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As Covid program advances, Enanta’s new CMO says it’s not ‘limited to antivirals’; With all eyes on Gilead-partnered cancer drugs, Arcus brings medical chief on board

Expect some pipeline adjustments at Enanta Pharmaceuticals in the coming years, because new CMO Scott Rottinghaus thinks the antiviral biotech can expand…

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Expect some pipeline adjustments at Enanta Pharmaceuticals in the coming years, because new CMO Scott Rottinghaus thinks the antiviral biotech can expand its horizons while also figuring out a way to address the yearslong Covid pandemic with an expected Phase II launch later this year.

“I would like to take a look at what we have as possibilities coming out of the lab. We have such a strong discovery program,” Rottinghaus told Endpoints News. “I don’t think we need to be limited to antivirals here at Enanta; we can take a broader look at some other therapeutic areas.”

Scott Rottinghaus

For now, though, the former hematology and nephrology clinical development leader at Alexion, which last year was swooped up by AstraZeneca, is returning to his roots in the infectious disease field.

In undergrad at Kansas State, polyomavirus structural proteins consumed Rottinghaus’ attention. Then it was vaccine work on measles and influenza during medical school and residency at Mayo Clinic. A stint working on HSV came next, as an infectious disease fellow at the University of Alabama at Birmingham in the mid-aughts. Antimicrobials and vaccines took center stage during an eight-year post at Pfizer, including a clinical lead role on bacterial infection med Tygacil.

“Big Pharma in the past decade has lost some interest in anti-infectives, which is what caused me to kind of move away as opportunities knocked. When I heard about the opportunity at Enanta, it was actually a fairly easy choice for me,” the CMO said.

In his telling, Rottinghaus is “very excited” or “really excited” about the work ahead, making it clear four times in the first minute of an interview on day three in the new C-suite post.

Covid-19 and respiratory syncytial virus are “right at the top of the list,” he said. Following Phase I data on its once-daily oral drug late last month, Enanta will meet with the FDA “in the very near future” to agree on a Phase II program for EDP-235, a 3CL protease inhibitor. That trial is slated to be global in scope to “move it forward as quickly as possible,” the new CMO said. Enanta is also in the midst of suing Rottinghaus’ former employer, Pfizer, over the Big Pharma’s Covid drug, Paxlovid.

Beyond Covid, Rottinghaus will dig into a Phase IIb testing EDP-938 in adults at high risk for getting infected with RSV. In May, the drug flunked a mid-stage test in otherwise healthy adults with community-acquired RSV.

Kyle LaHucik


Dimitry Nuyten

→ Things look a little hazier for Arcus Biosciences and Gilead’s CD73 candidate quemliclustat after analysts voice their disppointment with the latest update on a drug that “exceeded expectations” at AACR in early 2021. Dimitry Nuyten has now taken command of Arcus’ clinical development as CMO and presides over a pipeline that, alongside quemliclustat, includes a clutch of cancer drugs like domvanalimab and etrumadenant at the heart of the $725 million deal with Gilead. The ex-medical chief at Nektar and Aduro Biotech, Nuyten has also been VP of global product development for oncology at Pfizer and a group medical director for Bristol Myers Squibb.

Mathai Mammen

→ The big names in J&J’s leadership structure are gradually peeling away as head of R&D Mathai Mammen packs his bags to “pursue other opportunities outside of the Company,” according to a statement that provided few details beyond his interim successor, chief innovation officer William Hait. Mammen’s sudden departure late Monday follows that of ex-CSO Paul Stoffels, who’s now reshuffling the deck at Galapagos as CEO, and it comes nearly a year after J&J first announced that Joaquin Duato would replace Alex Gorsky as CEO.

Winselow Tucker

Eli Lilly’s Stephen Fry will retire at the end of the year as Loxo commercial chief Eric Dozier is set to replace him as SVP, human resources and diversity. Fry started as a systems analyst at the Indianapolis pharma in 1987 and has held his current role since 2011, while Dozier is also a longtime Lilly vet who’s held such roles as general manager, Puerto Rico and chief marketing officer for Japan. At the end of this month, Winselow Tucker will leave Bristol Myers and succeed Dozier as Loxo’s chief commercial officer. Tucker joined BMS from Novartis in 2019 as SVP and general manager, US hematology and was elevated to SVP, intercontinental in January.

