The FDA has approved IV amisulpride (Barhemsys – Acacia), a selective dopamine-2 and -3 (D2/D3) receptor antagonist, […]
Remdesivir (Veklury) for COVID-19
Date: November 30, 2020 Issue #: 1612 Summary: The FDA has approved the antiviral drug remdesivir (Veklury – Gilead) for IV treatment of COVID-19 in […]
FDA Insight: Hand Hygiene During COVID-19
Dr. Shah welcomes Elizabeth Jungman, director of CDER’s Office of Regulatory Policy, to talk about hand sanitizers and the COVID-19 pandemic.
GPs to be tested twice a week for COVID-19 under NHS-wide programme
GPs will be able to test themselves twice a week for COVID-19 under plans for routine testing of all patient-facing NHS staff, GPonline has learned.
Always clean your hands: FDA cites compounder for workers’ failure to change gloves after handling trash
Always clean your hands: FDA cites compounder for workers’ failure to change gloves after handling trash kblankenship Tue, 11/10/2020 – 08:21
Can Soy Prevent and Treat Prostate Cancer?
As I discuss in my video The Role of Soy Foods in Prostate Cancer Prevention and Treatment, a compilation of 13 observational studies on soy […]
Pharma’s response to COVID: Lilly and diabetes care
As part of our series looking at how pharma companies have adapted to the pandemic, Shannon Rush, leader of Eli Lilly & Co’s diabetes business […]
Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19
Shots: The US FDA has granted FT designation to NVX-CoV2373 which is currently in late-phase clinical development. Novavax expects to initiate pivotal P-III study in […]
Lack of skill and talent biggest challenge to digital transformation in pharma
A new report has highlighted the main challenges to digital transformation in pharma, a field which has garnered interest over the last year due to […]
Trial of new HIV PrEP medication stopped early due to effectiveness
The HIV Prevention Trials Network study (HPTN 084) evaluating the long-acting injectable antiretroviral drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected women, has […]
Merck to acquire VelosBio for $2.75 billion
Merck (MSD outside the US and Canada) and VelosBio Inc. have entered a definitive agreement under which Merck will acquire all outstanding shares for VelosBiofor […]
How Trump Sold Failure to 70 Million People
At some basic level, Americans do seem to agree that the coronavirus is a major threat. Despite attempts to politicize and divide us on the […]
How Trump Sold Failure to 70 Million People
At some basic level, Americans do seem to agree that the coronavirus is a major threat. Despite attempts to politicize and divide us on the […]
Lilly to ship COVID-19 drug straight away after FDA green light
Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody. The AbCellera-partnered […]
Use of paper tube-pouch could reduce plastic in pharma packaging
A new tube-pouch made with paper has been developed which could reduce the use of plastic in pharmaceutical packaging. Developed by Toppan Printing, the producer […]
NHS set to roll out COVID-19 shot in New Year, says health secretary
The UK’s NHS is ready to start rolling out a coronavirus vaccine, likely beginning in the new year, according to health secretary Matt Hancock. In […]
AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma
Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who […]
£150m to boost salaried GP posts through second coronavirus wave
A funding package worth £150m will be made available to general practice to boost salaried GP roles and create extra capacity during the second wave […]
Germany’s digital health changes will boost digital therapeutics in Europe
Digital therapeutics are gaining momentum worldwide and offer developers, including pharma, both a huge opportunity and a stimulating market access challenge, say Olaf Schoeman and […]
London’s digital health accelerator programme selects 20 new projects
DigitalHealth.London has announced the latest 20 small and medium sized businesses selected for its digital accelerator programme. The programme selects digital solutions or services with […]
Shut out of clinical trials, community hospitals miss out on ‘cutting-edge therapy’
The post Shut out of clinical trials, community hospitals miss out on ‘cutting-edge therapy’ appeared first on Healthy Debate.
