Formula Shortage Highlights Supply Chain Concerns Facing Pharma Industry
The ongoing COVID-19 pandemic, the war in Ukraine, rising fuel costs, manufacturing concerns and the ripple of other global events have led to supply chain issues across the world that, in the United States, has been most recently highlighted by a shortage of baby formula.
The formula shortage crisis was caused in part by the shutdown of a plant operated by Abbott following concerns over bacterial infections that led to a massive recall of cans of infant formula. The crisis caused by the shutdown of one plant, which is expected to begin production again within the next week or so, is a stark reminder of critical supply chain issues in other sectors, including the pharmaceutical industry.
The pharmaceutical industry is seeing a number of hurdles with supply chain issues. The war in Ukraine has caused a disruption in the supply of chemicals and compounds that drug researchers and developers across the globe rely on for their research. In Ukraine, the chemical company Enamine played a critical role by providing those all-important chemicals and compounds to drug developers everywhere. As BioSpace previously reported following Russia’s invasion of Ukraine, pharmaceutical companies the world over, including the larger western companies, relied on companies like Enamine to bolster their already vast chemical compound libraries. Prior to the invasion, Enamine had the capabilities to make approximately 22.7 billion potential new chemical combinations used across the world.
When the Russian invasion appeared certain, many Enamine scientists took it upon themselves to ship crucial compounds related to their work to secure locations outside of Ukraine. While some of the compounds were shipped, Enamine’s work has been hamstrung by the war that continues today.
Other supply issues abound across the industry, though. Last month, multiple reports were released highlighting some of the supply chain challenges facing the biopharmaceutical industry. Tony Quiñones, chief executive officer of Bright Path Laboratories told BioSpace that some critical components for drug manufacturing that come from China continue to be disrupted by pandemic-related lockdowns in that country. Those delays ripple across the globe. Delays in China impact drug manufacturing that takes place in India, where raw materials are turned into intermediary products, which are then shipped elsewhere to make a finished drug product.
Because of this concern, multiple companies within the life sciences have undertaken a supply chain risk assessment and are investing in supply chain technology and identifying backup suppliers in order to limit supply chain hiccups and support smooth operations.
Concerns over the supply chain in pharma are not a recent phenomenon. Two years ago, the U.S. government forged an agreement with Virginia’s Phlow to stockpile a reserve of key ingredients used in the manufacture of essential medications in order to reduce the burden of reliance on foreign sources and bolster the nation’s drug manufacturing infrastructure.
Prior to the outbreak of COVID-19, the U.S. was hit with multiple shortages of medications due to a number of reasons, including the sourcing of active pharmaceutical ingredients. In 2020, the U.S. Food and Drug Administration compiled a list of drugs that were at risk of a shortage due to the pandemic, and a survey of 500 healthcare professionals conducted by the United States Pharmacopeial Convention (USP) revealed that nine out of ten U.S. physicians were concerned that the drug supply chain may not be reliable in a time of crisis.
The Jaws Of Trade Squeezing The Supply Chain
The Jaws Of Trade Squeezing The Supply Chain
The jaws of the supply chain vise are squeezing trade so tight that the headache…
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.
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…
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 Inc (NASDAQ: REGN)
- Sanofi SA (NASDAQ: SNY)
- Novavax, Inc. (NASDAQ: NVAX)
- Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
- Global Blood Therapeutics Inc (NASDAQ: GBT)
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?
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?
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 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?
Global Blood Therapeutics
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?
If you enjoyed this article and you’re interested in learning how to trade so you can have the best chance to profit consistently then you need to checkout this YouTube channel. CLICK HERE RIGHT NOW!!dow jones sp 500 nasdaq stocks pandemic coronavirus covid-19 cdc disease control vaccine treatment fda preclinical genetic antibodies therapy rna european europe france
Will Royal Caribbean Ban a Popular Bad Habit, Add Unpopular Fee?
The cruise line’s President Michael Bayley addressed two controversial topics while cruising to Alaska on the annual President’s Cruise.
The cruise line's President Michael Bayley addressed two controversial topics while cruising to Alaska on the annual President's Cruise.
Cruise lines face a lot of challenges that traditional hotels don't deal with. A cruise ship is an enclosed space that's moving. This means that passengers impact each other more than they might in a traditional hotel, and the cruise line has to make decisions that some passengers may not like because they support the bottom line.
