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Federal government rejects 8 million N95 masks from single distributor

The federal government has suspended shipments of N95 respirators from a Montreal-based supplier after about eight million of the masks made in China failed to meet specifications. 




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Deficit reduction will have to wait for the economic recovery, federal officials say

As the fallout from COVID-19 adds hundreds of billions of dollars to the national debt, senior federal officials say there will be no aggressive attempts at deficit reduction until Canada's economic recovery is well underway.




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Start planting cold-tolerant plants and cool-season vegetables as May gets underway

Chicago's final frost date usually arrives in mid-May, meaning gardeners can start planting some of their hardier vegetables and seedlings.




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Now 103, Dame Vera to sing We'll Meet Again as UK marks VE Day

Dame Vera Lynn has performed her most iconic hit We'll Meet Again many times since she first sang it for the troops during World War Two and it became embedded as an anthem of hope in British life.




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Chez QUB Musique, Offenbach côtoiera les Rolling Stones

En quoi ce nouveau service d’écoute musicale en continu va se démarquer de ses gigantesques rivaux sur le marché. Explications en cinq points.




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SaaS Key Performance Indicator Index – An Operational Perspective

Over the last twenty years, SaaS investors and executives alike have done a great job at defining, evolving and managing to Key "Enterprise Valuation" Indicators such as Customer Acquisition Cost (CAC), Customer Acquisition Cost Ratio, Customer Lifetime Value (CLTV), CMRR/ARR, Gross Margin, Gross and Net Churn, and of course, the "Rule of 40".   Several industries influencers, such as Pacific Crest (Key Bank Capital Markets), OpenView, Insight Partners and KPMG, to name just a few, have done ...

Keep on reading: SaaS Key Performance Indicator Index – An Operational Perspective




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Marking VE Day, PM tells veterans: 'You will always be remembered'

Boris Johnson has declared that the UK's response to the coronavirus demands the same effort and courage as the armed forces showed in the Second World War.




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Rheumatoid Arthritis Triple Therapy Little Used in U.S.

(MedPage Today) -- Triple therapy -- with methotrexate, hydroxychloroquine, and sulfasalazine -- is little used for the treatment of rheumatoid arthritis (RA) in the U.S. today, and clinical outcomes showed less efficacy than regimens combining...




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A widespread outbreak could derail plans to ease restrictions, deputy medical chief says

It is very unlikely Australian sports fans will be able to pack out stadiums on grand final weekend, even if the plan to lift restrictions is successful, Deputy Chief Medical Officer Paul Kelly says.




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The Time a New York Governor Disobeyed the Federal Government

When Al Smith had the chance not to enforce Prohibition, he took it.




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The World Order Is Dead. Here’s How to Build a New One for a Post-Coronavirus Era.

U.S. and world leaders have a chance to craft an international system that works for this era. But they have to avoid the mistakes of the past.




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NRL island idea remains 'in consideration' as league tries to keep game afloat during coronavirus

Rugby league faces a dangerous financial crunch due to the coronavirus shutdown, but players, clubs and the NRL are working together to ensure the game's future.




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The NRL wants to return next month, but it faces several challenges before that can happen

The NRL has a number of crucial questions it must answer if it wants to restart its premiership season on May 28 as planned following the coronavirus-forced suspension of the competition, writes David Mark.




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Players who breached social-distancing rules put NRL restart at risk, Federal Sport Minister says

Federal Minister Richard Colbeck says he hopes sport halted by the coronavirus pandemic can get started again, but warns NRL players' misbehaviour threatens a return of play.




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An AFL premiership won't define Dangerfield, but he is still desperate to win a flag

He has claimed almost every individual honour there is in the AFL, but the highest goal continues to drive the Geelong star even during this uncertain 2020 season — a maiden premiership victory.




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New York attorney general's office questioned NBC News employees on sexual harassment

Former anchor Linda Vester and others have been called in.




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What's on TV Thursday: 'Tommy' on CBS; coronavirus TV coverage

What's on TV Thursday, May 7: 'Tommy' on CBS; coronavirus TV coverage; movies on TV; TV talk shows and more




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The hard-won liberation of Hayley Williams: 'It wasn't beautiful. It was painful'

After 16 years as the frontwoman for Paramore, and following a broken marriage and a lot of therapy, Hayley Williams is releasing her first solo album.




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'You could literally kill someone': Masks become a new COVID-19 battleground

As more states reopen their economies, officials say fighting the coronavirus outbreak means wearing a face covering. But some are balking at restrictions.




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'We're vulnerable': On the Navajo Nation, a rush to curb the coronavirus

A desperate attempt to halt coronavirus cases is underway on the country's largest reservation, which spans Arizona, New Mexico and Utah.




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Federal investigations curtailed amid coronavirus

Federal indictments were down 75 percent in April and 25 percent in march as prosecutors and investigators were forced to curtail operations in response to coronavirus.