Pfizer vaccine results leave questions about safety, longevity
Questions about production, distribution and, most importantly, the performance and capability of the shot itself still need to be answered, even if the numbers look […]
Pandemic at point where GPs should stop non-essential work, say RCGP and BMA
Most GP practices in the UK should be stopping either ‘some’ or ‘a significant volume’ of non-essential work as a result of the second wave […]
EUOSHA/2020/NE/F/SE/0133 – Prestacion de servicios de telefonía fija y servicios asociados / Provision of fixed telephony services and related services – Proced. negociado de escasa cuantía/ Negotiated procedure for low value contracts
10/11/2020 – 11:45 EUOSHA/2020/NE/F/SE/0133 – Prestacion de servicios de telefonía fija y servicios asociados / Provision of fixed telephony services and related services – Proced. […]
AHF acquires San Diego’s Hillcrest Pharmacy locations
AHF acquires San Diego’s Hillcrest Pharmacy locations Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 AHF Pharmacy, a division of AIDS Healthcare Foundation, has […]
Merck Signs $2.8B VelosBio buyout to acquire anti-ROR1 ADC
Merck Signs $2.8B VelosBio buyout to acquire anti-ROR1 ADC Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 Kenilworth, N.J.-based Merck has agreed to buy […]
COVID-19 vaccine safety efforts to feature app tracking of vulnerable groups
COVID-19 vaccine safety efforts to feature app tracking of vulnerable groups Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 New tools, along with existing […]
AmerisourceBergen reaches agreement with CDC to support independent community pharmacies’ access to COVID-19 vaccine
AmerisourceBergen reaches agreement with CDC to support independent community pharmacies’ access to COVID-19 vaccine Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 Under an […]
Vancomycin hypersensitivity reactions need better documentation
Vancomycin hypersensitivity reactions need better documentation Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 Vancomycin is the most commonly used antimicrobial in U.S. hospitals, […]
First COVID neutralizing antibody test okayed by FDA
First COVID neutralizing antibody test okayed by FDA Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 FDA said Friday it has granted an emergency […]
First COVID-19 vaccine doses to go to health workers, say CDC advisers
First COVID-19 vaccine doses to go to health workers, say CDC advisers Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 Health care workers almost […]
FDA panel declines to endorse controversial Alzheimer drug
FDA panel declines to endorse controversial Alzheimer drug Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 Hopes for a new Alzheimer disease (AD) treatment […]
Pfizer says early data signals COVID-19 vaccine is effective
Pfizer says early data signals COVID-19 vaccine is effective Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 Pfizer reported Monday early data from an […]
CVS taps Aetna executive Karen Lynch as next CEO
CVS taps Aetna executive Karen Lynch as next CEO Sun, 11/08/2020 – 19:00 cbaker_admin Tue, 11/10/2020 – 05:30 CVS Health Corp. has tapped Karen Lynch […]
UK study will evaluate aspirin as a potential COVID-19 treatment
RECOVERY study will assess if drug can reduce risk of blood clots
Waylivra, Tecentriq and more accepted by SMC
Akcea’s Waylivra approved via ultra-orphan pathway
New NHS Digital deal set to improve data sharing between different organisations
Deal will help to support integrated health and care activities
EU OK for AZ’s Calquence in CLL
BTK inhibitor approved based on results from two phase III trials
Divided Congress paves way for drug price reforms on Biden’s watch
Unless president Donald Trump is successful with legal challenges, Democratic rival Joe Biden looks to have won the White House in last week’s election but […]
‘No Mercy’ Chapter 7: After a Rural Town Loses Hospital, Is a Health Clinic Enough?