In addition, cruise lines face an age-old problem that every land-based casino operator has to deal with -- people like to smoke in casinos, but non-smokers hate smoky casinos. That creates a conundrum that's easier for a large land-based casino to solve than it is for a cruise line.
A land-based casino can have meaningful smoke-free areas. That can mean having a floor or a very distinct room designated smoke-free. It's possible to have meaningful separation because you have actual separate spaces.
That's much harder to do on a cruise. In most cases, there are smoking sections on a Royal Caribbean International (RCL) - Get Royal Caribbean Group Report ship, but smoke travels and sensitive non-smokers can't avoid it. The Wonder of the Seas does have a separate smaller casino (originally meant for high-rollers when the ship was supposed to sail out of China, but that's the only ship in the fleet that has two truly separated casino areas.
It's a problem the Royal Caribbean President Michael Bayley addressed during his company's annual President's Cruise.
Will Royal Caribbean Ban Smoking in its Casinos?
There was a period during the omicron variant section of the pandemic where Royal Caribbean tightened its mask rules and banned smoking in the casino. That was a practical concern because, at that time, the company was requiring customers to put their mask on between sips of a drink.
When that period ended, the cruise line reinstated smoking in its casinos. "It's a bit of a conundrum," Bayley said during a question and answer session on Ovation of the Seas during the President's Cruise, the Royal Caribbean Blog reported.
"The dilemma is that there are many people who do want to smoke in the casino. I know that's not a popular response, but it's it's the truth. I'm not judging anyone or anything, but there's a large group of people who do want to smoke in the casino," he said.
Banning smoking, which the company has tested, produces lower revenue in the casino.
"Every, I would say every couple of years, we do test this and we take one or two or three ships and we ban smoking in the casino. And the result is less people go in the casino and that's the reality of it," he explained.
Bayley does not expect a smoking ban to happen, but said the cruise line is looking at ways to make more area in the casino smoke free.
Will Royal Caribbean Add a Fuel Surcharge?
That's something Royal Caribbean has a legal right to do (it's in the long cruise contract you didn't read) but has held off so far on doing that. Bayley shut down fears of the cruise line adding one (at least right now), according to the Royal Caribbean Blog, which is not affiliated with the cruise line.
"The fuel fuel bill for Royal Caribbean is, as you can imagine, it's massive and it's gone up by I don't know what the percentages, but it's a huge chunk. It's hundreds of millions of dollars," he said. "But at the moment, we're not planning on putting a fuel surcharge on."oil pandemic china
Escobar: Behind The Tin Curtain – BRICS+ Vs NATO/G7
White House Is Quietly Modeling For $200 Oil “Shock”
How Representative Is The G7 Of The World It’s Trying To Lead?
Developing Leaders Spotlight: The Power of Relationships
Five Defense Stocks to Buy as Ukraine Fights to Preserve Its Freedom
Putin Travels To Friendly Central Asian Countries In 1st Trip Abroad Since War Began
University of Kentucky researchers develop online portal to show how biases in RNA sequences affect gene expression
NHS App could offer video consultations by 2024
Pharma’s post-pandemic launch performance problem: what’s the prognosis?
Hope from despair: how young people are taking action to make things better
Economics21 hours ago
RISING PRICES AND MORTGAGE RATES MAKE HOMEOWNERSHIP UNAFFORDABLE ACROSS MOST OF THE U.S.
Economics10 hours ago
ESPACE MONTMORENCY IN LAVAL COMES ALIVE
Bonds23 hours ago
Eurodollar Futures Interpretation Is Everywhere
Economics6 hours ago
Health Net Initiatives Recognized by Institute for Medicaid Innovation for Addressing Social Determinants of Health to Improve Health Equity
Economics22 hours ago
Churches Across US Build Tiny Home Villages Amid Worsening Affordability Crisis
Economics9 hours ago
Consulting Magazine Names Protiviti Executives to Its 2022 Top Consultants and Women Leaders in Technology Lists
Science14 hours ago
From trial design for patients to trial design with patients: a key topic at DIA ’22
Economics15 hours ago
Small and Midsize Business Confidence Plummets As Recession Fears Grow