Simba Gill

Simba Gill will only be CEO of Evelo Biosciences a little while longer, becoming chairman of Evelo’s board and heading back to Flagship Pioneering “to help launch, grow, and guide bioplatform companies” as an executive partner. Both appointments will take effect when a successor is named. As founding chief executive, Gill shepherded Evelo to an IPO in 2018 and into Phase II trials with its lead program in psoriasis and atopic dermatitis. With the bear market hitting the sector hard, Evelo cushioned the blow with a $79.2 million direct offering in late May.

Howard Davis

→ Bristol Myers partner PsiOxus Therapeutics, an Oxford, UK-based cancer biotech once backed by Neil Woodford, has lined up Howard Davis as CEO. Davis jumps to the top spot here after helping launch Third Harmonic Bio as COO; the Novartis and Biogen alum has also been a principal at Flagship. Priya Mande, the interim chief for the last year, will become PsiOxus’ COO and UK president.

Chris Frankenfield

Xilio Therapeutics propped open a window into some early data with XTX101 for solid tumors, and in the same release, the biotech shared the promotions of Uli Bialucha to CSO and Chris Frankenfield to chief legal and administrative officer. Both execs arrived last year, with Bialucha originally joining Xilio from Immunitas Therapeutics as SVP of research and Frankenfield coming from Blueprint Medicines to take on the role of general counsel.

Timothy Hunt

Timothy Hunt will take over as CEO of The Alliance for Regenerative Medicine on Sept. 6, replacing Janet Lynch Lambert. Once part of ARM’s Gene Editing Task Force, Hunt had just taken on the role of chief culture and corporate affairs officer at Xilio in October 2021. He was also chief corporate affairs officer at Editas Medicine from 2016-20 and a public affairs exec with Biogen.

Mike Nohaile

→ Concurrent with its $35 million Series C haul, San Francisco’s Prellis Biologics has welcomed Mike Nohaile as CEO. Nohaile leaves his CSO post at Flagship’s Generate Biomedicines and his Big Pharma background consists of multiple roles over a 14-year period at Novartis (including four years as global head of molecular diagnostics) and Amgen (rounding out his tenure as SVP of strategy, commercialization, and innovation). Prellis teamed up with Bristol Myers and Sanofi in separate antibody deals earlier this year.

→ Grounded by the FDA with a clinical hold on its CAR-T drug BEAM-201 for relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoma, Beam Therapeutics has installed John Lo as chief commercial officer. Big Pharma connections abound with Lo, who led the hematology franchise during his eight years at Novartis; worked on such drugs as Tagrisso and Imfinzi at AstraZeneca and was the pharma giant’s head of global marketing and market access; and became SVP of worldwide hematology for Bristol Myers in 2019 after the Celgene buyout.

Jason Damiano

The Appian Way: Los Angeles-based Appia Biodeveloping off-the-shelf CAR therapies with invariant natural killer T cells (iNKT) and teaming up with Kite in a deal worth up to $875 million — has rolled out the welcome mat for Jason Damiano as CSO. Damiano wraps up a three-year run at Unity Biotechnology as VP of biology, and from 2016-18 he was director of therapeutic antibody discovery and translational medicine at Achaogen. Ex-Kite and Lyell CSO Margo Roberts has sewn up a spot on the board of directors at Appia Bio, a company chaired by Nobel laureate David Baltimore and led by former Tenaya president JJ Kang.

Douglas Warner

→ Looking to regroup with its tomivosertib/Keytruda combo in NSCLC while swiftly sliding $EFTR into a penny stock morass, eFFECTOR Therapeutics has tapped Douglas Warner as CMO. Warner breaks away from Amgen after an 18-year run that ended as executive medical director, group product area lead. Along with tomivosertib, he takes charge of eFFECTOR’s early-stage studies of zotatifin in solid tumors and Covid-19.