Can’t see the audio player? Click here to listen. Family physician Maxwell Self is doing his same old job for a new employer. For two decades […]
Trump’s Anti-Abortion Zeal Shook Fragile Health Systems Around the World
In Ethiopia, health clinics for teenagers once supported by U.S. foreign aid closed down. In Kenya, a decades-long effort to integrate HIV testing and family […]
Orange County Struggles With Health Equity — And Battles State Restrictions
California’s most popular amusement park has become the focal point of a struggle over how best to contain COVID-19 while keeping the economy afloat. California’s […]
Sun Pharmaceuticals Industries Ltd-Openings for Packing Head -Apply Now
Sun Pharmaceuticals Industries Ltd-Openings for Packing Head -Apply Now Job Description We are Looking for Packing Head for Our Halol Plant Post Name: Packing Head Experience: 15-25 […]
After NICE okay, Scots denied access to Vifor’s Veltassa
The Scottish Medicines Consortium (SMC) has ruled that there’s not enough evidence to support NHS funding of Vifor Pharma’s Veltassa for excess potassium in the […]
Satya Pharma Innovations-Hiring Discovery Biologists-Apply Now
Satya Pharma Innovations-Hiring Discovery Biologists-Apply Now Satya Pharma Innovations-Hiring Discovery Biologists-Apply Now
Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19
Shots: The EUA is based on P-II BLAZE-1 study assessing bamlanivimab (700/2800/7000 mg) as monothx. vs PBO or in combination with second Ab for the […]
A new set of articles “This is how we lighten the load”
Back to news 10/11/2020 A new set of articles “This is how we lighten the load” A new set of articles on the FIOH website.See […]
Indus Pharma Pvt. Ltd-Openings for Quality Control/ IT Dept. -Apply Now
Indus Pharma Pvt. Ltd-Openings for Quality Control/ IT Dept. -Apply Now Indus Pharma Pvt. Ltd-Openings for Quality Control/ IT Dept. -Apply Now
Honour Lab Limited-Walk-In Drive for Freshers & Experienced On 14th & 15th Nov’ 2020
Honour Lab Limited-Walk-In Drive for Freshers & Experienced On 14th & 15th Nov’ 2020 Walk-In Drive for Freshers & Experienced -Production / QC / Engineering […]
Hetero-Recruitment for R&D QA-Asst Manager/ Deputy Manager-Apply Now
Hetero-Recruitment for R&D QA-Asst Manager/ Deputy Manager-Apply Now Job Description Responsible for Quality & Compliance of the R&D Lab (Analytical R&D). To report the daily […]
Pfizer and BioNTech’s BNT162b2 Demonstrates 90% Efficacy in Preventing COVID-19
Shots: The BNT162b2 showed more than 90% efficacy in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis, […]
AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia
Shots: The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated […]
What does the Pfizer Covid vaccine breakthrough mean for Australia?
Interim results show vaccine to be 90% effective, but findings have not been peer-reviewed, Australia has only secured enough for five million people, and there […]
Podcast: Electronic Prescriptions – A guide for practice managers
10 November, 2020: Find out what practice managers can do to get ready for implementation and hear advice from leading heath professionals currently benefiting from […]
Eli Lilly’s Antibody Treatment Gets Emergency F.D.A. Approval
The authorization raised immediate questions about who would get access to the antibody treatments, which are in short supply.
Eli Lilly’s Antibody Treatment Gets Emergency F.D.A. Approval
The authorization raised immediate questions about who would get access to the antibody treatments, which are in short supply.
Eli Lilly’s Antibody Treatment Gets Emergency F.D.A. Approval
The authorization raised immediate questions about who would get access to the antibody treatments, which are in short supply.
