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Emergent to make Providence Therapeutics potential COVID-19 vaccine

Emergent BioSolutions signed a five-year agreement with Providence Therapeutics to develop and manufacture the Canadian biotechnology company’s Covid-19 vaccine candidate for about $90 million.

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Emergent to make Providence Therapeutics potential COVID-19 vaccine

(Reuters) – Emergent BioSolutions Inc (EBS.N) signed a five-year agreement with Canadian biotechnology company Providence Therapeutics to develop and manufacture its COVID-19 vaccine candidate for about $90 million.

Emergent will produce drug substances for Providence’s vaccine candidate, PTX-COVID19-B, as well as provide services for finished products such as filling the vaccine in vials at its Winnipeg facility in Canada.

The vaccine uses the messenger RNA (mRNA) technology, also used in COVID-19 shots developed by Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N). Providence’s vaccine is currently being tested in a mid-stage trial in Canada.

A woman holds a test tube in front of displayed Emergent logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/Illustration

Emergent expects to manufacture tens of millions of doses of Providence’s shot in 2022, as well as batches of formulated bulk drug substance for the vaccine with the potential to yield hundreds of millions more doses.

The agreement covers cost for manufacturing services, studies to support global supply chain activities, as well as facility and equipment investments, the companies said on Tuesday.

Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/emergent-make-providence-therapeutics-potential-covid-19-vaccine-2021-09-14

 

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Spread & Containment

Long COVID: double vaccination halves risk of developing long-lasting symptoms

Want to avoid long COVID? Get vaccinated.

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Studio Romantic/Shutterstock

In unvaccinated people, around one in 20 who get symptomatic COVID-19 experience symptoms for at least eight weeks. Around one in 50 have symptoms that drag out for three months or more.

We wanted to know whether COVID-19 vaccines might protect against developing long-lasting symptoms. To find out, we looked at data provided by more than a million regular contributors to the COVID Symptom Study, a project in which members of the public log their symptoms via an app to help with research.

Our latest analysis of the study’s data, covering around 2 million vaccine doses, shows that vaccines significantly reduce the risk of catching COVID-19, with only 0.2% of those fully vaccinated later testing positive for the virus.

Even if you’re unlucky enough to catch the virus after being vaccinated, your chances of falling seriously ill or dying are slashed. Double-vaccinated people are 31% less likely to experience acute COVID-19 symptoms and 73% less likely to be hospitalised – a result that’s borne out in the relatively low hospitalisation and death rates we’re seeing now even as tens of thousands of people are still testing positive every day in the UK.

Reassuringly, for those who did fall ill with COVID-19 after being vaccinated, only around 5% went on to have symptoms that lasted for more than four weeks, meaning their chances of developing long COVID were cut by half. One of the best ways to reduce your risk of getting long COVID is to get fully vaccinated as soon as possible.

However, we did notice that frail older people and those living in more socially deprived areas were more likely to be infected and fall ill with COVID-19 after being vaccinated, especially if they had only had one vaccine dose. This suggests that we should prioritise further vaccination efforts and public health measures such as masking and social distancing among these groups, especially where infection rates are high and people are mixing and moving around.

Vaccines and long COVID

As the UK vaccination programme rolled out, we also started to notice anecdotal reports from people living with long COVID that their symptoms seemed to improve after being vaccinated.

The patient-led LongCovidSOS group chose to investigate this by surveying over 800 long COVID patients early in 2021. More than half of those surveyed noticed an overall improvement in their symptoms after vaccination, which then appeared to be sustained in about half of this group. Around a quarter of the overall respondents reported no difference and one-fifth said their symptoms had got worse. These findings have been released as a preprint, so haven’t yet been reviewed by other scientists, but they’ve been backed up by data from the COVID Symptom Study, which we’ll be publishing soon.

However, while there does seem to be some kind of link between receiving a COVID-19 vaccine and improvements in long COVID, it’s not clear exactly how the two are connected. It could be that the immune response triggered by the vaccine has a direct impact on symptoms.

Alternatively, it could just be that time has continued to pass since these people were originally infected and they’re experiencing a natural recovery from the virus. Or it could be a bit of both. Either way, more research is needed to tease out what’s going on.