Kenneth Truitt

Kenneth Truitt has signed on as CMO of Aquestive Therapeutics, which changed CEOs three months ago as it tries to get in the good graces of the FDA with the seizure drug Libervant and its epinephrine oral film AQST-109. Truitt, whose first day at Aquestive is Sept. 6, spent 16 years at Daiichi Sankyo before his appointments as medical chief of ImmusanT in 2018 and Venthera a year later. Meanwhile, Humanigen COO and CFO Tim Morris has joined Aquestive’s board of directors.

Caroline Germa

→ Big Pharma vet Caroline Germa has been named EVP, global medicine development and CMO at Chinese antibody biotech Transcenta. Germa’s CV reads like a who’s who of the industry: After six years at Eli Lilly, she was clinical lead for breast cancer med neratinib (Nerlynx) during her four years at Pfizer. She then jumped to Novartis in 2011, where she rose to senior global program clinical head for ribociclib (Kisqali) and canakinumab. She then left for Bristol Myers in 2018, staying there for a year before joining AstraZeneca as VP and head of the early development clinical group for oncology.

PJ Ramtin

PJ Ramtin has settled in as SVP of business operations at Spruce Biosciences, which is developing tildacerfont for endocrine disorders such as classic congenital adrenal hyperplasia. Ramtin joined Spruce in June after three years with BridgeBio as VP, commercial operations and VP, business operations. Earlier, she was oncology business director at Regeneron and had two separate stints at Genentech.

Vikram Lamba

→ California CAR-T player ImmPACT Bio has had itself a year with $111 million in Series B funding, the addition of board chair Sheila Gujrathi and a growing C-suite that now includes ex-Zosano Pharma chief Vikram Lamba as CFO and head of business development. The Bayer vet had been CFO of diagnostics company ChromaCode since April 2021. ImmPACT Bio has also appointed a chief technology officer (Sylvain Roy) and COO (Venkat Yepuri) in the last few months.

Joy Zhou

→ Tucked into its Q2 report, natural killer biotech MiNK Therapeutics mentioned that Joy Zhou has been appointed head of CMC. Zhou is the former head of drug product development, cell therapy at Takeda who recently led MS&T (manufacturing sciences & technology) at Rubius Therapeutics; early in her career, she was a scientist at Pfizer and J&J. Just before the bottom fell out of the sector, MiNK went public in October 2021 with a $40 million IPO.

Nicholas Pachuda

Peter Thiel-backed peptide drug design biotech Peptilogics has enlisted Atul Deshpande as chief strategy officer and promoted Nicholas Pachuda to COO. Deshpande joins the Pittsburgh-based company from Immediate Therapeutics, where he served at the helm of the company as CEO. Prior to that stint, Deshpande was chief strategy officer and head of US operations for Harbour BioMed and global operations head for the Dupixent franchise at Sanofi.

Pachuda joined Peptilogics in 2020, starting as SVP of portfolio and development. Pachuda hopped aboard Peptilogics after a gig at J&J, leading external innovation for the company’s orthopedic device franchise.

Sabine Sydow

→ German CDMO Rentschler Biopharma, which was slapped with a Form 483 for multiple production issues in June, has brought aboard Sabine Sydow as chief of staff and Falk Nuernberger as corporate general counsel. Sydow formerly had a 16-year run with vfa bio, having served as head. Meanwhile, Nuernberger served as general counsel Europe of Viatris and has had stints at MediGene, Sandoz and Actavis.

→ Early cancer screening and detection-focused biotech AnPac Bio-Medical Science has ushered in Yuyang Cui as co-chairman of the board and co-CEO of the company and Jiawen Kang as a member of its board of directors. Cui and Kang’s appointments come as AnPac has re-shuffled some of its board and exec team. AnPac relieved Aidong Chen from his duties as co-chairman and co-CEO and removed Sheng Liu from its board. In addition, the company has re-designated Chris Chang Yu as CEO and chairman of the board.

Joseph Damasio

→ Bioengineering company Biostage has pulled in Joseph Damasio as CFO. Damasio formerly served as CGO, VP finance and controller at Inhibikase Therapeutics, Cue Biopharma and Pressure Biosciences.

→ With the smallpox antiviral Tembexa (brincidofovir) awaiting a contract signature from BARDA and talks of potential use in the monkeypox outbreak — after the compassionate-use hubbub in 2014 that involved young Josh Hardy receiving the drug — Chimerix has pegged Christopher Jordan as VP, regulatory affairs. Jordan, an Eli Lilly alum, held the role of senior global program regulatory director at Novartis after a string of regulatory posts at Endocyte from 2013-19.