Manchin shoots down chance that Senate Democrats nix filibuster, expand court
Sen. Joe Manchin (D-W.Va.) on Monday night effectively shot down any chance that Democrats are able to nix the legislative filibuster if they find themselves with […]
‘Our Work Begins with Getting COVID Under Control’: What a Biden Administration Means for Home-Based Care
After one of the closest and most hotly contested campaigns in modern history, President-Elect Joe Biden addressed the nation on Saturday from an outdoor platform […]
Four takeaways from CVS Health’s Q3 earnings
CVS Health named a new CEO in its earnings call on Friday. Between plans to further integrate its pharmacy and insurance businesses, and discussion about […]
New cancer drugs saved 1.3 million lives
That is the finding from a recent paper by myself and co-authors Joanna MacEwan, Syvart Dennen, Rebecca Kee, Farzad Ali, and Katharine Batt. An excerpt […]
FDA issues emergency use authorization for Eli Lilly COVID-19 antibody drug
The Food and Drug Administration (FDA) issued an emergency use authorization on Monday for and Eli Lilly antibody drug to treat mild to moderate cases […]
U.S. allows 1st emergency use of a COVID-19 antibody drug
The therapy is still undergoing additional testing to establish its safety and effectiveness. It is similar to a treatment President Donald Trump received after contracting […]
Coronavirus (COVID-19) Update: November 9, 2020
Coronavirus (COVID-19) Update
Free risk assessment for mining sector in Portugal thanks to OiRA
10/11/2020 Free risk assessment for mining sector in Portugal thanks to OiRA © EU-OSHA/Adam Skrzypczak
EU Strategic Framework on Health and Safety at Work (2021-2027) – public consultation
10/11/2020 EU Strategic Framework on Health and Safety at Work (2021-2027) – public consultation The COVID-19 crisis has highlighted the crucial importance of health, including […]
Justices Bound to See ACA as ‘Indispensable,’ Says Californian Leading Defense
SACRAMENTO — When the U.S. Supreme Court hears a case Tuesday that could decide the fate of the Affordable Care Act, California will be leading […]
LHC Group to Acquire End-of-Life Care Provider in the Arizona Market
LHC Group Inc. (Nasdaq: LHCG) announced Monday it has agreed to purchase Arizona-based East Valley Hospice and East Valley Palliative Care. The deal is expected […]
Michigan rolls out statewide coronavirus exposure app
Those testing positive for the virus are given a PIN by contact tracers that allows them to share their result anonymously on the app, which […]
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
Today, the FDA issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric […]
Why Complex Care Management Is Charter Healthcare’s ‘Crown Jewel’
In the midst of the in-home care M&A resurgence, Charter Healthcare Group has made a few moves of its own. Its recent acquisitions of Heartwood […]
Coronavirus cases hit record numbers in Virginia, Maryland
Coronavirus cases across Maryland and Virginia have spiked to record levels in recent days, part of a national trend of rapidly rising infections that shows […]
New Covid-19 risk model available via Epic’s patient portal
A risk prediction model for Covid-19, developed by researchers at Cleveland Clinic, is now available to all health systems worldwide that use the Epic MyChart […]
As cases rise, states say they’ll work with Biden on virus
Biden’s announcement of a virus task force on Monday coincided with tougher actions or statements from a number of governors, including Republicans, as COVID-19 cases […]
Overnight Health Care: Pfizer vaccine more than 90 percent effective in interim analysis | Biden lauds Pfizer news, but urges caution | US surpasses 10 million COVID-19 infections
Welcome to Monday’s Overnight Health Care. There’s some good news on the vaccine front, but the U.S. has now confirmed 10 million COVID-19 cases. And President-elect […]
ObamaCare faces Supreme Court test with new conservative majority
The Supreme Court will hear arguments Tuesday in the latest GOP challenge to ObamaCare, this time with a strengthened conservative majority on the bench.The arguments […]
Ogilvy Health’s global CEO looks to help pharma reassess corporate branding amid pandemic
Ogilvy Health’s global CEO looks to help pharma reassess corporate branding amid pandemic bbulik Mon, 11/09/2020 – 17:48
COVID-19-related OSHA complaints, fines pile up for healthcare facilities
“OSHA was getting a lot of really bad press about how aggressively they were responding,” lawyer Eric Conn said. “And … maybe for some theater, […]
OhioHealth launches medical respite care program
OhioHealth has joined a growing number of providers who are investing in programs aimed at addressing the health needs of homeless patients.
