Connect with us

Futures Flat After Hawkish Fed Comments, Dollar Ascent Resumes

Futures Flat After Hawkish Fed Comments, Dollar Ascent Resumes

The downbeat market mood continued for a fourth day, with US stock futures…

Published

on

Futures Flat After Hawkish Fed Comments, Dollar Ascent Resumes

The downbeat market mood continued for a fourth day, with US stock futures turning red and erasing earlier gains after a three-day drop saw the S&P 500 lose $1.4 trillion in market capitalization amid renewed concerns about a hawkish Fed and a potential J-Pow bomb during Friday's J-Hole symposium (that said, with expectations so bearish, there is almost no way Powell can sound hawkish). S&P 500 futures dropped 0.1% at 7:00am ET after falling as much as 0.5%. Nasdaq 100 futures were also modestly red as the yield on the 10-year Treasury hit 3.05%. The US dollar reversed yesterday's sharp drop and extended its recent surge as the EURUSD resumed its plunge trading ever farther from parity, and at 0.992 last. Oil meanwhile has continued its ascent, pushing Brent above $100, and leading to the first Diesel price increase at the Pump since mid-June.

“Globally we haven’t seen a deceleration like this that has been so synchronized in many decades,” Frances Stacy, director of strategy at Optimal Capital Advisors LLC, said on Bloomberg Television. “I don’t want to be directional” in picking trades, she added.

The latest data showed economic activity weakening from the US to Europe and Asia, underlining the dire dilemma the Fed faces in hiking interest rates to bring down high inflation without sparking a recession. Still, Minneapolis Fed President Neel Kashkari said inflation is very high and the central bank must act to bring it back down to 2% and it is "very clear" they need to tighten monetary policy. Kashkari also stated that half to two-thirds of US high inflation is driven by supply-side shocks and help is needed on the supply side to get inflation down, with the more help they get from the supply side, the less the Fed has to do and will be better able to avoid a hard landing. Furthermore, he said there is currently no trade-off between employment and inflation mandates and they can only relax on rate hikes when they see compelling evidence inflation is heading toward 2%.

In US pre-market trading, Nordstrom plunged as much as 14% and was set for its biggest drop in nine months, after an outlook cut prompted analyst worries that the need to clear inventory and discounting could hurt margins in the second half. Brokers said that the higher-end department store owner’s results have been more volatile than expected and show that the company is “not immune” to a difficult macroeconomic backdrop. Bed Bath & Beyond shares rose as much as 18% in premarket trading following a WSJ report that the home goods retailer told prospective lenders that it has selected a lender for a loan after a marketing by JPMorgan Chase. Other notable premarket movers:

  • Urban Outfitters (URBN US) delivered quarterly results that look broadly in line with other apparel retailers, with a slowdown in lower-end brands and pressure on margins from markdowns, analysts say.
  • Frontier GroupHoldings (ULCC US) is resumed with an overweight rating at Morgan Stanley, with broker saying that the company is “the quintessential ultra-low-cost carrier” and has attractive margins.
  • Starbox (STBX US) shares jump as much as 30% in US premarket trading, with the Malaysian digital payments firm set for another day of gains after soaring in Tuesday’s Nasdaq Stock Market debut.

Stock futures were rangebound in muted volumes, as traders assessed the fact that directors at two of the Fed’s 12 regional branches favored a 100 basis-point increase in the discount rate in July. One of them, Minneapolis President Neel Kashkari, said US inflation is very high and the central bank must act to bring it back under control. All eyes remain on Fed officials as they head to Jackson Hole, Wyoming, this week for an annual conference, where Chair Jerome Powell will have a chance to reset investor expectations when he speaks on the economic outlook at 10am on Friday.

“We’ve been getting mixed signals from the Fed, highlighting risks of over-tightening but also concerns over still elevated inflation,” Madison Faller, global strategist at JPMorgan Private Bank, told Bloomberg Television. “It’s going to take more than one reading, we are going to have to see inflation fall over several months before we can really get a sense of whether a Fed pivot is on the way.”

According to an analysis of 13F reports by Goldman, last quarter hedge funds ramped up bets on megacap US tech stocks and whittled down overall holdings to concentrate on favored names, with conviction growing to levels last seen before the pandemic. The funds boosted tech and consumer discretionary holdings, while cutting energy and materials wagers, a trade which once again backfired spectacularly as tech crashed and energy soared. Since then however, the story has changed as Nasdaq 100 valuations rose well above the average for the past decade as the index soared from its June lows. The gauge remains under pressure, however, as higher rates weigh on the present value of future profits, hurting growth sectors like tech.

