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US frets over pharma supply chain security

The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and
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The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. Ben Hargreaves finds out how the issue of foreign manufacturing has become a major US political talking point and how this could influence the pressures facing the industry.

In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap. The pharmaceutical industry is no different, with India and China becoming two of the leading manufacturers and exporters of generic medicine, as well as medical supplies, antibiotics and ingredients required to manufacture treatments.

According to research, the US is reliant on overseas production for two-thirds of its demand for generic medicine and 90% of generic active pharmaceutical ingredient (API) facilities are not located within the US. This puts the US in a position where it is almost entirely dependent on other countries for access to certain treatments. In particular, China is the second largest exporter of drugs and biologics to the US and the largest for medical devices. In recent years, this has become a major talking point within US politics.

Security of supply

The reason the US government is worried about the supply of pharmaceuticals is immediately clear, a problem securing access to antibiotics, for example, would be a major public health issue. According to data from a report by the American Action Forum, the US is not overly dependent on one country for its broader supply of antibiotics, with Canada, India, Italy and China supplying the bulk of demand. However, for individual antibiotics, China is the main source of the ingredients for penicillin and cephalosporin, which represent approximately two-thirds of the antibiotics used in the US each day.

This is enough to cause concern within the US government, leading it to recently pass a bill through the Senate with aims to boost the US manufacturing sector and to diversify the supply chain, specifically in regard to a perceived overdependence on China. The government’s stance reflects a wider mood within the US population, as a poll conducted by Americans for Safe Drugs suggested that 85% of respondents deemed US government policies to encourage domestic production of generic products as being ‘somewhat’ or ‘very important’.

The pandemic effect

The growing importance of the question over supply will likely grow, as the pandemic has raised fears over the supply of medicine. The worries over potential supply issues were not helped when, for a brief period during the early period of the pandemic, India restricted the export of certain APIs and drugs. As a major trading partner of India for pharmaceuticals – the US market represents the destination of 54% of India’s drug, pharmaceutical and fine-chemicals exports – this will have raised alarm bells for the US government.

However, one of the greater challenges during the early parts of the pandemic was one of access – with much of the world limited in terms of movement. The US FDA plays a key role in ensuring the quality of drugs that are being manufactured and brought into the country, a task that became fundamentally more difficult alongside the pandemic.

Last year, the FDA published a report detailing its efforts to carry out its work during the pandemic and its plans to address postponed inspectional work. By its own figures, the agency managed 61% of the planned inspections it had scheduled for 2020. As a result of the pandemic, the FDA has had to ‘roll over’ any missed inspections into the following year, meaning that its planned inspections grew from 21,000 in 2020 to 26,250 in 2021. As a means to navigate the pandemic environment, the FDA carried out in-person inspections for only facilities considered high-risk, while opting to rely on remote interactive evaluations for low- and moderate-risk facilities.

All of these factors have led to a reduction in foreign inspections, with the agency reporting that between April and September 2021, it had carried out 37 human drugs-related inspections. Though the work carried out by the agency could not be carried on as normal due to the pandemic, this did not stop the United States Government Accountability Office releasing a report calling for improvements to its foreign inspection program.

With a greater political emphasis on improving domestic manufacturing of treatments, the industry itself is being pushed, in turn, by the FDA to strengthen its own supply chain. In a release last month, the agency called on companies to mitigate or prevent drug shortages due to “drug quality problems, vulnerabilities in the global supply chain, unanticipated increases in demand, market withdrawals of drugs, or natural disasters.” As part of its recommendation, the agency called on companies to develop, maintain, and implement risk management plans for their supply chains.

How industry is reacting

For the industry’s part, PhRMA published a report last year where it suggested that it would improve supply chain capacity and highlighted the importance of investing in pandemic preparedness and planning. The industry had been helped in this goal through the huge amount of funding that went into boosting capacity for vaccines and for vaccines supplies through Operation Warp Speed, with a significant portion of this investment seeing facility expansions in the US.

Broader than just products related to the pandemic, there have also been strategic investments made to cater to the political demand for greater domestic manufacturing in other areas. Jackson Healthcare announced last year that it would reopen a US manufacturing facility for the production of antibiotics, after acquiring the site and operating the business through its subsidiary, USAntibiotics. The company stated that it would become the only US company able to manufacture amoxicillin and would be able to meet the country’s entire demand for the antibiotic once the facility was operational.

“As the first doses of USAntibiotics’ life-saving drugs move down the assembly line, America will have declared its independence from Chinese antibiotics,” said Rick Jackson, founder, CEO, and chairman of Jackson Healthcare, at the same time as the facility reopening was announced. A spokesperson for USAntibiotics declined to provide further details on the company’s plans and the wider supply chain issues in the US.