→ Houston-based TCR-T outfit Alaunos Therapeutics, once known as Boston-based Ziopharm Oncology, is bringing in Abhishek Srivastava as VP, technical operations. A former assistant professor at the University of Pittsburgh School of Medicine, Srivastava comes to Alaunos from Athenex, where he was VP, cell therapy development.

Mary McNamara-Cullinane

ClearPoint Neuro has recruited Mary McNamara-Cullinane as VP of regulatory affairs. McNamara-Cullinane joins from Alira Health, where she was SVP of regulatory affairs. Prior to that, McNamara-Cullinane was principal of MMC regulatory consulting at Intrinsic Therapeutics and Echo Therapeutics.

KemPharm, which forked over $12.8 million in cash for Orphazyme and its “pipeline-in-a-product” in May, has selected Nichol Ochsner as VP, investor relations and corporate communications. Ochsner was previously an investor relations and communications exec with Statera Biopharma and TherapeuticsMD.

John Maraganore

→ Just when you think the Maraganore Meter is taking a breather at Peer Review, here he comes again: Former Alnylam CEO John Maraganore is making his way to the board of directors at ProKidney with Nuvation Bio CFO Jennifer Fox. The list of board appointments and advisory roles for Maraganore is as long as your arm, from chairing the board at Hemab Therapeutics to helping out Overland Pharmaceuticals as a strategic advisor — and beyond.

→ Former HHS Secretary Alex Azar has popped up over at 3D Systems as part of the company’s medical advisory board. Azar brings with him a wealth of experience including his time as president of the US division of Eli Lilly and as a board member of BIO. Leading up to his role as HHS secretary under former president Donald Trump, Azar formerly served as general counsel of HHS starting in 2001.

Thomas Soloway

Natalie Holles-led Third Harmonic Bio is shoring up its board of directors by appointing Thomas Soloway. The current T-knife CEO was Holles’ COO at Audentes and he’s also on the board at Satsuma Pharmaceuticals.

→ Liver disease biotech Albireo has elected Habib Dable and Susan Alesina to the board of directors. Dable was president and CEO of Acceleron after a 22-year career with Bayer, while Alesina is a MilliporeSigma and Sunovion vet who is VP, national business development and alliances at Boston Children’s Hospital.

MindMed, the company focused on brain health disorders, has signed on Suzanne Bruhn and Roger Crystal to its board of directors. Bruhn is president, CEO and director of Tiaki Therapeutics while Crystal is the president, CEO and director of Opiant Pharmaceuticals and the lead inventor of the Narcan nasal spray.

→ Carlsbad, CA-based Curate Biosciences has tapped Daniel Getts as a new member of its board of directors. Getts is the co-founder and CEO of Myeloid Therapeutics and has previously had gigs as VP of research at TCR2 Therapeutics and co-founder and CSO of Cour Pharmaceuticals.

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Coronavirus dashboard for October 5: an autumn lull as COVID-19 evolves towards seasonal endemicity

  – by New Deal democratBack in August I highlighted some epidemiological work by Trevor Bedford about what endemic COVID is likely to look like, based…

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 - by New Deal democrat

Back in August I highlighted some epidemiological work by Trevor Bedford about what endemic COVID is likely to look like, based on the rate of mutations and the period of time that previous infection makes a recovered person resistant to re-infection. Here’s his graph:




He indicated that it “illustrate[s] a scenario where we end up in a regime of year-round variant-driven circulation with more circulation in the winter than summer, but not flu-like winter seasons and summer troughs.”

In other words, we could expect higher caseloads during regular seasonal waves, but unlike influenza, the virus would never entirely recede into the background during the “off” seasons.

That is what we are seeing so far this autumn.