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VE Day: The story behind Vera Lynn's We'll Meet Again

The song encapsulated the sadness and determination felt by families separated during WW2.




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Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.




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TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule

#TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected).

The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP.




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Gujarat pharma industry upbeat as around 900 out of 1,100 plants start operations despite lockdown




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Soft Actuator and Sensor for Underactive Bladder Treatment

Researchers at the National University of Singapore have developed a soft sensor and actuator to monitor bladder volume and help empty it on-demand. The device is intended to be implanted on the bladder surface during a surgical procedure to treat patients who cannot completely empty their bladders voluntarily. Patients can suffer from an underactive bladder […]




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Supersaturated Oxygen Therapy Cleared in EU to Treat Widowmaker Heart Attacks

ZOLL Medical, a part of the Asahi Kasei Group, won EU clearance for its SuperSaturated Oxygen (SSO2) Therapy System to be used to minimize the damage that heart attacks cause within heart muscle. Approved about a year ago in the United States, SSO2 is the only option beyond percutaneous coronary intervention (stenting) that can help […]




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Friday Feedback: Research on Lipid-Lowering Therapies 'Alive and Well'

Experts discuss recent cancellation of first-in-class drug




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Crescendo links with CRUK to progress cancer therapy

The charity's Centre for Drug Development will sponsor and fund a future Phase I clinical trial for CB213




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Rebiotix, Ferring's microbiome-based therapy RBX2660 shows promise

RBX2660 may bring an innovative therapeutic option to patients suffering from C. diff




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Merck names Doina Ionescu as UK and Ireland general manager

Dr Mike England joins as medical director for UK & ROI




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Bio Roundup: Remdesivir Data, Erasca’s $200M, a New FDA Nod & More

Remdesivir, the investigational Gilead Sciences antiviral drug, looks more likely than ever to become the first treatment authorized by the FDA to treat patients with COVID-19. National Institute of Allergy and Infectious Diseases (NIAID) head Anthony Fauci praised the drug after preliminary data released this week from a federally funded trial involving more than 1,000 […]




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Lyra Therapeutics IPO Raises $56M for Tests of Tech for Runny Noses

Lyra Therapeutics, a biotech company developing a new way to treat your persistently runny nose, has raised $56 million in its public markets debut. Late Thursday, Lyra offered 3.5 million shares priced at $16 apiece, which was the high end of its projected $14 to $16 price range. Those shares are expected to begin trading […]




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Encouraging Signals for New Cancer Cell Therapy Strategies

Chimeric antigen receptor T-cell therapies have shown remarkable efficacy in leukemia and lymphoma patients who relapsed or were refractory to several prior treatments, but many challenges remain in the cancer cell therapy field. Strategies that may improve upon first-generation therapies were presented during the American Association for Cancer Research virtual meeting with encouraging early activity, […]




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PTC Therapeutics to Acquire Censa Pharma for Mid-Stage Rare Disease Drug

PTC Therapeutics has reached an agreement to acquire Censa Pharmaceuticals and its lead asset, an experimental metabolic disorder therapy that is now being prepared for a pivotal study. The deal, announced after the market close Wednesday, will bring South Plainfield, NJ-based PTC (NASDAQ: PTCT) another compound for its pipeline of rare disease drugs. Wellesley, MA-based […]




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Join Us Online May 13 for Xcelerating Life Sciences: Biopharma’s Future in Digital Health

Learn how digital tech is accelerating medical breakthroughs by registering your team to attend Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health. While some content focuses on the Boston ecosystem, we’re confident the forum – and virtual networking – will be valuable to a national audience. The May 13, 2020 event will explore the […]




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Disarm Therapeutics hires Dr Alvin Shih as new President and CEO

Massachusetts-based biotech Disarm Therapeutics has hired Dr Alvin Shih as their new President and CEO.

The Cambridge, Mass.-based firm has set itself the task of creating a new class of disease-modifying therapeutics for patients with axonal degeneration, a central drive of neurological disease.

Dr Shih brings to the role a range of experiences. Having graduated with a biology degree from Vanderbilt University in 1996, Shih joined management consultancy McKinsey where he worked as a business analyst for two years.

read more




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General Pharmaceutical Council appoints Laura Fraser as director for Scotland

The General Pharmaceutical Council has appointed Laura Fraser, former clinical fellow for the Scottish Chief Pharmaceutical Officer as the new Director for Scotland.

Fraser has held leadership roles in community pharmacy across Scotland including board member of Community Pharmacy Scotland. She has also worked for the Scottish Government as Clinical Leadership Fellow. Prior to her position as board member she was area and regional manager for nearly nine years.

read more




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FibroGen names Lilly veteran as new CEO

Eli Lilly veteran Enrique Conterno has been revealed as the new Chief Executive Officer of FibroGen following the unexpected death of its previous long-term Chief Thomas Neff in August last year.

