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The great opportunities of cell and gene therapy (CGT) are self-evident. Life sciences businesses can find a new purpose in a generation of products that could treat or cure millions.   But the CGT industry is early on in its learning curve. Therapies currently priced… Read More »Automation is key in cell and gene therapy manufacturing

Medical research charities are urging the UK government to financially support charity-funded research to protect the UK’s position as a global leader in science. The charities, including the British Heart Foundation and Cancer Research UK (CRUK), propose the government introduces a Life Sciences-Charity Partnership Fund,… Read More »COVID-19 is threatening the UK’s medical research prowess, say charities

Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.

These prescription-only drugs will be available at all retail medical outlets and hospital pharmacies across the country, from November 1, 2020, FDC said in a BSE filing.

In consultation with other federal partners, FDA has developed a list of drug and biological product essential medicines, drug, biological product, and device medical countermeasures, and critical inputs, as required by Executive Order 13944. FDA welcomes public comment on this list.

The United States on Thursday hit a new record for a single-day increase in coronavirus infections with nearly 90,000 new cases reported, according to data collected from Johns Hopkins University. On Thursday, the U.S. had 88,521 new…

During the first COVID-19 surge of the spring, the mantra was “Flatten to curve”—to buy time, using every tool available. Seven months later, it’s possible to measure what that time has bought: The death rate for COVID-19 has fallen dramatically. Hospitals in most places are… Read More »The Best Time to Get COVID-19

Findings come from new research funded by Cancer Research UK and NIHR

Drug significantly eliminated oral corticosteroid (OCS) in OCS-dependent asthma patients

The UK BIA Antibody Taskforce is set to take combinations into further development as a cocktail

30/10/2020 Free online training for psychosocial risk assessment Psychosocial risk assessment (PRA) is a legal requirement and a complicated process faced by companies that want to offer their employees optimal working conditions. A free online training offered through PsyHealth worXs! has been specifically…

The company said that by December, it expected to have produced enough drug to treat 2 million patients and that it was studying an inhaled form of the drug that could expand its use to outpatients.

We have begun a Health Technology Assessment process for all products currently subsidised under the Continuous Glucose Monitoring (CGM) Initiative.

U.S. reaches $375 million deal for Lilly COVID-19 antibody drug Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Eli Lilly & Co. says it will provide 300,000 doses of bamlanivimab, its experimental COVID-19 antibody drug, to the U.S. government for $375 million if the… Read More »U.S. reaches $375 million deal for Lilly COVID-19 antibody drug

Medicare, Medicaid will cover costs of future COVID-19 vaccine under new policy Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 In an official announcement on Wednesday, CMS said Medicare beneficiaries will receive any FDA-approved coronavirus vaccine for free. The new policy calls for providers… Read More »Medicare, Medicaid will cover costs of future COVID-19 vaccine under new policy

FDA approves fewer generics in FY2020, ending record streak Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 After 4 consecutive years of posting record numbers of abbreviated new drug application (ANDA) approvals, FDA approved 22% fewer generic drugs in the 2020 fiscal year (FY2020)… Read More »FDA approves fewer generics in FY2020, ending record streak

Opinion: I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective. Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, says to encourage trust in any COVID-19… Read More »Opinion: I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective.

Oregon, Washington, and Nevada join California to vet COVID-19 vaccine Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 The states of Washington, Nevada, and Oregon said Tuesday they will work with California to evaluate any COVID-19 vaccine before offering it to the public. The… Read More »Oregon, Washington, and Nevada join California to vet COVID-19 vaccine

Stop & Shop offers free virtual education series for National Diabetes Awareness Month Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Stop & Shop will host a month-long webinar series highlighting National Diabetes Awareness Month this November. The series is designed to educate participants,… Read More »Stop & Shop offers free virtual education series for National Diabetes Awareness Month

Medical crowdfunding in U.S. is much likelier to be for routine care Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 New research indicates that medical crowdfunding efforts in the United States are more likely to be for routine medical care compared with other countries.… Read More »Medical crowdfunding in U.S. is much likelier to be for routine care