COVID-19 could depress 2021 Medicare Advantage payments, analysis suggests
Consultancy Avalere also warned that MA plans should brace themselves for dealing with chronically ill enrollees whose health has declined due to foregoing care during […]
4 issues to listen for in the Supreme Court’s ACA oral arguments
The arguments have high stakes because the justices’ decision could destabilize the framework the healthcare industry has operated under for a decade.
Connected stethoscope-maker Eko raises $65M
The company, which makes a digital stethoscope and electrocardiogram, raised $65 million in series C funding. It plans to use the funds to build out […]
NIH study: Hydroxychloroquine had no benefit for hospitalized COVID patients
Hydroxychloroquine provides no benefit for hospitalized COVID-19 patients, a study from the National Institutes of Health has officially concluded.The data were published in the Journal […]
6 healthcare moves Trump could make before he leaves office
The Trump administration will likely sign off on Medicare payment rules before inauguration day, but it could also wrap up its deregulatory agenda to ease […]
5 things to know about the Pfizer vaccine news
After weeks of mounting coronavirus cases and hospitalizations, the country received a bolt of good news on Monday morning: An interim analysis found Pfizer’s vaccine […]
French CMO Fareva adds 4 facilities, more than 1,000 employees in Euro growth spurt
French CMO Fareva adds 4 facilities, more than 1,000 employees in Euro growth spurt kblankenship Mon, 11/09/2020 – 16:20
RWJBarnabas Health reorganizes with COVID-19 in mind
The 13-hospital system formed a strategic council to guide C-suite executives through sharing best practices, setting priorities and allocating resources.
M&A: Centene to Acquire AI Healthcare Analytics Platform Apixio
What You Should Know: – Centene Corporation acquires AI healthcare analytics platform Apixio to additional data and AI capability to technology portfolio. – Apixio will […]
Researchers use ‘big data’ approach to identify melatonin as possible COVID-19 treatment
A new study suggests that melatonin, a hormone that regulates the sleep-wake cycle and is commonly used as an over-the-counter sleep aid, may be a […]
FDA publishes list of essential meds required by medical order
FDA publishes list of essential meds required by medical order Mon, 11/09/2020 – 15:18 mcathers_editor Mon, 11/09/2020 – 15:11 The list, developed in collaboration with […]
Global markets: winners and losers as Covid vaccine hopes send shares surging
But the news highlighted divergences in fortunes across sectors during the pandemic Global stock markets surge after Pfizer Covid vaccine news Nils Pratley: ‘A great […]
Pfizer’s Covid Vaccine: 11 Things You Need to Know
What’s the big deal? Was it part of Operation Warp Speed? When can you get one?
VHA, Ontrak Launch 3-Year AI Study to Help Prevent Veteran Suicide
What You Should Know: – The Veterans Health Administration has selected Ontrak in collaboration with Harvard Medical School and Brown University to transform suicide prevention […]
[Sponsored] How ACHC’s New Distinction in Telehealth Places Agencies Above Competitors
The COVID-19 pandemic has given home-based care providers a renewed urgency for telehealth adoption, and national accreditor Accreditation Commission for Health Care (ACHC) has a […]
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With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race
The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence […]
Office of Lifecycle Drug Products
Office of Lifecycle Drug Products
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DispatchHealth adds to evidence backing safety, efficacy of hospital-at-home programs
Amid the Covid-19 pandemic and a growing interest in at-home care, DispatchHealth has published new data showing that its hospital-at-home program did not result in […]
Public Notification: Black Mamba Premium 18000 contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Black Mamba Premium 18000, a product promoted for sexual enhancement and distributed […]
CMS signs off on Medicaid managed-care changes
The final rule gives states more flexibility to set rates for their managed-care plans and ensure plans have adequate provider networks.