There is clearly a growing appetite across the industry to call attention to expanding manufacturing presence within the US. Only last month, Eli Lilly unveiled a $2.1 billion investment for two US manufacturing facilities in Indiana and underlined the company’s history in the area. While manufacturing projects for proprietary products will remain feasible in the US, where the necessary infrastructure and talent is a significant aid, it remains to be seen whether the industry will make similar moves in low profit areas, such as in genetics and antibiotics. However, while the direction of travel in politics is clearly moving towards greater domestic manufacturing, the industry can expect greater calls for this to happen.

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Government

New Hampshire Governor Vetoes Ivermectin Bill

New Hampshire Governor Vetoes Ivermectin Bill

Authored by Alice Giordano via The Epoch Times (emphasis ours),

New Hampshire’s Republican…

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New Hampshire Governor Vetoes Ivermectin Bill

Authored by Alice Giordano via The Epoch Times (emphasis ours),

New Hampshire’s Republican Gov. Chris Sununu vetoed a bill that would have made Ivermectin available without a prescription.

Ivermectin tablets packaged for human use. (Natasha Holt/The Epoch Times)

The Republican governor vetoed the bill on June 24, the same day that the U.S. Supreme Court overturned Roe v. Wade. Some fellow Republicans questioned the timing.

It certainly seemed like a convenient way to bury a veto of a bill that won support from the vast majority of Republicans in New Hampshire,” JR Hoell, co-founder of the conservative watchdog group RebuildNH, told The Epoch Times.

Hoell is a former four-term House Republican planning to seek re-election after a four-year hiatus from the the New Hampshire legislature.

Earlier this year, the New Hampshire Department of Children Youth and Family (DCYF) tried to take custody of Hoell’s 13-year old son after a nurse reported him for giving human-grade ivermectin to the teen months earlier.

Several states have introduced bills to make human-grade ivermectin available without a prescription at a brick and mortar store. Currently, it can be ordered online from another country. In April, Tennessee became the the first state to sign such a measure into law. New Hampshire lawmakers were first to introduce the idea.

Both chambers of the state’s Republican controlled legislature approved the bill.

In his statement explaining the veto, Sununu noted that there are only four other controlled medications available without a prescription in New Hampshire and that each were only made available after “rigorous reviews and vetting to ensure” before being dispensed.

“Patients should always consult their doctor before taking medications so that they are fully aware of treatment options and potential unintended consequences of taking a medication that may limit other treatment options in the future,” Sununu said in his statement.

Sununu’s statement is very similar to testimony given by Paula Minnehan, senior vice president of state government regulations for the New Hampshire Hospital Association, at hearings on the bill.

Minnehan too placed emphasis on the review that went into the four prescription medications the state made available under a standing order. They include naloxone, the generic name for Narcan, which is used to counter opioid overdoses, hormone replacement therapy drugs, and a prescription-version of the morning after pill.

It also includes a collection of smoking cessation therapy drugs like Chantix, which has been linked to suicide, depression, and other neuropsychiatric conditions. Last year, Pfizer, the leading maker of the FDA-approved drug, conducted a voluntarily recall of Chantix. Narcan has also been linked to deaths caused by severe withdrawals that have led to acute respiratory distress.

Rep. Melissa Blasek, a Republican co-sponsor of the New Hampshire ivermectin bill, told The Epoch Times, that one could veto any drug-related bill under the pretense of overdose concerns.

The reality is you can overdose on Tylenol,” she said. “Ivermectin has one of the safest track records of any drug.”

The use of human-grade ivermectin became controversial when some doctors began promoting it for the treatment and prevention of COVID-19. Government agencies including the FDA and CDC issued warnings against its use while groups like Front Line COVID-19 Critical Care Alliance (FLCCC) heavily promoted it.

Some doctors were  disciplined for prescribing human-grade ivermectin for COVID-19 including a Maine doctor whose medical license was suspended by the state.

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Tyler Durden Thu, 06/30/2022 - 20:30

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Economics

The Jaws Of Trade Squeezing The Supply Chain

The Jaws Of Trade Squeezing The Supply Chain

By FreightWaves

The jaws of the supply chain vise are squeezing trade so tight that the headache…

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The Jaws Of Trade Squeezing The Supply Chain

By FreightWaves

The jaws of the supply chain vise are squeezing trade so tight that the headache it is creating will be a whopper for logistics managers this peak season. Port congestion is growing again as a result of labor and equipment inefficiencies. Trade requires people, and what we see in the CNBC Supply Chain Heat Maps is the people component in trade is behind this latest squeeze.

Shanghai is still in the process of reopening, and while there are more green lights on the screen, the supplying of drivers and people to move and make the product is slower than normal. This is affecting the delivery of critical medical devices. 

