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Manufacturer to move hydroxychloroquine production to the UK to avoid shortages

A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages.

To read the whole article click on the headline




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NHS England advises pharmacies to 'risk assess' BAME staff for susceptibility to COVID-19

NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background.

To read the whole article click on the headline




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FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment

March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […]




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CHC Endorses Request Calling for Veto of Maryland Tax on Digital Advertising

April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […]




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Despite Late Changes and COVID-19, CCPA Enforcement Date Remains July 1

April 20, 2020 – With additional changes to the regulations still in administrative review and businesses grappling with pressing COVID-19 issues, a group of nearly 100 advertising trade associations, organizations and companies asked California Attorney General Xavier Becerra (D) to delay the July 1 enforcement date for the California Consumer Protection Act (CCPA). But it […]




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COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]




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As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds

May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […]




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EMA starts reviewing Gilead's remdesivir data to accelerate approval of COVID-19 antiviral

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.




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Inovio's COVID-19 vaccine claims echo Theranos, says short attack

Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine.




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Newron ditches sarizotan program after pivotal trial flop, sees shares crater

Newron will terminate work on its experimental Rett syndrome drug sarizotan after a complete failure in its pivotal STARS trial.




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Lilly-partnered AbCellera gets COVID-19 boost from Canadian government

After penning a deal with Eli Lilly last month with the aim to have an antibody in the clinic within four months, Canadian-based AbCellera has been given a financial boost by its government.




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Alnylam, Vir plan year-end trial of new RNAi COVID-19 antiviral

Alnylam and Vir Biotechnology have identified an anti-SARS-CoV-2 development candidate, putting them on track to start testing the inhaled RNAi treatment for COVID-19 in humans around the end of the year.




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Oberland Capital nabs $1.05B raise for late-stage plays, handing out cash for royalties

Come on in, the water’s warm. After billions already raised by VC firms since the advent of the pandemic for life science companies, Oberland Capital has tossed more than $1 billion into the pot.




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CSL Behring joins pandemic R&D fight with antibody work

Australia’s largest biotech company CSL says it is working on a plasma-based therapy for patients with more severe forms of COVID-19.




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COVID-19: Lilly ramps up to beat the virus with neutralizing antibodies as scientists raise worries

Eli Lilly has teamed with China’s Junshi Biosciences in the U.S., marking the company's second COVID-19 pact to develop neutralizing antibodies against the virus. It promises to be a faster approach than designing a new small-molecule drug would be, but getting from idea to an effective product may not be so simple.




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Janssen promotes R&D exec into newfound data science role

Following in the footsteps of an increasing number of biopharmas that want to use data to get more bang for their buck in R&D, J&J has promoted Najat Khan, Ph.D., to the role of chief data science officer.




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Could Sanofi and Regeneron's Dupixent also treat age-related macular degeneration?

Sanofi and Regeneron’s Dupixent has become a popular treatment for atopic dermatitis and asthma. Now, a research team in Japan has discovered that IL-4 and its receptor—which Dupixent inhibits—could be promising targets for treating the eye disease age-related macular degeneration.




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GSK taps experimental arthritis antibody to calm the cytokine storm hitting COVID-19 patients

GlaxoSmithKline is hard at work with partner Sanofi in getting a vaccine tested for COVID-19, but this morning it said it was now also entering the race to treat patients already hit with the disease.




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Chutes & Ladders—Johnson & Johnson elevates Khan to data science officer role

Johnson & Johnson taps Khan for chief data role; Icon poaches AstraZeneca vet Buck as CMO; Intellia signs on Lebwohl as CMO.




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Sorrento ventures into COVID-19 with Mount Sinai antibody pact

Sorrento Therapeutics is jumping into the race to develop therapies against COVID-19, teaming up with Mount Sinai to develop a cocktail of antibodies from the blood of 15,000 recovered patients. The company's scientists believe their multipronged therapy will sidestep risks such as treatment resistance.




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BENEO president: ‘We have seen higher and more volatile demand during the pandemic’

From fewer containers and reduced shift work at harbors to delays in planned maintenance in factories, the coronavirus pandemic is impacting global supply chains in myriad ways. FoodNavigator-USA (FNU) caught up with Jon Peters (JP), president at Beneo, a leading supplier of chicory root fiber, rice ingredients, and the specialty low-GI carbs Isomalt and Palatinose, to find out more.




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Despite sales bump, brands that are not preparing for stormy seas ahead could struggle, consultant says

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.




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Probiotic combination boosts amino acid absorption from plant protein: RCT

A novel combination of two Lactobacillus paracasei strains may increase absorption of key amino acids in plant proteins, according to a new placebo-controlled, randomized, double-blind, multicenter, crossover study.




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CRN’s Mister: ‘This could be a sea change for the industry as consumers take more interest in their health’

Consumers are turning to dietary supplements in record numbers, but the industry must deliver on the results the products are promising if the industry is to convert them to long term customers, says Steve Mister.




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Bifido probiotic may enhance effects of exercise and boost training results: Study

Combining exercise with a bacterial strain isolated from an Olympic weightlifting gold medalist may synergistically increase endurance compared to training or the probiotic alone, suggests data from a mouse study.




