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Tuesday, July 6, 2021

Supermarkets are stockpiling inventory as food costs ris

 Supermarkets are stocking up on everything from sugar to frozen meat before they get more pricey, girding for what some executives anticipate will be some of the highest price increases in recent memory.

Some supermarkets said they are buying and storing supplies to keep their shelves full amid stronger demand. Grocery sales in the U.S. for the week ended June 19 rose about 15% from two years earlier and increased 0.5% from a year earlier, according to Jefferies and NielsenIQ data.

Stockpiling by food retailers is driving shortages of some staples, grocery industry executives said, and is challenging a U.S. food supply chain already squeezed by transportation costs, labor pressure and ingredient constraints.

The move is a reversal from last year when consumers hoarded groceries because of concerns about food availability, disrupting the food industry. Now, retailers themselves are stockpiling to keep costs down and protect margins.

"We’re buying a lot of everything. Our inventories are up significantly over the same period last year," said David Smith, chief executive officer of Associated Wholesale Grocers Inc. The nation’s largest wholesaler for more than 3,000 grocery stores recently purchased 15% to 20% more inventory, mainly of packaged foods with longer shelf life, he said.


Keeping bigger supplies also helps Associated offer higher in-stock levels, as the food industry fights shortages of items like beverages and frozen food.

When prices start rising, food sellers often purchase more inventory than they need to protect their profit. Price changes have been minor in recent years, executives said, generally involving a pool of specific products. The current price increases are bigger and are playing out more broadly across supermarket aisles, executives said.

General Mills Inc., Campbell Soup Co. , and J.M. Smucker Co. are among food makers raising prices to compensate for higher costs. Meat and produce prices have been climbing, too, with retailers anticipating more increases through the rest of the year.

Supermarkets say they are passing along some of those increases to shoppers, who continue to buy more groceries than they did before the pandemic, as prices also climb for used cars, airline tickets and other products. So far consumers have yet to see the same price increases confronting supermarket operators, as grocers said they hold down some prices to better compete against discount or low-price chains.


Few retailers expect pricing pressure to ease soon. Worker shortages are keeping labor and transportation expensive, industry executives said, as companies boost wages and offer bonuses to recruit and keep employees.

"When you have a uniquely inflationary period like now, it’s a feeding frenzy," said Tony Sarsam, chief executive officer of SpartanNash Co. The Grand Rapids, Mich.-based retailer and distributor is stockpiling about 20% to 25% more groceries such as frozen meat and boxed foods after more than 100 suppliers notified SpartanNash that they would raise prices, he said.

Other supermarkets are rethinking how they store inventory as consumer spending remains strong and pushes up sales.

Ahold Delhaize USA is holding more safety stock, said Chris Lewis, president of Ahold’s supply-chain company. He said total inventory is higher than it was two years ago, including 20% more supply of paper and cleaning products. Ahold Delhaize USA, which owns the Food Lion and Stop & Shop chains, is also expanding capacity in its warehouses.

For food sellers, stockpiling can require complicated math to determine what to purchase, when and how much. For instance, perishable foods can’t be stored for a long time, while bulky products take up more space. Grocers face the possibility of losing money if prices drop after they purchase inventory, though that isn’t expected to happen this year, executives say.


Stockpiling can also worsen shortages as food makers and sellers look toward recovery. The supermarket industry has bounced back from last year’s widespread shortages driven by consumers’ panic buying early in the pandemic. But retailers said they are now running low on some items, with many receiving about 80% of their orders from suppliers, compared with more than 90% before the pandemic.

"It runs the risk of making a bad situation worse," said Mark Griffin, president of B&R Stores Inc., which is storing 10% more groceries including sugar, flour and cereal. B&R tries to negotiate lower prices if manufacturers push back on the volume the chain wants to secure, he said, while monitoring competitors.

"If Walmart raises prices, so will we," Mr. Griffin said.

https://www.foxbusiness.com/economy/supermarkets-stockpiling-inventory-food-costs-rise

Arrowhead: Positive Interim Results from Phase 1b Study of ARO-HIF2 for Kidney Cancer

 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced positive interim results from the first two cohorts of AROHIF21001, a Phase 1b dose-finding clinical study of ARO-HIF2, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with clear cell renal cell carcinoma (ccRCC). ARO-HIF2 is the first tumor-targeted investigational medicine to utilize Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform in a clinical trial. Arrowhead is currently enrolling the third planned patient cohort of AROHIF21001 and the company intends to present additional data at an appropriate medical congress.

James Hamilton, M.D., MBA, senior vice president of discovery and translational medicine at Arrowhead, said: "The AROHIF21001 Phase 1b study is designed to evaluate safety as well as preliminary pharmacodynamics and efficacy in an advanced ccRCC patient population. We believe that in the first two dose cohorts investigational ARO-HIF2 is showing clear signs of meaningful target engagement and some potentially early signs of efficacy in at least one patient. This is an encouraging start for the study. Specifically, in seventeen patients treated with investigational ARO-HIF2, nine had tumor biopsy material that could be evaluated. Seven of these nine tumor samples demonstrated reductions in HIF2α protein, as measured by immunohistochemistry H-score. The mean of these reductions was -48% with a range from -9% to -82%. In addition, one patient achieved a partial response with tumor shrinkage of approximately 65% and four additional patients in cohort 2 remain on study drug with stable disease. Tumors typically have a high level of heterogeneity and the patients in AROHIF21001 have advanced ccRCC and have failed multiple lines of treatment including checkpoint inhibitors and anti-VEGF regimens, so these early results in a heavily pre-treated population are encouraging for investigational ARO-HIF2 and our tumor-targeted platform broadly. ARO-HIF2 has been generally well-tolerated and we look forward to continued dose escalation."