A woman with long COVID lying on a bed, covering her face
There isn’t a definitive answer yet on whether vaccines can relieve people’s long COVID symptoms. True Touch Lifestyle/Shutterstock

What we can say is that COVID-19 vaccines certainly aren’t harmful for people with long COVID. What’s more, because we know that it’s possible to be reinfected with the virus, there’s a risk that catching it a second time could exacerbate symptoms for people living with long COVID and set them back even further. It’s therefore vital that we encourage anyone with long COVID who has not been vaccinated to do so as soon as possible, to help protect themselves and those around them.

A serious threat

Although the chances of developing long COVID after being vaccinated are small, this is a numbers game and a small percentage of a big number can still be substantial. As long as we are seeing tens of thousands of cases every day, we can still expect to see a substantial number of people living with lingering symptoms over the coming months.

This is particularly important for younger people, who may be less worried about hospitalisation or death, yet who can still be susceptible to the debilitating long-term effects of the virus. A lot can happen in a few months when you’re young, and long COVID can mean that people miss out on life-changing opportunities, like sitting an exam or taking up a new job, as well as the social activities that bring joy and wellbeing to life.

It’s likely that we’ll all be living with COVID-19 for some time to come. But with a combination of vaccination and public health measures where necessary, we can help to make sure that as few people as possible have to directly live with its life-limiting long-term effects.

The Conversation

Claire Steves consults for ZOE Ltd which is the company which developed the COVID Symptom Study together with King's College London. She receives funding from the Medical Research Council, the National Institute for Health Research, the Wellcome Trust and Chronic Disease Research Foundation.

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Science

Incyte nabs approval of topical ruxolitinib in atopic dermatitis, but gets slapped with JAK warning

Incyte has made a pretty penny with its JAK inhibitor ruxolitinib over the years, but on Tuesday the drug crossed a new threshold.
Julie Block
The FDA approved a topical formulation of the drug for mild-to-moderate atopic dermatitis, Incyte announced…

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Incyte has made a pretty penny with its JAK inhibitor ruxolitinib over the years, but on Tuesday the drug crossed a new threshold.

Julie Block

The FDA approved a topical formulation of the drug for mild-to-moderate atopic dermatitis, Incyte announced Tuesday afternoon, giving the Wilmington, DE-based company a new arrow in its ruxolitinib quiver. The drug, which will be marketed as Opzelura, is the first topical JAK inhibitor approved in the US and is indicated for AD patients aged 12 and up who struggle to control their disease on other prescription creams.

“It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients,” said Julie Block, CEO of the National Eczema Association, in a statement. “The chronic itch is difficult to cope with and related sleep issues can be exhausting.”

It wasn’t immediately clear how Incyte planned to price the drug. Endpoints News has reached out for comment and will update accordingly.

Tuesday’s approval also came with the black box warning seen across the JAK class of drugs, highlighting risks of serious infections, heart attack, stroke or cardiac death.

Ruxolitinib has morphed into a blockbuster for Incyte since it garnered its first approval as an oral treatment for myelofibrosis back in 2011. The drug continued to rack up FDA endorsements ever since, getting nods for polycythemia vera in 2014 and acute graft-versus-host disease in 2019.

In these indications, the drug is marketed as Jakafi in the US and as Jakavi by Novartis elsewhere. Jakafi netted $995 million in revenue through the first half of 2021, maintaining some growth but also taking sales hits due to the Covid-19 pandemic, Incyte said.

But Incyte has been pushing to move ruxolitinib into a topical formulation for a while as well. By treating mild and moderate AD with a cream, patients can more easily treat their affected areas than with an oral drug. The topical formulation is also in development for vitiligo, another skin condition that can result in the loss of pigmentation.

The approval will also give Regeneron and Sanofi’s Dupixent some competition in the eczema field. Incyte is hoping it can advance Opzelura on ease of use, given that Dupixent is administered by injection. The company will have a tough task ahead, however, as Dupixent pulled in nearly $1.5 billion in sales in 2021’s second quarter alone.

At the very least, Incyte has hoped topical ruxolitinib can prove a more appealing alternative to corticosteroids, the standard of care in mild-to-moderate AD. Tuesday’s approval came on the basis of two Phase III studies that compared the cream to a placebo, with patients seeing at least a two-point improvement on an investigator assessment and a reduction in itch from baseline after eight weeks.

Peak sales estimates for the topical drug have ranged from $300 million to $1.1 billion by 2025.