“The manufacturing plant in Shanghai was down for 75 days because of the ‘zero-COVID’ restrictions,” explained Gerry LoDuca, president of Dukal, which sells infection-control products and has manufacturing plants in Shanghai, Wuhan and Xingtai, China. “They are now operating 24/7 and they will be caught up by the end of July. Then the products will need to be packed up, shipped to Shanghai port and moved by vessel.”

Unfortunately, this delay is one of many being experienced by global importers.

Another vise squeezing trade is Europe.

Labor strife between the German trade union ver.di and the Central Association of German Seaport Companies (ZDS) is white-hot. Almost all ports in the German Northern Sea were impacted by a second warning strike last week that lasted 24 hours.  

According to sources, a final offer of a wage increase of up to 11% in 18 months was offered. Some hope for a conciliation procedure in which politicians or a neutral person become involved in mediation.

The delays created by the latest warning strike have added to the congestion already plaguing the German ports. Container ships are currently delayed by several weeks at some German ports. Logistics executives are concerned the congestion is going to get worse, as will the availability of empty containers to be filled with trade.

“The overall situation in North European ports is deteriorating,” warned Andreas Braun, EMEA ocean product director for Crane Worldwide Logistics. “Port congestion is on the increase as well as yard occupancy. The first shipping lines like MSC are reacting to the current scenario with emergency storage surcharges for both imports and exports. These surcharges will be applied after exceeding the standard storage free time and are in addition to the standard tariffs.  Although this surcharge is currently limited to Dutch ports only, and to date only MSC has circulated communication relating to the additional fees, we can assume that other ports and shipping lines will follow.”

Ocean carrier Hapag-Lloyd issued a notice on the increased demand on trucks as a result of this labor slowdown. And Maersk reported it would “absorb” the stoppage at its German terminals, telling customers that “in the interest of minimizing any further disruption to your supply chain, we will be keeping a close eye on developments up to and during the next round of meetings between trade union ver.di and ZDS, acknowledging that further strike action is possible.”

The U.S. logistics system continues to have its own host of issues with the persistent rail problems, chassis shortages and warehouses at capacity.

“Consumer trends are changing,” explained Spencer Shute, senior consultant at Proxima. “Buying patterns have shifted from home, electronics, casual apparel to more services. We are seeing buying apparel for travel and cosmetics coming back to pre-pandemic levels. Luggage, sunscreen, bug spray, these are items in higher demand because consumers need them in their experience pursuits. Larger appliances are not being purchased anymore. It’s an interesting dynamic to see how quickly the consumer has flipped considering what is going on in the economy.”

Despite the historic volume of containers, a pullback is expected as future orders for Chinese manufacturing have dropped anywhere from 20% to 30%, according to shippers surveyed.  Lumber orders have been cut along with orders for furniture, appliances and DIY products.

“But for other sectors like garments, sporting goods and e-commerce, they are still seeing strong demands,” explained Akhil Nair, senior vice president of products for Asia-Pacific at Seko Logistics.

Steve Lamar, CEO of the American Apparel and Footwear Association, explained the continued strength in orders is a result of consumers looking to outfit themselves for experiences like back to school, back to in-office work and travel. But despite this demand, the impact of inflation is a top worry.

“We remain deeply concerned that persistently high prices — in our sector and throughout the economy — will begin to dampen consumer spending and harm American families,” Lamar said. “That is why, with consumers still being a driver for economic growth in our economy, we continue to push for the [Biden] administration to avail itself of all its own inflation-cutting tools, including relief from the high and regressive tariffs that are currently being charged on products in our industry.”

Alan Baer, CEO of OL USA, tells American Shipper the decrease in container volume is being seen.

“We are seeing drops by some customers from 30-50 FEU per week down to 10 FEU per week,” Baer said. 

The squeeze is on. Time to pop that aspirin.

Tyler Durden Thu, 06/30/2022 - 15:45

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Government

5 Top Biotech Stocks To Watch In July 2022

Amid choppy markets, could there be potential in these top biotech stocks?
The post 5 Top Biotech Stocks To Watch In July 2022 appeared first on Stock…

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Should Investors Be Watching These Top Biotech Stocks In The Stock Market Now?

Just as most people think that pandemic woes are behind us, we now have the emergence of the monkeypox. While this virus may not be as contagious as the coronavirus, there is still a real cause for concern. On Tuesday, the Centers for Disease Control and Prevention (CDC) announced the activation of an emergency operations unit for monkeypox. This signals the initial stages of a public health concern. Epidemiologist Dr. Eric Feigl-Ding believes that the number of cases could reach 100,000 worldwide by August. In light of these circumstances, biotech stocks could be gaining more attention in the stock market. 