In Europe, the Stoxx 600 index edged lower, heading for a fourth straight day of declines, with retailers under pressure after US peer Nordstrom trimmed its full-year outlook. Luxury-goods giant Richemont surged after selling a stake in its online business. European natural gas prices increased, with outages at plants in the US and Norway adding to supply curbs from Russia. Here are some of the biggest European movers today:

  • Richemont shares rise as much as 3.3% after the luxury retailer announced the sale of its YNAP stake to US online retailer Farfetch, which was up 9.4% in US premarket trading
  • Tenaris gains as much as 3.3%, extending Tuesday’s 8.8% jump, with Banca Akros upgrading the company to buy from accumulate noting its outlook remains positive
  • ASR Nederland shares jump as much as 4.1% after the insurer reported interim results. KBC says the company delivered solid results despite headwinds from Non-Life segment
  • Lookers shares gain as much as 8%. The motor vehicle dealer’s pretax profit beat last year’s “exceptional performance” and was “comfortably ahead” of expectations, Peel Hunt (buy) says
  • CTS Eventim shares gain as much as 4% after the ticket seller’s 2Q results, with Jefferies pointing to a significant beat driven by ticketing
  • Norwegian fish farming stocks drop, led by Mowi, Leroy and Austevoll after the trio reported their respective quarterly results, with DNB expecting cuts to Mowi consensus estimates
  • Vimian shares sink as much as 14% to a record low after the animal health company reported 2Q results that saw only slight organic growth and a lower Ebita margin
  • Sydbank shares slide as much as 6.1% after the Danish lender’s latest results included a miss on net income, while saying its 2022 net profit will likely be in upper end of the previously reported range
  • Agfa-Gevaert shares decline as much as 11%, the most intraday since May 2021, despite a 2Q revenue beat as ING questioned the quality of the earnings

Earlier in the session, Asian stocks headed for a fifth day of declines, weighed down by losses in China, with investors trimming risky bets as they await clarity on the Federal Reserve’s policy path at the Jackson Hole meeting. The MSCI Asia Pacific Index dropped as much as 0.7%, set for its longest losing streak in two months. The consumer discretionary sector was the biggest drag. China’s CSI 300 Index slumped 1.9%, the most among regional benchmarks, with electric-vehicle linked shares leading the declines after CATL reported weaker battery margins. Fed Minneapolis President Neel Kashkari said US inflation is very high and the central bank must act to bring it under control, in the latest run of hawkish remarks by US officials. That, coupled with weak US business activity data overnight, renewed concerns about global growth as central bankers gather for an annual symposium in Jackson Hole. 

“We could see more short-term pressure on equities, starting in the US. This could also spill over to Asia given that corporate earnings in APAC are relatively sensitive to the region’s export performance,” said Tai Hui, APAC chief global market strategist at JP Morgan Asset Management. “We expect market sentiment to remain cautious as we approach the Jackson Hole meeting.”   In addition to a flurry of earnings this week from the region’s heavyweights, investors are also closely watching the impact of a drought in China that has led to shutdown of factories. 

Japanese equities ended lower, erasing earlier gains, as investors assess the potential for further tightening by the Federal Reserve to fight inflation.  The Topix Index fell 0.2% to 1,967.18 as of market close Tokyo time, while the Nikkei declined 0.5% to 28,313.47. Sony Group Corp. contributed the most to the Topix Index decline, decreasing 1.4%. Out of 2,170 stocks in the index, 1,165 rose and 861 fell, while 144 were unchanged. “The key point to watch on the Jackson Hole is whether Powell will be hawkish, or a little less hawkish,” said Ayako Sera, a market strategist at Sumitomo Mitsui Trust Bank.

India’s benchmark equities index closed slightly higher, after seesawing between gains and losses several times throughout the day, helped by an advance in lenders.  The S&P BSE Sensex rose 0.1% to close at 59,085.43 in Mumbai, after falling as much as 0.5% earlier in the session. The NSE Nifty 50 Index added 0.2%.   ICICI Bank Ltd. provided the biggest boost to the Sensex, which saw 16 of the 30 member stocks ending higher. Fourteen of 19 sectoral sub-indexes compiled by BSE Ltd. rose, led by a gauge of realty companies.  Investors will focus on Fed Chair Jerome Powell’s speech at the Jackson Hole symposium on Friday for a sense of how aggressive the US central bank will be in the face of weak economic trends.  “Market strategists blamed the three-day losing streak in U.S. stocks on a number of factors, including nerves ahead of Federal Reserve Chairman Jerome Powell’s speech on Friday, combined with a drumbeat of downbeat economic news, along with anxieties about rising Treasury yields and a stronger U.S. dollar,” Deepak Jasani, head of retail research at HDFC Securities Ltd., wrote in a note. 

In FX, the Bloomberg Dollar Spot Index was little changed and the greenback advanced against most of its Group-of-10 peers. Treasuries advanced, outperforming European peers, amid some paring of Fed rate hike bets. The euro traded in a narrow range around $0.950. Germany’s 10-year yield climbed to the highest since July 1 as money markets added to ECB rate-hike wagers before paring most of that rise. The pound slipped against the dollar and was steady versus the euro. Gilts underperformed with UK 2-, 5 and 30-year yields extending their advance to the highest since 2008, 2011 and 2014 respectively, before paring; the 10-year yield rose to the highest in two months.

In rates, Treasuries were mixed with 20-year sector outperforming, and broader market faring better than UK and euro-zone bond markets, where a full point of ECB hikes by October is priced in for the first time with energy seen adding to inflationary pressures. The 10Y TSY yield rose modestly to 3.05% after trading north of 3.00% all session. The New 2-year is ~1bp richer on the day with UK 2-year cheaper by ~15bp, German 2-year by ~6bp; 20-year Treasuries are richer by ~1bp outright and ~2bp on the 10s20s30s fly. The US Treasury auction cycle resumes with $45b 5-year at 1pm ET, concludes with $37b seven-year Thursday; Tuesday’s 2-year sale tailed by 1.4bp.