CVS pharmacies in Philadelphia closed early Wednesday after 20 stores damaged during looting Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Civil unrest in Philadelphia, marked by protests and looting, prompted CVS Pharmacies to lock up local stores early on Tuesday and Wednesday. With… Read More »CVS pharmacies in Philadelphia closed early Wednesday after 20 stores damaged during looting

Kroger Health launches COVID-19 rapid antibody testing at pharmacy locations Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Kroger Health announced Wednesday the launch of rapid antibody COVID-19 testing at its California (Ralphs) and Michigan pharmacies. According to the company, the rapid antibody testing… Read More »Kroger Health launches COVID-19 rapid antibody testing at pharmacy locations

Somatic mutations in UBA1 and severe adult-onset autoinflammatory disease Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 A study partially funded by NIH examined differences in ubiquitin-related genes, which play a role in autoinflammatory disease and may characterize previously unknown conditions. The research involved… Read More »Somatic mutations in UBA1 and severe adult-onset autoinflammatory disease

Ticagrelor vs. clopidogrel and adverse events in patients with acute coronary syndrome undergoing PCI Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Ticagrelor is the recommended P2Y12 platelet inhibitor for patients with acute coronary syndrome (ACS), but because this indication is largely based on… Read More »Ticagrelor vs. clopidogrel and adverse events in patients with acute coronary syndrome undergoing PCI

Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Sunstar Americas, Inc. (SAI) announced a voluntary, nationwide recall of certain chlorhexidine gluconate oral rinse (Paroex), USP, 0.12% products because… Read More »Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination

In the scheme for bulk drugs the government has replaced the criteria of ‘minimum threshold’ investment with ‘committed’ investment by the selected applicant.

29/09/2020 Virtual campaign partnership meeting: Healthy Workplaces Lighten the Load 2020-2022 Ahead of the launch of the 2020-2022 campaign — Healthy Workplaces Lighten the Load — representatives of European and international enterprises and organisations joined EU-OSHA for a virtual campaign partnership meeting. They learned about… Read More »Virtual campaign partnership meeting: Healthy Workplaces Lighten the Load 2020-2022

30/10/2020 Lighten the load calls for partners to address MSDs in the workplace EU-OSHA presented its latest campaign partnership offer at a virtual meeting last 29 September, urging companies and organisations from across Europe to sign up to the 2020-2022 Healthy Workplaces Lighten the Load… Read More »Lighten the load calls for partners to address MSDs in the workplace

Shirley Ryan AbilityLab in Chicago is learning new approaches to caring for patients who face long, difficult recoveries from the coronavirus.

The food industry will face significant challenges in the future. However, an EU-funded project has created an international research network capable of confronting environmental threats as well as consumer demand for traceable, ethical ingredients.

House Speaker Nancy Pelosi says remaining obstacles to an agreement include more than half a dozen big-ticket items, including a testing plan, aid to state and local governments, funding for schools, jobless benefits and a GOP-sought shield against coronavirus-related lawsuits.

The doctor will Zoom you now: Pharma execs talk ins and outs of telehealth bbulik Thu, 10/29/2020 – 19:17

Ascension Rx—the newly launched brand for its national pharmacy—offers specialty medication packaging and delivery, infusion therapy and medication management, including financial aid coordination.

The COVID-19 pandemic has brought the home healthcare industry to a crossroads. More older adults are comfortable with mobile devices and smart technologies that help them safely age in place. Some individuals may be seeking to avoid full-time care in a congregate care setting due to… Read More »Why Home Healthcare Needs More Technology and Training

Welcome to Thursday’s Overnight Health Care.The spike in COVID-19 cases is putting a massive strain on the nation’s hospitals as the country reached a record number of new infections this week. Meanwhile, House Democrats released documents showing…

Providers will be able to use telehealth if it’s outlined in a patient’s care plan and tied to a specific goal to improve treatment. CMS bumped pay for home health by 1.9%, or about $390 million.

Community health centers warned that they will lose out on 340B discounts if the program goes into effect.

The U.S. on Thursday set a new weekly record for COVID-19 infections with more than 500,000, according to data from the COVID Tracking project, as a wave of cases builds ahead of winter.Twenty-five states have set a new record for cases in…

Researchers have found that a more intensive, less frequent drug regimen with currently available therapeutics could cure the infection that causes Chagas disease.