Confirmed cases have continued to decline, presently just under 45,000/day, a little under 1/3rd of their recent summer peak in mid-June. Deaths have been hovering between 400 and 450/day, about in the middle of their 350-550 range since the beginning of this past spring:



The longer-term graph of each since the beginning of the pandemic shows that, at their present level cases are at their lowest point since summer 2020, with the exception of a brief period during September 2020, the May-July lull in 2021, and the springtime lull this year. Deaths since spring remain lower than at any point except the May-July lull of 2021:



Because so many cases are asymptomatic, or people confirm their cases via home testing but do not get confirmation by “official” tests, we know that the confirmed cases indicated above are lower than the “real” number. For that, here is the long-term look from Biobot, which measures COVID concentrations in wastewater:



The likelihood is that there are about 200,000 “actual” new cases each day at present. But even so, this level is below any time since Delta first hit in summer 2021, with the exception of last autumn and this spring’s lulls.

Hospitalizations show a similar pattern. They are currently down 50% since their summer peak, at about 25,000/day:



This is also below any point in the pandemic except for briefly during September 2020, the May-July 2021 low, and this past spring’s lull.

The CDC’s most recent update of variants shows that BA.5 is still dominant, causing about 81% of cases, while more recent offshoots of BA.2, BA.4, and BA.5 are causing the rest. BA’s share is down from 89% in late August:



But this does not mean that the other variants are surging, because cases have declined from roughly 90,000 to 45,000 during that time. Here’s how the math works out:

89% of 90k=80k (remaining variants cause 10k cases)
81% of 45k=36k (remaining variants cause 9k cases)

The batch of new variants have been dubbed the “Pentagon” by epidmiologist JP Weiland, and have caused a sharp increase in cases in several countries in Europe and elsewhere. Here’s what she thinks that means for the US:


But even she is not sure that any wave generated by the new variants will exceed summer’s BA.5 peak, let alone approach last winter’s horrible wave:



In summary, we have having an autumn lull as predicted by the seasonal model. There will probably be a winter wave, but the size of that wave is completely unknown, primarily due to the fact that probably 90%+ of the population has been vaccinated and/or previously infected, giving rise to at least some level of resistance - a disease on its way to seasonal endemicity.

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JOLTs jolted: Did the Fed break the labour market?

In the Bureau of Labor Statistics (BLS) August release of the Job Openings and Labor Turnover Survey (JOLTS) report, the number of job openings, a measure…

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In the Bureau of Labor Statistics (BLS) August release of the Job Openings and Labor Turnover Survey (JOLTS) report, the number of job openings, a measure of demand for labour, fell to 10.1 million. This was short of market estimates of 11 million and lower than last month’s level of 11.2 million.

It also marked the fifth consecutive month of decreases in job openings this year, while the August unemployment rate had ticked higher to 3.7%, near a five-decade low.

In the latest numbers, the total job openings were the lowest reported since June 2021, while incredibly, the decline in vacancies of 1.1 million was the sharpest in two decades save for the extraordinary circumstances in April 2020. 

Healthcare services, other services and retail saw the deepest declines in job openings of 236,000, 183,000, and 143,000, respectively.

With total jobs in some of these sectors settling below pre-pandemic levels, the Fed’s push for higher borrowing costs may finally be restricting demand for workers in these areas.

The levels of hires, quits and layoffs (collectively known as separations) were little changed from July.

The quits rate (a percentage of total employment in the month), a proxy for confidence in the market was steady at 2.8%.

Source: US BLS

From a bird’s eye view, 1.7 openings were available for each unemployed person, cooling from 2.0 in the month prior but still above the historic average. 

The market still appears favourable for workers but seems to have begun showing signs of fatigue.

Ian Shepherdson, Economist at Pantheon Macroeconomics noted that it was too soon to suggest if a new trend had started to emerge, and said,

…this is the first official indicator to point unambiguously, if not necessarily reliably, to a clear slowing in labour demand.

Nick Bunker, Head of Economic Research at Indeed, also stated,

The heat of the labour market is slowly coming down to a slow boil as demand for hiring new workers fades.

Ironically, equities surged as investors pinned their hopes on weakness in headline jobs numbers being the sign of breakage the Fed needed to pull back on its tightening.

Kristen Bitterly, Citi Global Wealth’s head of North American investments added,

(In the past, in) 8 out of the 10 bear markets, we have seen bounces off the lows of 10%…and not just one but several, this is very common in this type of environment.