In commodities, WTI crude drifted above $94 a barrel, bolstered by shrinking US stockpiles and possible OPEC+ output cuts.

Bitcoin is incrementally softer but resides towards the mid-point of relatively contained parameters and remains comfortably above the USD 21k mark.

Looking at the day ahead now, and data releases from the US include the preliminary durable goods orders and core capital goods orders for July, along with pending home sales for that month too. Otherwise, earnings releases include Nvidia, Salesforce and Royal Bank of Canada.

Market Snapshot

  • S&P 500 futures little changed at 4,133.25
  • STOXX Europe 600 little changed at 431.26
  • MXAP down 0.5% to 157.88
  • MXAPJ down 0.6% to 512.64
  • Nikkei down 0.5% to 28,313.47
  • Topix down 0.2% to 1,967.18
  • Hang Seng Index down 1.2% to 19,268.74
  • Shanghai Composite down 1.9% to 3,215.20
  • Sensex little changed at 58,991.22
  • Australia S&P/ASX 200 up 0.5% to 6,998.12
  • Kospi up 0.5% to 2,447.45
  • German 10Y yield little changed at 1.32%
  • Euro down 0.2% to $0.9949
  • Gold spot up 0.1% to $1,750.10
  • U.S. Dollar Index little changed at 108.65

Top Overnight News from Bloomberg

  • Federal Reserve Bank of Minneapolis President Neel Kashkari said US inflation is very high and the central bank must act to bring it back under control
  • The head of macro and FICC research at Sweden’s biggest lender, SEB AB, has urged the Riksbank to stop selling off its own currency because it risks hurting the economy
  • The latest round of euro weakness has resulted in a series of bearish options structures for hedge funds and macro accounts. First stop for the common currency could be the $0.98 handle
  • The world’s largest pension fund said its equity investments based on environmental, social and governance criteria have outperformed as global stocks slump on concerns over inflation and monetary tightening
  • Oil rose for a second day as an industry report signaled another drawdown in US crude inventories, adding to a tightening supply outlook after Saudi Arabia flagged possible cuts to production
  • The UK imported no fuel from Russia for the first time on record in June as the government achieved its ambition to phase out all purchases of natural gas and oil in the wake of the invasion of Ukraine

A more detailed look at global markets courtesy of Newsquawk

Asia-Pacific stocks were mixed and only partially shrugged off the lacklustre lead from global counterparts. ASX 200 reclaimed the 7,000 level and was led by the tech and commodity-related sectors although gains were capped amid another busy day of earnings releases. Nikkei 225 failed to sustain opening advances following reports that Japan is considering lowering the COVID employment subsidy. Hang Seng and Shanghai Comp declined with property names pressured by several bearish factors including weak developer earnings and a default warning by Guangzhou R&F Properties, while China is also reportedly probing real estate executives for possible law violations.

Top Asian News

  • China Securities Times noted that moderate CNY depreciation is positive for export competitiveness and that the widening US-China interest rate spread has a limited impact on CNY.
  • Hong Kong is considering a storm level 8 from 18:00 local time 11:00BST/06:00EDT which could result in a market closure on Thursday, according to Bloomberg.
  • Japanese PM Kishida announced to relax border rules on COVID and will waive tests for vaccinated passenger arrivals from September 7th, but added there was no decision yet on raising the number of daily arrivals, according to Reuters.

Cautious price action in European hours with fresh drivers limited and the docket sparse ahead of Jackson Hole commencing on Thursday (Powell Friday), Euro Stoxx 50 -0.1% Stateside, futures are in-fitting both directionally and in terms of magnitude, ES -0.1%. In Europe, the FTSE 100 is the marginal laggard with metals (ex-aluminium) under broad pressure as the USD gains momentum.

Top European News

  • Scottish Power CEO proposed to UK Business Secretary Kwarteng capping household energy bills at around GBP 2000/year which would need funding of over GBP 100bln over two years, according to FT citing sources.
  • ECB's Rehn says the investigation phase for the digital EUR is expected to conclude in October 2023, will then determine whether to embark on actually building a digital EUR.
  • Ukraine Latest: US to Mark Kyiv’s Independence With New Arms
  • BNP Hires Zink Secher as Head of ESG Ratings Advisory for EMEA
  • Cineworld Short Seller Argonaut Says Shareholders to Get Nothing
  • Euro Traders Bet on Move Below $0.98 as Bold Wagers Also in Play

FX

  • DXY attempted to claw back some of Tuesday’s losses overnight but lost momentum at a current session peak of 108.81.
  • EUR is subdued as the bearish bias persists, GBP/USD is under similar mild pressure around (and marginally below) 1.1800.
  • Non US-dollars are all softer against the USD whilst havens JPY and CHF outperform.

Fixed Income

  • Initial pronounced EGB pressure briefly abated and brought benchmarks into positive territory; though, this failed to cement itself.
  • Gilts are leading the downside though are circa. 20 ticks off worst levels, complex cognisant of the upcoming Ofgem announcement and inflation/rate implications.
  • USTs are bucking the trend once more and are incrementally positive with 5yr issuance due and the curve incrementally steeper.