Neff passing took the company off-guard, bringing a sad and abrupt end to his 26 years of service. In the wake of the loss, FibroGen appointed Board member James Schoeneck to lead the company until a permanent replacement could be found.

read more




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Steven T Gill returns to Alimera as VP, Thought Leader Engagement

Ophthalmology specialist Alimera Sciences has announced that Steven T Gill is to return to the company in the newly created role of Vice President, Thought Leader Engagement.

Gill had previously served at Alimera as its Senior Director, Thought Leader Liaison, before leaving the company for Novartis, where he most recently held the position of Associate Director, Thought Leader Liaison at Novartis US.

read more




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Dr John C. McKew promoted to Chief Operating Officer at Lumos Pharma

Lumos Pharma, Inc. has promoted Dr John McKew to the position of Chief Operating Officer effective 1 April 2020.

McKew is already Chief Scientific Officer and he will do both roles simultaneously. With his new role, he will lead Lumos’s clinical development plan as the company looks toward adding additional assets to its pipeline.

read more




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Industry veteran Dr David Setboun joins BrainStorm as Executive VP and COO

BrainStorm Cell Therapeutics, a firm developing cellular therapies to tackle neurodegenerative diseases, has named industry Big Pharma veteran Dr David Setboun as its new Executive Vice President and Chief Operating Officer.

Dr Setboun has served for two decades at some of the biggest names in pharma. His most recent role was Vice President of Corporate Development, Strategy & Business at Life Biosciences, where he helped drive development of a range of vital commercial, operating and funding milestones.

read more




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Seres Therapeutics appoints Dr Lisa von Moltke as new Chief Medical Officer

Dr Lisa von Moltke has left Aklermes and has joined Seres Therapeutics as its new Chief Medical Officer.

Chief Executive Officer at Seres, Eric Shaff, said Seres will benefit from von Moltke’s “extensive experience directing successful development programs, leading clinical teams, and interacting with regulatory agencies across multiple areas of medicine.”

read more




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Novartis acquires digital therapeutics specialist Amblyotech

The pharmaceutical firm has purchased the company, which specializes in advancing treatments and diagnostics for ocular disorders.



  • Markets & Regulations

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Research collaboration drives to accelerate COVID-19 solutions

Led by Medable, the multi-company effort is geared toward ramping up development of treatments, diagnostics and other solutions for the pandemic-causing virus.




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Express Scripts + Prime Therapeutics: Our Four Takeaways From This Market Changing Deal (rerun)

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

I suspect this deal will remain profitable for the participating companies even as COVID-19 alters the US. prescription payer mix. Click here to see the original post and comments from January 2020. National market shares for the largest PBMs in 2019 appears as Exhibit 88 of our 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers.

P.S. Sorry that today's meme is one day too late for Star Wars day.



Just before the holidays, Cigna’s Express Scripts business announced a market-changing deal with Prime Therapeutics. Click here to read the press release.

There's been very little written about this transaction, though it has potentially major implications. Below, I share my thoughts on the following topics arising from the deal:
  • Implications for manufacturers and pharmacies
  • The role of the secretive Ascent Health Services
  • What this all means for Walgreens
  • Why the Federal Trade Commission won’t challenge the deal
A few weeks ago, I explained why integrated insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels. The Express Scripts / Prime deal signals that the channel will continue its amazing pace of reinvention.

The scale, scope, and interconnectedness of today’s market participants make the system increasingly resistant to massive disruption from either external players like Amazon or a government takeover. Like it or not, the channel will continue to gain power and extract profit. Read on and see if you agree.
Read more »
        




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Rabbit Virus Could Provide Gene Therapy

Originally published in February 1967

-- Read more on ScientificAmerican.com




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Heat and Humidity Are Already Reaching the Limits of Human Tolerance

Events with extreme temperatures and humidity are occurring twice as often now as they were 40 years ago

-- Read more on ScientificAmerican.com




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Bayer donates 8 million chloroquine tablets to the German Federal Government

Additional donations of chloroquine sent to governments in numerous other countries / Various clinical and preclinical studies investigate the efficacy and adverse effects in COVID-19 infections / Bayer plans considerable expansion of production capacities in the event that the efficacy of chloroquine is proven for COVID-19




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We're desperate for a coronavirus cure, but at what cost to the human guinea pigs? | Kenan Malik

Big drugs companies have long favoured outsourcing clinical trials to poor countries with lax regulations to cut costs and maximise profit

• Coronavirus latest updates

• See all our coronavirus coverage

Last week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine.

Related: Africa's Covid-19 research must be tailored to its realities – by its own scientists | Monique Wasunna

In India, many poor people were recruited to HIV trials without knowing that they were taking part in experiments

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