The worst may be yet to come

As for the health of the economy, after much seesawing in its projections, which swung between 0.3% as recently as September 27 and as high as 2.7% just a couple of weeks earlier, the Atlanta Fed GDPNow estimate was finalized at a sharply rebounding 2.3% for Q3, earlier in the week.

Rod Von Lipsey, Managing Director, UBS Private Wealth Management was optimistic and stated,

…looking for a stronger fourth quarter, and traditionally, the fourth quarter is a good part of the year for stocks.

As I reported in a piece last week, a crucial consideration that has been brought up many a time is the unknown around policy lags.

Cathie Wood, Ark Invest CEO and CIO noted that the Fed has increased rates an incredible 13-fold in a span of just a few months, which is in stark contrast to the rate doubling engineered by Governor Volcker over the span of a decade.

Pedro da Costa, a veteran Fed reporter and previously a fellow at the Peterson Institute for International Economics, emphasized that once the Fed tightens policy, there is no way to know when this may be fully transmitted to the economy, which could lie anywhere between 6 to 18 months.

The JOLTs report reflects August data while the Fed has continued to tighten. This raises the probability that the Fed may have already done too much, and the environment may be primed to send the jobs market into a tailspin.

Several recent indicators suggest that the labour market is getting ready for a significant deceleration.

For instance, new orders contracted aggressively to 47.1. Although still expansionary, ISM manufacturing data fell sharply to 50.9 global, factory employment plummeted to 48.7, global PMI receded into contractionary territory at 49.8, its lowest level since June 2020 while durable goods declined 0.2%.

Moreover, transpacific shipping rates, a leading indicator absolutely crashed, falling 75% Y-o-Y on weaker demand and overbought inventories.

Steven van Metre, a certified financial planner and frequent collaborator at Eurodollar University, argued

“…the next thing to go is the job market.“

A recent study by KPMG which collated opinions of over 400 CEOs and business leaders at top US companies, found that a startling 91% of respondents expect a recession within the next 12 months. Only 34% of these think that it would be “mild and short.”

More than half of the CEOs interviewed are looking to slash jobs and cut headcount.

Similarly, a report by Marcum LLP in collaboration with Hofstra University found that 90% of surveyed CEOs were fearful of a recession in the near future.

It also found that over a quarter of company heads had already begun layoffs or planned to do so in the next twelve months.

Simply put, American enterprises are not buying the Fed’s soft-landing plans.

A slew of mass layoffs amid overwhelming inventories and a weak consumer impulse will result in a rapid decline in price pressures, exacerbating the threat of too much tightening.

Upcoming data

On Friday, the markets will be focused on the BLS’s non-farm payrolls data. Economists anticipate a comparatively small addition of jobs, likely to be near 250,000, which would mark the smallest monthly increase this year.

In a world where interest rates are still rising, demand is giving way, the prevailing sentiment is weak and companies are burdened by excessive inventories, can job cuts be far behind?

The post JOLTs jolted: Did the Fed break the labour market? appeared first on Invezz.

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International

Trade Deficit decreased to $67.4 Billion in August

From the Department of Commerce reported:The U.S. Census Bureau and the U.S. Bureau of Economic Analysis announced today that the goods and services deficit was $67.4 billion in August, down $3.1 billion from $70.5 billion in July, revised.August exp…

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From the Department of Commerce reported:
The U.S. Census Bureau and the U.S. Bureau of Economic Analysis announced today that the goods and services deficit was $67.4 billion in August, down $3.1 billion from $70.5 billion in July, revised.

August exports were $258.9 billion, $0.7 billion less than July exports. August imports were $326.3 billion, $3.7 billion less than July imports.
emphasis added
Click on graph for larger image.

Exports increased and imports decreased in August.

Exports are up 20% year-over-year; imports are up 14% year-over-year.

Both imports and exports decreased sharply due to COVID-19 and have now bounced back.

The second graph shows the U.S. trade deficit, with and without petroleum.

U.S. Trade Deficit The blue line is the total deficit, and the black line is the petroleum deficit, and the red line is the trade deficit ex-petroleum products.

Note that net, imports and exports of petroleum products are close to zero.

The trade deficit with China increased to $37.4 billion in August, from $21.7 billion a year ago.

The trade deficit was slightly lower than the consensus forecast.

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