Commodities

  • WTI and Brent October futures have been grinding higher since the European entrance following an APAC session of consolidation.
  • Spot gold has been drifting higher after mounting the USD 1,750/oz mark.
  • Base metals are mixed with 3M LME copper lower but still north of USD 8,000/t, whilst aluminium outperforms.
  • US Private Inventory report (bbls): Crude -5.6mln (exp. -0.9mln), Cushing +0.7mln, Gasoline +0.3mln (exp. -1.5mln), Distillates +1.1mln (exp. +0.6mln).
  • Canada and Germany signed a hydrogen alliance deal to accelerate exports of Canadian hydrogen to Germany by 2025, according to Reuters.
  • Russia's Sakhalin has scrapped a gas shipment to a buyer due to a payment issue, via Bloomberg.
  • Major oil traders and some producers have ceased direct sales of crude to India's Nayara energy amid concerns regarding Russian sanctions, according to Reuters sources.
  • American Automobile Association says that US diesel pump prices have climbed for the first time since mid-June.
  • Indonesia extends the palm oil export levy waiver until October 31st, according to the Trade Minister.

US Event Calendar

  • 07:00: Aug. MBA Mortgage Applications, prior -2.3%
  • 08:30: July Durable Goods Orders, est. 0.8%, prior 2.0%; Durables-Less Transportation, est. 0.2%, prior 0.4%
    • July Cap Goods Orders Nondef Ex Air, est. 0.3%, prior 0.7%
    • July Cap Goods Ship Nondef Ex Air, est. 0.5%, prior 0.7%
  • 10:00: July Pending Home Sales (MoM), est. -2.6%, prior -8.6%; YoY, est. -21.4%, prior -19.8%

DB's Tim Wessel concludes the overnight wrap

Despite the best efforts of data releases, US rates markets just do not want to fundamentally re-price the outlook until Chair Powell’s remarks this Friday at Jackson Hole (and, to an extent, the next round of employment and inflation data before the September FOMC). Our US economists have published a preview for his remarks (link here), with the one-line takeaway being they are looking for the Chair to fill in reaction function details. These being my last hours on the clock before the Chair’s remarks (as we here at EMR HQ navigate the summer holiday minefield that my inbox stuffed with automatic out-of-office replies suggest is ubiquitous across the financial sector) I can’t help but leave you, dear reader, with my final thoughts. The retracement of every rally following downside data surprises, along with the build up in short policy futures positions, suggests that the market is looking for a very hawkish tone from the Chair. That a priori expectations are for such hawkish messaging, the bar to clear for rates to selloff further is that much higher. It does not seem like the Chair can deliver the sort of shock necessary to drive a material re-pricing of policy, especially with inflation and employment data still due before the September FOMC, but time will tell. The case that a hawkish shock is to come is that the Chair most frequently has to speak publicly on behalf of the Committee, and this is his opportunity to slant his remarks towards his own personal bias. The Chair may well personally weigh the balance of risks toward worse inflation outcomes, but let’s see if his lean is strong enough to satiate the market’s appetite.

The latest example of rates markets retracing back to their starting point came yesterday, when PMIs, the Richmond Fed Manufacturing Index, and New Home Sales all missed to the downside in quick succession. In particular, the Services PMI (44.1 v 49.8 expected) fell to its lowest on record outside of the pandemic, with the survey showing weakness across new sales, new orders, and employment elements, along with abating price pressures. Nevertheless, respondents were optimistic about the path ahead, not making it any easier for market participants to disentangle signal from noise. Rounding out the other morning data, Manufacturing PMI fared better than Services, printing at 51.3 vs. 51.8 expected, still leaving the Composite at 45.0, its worst reading since February 2021. The Richmond Fed Manufacturing index was -8 vs. -2 expectations, while there were 511k new home sales in July vs. 575k expectations, another print on the downbeat for US housing markets.

Following the lackluster data, 2yr Treasury yields fell -11.8bps peak-to-trough, only, as intimated, to stage a retracement to end the day a mere -1.0bp lower. Similarly, 10yr Treasury yields were -9.3bps lower, peak-to-trough, but retraced with more vigor, nearly returning to intraday highs, ultimately closing +3.2bps higher at 3.05%. The S&P 500 followed a similar cadence, staging an initial bad-news-is-good-news rally following the data, increasing +0.53%, reverting to a narrow range just in the red the rest of the day, finishing down -0.22%. The NASDAQ danced to the same tune, but was even more reluctant to re-evaluate the outlook, closing perfectly flat, day-over-day. Futures are currently lower as we go to press, with the S&P 500 (-0.37%), NASDAQ 100 (-0.46%) and DAX (-0.65%) all in the red.

Most European assets were similarly subdued, with 10yr bunds (+1.2bps), OATs (+2.0bps), and BTPs (+1.8bps) trading near the prior day’s levels. The bund curve also twist steepened, with 2yr yields falling -3.8bps. Risk fared a touch worse; the STOXX 600 fell -0.42% and the DAX was -0.27% lower. Eurozone PMIs were a bit stronger than US counterparts, across Manufacturing (49.7 vs. 49.0), Services (50.2 vs. 50.5), and the Composite (49.2 vs. 49.0). Meanwhile, consumer confidence bounced back from record lows set in July, printing at -24.9 (vs. -28.0). Sentiment in Europe was boosted by a slight retrenchment in energy prices; German power fell -1.92%, the first daily decline in more than two weeks, while natural gas futures were -2.78% lower. The euro was able to temporarily break through parity versus the US dollar after the weak US data, but finished the day below the mark at $0.997.