Universal Health Services’ net income was $241.3 million in the quarter ended Sept. 30, compared with $97.2 million in the prior-year period.

The payer reported it spent $35 million on COVID-19 care in the quarter. But as cases reach new heights in the U.S., it expects members to again defer care as virus costs are likely to increase.

The potential violations all occurred over a six-month period in 2017 and affected a total of more than 18,000 members, the HHS Office for Civil Rights said. The payer is not admiting liability.

HCA Healthcare employees are asking company investors to meet with workers and demand answers from HCA over PPE and workplace safety concerns.

Facing budget crunches, states will need more time to assess their Medicaid rolls, experts said during a MACPAC hearing.

‘Passion point’: Katie Couric, Merck unveil expanded cancer-stories campaign bbulik Thu, 10/29/2020 – 16:13

Four FAERS summary statistics reports updated with data through December 31, 2013.

Two people who attended President Trump’s rally at an airport in Gaston County in North Carolina last week have tested positive for COVID-19, the county health department said Thursday.The Gaston County Department of Health and Human Services said…

Molina reported an operating income of $289 million in the third quarter, down from $424 million in the second quarter.

Molina reported an operating income of $289 million in the third quarter, down from $424 million in the second quarter.

As a powerful new wave of infections sweeps the U.S. just ahead of Election Day, the nation’s handling of the nearly 8-month-old crisis has been marked by what health experts see as grave missteps, wasted time and squandered opportunities by leaders at all levels of… Read More »‘So frustrating’: Grave missteps seen in U.S. virus response

Sorry, down for maintenance. We apologize for the inconvenience, but we’re performing some maintenance on the subsidy calculators. We hope to have them available shortly. ** Note: This calculator has been updated with premiums for 2020 plans. The Health Insurance Marketplace Calculator provides estimates of health… Read More »Health Insurance Marketplace Calculator

Medtronic allegedly paid a South Dakota neurosurgeon kickbacks to use their products and hosted more than 100 events at a restaurant owned by the physician.

Moderna is on track to report initial results from its coronavirus vaccine trial next month, company executives said Thursday.The company is one of the front-runners to produce a vaccine for COVID-19. During an earnings call, Chief Medical Officer…

Eli Lilly and Company have entered a $375 million agreement to supply the US government with 300,000 vials of bamlanivimab (LY-CoV555), an investigational neutralising monoclonal antibody for the treatment of mild to moderate COVID-19 in high-risk patients. According to Lilly, under the terms of the… Read More »US to receive 300,000 vials of experimental COVID-19 antibody therapy

This page contains the meeting materials for the Peripheral and Central Nervous System Drugs Advisory Committee meetings for 2018, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, and transcript.

This page contains the meeting materials for the Peripheral and Central Nervous Advisory Committee meetings for 2016, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, etc.

Sanofi, despite COVID-19, sees early gains from CEO Hudson’s strategy revamp esagonowsky Thu, 10/29/2020 – 11:26

2017 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee

2020 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee

Sanofi and GlaxoSmithKline (GSK) have signed a statement of intent to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine candidate available to the COVAX Facility. The supply is subject to regulatory approval. The statement was signed with Gavi, the global vaccine alliance… Read More »200 million doses of COVID-19 vaccine to be made available for COVAX

Integrated Assessment of Marketing Applications Virtual Workshop

HHS’ Office of the National Coordinator for Health Information Technology has issued an interim final rule to delay compliance deadlines until at least 2021.

December 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

An updated EndoScan-V software platform for endotoxin detection and measurement; and the introduction of the Celsis® automated detection solution for rapid sterility to ensure continued product quality and contamination control for pharmaceutical manufacturing clients. READ MORE The post News: Microbial solutions product portfolio updates appeared… Read More »News: Microbial solutions product portfolio updates

Catalent continues big push into cell and gene therapies with Belgian facility buyout kblankenship Thu, 10/29/2020 – 10:57

Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book

In a study using genetically modified mice, researchers found that the nucleus accumbens recruited by cocaine use are largely distinct from nucleus accumbens recruited by sucrose, or table sugar. Because they are separate, this poses the possibility that drug use can be addressed without affecting… Read More »Nucleus accumbens recruited by cocaine, sugar are different

Electronic Submissions

With COVID-19 cases on the rise in Michigan and flu season approaching, healthcare executives said in a news conference that demand for clean laundry has become even more important.