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Government

The Market is Deeply Oversold And Looking For A “Dovish” Fed

As we will discuss, the market is deeply oversold and looking for a "dovish" Fed to spark buying. Traders and investors will be laser-focused on the Fed meeting adjourning at 2 pm ET. Of importance, the decision on taper and their characterization of…

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As we will discuss, the market is deeply oversold and looking for a “dovish” Fed to spark buying. Traders and investors will be laser-focused on the Fed meeting adjourning at 2 pm ET. Of importance, the decision on taper and their characterization of the economic recovery and inflation. If they do elect to announce a taper schedule, the pace of tapering and any caveats that may delay tapering will be of utmost importance.

Like yesterday markets are opening up a half to one percent higher. Will they hold onto the gains, unlike yesterday? The answer likely lies with the Fed at 2 pm.

What To Watch Today

Economy

  • 7:00 a.m. ET: MBA Mortgage Applications, week ended September 17 (0.3% during prior week)
  • 10:00 a.m. ET: Existing home sales, month-over-month, August (-1.7% expected, 2.0% in July)
  • 2:00 p.m. ET: FOMC policy decision

Earnings

Pre-market

  • 7:00 a.m. ET: General Mills (GIS) is expected to report adjusted earnings of 89 cents per share on revenue of $4.30 billion

Post-market

  •  4:10 p.m. ET: KB Home (KBH) is expected to report adjusted earnings of $1.62 per share on revenue of $1.57 billion
  • 5:05 p.m. ET: BlackBerry (BB) is expected to report adjusted losses of 7 cents per share on revenue of $166.80 million

Politics

Market Deeply Oversold – Looking For Some “Dovish” Tones

The rolling correction over the last 3-weeks has pushed the market into deeply oversold conditions on a short-term basis. Such provides plenty of “fuel” for a decent rally over the next month or two given some news to spark buying. Today, the Fed could do the trick with Jerome Powell delivering his post-FOMC press conference with a “dovish” tone. With Congress battling over the debt ceiling, the Treasury running out of money, and the risk of a Government “Shutdown” looming, the Fed has all it needs to provide plenty of “caveats” to its “taper” plans.

Fear Greed Index Near Lows

Another reason for near-term bullish optimism, is that both the AAII bullish allocation and the “Fear/Greed” index are near their respective lows. Combined with the oversold market conditions, such typically provides a buying catalyst as traders reposition themselves in equity risk.

Trading Game Plan for the S&P 500

The markets are trading well in overnight trading following yesterday’s flat-trading day. The bounce provides us with another set of levels, in addition to the 50, 100, and 200-dmas, to guide our trading. The graph below shows the Fibonacci retracements from the recent high to low. If this rally proves to be a bull trap, it is likely to give up between the 38% retracement (4395) and the 62% retracement (4451). There is also a gap between 4400 and 4430.

It is common for such gaps to fill and then reverse direction. If the market surges higher through the gap and retracement levels, the outlook becomes more bullish. A rally above the 4451 retracement level and well through the 50dma (4436) will likely lead to new highs. Conversely, the 50 dma (4436) may prove to be resistance. The first line of support is yesterday’s lows and the 100dma (4328). A break of the recent low leaves a target of 4106, the 200dma.

Follow Up to Monday Market Mayhem

Easy Lending Standards

Employment and inflation tend to get the headlines as far as rationales for the Fed to take action. As we consider what the Fed may do tomorrow, we should also consider lending standards. The graph below shows the lending standards for large banks’ credit card customers are as easy as they have been in 20 years. On its own, very easy lending standards, as we have, push the Fed toward a more hawkish stance. Easy borrowing conditions incentivize personal consumption. More consumer activity, especially given current supply line problems, is likely to further agitate inflationary conditions.

Chinas & Evergrande. Will They or Won’t They?

In addition to concerns with China, Evergrande, and possible contagion, the markets are also grappling with Wednesday’s Fed meeting. In what was likely a purposeful leak last week, the WSJ laid the groundwork for a taper announcement Wednesday and the reduction in asset purchases in November. With the U.S. and foreign markets skidding yesterday some are asking how the Fed might react. In a Bloomberg interview, ex-New York Fed President, Bill Dudley, warns “They’re not going to react to small market moves and defer the tapering on that basis. They have to change their economic forecast,” he said Monday during an interview on Bloomberg Television with Lisa Abramowicz, Tom Keene and Jonathan Ferro. “At this point, it’s really premature to reach that conclusion.”

The post The Market is Deeply Oversold And Looking For A “Dovish” Fed appeared first on RIA.

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