Gilt yields increased more than other core sovereign bonds, with 2yr yields +9.8bps higher and 10yr benchmarks +6.1bps higher. UK Manufacturing PMI registered a poor 46.0 (vs. 51.0), though Services (52.5 vs. 51.6) and the Composite (50.9 vs. 51.0) fared better. However, the fear that UK inflation will continue to present a large problem is forcing gilts to underperform. On top of that, the threat of looming labour strife only intensifies the risks ahead. The FTSE 100 underperformed, falling -0.61%.

Following headlines from the Saudi energy minister yesterday, Brent crude oil rallied +3.39% closing above $100/bbl for the first time since late July. While progress on the Iranian nuclear deal still seemed positive, up to nine OPEC+ members confirmed they would support production cuts if Iranian supply came back online or if the global economy entered a recession, fueling the rally.

Overnight, Asian equity markets are again slipping into the red this morning amid growth fears. The Hang Seng (-1.49%) is leading losses with the Shanghai Composite (-1.38%), the CSI (-0.63%) and the Nikkei (-0.40%) all trading in negative territory. Elsewhere, the Kospi (+0.02%) is oscillating between gains and losses after opening higher.

Moving on to FX news, the Chinese Yuan (-0.42%) fell to its weakest level in almost two years against the US dollar, trading at 6.86 per dollar, as the PBOC looks to ease policy to support the economy while property sector troubles remain top of mind.

Minneapolis Fed President Kashkari in an overnight speech reiterated the need for more aggressive rate hikes to control inflation and sees another two full percentage points by the end of next year. Kashkari downplayed the two-sided risk of Fed tightening that has permeated recent discourse, noting that if inflation were at 4%, he would be willing to consider a more gradual path to avoid the risk of overdoing tightening. Alas, it is not.

To the day ahead now, and data releases from the US include the preliminary durable goods orders and core capital goods orders for July, along with pending home sales for that month too. Otherwise, earnings releases include Nvidia, Salesforce and Royal Bank of Canada.

Tyler Durden Wed, 08/24/2022 - 07:33

Read More

Continue Reading

Government

FDA’s drug shortages leader wants companies to start reporting increases in demand

It is no secret that drug shortages have been prevalent in 2022. Several major drug products, such as amoxicillin and Adderall, have been in short supply…

Published

on

It is no secret that drug shortages have been prevalent in 2022. Several major drug products, such as amoxicillin and Adderall, have been in short supply for several months and have led to members of Congress applying pressure on the FDA and HHS to resolve the situation.

Valerie Jensen

Speaking at a webinar hosted by the Alliance for a Stronger FDA, Valerie Jensen, the associate director of the FDA’s Drug Shortage Staff, noted both the rise in quality-related issues and increased demand for some products. She called on companies to report such demand increases, even though they are not currently required to do so.

During the Covid-19 pandemic, she said, the agency has seen new challenges mainly related to these increases in demand.

“During the pandemic as well, we had competition on manufacturing lines and that’s still occurring due to vaccine production and other Covid products,” Jensen said. “So, the same products are being made on those lines that are making the vaccines and Covid-related products, and then that creates a competition situation.”

Jensen added that an increase in demand for manufacturing commodities due to large-scale vaccine production is also leading to shortages. Items such as glass, filters and vial hoppers are in short supply. And now the increased demand is centered around the increase in drugs to counter respiratory illnesses.

She said the physical number of drug shortages currently sits at 123, which is “a little above normal,” but there have been around 100 shortages at any given time over the past seven years. Some of those can be chalked up to companies not producing the volumes required to meet market demand. She also added that there were 38 new shortages in 2021, but the FDA is still dealing with them this year.

For some temporary solutions, Jensen said that she has been coordinating with international regulatory authorities more often, to find out what is being marketed and to see if they can import a drug in short supply in the US. She is also coordinating experts to try to mitigate the situation, providing the public with widely available information as well as expediting the review of anything that manufacturers need to boost supplies.

However, Jensen said that the increase in the demand for drugs is not something that will be going away anytime soon.

“One thing that we really see going forward are these demand increases, this is something that is fairly new to us. It’s something that we’re looking at closely,” she said. “We would really want companies to inform us if they’re seeing spikes in demand because that’s currently not required.”

While producers do need to let the FDA know of supply disruption, companies do not need to let the FDA know of spikes in demand, and Jensen would like to see this changed. Also, she would like to apply different uses for supply chain data to look for signals or patterns and ultimately predict shortages.

Jensen added that in some cases it is impossible to prevent a shortage, but she stresses that better notification of when companies are seeing a spike in demand can be a key solution:

In those cases, when we can prevent (a shortage), we are using those same tools to prevent it. So, we’re expediting review, we’re looking at potential ways that we can use flexibility to allow a product to be on the market while the company fixes a problem. All of those tools are really the same for prevention and mitigation. But I think that really the key is early notification. The earlier companies let us know about an issue the earlier we can deal with it.