Federal agencies warned that cybercriminals are unleashing a wave of data-scrambling extortion attempts against the U.S. healthcare system designed to lock up hospital information systems, which could hurt patient care just as nationwide cases of COVID-19 are spiking.

A Trump administration official suggested that the theme of a roughly $250 million taxpayer-funded ad campaign to “defeat despair” around coronavirus could be “Helping the President will Help the Country,” according to documents obtained by the…

Among clinicians, there’s a reluctance to raise the issue of cost in any way and run afoul of federal laws. Emergency rooms must at least stabilize everyone, regardless of their ability to pay, under a federal law.

Jefferies analyst David Windley called the results “robust overall but mixed in the details,” calling membership growth underwhelming, and shares fell. 

Movilitas has announced the integration of its Movilitas.Cloud with NiceLabel’s cloud-based label printing solution to simplify serialised label printing for highly regulated industries. With 50 percent of all label printers globally shipped with NiceLabel technology and over 16 million labels printed on cloud-connected printers monthly,… Read More »Integration of Movilitas.Cloud and NiceLabel simplifies serialised label printing for highly regulated industries

Commercial payers are likely already modeling costs. Anthem CEO Gail Boudreaux said Wednesday the insurer considered multiple variables when determining pricing and will follow CMS guidance.

Gilead Sciences said Wednesday that remdesivir, which has been authorized for emergency use since the spring, brought in $873 million in revenues so far this year.

Watch out Merck: FDA grants Regeneron, Sanofi’s Libtayo priority review for coveted first-line use in lung cancer arlene.weintraub Thu, 10/29/2020 – 09:58

Health insurers will be required to publicly post, in advance, the price for the most common services and procedures, under a rule finalized by the Trump administration on Thursday.The final rule is an effort to inject transparency into the opaque…

The rule forces employer health plans and insurance companies to post in-network and out-of-network rates they negotiate with providers. It also requires insurers to develop online price transparency tools to give patients cost-sharing information.

Takeda, Moderna partner up to bring 50M coronavirus shots to Japan kblankenship Thu, 10/29/2020 – 09:06

November 2, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

Top infectious disease expert Anthony Fauci said Wednesday that it might be 2022 until the U.S. sees “some semblances of normality.”During a University of Melbourne panel discussion, Fauci said it’s possible a “substantial proportion of the people”…

Post issuance of the detailed guidelines, the department received several suggestions and inputs from the pharmaceutical and medical device industry seeking certain amendments in the schemes to enable effective participation of the industry, the statement said.

The nation’s top infectious disease expert, Dr. Anthony Fauci, expressed support for a national mask mandate in an interview late Wednesday with CNBC.Fauci explained that the U.S. rate of new coronavirus infections is trending in the wrong…

Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA’s current thinking and policy interpretation.

A greater share of hospitals’ and nursing homes’ political contributions have gone to Democrats in 2020 than in prior election cycles.

Does a pharmaceutical company have a moral obligation to acknowledge my participation with an ongoing supply of the product that I helped test?

The far-right group Super Happy Fun America protests in Boston on October 18. (Mark Peterson / Redux) Kurtis, a young accountant in McKinney, Texas, likes the thing that many people hate about Donald Trump: that the president has left the pandemic response almost entirely up… Read More »Donald Trump, Coronavirus Hero

Chairman of Dr Reddys Laboratories, Satish Reddy said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine… Read More »Dr Reddy’s partners with Department of Biotechnology for Sputnik V vaccine clinical trials in India

Advocate M L Sharma petitioner in-person referred to the bench, also comprising Justices A S Bopanna and V Ramasubramanian, the World Health Organization (WHO) report of October 15 and said that nowhere these medicines are designated officially as medicines for coronavirus.