Eiger BioPharma Starts Peginterferon Lambda Phase 3 Study of Newly Diagnosed COVID-19 Outpatients

 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients were dosed with Peginterferon Lambda (Lambda) in the Phase 3 TOGETHER platform study in outpatients with COVID-19. Lambda is administered as a convenient, one-time, subcutaneous dose.

TOGETHER is a multi-center, investigator-sponsored, randomized, placebo-controlled Phase 3 study evaluating multiple therapeutics in newly diagnosed, outpatients with COVID-19. The primary endpoint is a clinical outcome comparing emergency room visits and/or hospitalization in each active arm versus placebo. Each arm targets enrollment of up to 800 patients at high risk for developing complications from progression of COVID-19, with planned interim analyses for futility.

"Effective treatments are desperately needed for newly diagnosed COVID-19 outpatients that can be quickly and easily administered upon diagnosis, outside the hospital," said David Cory, President and CEO of Eiger. "Lambda stimulates immune responses that are critical for the development of host protection during viral infections and may be ideal for addressing variants of SARS-CoV-2, which remain an ongoing concern with approved monoclonal antibodies and vaccines. We are excited to include Lambda in the TOGETHER study and look forward to reporting results in the future."

For more information about the TOGETHER platform study, please visit www.togethertrial.com.

https://finance.yahoo.com/news/eiger-biopharmaceuticals-announces-first-patients-120000883.html

Dynavax to Supply Adjuvant for Biological E's COVID-19 Vaccine Candidate

  Dynavax Technologies Corporation (Dynavax, Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines and Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018TM advanced adjuvant, for use in BE's subunit COVID-19 vaccine candidate, CORBEVAX™. The commercial supply agreement extends through 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between the Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. Pending conditional regulatory approvals in India, BE expects to commence product launch of CORBEVAX™ later this year.

In June 2021, India's Union Ministry of Health announced that it had finalized arrangements with BE to reserve 300 million doses of CORBEVAX™. The arrangement with BE is part of the wider endeavor from the Government of India to encourage indigenous vaccine manufacturers by providing financial support.

https://finance.yahoo.com/news/dynavax-biological-e-announce-commercial-120000844.html

MediciNova: New Patent Covering MN-166 (ibudilast) for Ophthalmic Disease

 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of ophthalmic disease.

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than October 2039. The allowed claims cover methods of treating an ophthalmic disease/disorder or injury associated with a neurodegenerative disease/disorder or a neuro-ophthalmologic disorder by administering to a human patient a therapeutically effective amount of MN-166 (ibudilast). The allowed claims specifically cover the treatment of macular injury. The allowed claims cover a wide range of doses and formulations of MN-166 (ibudilast) and a range of different dosing frequencies.

https://finance.yahoo.com/news/medicinova-receives-notice-allowance-patent-103000250.html

Expanded Indication OKd for Merck’s KEYTRUDA in Locally Advanced Cutaneous Squamous Cell Carcinoma

 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated an objective response rate (ORR) of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease. Among the 27 responding patients, 81% had a duration of response (DOR) of six months or longer, and 37% had a DOR of 12 months or longer. In June 2020, KEYTRUDA was granted its first indication in cSCC, as monotherapy for the treatment of patients with recurrent or metastatic disease that is not curable by surgery or radiation.

"This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community. KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation," said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. "This expanded indication reinforces the role of KEYTRUDA in this cancer type, which is the second most common form of non-melanoma skin cancer."

https://finance.yahoo.com/news/fda-approves-expanded-indication-merck-104500094.html

Opthea Gets FDA Fast Track Designation for Wet Age-Related Macular Degeneration Med

 Opthea Limited (ASX:OPT; Nasdaq:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s VEGF-C/-D ‘trap’ inhibitor, OPT-302, in combination with anti-VEGF-A therapy for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD).

The FDA’s Fast Track program offers a number of benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of getting important new therapies to patients more quickly. This Fast Track designation acknowledges the significant unmet medical need in the management of neovascular AMD, and the potential role that OPT-302 may have in addressing it.

With the Fast Track designation, Opthea is eligible for more frequent regulatory meetings and communications with the FDA, as well as a Rolling Review of completed sections of its Biologic Drug Application (BLA) which will help expedite the Phase 3 development program and subsequent approval review process. Under the Fast Track designation, OPT-302 may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

“Given the need to improve therapeutic options for wet AMD patients, we welcome this Fast Track designation for OPT-302 and the regulatory support it provides in expediting the Phase 3 development program to advance this promising novel treatment to patients sooner,” commented Dr. Megan Baldwin, Chief Executive Officer and Managing Director of Opthea. “The recognition from the FDA to grant OPT-302 Fast Track designation reflects the seriousness of wet AMD as a debilitating eye disease and the importance of advancing new therapies such as OPT-302 to address the significant unmet medical need for wet AMD patients, many of whom experience an incomplete response to VEGF-A inhibitors despite regular, ongoing therapy. By targeting a novel mechanism of action, OPT-302 has the potential to be a truly differentiated treatment option that when used in combination offers patients improved vision outcomes over standard of care anti-VEGF-A monotherapy.”