With the uptick in respiratory illnesses and shortages of drugs such as amoxicillin, Jensen noted that it’s a matter of reaching out and monitoring the market to see what manufacturers are contending with. Also, Jensen will look to work with pharmacy associations and other trade groups to see what is occurring at the pharmacy level and then “put all of those pieces together” to try and help end the shortage.

Read More

Continue Reading

Uncategorized

nTIDE November 2022 Jobs Report: People with disabilities continue to outperform people without disabilities in labor market

East Hanover, NJ – December 2, 2022 – Job numbers rose again for people with disabilities, in contrast to people without disabilities, according to…

Published

on

East Hanover, NJ – December 2, 2022 – Job numbers rose again for people with disabilities, in contrast to people without disabilities, according to today’s National Trends in Disability Employment – Monthly Update (nTIDE), issued by Kessler Foundation and the University of New Hampshire’s Institute on Disability (UNH-IOD). People with disabilities continued to show strength in the labor market in November, as evidenced by the substantial rise in their employment-to-population ratio.

Credit: Kessler Foundation

East Hanover, NJ – December 2, 2022 – Job numbers rose again for people with disabilities, in contrast to people without disabilities, according to today’s National Trends in Disability Employment – Monthly Update (nTIDE), issued by Kessler Foundation and the University of New Hampshire’s Institute on Disability (UNH-IOD). People with disabilities continued to show strength in the labor market in November, as evidenced by the substantial rise in their employment-to-population ratio.

Month-to-Month nTIDE Numbers (comparing October 2022 to November 2022)

Based on data from the U.S. Bureau of Labor Statistics (BLS) Jobs Report released today, the employment-to-population ratio for people with disabilities (ages 16-64) increased from 35.5 percent in October to 36.5 percent in November (up 2.8 percent or 1 percentage point). For people without disabilities (ages 16-64), the employment-to-population ratio decreased from 74.6 percent in October to 74.4 percent in November (down 0.3 percent or 0.2 percentage point). The employment-to-population ratio, a key indicator, reflects the percentage of people who are working relative to the total population (the number of people working divided by the number of people in the total population multiplied by 100).

“Similar to last month, the employment-to-population ratio for people with disabilities increased and remains above historic highs. For those without disabilities, however, the ratio dropped,” said John O’Neill, PhD, director of the Center for Employment and Disability Research at Kessler Foundation. “This decline may be a sign of the Fed’s efforts to slow the labor market. This is interesting in light of this month’s strong gain for people with disabilities.”

Findings were similar for November’s labor force participation rate. For people with disabilities (ages 16-64), the labor force participation rate was increased slightly from 38.7 percent in October to 38.8 percent in November (up 0.3 percent or 0.1 percentage point). Conversely, the labor force participation rate decreased slightly for people without disabilities (ages 16-64), from 77.1 percent in October to 76.9 percent in November (down 0.3 percent or 0.2 percentage point). The labor force participation rate is the percentage of the population that is working, not working, and on temporary layoff, or not working and actively looking for work.

“While labor force participation for people with disabilities remains stable, increases in the employment to population ratio for people with disabilities suggest that more people with disabilities are succeeding in finding jobs,” remarked Debra Brucker, PhD, research associate professor at the UNH-IOD. “Keep in mind that gains in employment may in part reflect the need to boost income in the face of rising prices. Also, these data are not seasonally adjusted, so some of this increase may be due to seasonal employment.”

Why have people with disabilities been outperforming people without disabilities? Favorable changes in the workplace as employers adapted to COVID-19 restrictions may be a factor. Our new survey compares the workplaces of 2017 and 2022, revealing gains in recruiting, hiring, accommodating, and retaining employees with disabilities. Read more about the 2022 National Employment & Disability Survey: Effects of COVID-19 Pandemic Supervisor Perspectives.

Year-to-Year nTIDE Numbers (Comparing November 2021 to November 2022)

Reflecting the continued strength of the employment of people with disabilities over the course of the year, the employment-to-population ratio for working-age people with disabilities increased substantially from 34.6 percent in November 2021 to 36.5 percent in November 2022 (up 5.5 percent or 1.9 percentage points). However, the employment-to-population ratio increased slightly for working-age people without disabilities, from 73.8 percent in November 2021 to 74.4 percent in November 2022 (up 0.8 percent or 0.6 percentage points).

Similarly, for people with disabilities (16-64), the labor force participation rate increased substantially from 37.7 percent in November 2021 to 38.8 percent in November 2022 (up 2.9 percent or 1.1 percentage points). The labor force participation rate increased slightly for people without disabilities (ages 16-64), from 76.7 percent in November 2021 to 76.9 percent in November 2022 (up 0.3 percent or 0.2 percentage points).

In November, among workers ages 16-64, the 5,962,000 workers with disabilities represented 4 percent of the total 148,009,000 workers in the U.S.