Furthermore, the coronavirus is not going away anytime soon. Recently, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that there is a need to modify the current strain composition of available COVID-19 vaccines to target the Omicron variant. If this is approved, vaccine makers such as Pfizer/BioNTech, and Moderna (NASDAQ: MRNA) will need to provide modified boosters of their coronavirus vaccines. In fact, Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) just announced a new vaccine supply agreement with the U.S. government. Under the agreement, the U.S. government will receive 105 million doses with an option of up to 195 million additional doses. With all this in mind, here are five of the top biotech stocks to note in the stock market today. 

Biotech Stocks For Your July 2022 Watchlist

Regeneron Pharmaceuticals 

biotech stocks to buy (regn stock)

First up, we have the integrated biotech company, Regeneron Pharmaceuticals. Essentially, the company discovers, invents, manufactures, and commercializes medicines for serious diseases. For the most part, its medicines and products aim to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular, and metabolic diseases. REGN stock has been trading sideways over the past year. 

Having said that, the company received a boost on Wednesday as the U.S. FDA has accepted for review the EYLEA Injection supplemental Biologics License Application for every 16-week 2 mg dosing regimen. This specifically caters to patients with diabetic retinopathy. Should this go according to plan, the 16-week dosing regimen could offer patients a potentially longer treatment interval. Also, it will allow doctors to have greater flexibility to individualize treatment. Given such a positive development, should investors be paying more attention to REGN stock?

[Read More] Stock Market Today: Dow Jones, S&P 500 Falter; Walgreens Stock Slides Despite Strong Quarter

Sanofi

best health care stocks to buy now (SNY stock)

Another top biotech name making waves this week is Sanofi. The France-based company engages in the research, development, and marketing of therapeutic solutions. Over the past week, there have been several key developments that could potentially excite investors. For starters, the company and GSK (NYSE: GSK) announced positive data from their vaccine trial last Friday. The vaccine candidate is the first to ever demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation. 

Furthermore, Sanofi’s Nexviadyme (avalglucosidase alfa) has recently gained marketing authorization from the European Commission. For the uninitiated, this is an enzyme replacement therapy for long-term treatment of both late-onset and infantile-onset Pompe disease. This is a significant development because Nexviadyme is the first and only newly approved medicine for Pompe disease in Europe since 2006. On that note, would you say that SNY stock is a top biotech stock to watch?

Novavax

best biotech stocks (NVAX stock)

Following that, let us look at the biotech company, Novavax. In detail, it promotes improved health globally through the discovery, development, and commercialization of vaccines to prevent serious infectious diseases. Its recombinant technology platform harnesses the power and speed of genetic engineering. As a result, the company produces immunogenic nanoparticles designed to address urgent global health needs. That said, NVAX stock has been struggling to find its footing since the start of the year. 

During the VRBPAC meeting, Novavax highlighted data showing that its protein-based coronavirus vaccine showed epitopes across both the original strain and emerging variants. Therefore, it will be able to contribute to the generation of broadly cross-reacting antibodies. The company also provided pre-clinical data that suggests boosting with Novavax’s Omicron or prototype vaccine will induce an immune response against Omicron variants. Overall, there are reasons to believe that Novavax will close the second half of the year on a better note. With that in mind, would you consider adding NVAX stock to the top of your watchlist?

Arrowhead Pharmaceuticals 

ARWR stock

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. It uses a portfolio of ribonucleic acid (RNA) chemistries and modes of delivery. Most of its therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. Those following the medical space would notice that gene therapies have been gaining popularity within the industry over the past few years. Hence, it would not be surprising if investors are taking note of Arrowhead. 

As a matter of fact, the company recently claimed that its experimental drug fazirsiran can reduce the accumulation of mutant protein known as Z-AAT by 83%. This result is based on an open-label phase 2 trial involving 16 volunteers with alpha1-antitrypsin deficiency disease. For now, there is still no approved treatment for such genetic liver disease. All in all, Arrowhead appears to be making strides in the right direction. Thus, should you be keeping a closer tab on ARWR stock?

[Read More] Best Long-Term Stocks To Buy Now? 5 Semiconductor Stocks To Know

Global Blood Therapeutics

gbt stock

To sum it all up, we have the biopharmaceutical company, Global Blood Therapeutics. As its name suggests, this is a company that specializes in blood-related treatments. The company is currently focused on Oxbryta, an FDA-approved medicine that inhibits sickle hemoglobin polymerization. In addition, it is also advancing its pipeline program in Sickle Cell Disease with inclacumab, and GBT021601. Impressively, GBT stock has been on bullish momentum lately, rising more than 28% within the past month.

Not to mention, the company announced on Thursday that it initiated the Phase 2 portion of its Phase 2/3 trial of GBT021601. The study aims to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of the drug. So far, the preclinical results and data have been encouraging. Smith-Whitley, the company’s head of research and development, believes the drug has “the potential to improve on the clinical results achieved with Oxbryta® at a lower daily dose.” If so, this would be a huge boost for the company as it continues to work towards its long-term goals. All things considered, is GBT stock a buy right now?

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