Collaboration includes two therapeutic candidates – MP0420 and MP0423

French pharma will test investigational candidate alongside MSD’s Keytruda

New guidance based on research from University of Manchester

Agreement will also see companies develop treatments for frontotemporal dementia

The company said the newly approved medication will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

Florida fails to attract bidders for Canada drug importation program Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Gov. Ron DeSantis of Florida wants the state to buy less expensive prescription drugs from Canada under a plan he designed and President Trump endorsed. However,… Read More »Florida fails to attract bidders for Canada drug importation program

Vaccine makers can skip U.S. inspections Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 FDA typically conducts inspections of drug manufacturing plants before granting approval for a pharmaceutical company’s new drug. However, inspections will not be necessary for COVID-19 vaccine developers that gain emergency… Read More »Vaccine makers can skip U.S. inspections

Bipartisan lawmakers call for overhauling medical supply chains Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 At The Hill‘s “America’s Agenda: COVID-19 & A Responsive Rx Supply Chain” event on Tuesday, lawmakers from both parties said the nation needs to examine and restructure its… Read More »Bipartisan lawmakers call for overhauling medical supply chains

Rampant shoplifting leads to another Walgreens closing in S.F. Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Following months of widespread thefts by brazen shoplifters, the Walgreens at Van Ness and Eddy in San Francisco is getting ready to close, according to Walgreens spokesman… Read More »Rampant shoplifting leads to another Walgreens closing in S.F.

Gateway Health and Giant Eagle Pharmacy pilot an innovative approach to addressing the opioid epidemic in Allegheny County Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Pittsburgh-based Gateway Health Plan has partnered with Giant Eagle Pharmacy to introduce Medicaid members to Project Lifeline, a… Read More »Gateway Health and Giant Eagle Pharmacy pilot an innovative approach to addressing the opioid epidemic in Allegheny County

Despite the Trump administration’s new policy, many pharmacies still won’t vaccinate children against influenza Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Although the Trump administration has empowered U.S. pharmacists to administer influenza vaccine to children in hopes of reducing the effect of concurrent… Read More »Despite the Trump administration’s new policy, many pharmacies still won’t vaccinate children against influenza

Hospitals are reeling under a 46% spike in COVID-19 patients Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 The number of Americans falling ill with COVID-19 is escalating, and hospitals are staggering under the burden. The hospitalization rate is up approximately 46% nationwide from… Read More »Hospitals are reeling under a 46% spike in COVID-19 patients

Oxford, AstraZeneca vaccine shows promising immune response in older adults Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 An interim analysis suggests that a COVID-19 vaccine being developed by AstraZeneca and the University of Oxford produces a favorable immune response and low levels of… Read More »Oxford, AstraZeneca vaccine shows promising immune response in older adults

Association of therapies with reduced pain and improved quality of life in patients with fibromyalgia Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Researchers in Brazil and Australia scrutinized therapies for alleviating pain and enhancing quality of life (QOL) in people with fibromyalgia, most… Read More »Association of therapies with reduced pain and improved quality of life in patients with fibromyalgia

Preventing the spread of SARS-CoV-2 with masks and other ‘low-tech’ interventions Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Use of face masks is essential for combating coronavirus infection, which is primarily transmitted through respiratory droplets, explains National Institute of Allergy and Infectious Diseases… Read More »Preventing the spread of SARS-CoV-2 with masks and other ‘low-tech’ interventions

Severe COVID-19 cases leave lasting effects, including on mental state Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Physicians are now starting to understand the long-term effects of COVID-19, including fatigue, chest pain, and heart inflammation. Many of these effects do not have any… Read More »Severe COVID-19 cases leave lasting effects, including on mental state

FDA approves lotion for nonprescription use to treat head lice Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 FDA approved on Tuesday a lotion to treat head lice for nonprescription use through a process known as a prescription-to-OTC switch. FDA originally approved ivermectin (Sklice—Arbor… Read More »FDA approves lotion for nonprescription use to treat head lice

Teladoc Health posted $288.8 million in revenue for 2020’s third quarter as it prepares for a pending $18.5 billion merger with Livongo.

Medicare will cover any potential coronavirus vaccine for free, under a new Trump administration policy officially announced Wednesday.The new rule from the Centers for Medicare and Medicaid Services means any vaccine that receives Food and Drug…

Welcome to Wednesday’s Overnight Health Care.The White House wants to clarify that President Trump does not really think the pandemic is over and is instead making ending it his top priority. There’s more evidence masks work. And Anthony Fauci doesn…

Coronavirus (COVID-19) Update