Ask Questions about Disability and Employment

Each nTIDE release is followed by an nTIDE Lunch & Learn online webinar. This live broadcast, hosted via Zoom Webinar, offers attendees Q&A on the latest nTIDE findings, provides news and updates from the field, as well as invited panelists to discuss current disability-related findings and events. On December 2, 2022 at 12:00 pm Eastern, Chai Feldblum, JD, vice chair the of Ability One Commission, a federal agency devoted to the employment of people with significant disabilities, joins Drs. O’Neill and Brucker, and Denise Rozell, Policy Strategist at the Association of University Centers on Disabilities (AUCD). Join our Lunch & Learns live or visit the nTIDE archives at: ResearchonDisability.org/nTIDE.

NOTE: The statistics in the nTIDE are based on Bureau of Labor Statistics numbers but are not identical. They are customized by UNH to combine the statistics for men and women of working age (16 to 64). nTIDE is funded, in part, by grants from the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) (90RT5037) and Kessler Foundation.

About the Institute on Disability at the University of New Hampshire

The Institute on Disability (IOD) at the University of New Hampshire (UNH) was established in 1987 to provide a university-based focus for the improvement of knowledge, policies, and practices related to the lives of persons with disabilities and their families. For information on the NIDILRR-funded Research and Training Center on Disability Statistics, visit ResearchOnDisability.org.

About Kessler Foundation

Kessler Foundation, a major nonprofit organization in the field of disability, is a global leader in rehabilitation research that seeks to improve cognition, mobility, and long-term outcomes – including employment – for people with neurological disabilities caused by diseases and injuries of the brain and spinal cord. Kessler Foundation leads the nation in funding innovative programs that expand opportunities for employment for people with disabilities. For more information, visit KesslerFoundation.org.

Stay Connected with Kessler Foundation

Twitter | Facebook | YouTube | Instagram | iTunes & SoundCloud

To interview an expert, contact:

Deborah Hauss, DHauss@kesslerfoundation.org;

Carolann Murphy, CMurphy@KesslerFoundation.org.

 

 


Read More

Continue Reading

Spread & Containment

Scientists reveal encouraging findings in first-in-human clinical trial evaluating HIV vaccine approach

NEW YORK and LA JOLLA, CA—While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy being…

Published

on

NEW YORK and LA JOLLA, CA—While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy being pursued by researchers at Scripps Research, IAVI, Fred Hutchinson Cancer Center (Fred Hutch) and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) shows new promise, according to data from a first-in-human clinical trial.

Credit: CHRISTOPHER COTTRELL, CREATED WITH BIORENDER.COM

NEW YORK and LA JOLLA, CA—While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy being pursued by researchers at Scripps Research, IAVI, Fred Hutchinson Cancer Center (Fred Hutch) and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) shows new promise, according to data from a first-in-human clinical trial.

In a paper published in Science on December 2, 2022, the scientists reveal critical new insights into their novel vaccine strategy, which involves a stepwise approach to producing antibodies capable of targeting a wide range of HIV variants. 

“The data we are publishing in Science demonstrates for the first time that one can design a vaccine that elicits made-to-order antibodies in humans. We specified in advance certain molecular properties of the antibodies that we wanted to elicit, and the results of this trial show that our vaccine antigen consistently induced precisely those types of antibodies,” says co-senior author William Schief, PhD, a professor and immunologist at Scripps Research and executive director of vaccine design at IAVI’s Neutralizing Antibody Center, whose laboratory developed the vaccine antigen. “We believe this vaccine design strategy will be essential to make an HIV vaccine and may help the field create vaccines for other difficult pathogens.”

The Phase 1 trial, known as IAVI G001, tested the first stage in a multi-stage HIV vaccine regimen the researchers are developing. The trial results show that the vaccine had a favorable safety profile and induced the targeted response in 97% of people who were vaccinated. Importantly, the Science study also provides a detailed immunological analysis of the vaccine responses.

“HIV represents an area of dire unmet need across the world, which is what makes the findings from our Phase 1 clinical trial so encouraging,” says Mark Feinberg, MD, PhD, president and CEO of IAVI. “Through the close-knit collaboration of many different scientists, disciplines and institutions, we are that much closer to designing an effective vaccine that could help end the HIV pandemic.”  

Priming the Immune System

Broadly neutralizing antibodies (bnAbs) are a rare type of antibody that can fight and protect against many different variants of a virus—including HIV. This is why scientists have tried to develop an HIV vaccine that induces bnAbs, but thus far without success.   

The researchers in the study are using a strategy known as ‘germline targeting’ to eventually produce bnAbs that can protect against HIV. The first step of germline targeting involves stimulating the rare immune cells—known as bnAb-precursor B cells—that can eventually evolve into the cells that produce the bnAbs needed to block the virus. To accomplish this first step, the researchers designed a customized molecule—known as an immunogen—that would “prime” the immune system and elicit responses from these rare bnAb-precursor cells.

The overarching goal of the IAVI G001 trial was to determine if the vaccine had an acceptable safety profile and could induce responses from these bnAb-precursor B cells.

“Through extensive safety and tolerability monitoring during the trial, we showed the vaccine had a favorable safety profile, while still inducing the necessary target cells,” says study author Dagna Laufer, MD, vice president and head of clinical development at IAVI. “This represents a large step forward in developing an HIV vaccine that is both safe and effective.”

To determine if the targeted bnAb-precursor B cells were induced, the researchers carried out a sophisticated analytical process.