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Experts lay out post-pandemic retailing strategies

Marketing experts recommend that brands formulate a strategy to be as nimble as possible to deal with the as yet unknown changes to the supplement marketplace in the post pandemic world. A greater online capability is seen as one of key parts of that toolkit.




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Precision in Oncology: Using the Macro and Micro

Last week, the New York Times had a nice piece “A Faster Way to Try Many Drugs on Many Cancers” on basket clinical trials, which matches patients to a therapy based on the genetics of their tumor as opposed to the site of their primary tumor. This type of trial feeds into the current excitement about precision

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None Better than One? (A Brief Note on VC in Smaller Hubs)

Biotech venture funding metrics continue at historic highs, highlighting that the robust financing environment in the public markets continues to fuel the private markets as well.  – Bruce Booth, partner Atlas Venture in Data Snapshot: Venture-Backed Biotech Financing Riding High, April 2015 Here in Madison, Wisconsin, you might not know that was true if you

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Some Questions On The Future Of The Coronavirus Vaccine, Answered

Scientists work tirelessly to find a coronavirus vaccine. But there are some questions to answer: How soon a viable vaccine would be developed? Would billions of people worldwide be able to to get it?




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V-E Day: Europe Celebrates A Subdued 75th Anniversary During COVID-19 Pandemic

"Today, 75 years later, we are forced to commemorate alone, but we are not alone!" Germany's President Frank-Walter Steinmeier says, celebrating international unity in the post-war era.




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Seen 'Plandemic'? We Take A Close Look At The Viral Conspiracy Video's Claims

The video has been viewed millions of times on YouTube via links that are replaced as quickly as the video-sharing service can remove them for violating its policy against "COVID-19 misinformation."




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Coronavirus FAQs: Do Temperature Screenings Help? Can Mosquitoes Spread It?

And as summer nears, the question must be asked: Is it risky from a COVID-19 standpoint to go in a swimming pool?




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Haitian Doctor Says This Is The Worst Epidemic He's Faced

A major health agency fears a humanitarian crisis. Migrant workers are returning home from the hard-hit Dominican Republic. Medical equipment is in short supply. And social distancing is improbable.




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Public Health Experts Say Many States Are Opening Too Soon To Do So Safely

By Monday at least 31 states will be open or partially open. This as President Trump pushed for the country to get back to work despite public health experts warning that it's too soon.




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COMIC: Hospitals Turn To Alicia Keys, U2 And The Beatles To Sing Patients Home

Call them victory anthems. Every time a patient with COVID-19 is well enough to be discharged, hospitals in New York and elsewhere play songs of celebration over the intercom. A doctor explains.




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Anti-Vaccination Activists Join Stay-At-Home Order Protesters

Among those rallying against state shutdown orders are anti-vaccination activists. They see these protests as a way to form political alliances that promote their movement.




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So, You're Not Talking Much In Quarantine. Here's How To Keep Your Voice Healthy

With social distancing, many people are speaking less and their voices sound raggedy. NPR's Scott Simon talks with speech pathologist Sandy Hirsch, about keeping the voice sounding as it should.




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Tracking The Pandemic: How Quickly Is The Coronavirus Spreading State By State?

View our map and graphics to see where COVID-19 is hitting hardest in the U.S., which state outbreaks are growing the fastest and which are leveling off.




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Day Three Notes – JP Morgan Healthcare Conference, San Francisco

Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies.  I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading




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PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative: aims to cut the time it takes to...… Continue Reading




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En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading




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Looking Forward/Looking Backward – Day 1 Notes from the JPMorgan Healthcare Conference

A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the action. This is the week of the annual JP Morgan Healthcare conference in San Francisco, with many thousands of healthcare...… Continue Reading




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Food for Thought (and Health): Day 2 Notes from the JP Morgan Healthcare Conference

Addressing the Social Determinants of Health:  Is the healthcare industry pushing a rock up a hill?  We collectively are trying to provide healthcare with improved quality and reduced cost, but the structure of the nation’s healthcare system remains heavily siloed with the social determinants of health often falling wholly or partly outside the mandate and...… Continue Reading




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The Old and the New – Day 3 Notes from the JPMorgan Healthcare Conference

Day 3 of the JPMorgan healthcare conference was one of striking contrasts between the old and the new. (And, by the way, the rain finally stopped for a day, but it will be back tomorrow to finish off the last day of the conference). The Old:  Sitting in the Community Health Systems (CHS) presentation and...… Continue Reading




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Notes on Day 4 of the JPMorgan Healthcare Conference

Some interesting presentations on the last day of the JPMorgan Healthcare Conference that concentrated on common themes – the increasing importance of ancillary business line to bolster core business revenue and of filling in holes to achieve scale and full-service offerings. Genesis Healthcare – The largest U.S. skilled nursing facility (SNF) provider, which also is...… Continue Reading




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WannaCry Ransomware Alert

This is not a drill. Companies and law enforcement agencies around the world have been left scrambling after the world’s most prolific ransomware attack hit over 500,000 computers in 150 countries over a span of only 4 days. The ransomware – called WannaCry, WCry, WannaCrypt, or WannaDecryptor – infects vulnerable computers and encrypts all of...… Continue Reading





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Healthcare needs immigrants



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Can pharma become a digital industry?



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A vaccine probably won’t arrive any time soon.