“The workflow of multidimensional immunological analyses has taken clinical trial evaluation to the next level,” says co-senior author Adrian B. McDermott, PhD, former chief of the Vaccine Immunology Program at the NIAID VRC. “In evaluating these important immunological factors, we helped show why the vaccine antigen was able to induce the targeted response in 97% of vaccine recipients.” 

IAVI G001 was sponsored by IAVI and took place at two sites: George Washington University (GWU) in Washington, D.C., and Fred Hutch in Seattle, enrolling 48 healthy adult volunteers. Participants received either a placebo or two doses of the vaccine antigen, eOD-GT8 60mer, along with an adjuvant developed by the pharmaceutical company GSK. Julie McElrath, MD, PhD, co-senior author, senior vice president and director of Fred Hutch’s Vaccine and Infectious Disease Division, and David Diemert, MD, professor of medicine at GWU School of Medicine and Health Sciences, were lead investigators at the trial sites.

A Deeper Immunological Dive

The study also carefully examined the properties of the antibodies and B cells induced by the vaccine antigen, in what Schief likens to “looking under the car hood” to understand how the immune system operated in response to the vaccine. One analysis showed that the vaccine antigen first stimulated an average of 30 to 65 different bnAb precursors per person vaccinated, and then caused those cells to multiply. This helped explain why the vaccine induced the desired response in almost all participants.

Other analyses delved into the specific mutations the bnAb-precursor B cells acquired over time and how tightly they bound to the vaccine antigen. These investigations showed that that after each dose of the vaccine, the bnAb-precursor B cells gained affinity and continued along favorable maturation pathways.

One concern for this type of vaccine approach is the notion of “competitors”—in other words, the B cells induced by the vaccine antigen that are not bnAb precursors. The researchers extensively studied the “competitor” responses, and the results were very encouraging. Although the majority of the B cells triggered by vaccination were, in fact, “competitors”, these undesired B cells could not match the binding strength of the desired bnAb precursors and did not seem to impede maturation of the bnAb-precursor responses.

“These findings were very encouraging, as they indicated that immunogen design principles we used could be applied to many different epitopes, whether for HIV or even other pathogens,” adds Schief.

With these promising data in hand spanning both safety and immune responses, the researchers will continue to iterate and design boosting immunogens that could eventually induce the desired bnAbs and provide protection against the virus. These findings also come shortly after two additional studies in Immunity published in September 2022, which helped validate the germline-targeting approach for vaccinating against HIV.

“Working together with IAVI, Scripps Research, the VRC, GWU, additional investigators at Fred Hutch and many others, this trial and additional analyses will help inform design of the remaining stages of a candidate HIV vaccine regimen—while also enabling others in the field to develop vaccine strategies for additional viruses,” says McElrath of Fred Hutch.

IAVI, Scripps Research, NIAID, the Bill & Melinda Gates Foundation and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID) are partnering with the biotechnology company Moderna to develop and test mRNA delivery of these HIV vaccine antigens. Two Phase I clinical trials are underway that build on IAVI G001, one (IAVI G002) at four sites in the U.S. and another (IAVI G003) at the Center for Family Health Research in Kigali, Rwanda, and The Aurum Institute in Tembisa, South Africa. Both are testing mRNA delivery of the eOD-GT8 60mer that was evaluated as recombinant protein in IAVI G001, and the U.S. trial includes a boost antigen designed by the Schief lab and delivered with Moderna mRNA technology. A third trial (HVTN302), at ten sites in the U.S., is testing mRNA delivery of three different stabilized HIV trimers designed in the Schief laboratory that are candidates for late-stage boosters in multi-stage vaccines aiming to induce bnAbs. Using mRNA technology could significantly accelerate the pace of HIV vaccine development as it allows for faster production of clinical trial material.

This work was supported by the Bill & Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery; the IAVI Neutralizing Antibody Center; NIAID; Scripps Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery and Scripps Consortium for HIV/AIDS Vaccine Development; and the Ragon Institute of MGH, MIT, and Harvard. Other collaborating organizations include Duke Human Vaccine Institute, Karolinska Institutet, and La Jolla Institute. 

Research at the IAVI Neutralizing Antibody Center that contributed to the development of the vaccine antigen eOD-GT8 60mer was also made possible by the government of the Netherlands through the Minister of Foreign Trade & Development Cooperation and through the generous support of the American people through PEPFAR through USAID. The contents are the responsibility of IAVI and Scripps Research and do not necessarily reflect the views of PEPFAR, USAID, or the United States government.

About IAVI

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at iavi.org.

About Scripps Research

Scripps Research is an independent, nonprofit biomedical institute ranked the most influential in the world for its impact on innovation by Nature Index. We are advancing human health through profound discoveries that address pressing medical concerns around the globe. Our drug discovery and development division, Calibr, works hand-in-hand with scientists across disciplines to bring new medicines to patients as quickly and efficiently as possible, while teams at Scripps Research Translational Institute harness genomics, digital medicine and cutting-edge informatics to understand individual health and render more effective healthcare. Scripps Research also trains the next generation of leading scientists at our Skaggs Graduate School, consistently named among the top 10 US programs for chemistry and biological sciences. Learn more at www.scripps.edu.


Read More

Continue Reading

Trending