COVID-19 and SARS-CoV-2 new research, vaccine and drug development news

BioTechniques | April 15, 2020

News covering COVID-19 is still to slow down, with this week’s big hitter being the announcement that US President Donald Trump has put funding for the WHO on hold pending a review. Accusing the WHO of “severely mismanaging and covering up” the threat, critics have been quick to respond, with the UN Secretary General António Guterres declaring now is “not the time to reduce the resources for the operations of the WHO…”. With the US contributing over $400m out of its $6bn for 2018-2019, this is a large chunk. In lighter news, researchers are attempting to develop ultraviolet LEDs capable of surface decontamination, and potentially also air and water. “One major application is in medical situations – the disinfection of personal protective equipment, surfaces, floors, within the HVAC systems, et cetera,” explained Christian Zollner (University of California Santa Barbara, USA), one of the researchers involved in the work.

Spotlight

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose.

Spotlight

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose.

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PHARMACY MARKET

Baseball Legend John Smoltz Featured on PLx Pharma’s Social Channels

PLx Pharma Inc. | September 13, 2022

PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on its clinically-validated and patent-protected PLxGuard™ that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs. The Company, with its lead products VAZALORE 81 mg and VAZALORE 325 mg liquid-filled aspirin capsules has launched a new VAZALORE 325 mg advertising campaign on Facebook featuring legendary professional baseball pitcher and avid golfer John Smoltz. “From baseball to golf, I don’t want aches and pains to slow me down,” said Smoltz. “VAZALORE is the only pain reliever I have found that works quickly on my aches and pains and doesn’t upset my stomach.” “September is Pain Awareness Month, a time dedicated to raising awareness of pain and pain management options, like aspirin. We are very excited to launch our new Facebook campaign with John, a current VAZALORE user and believer in its many benefits. Millions of people rely on aspirin for the temporary relief of minor aches and pains. The unique complex inside VAZALORE capsules allows for targeted release of aspirin to temporarily relieve minor aches and pains and is specially designed to help protect the stomach.” Natasha Giordano, President & CEO of PLx Pharma PLx Pharma’s VAZALORE is the first and only U.S. Food and Drug Administration (FDA)-approved liquid-filled aspirin capsule. The product was launched in August 2021 and is available over the counter in more than 30,000 drugstores, supermarkets, mass merchandisers and e-commerce sites nationwide. About VAZALORE VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule is designed for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin. About PLx Pharma Inc. PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on improving how and where active pharmaceutical ingredients (APIs) are absorbed in the gastrointestinal (GI) tract via its clinically validated and patent protected PLxGuard™ technology. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach injury associated with certain drugs.

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PHARMA TECH

Silverback Therapeutics and ARS Pharmaceuticals Announce Merger

Silverback Therapeutics and ARS Pharmaceuticals | July 22, 2022

Silverback Therapeutics, Inc. and ARS Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which ARS will merge with Silverback in an all-stock transaction. The combined company will focus on the potential regulatory approval and commercialization of neffy, ARS’s investigational epinephrine nasal spray for the treatment of Type I allergic reactions including anaphylaxis. The combined company is expected to have approximately $265M in cash, cash equivalents and marketable securities at closing. Upon stockholder approval, the combined company is expected to operate under the name ARS Pharmaceuticals and trade on the Nasdaq Capital Market under the ticker symbol “SPRY.” The merger is currently expected to close in the fourth quarter of 2022. Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. ARS designed neffy to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device. With its needle-free administration, neffy may help eliminate the anxiety and hesitation associated with using an autoinjector. “We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of neffy. neffy is on the cusp of achieving what has not been possible before – the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but with a simple to administer nasal spray. We have completed a comprehensive registration program with neffy and based on a favorable pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”), we are preparing to submit our New Drug Application (“NDA”) in the third quarter of 2022. This merger positions ARS and our experienced team to execute on the potential launch of neffy in 2023 by providing the requisite capital needed for launch. ARS was founded with a mission of solving many of the issues that patients and caregivers express about their epinephrine autoinjectors. Today is an important step toward bringing this novel treatment to patients and caregivers to improve their treatment options for these serious and potentially life-threatening allergic reactions.” Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS Data across three registration studies supports that neffy should meet all clinical endpoints recommended by regulators and that its pharmacokinetics are within the range of approved efficacious epinephrine injection products. In addition, neffy has been well-tolerated to date with more than 500 individuals having received at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature and comparable to injection products. Based on the totality of data, ARS is preparing to submit its NDA for neffy for use in adults and pediatric patients who are 30 kg or greater in the third quarter of 2022. If approved, ARS is planning to launch neffy in the United States in 2023. “This transaction represents the result of a thorough and thoughtful strategic review process by Silverback,” said Laura Shawver, Ph.D., chief executive officer of Silverback. “ARS is an exciting late-stage company with compelling clinical data demonstrated with neffy, a path to near-term commercialization in a large and dissatisfied market, and an expert team with proven experience in launching and commercializing market-leading nasal spray products, such as NARCAN. I believe we have found the optimal partner to provide value for our stockholders, and even more so, the potential to transform treatment for millions of people with or at-risk for Type I severe allergic reactions.” About the Proposed Merger Under the terms of the merger agreement, assuming that Silverback’s net cash at closing is $240 million, Silverback equity holders are expected to own approximately 37% of the combined company and pre-merger ARS equity holders are expected to own approximately 63% of the combined company on a fully-diluted basis on a treasury stock method. The percentage of the combined company that Silverback’s equity holders will own as of the close of the transaction is subject to certain adjustments as described in the merger agreement, including the amount of Silverback’s net cash at closing. Upon closing of the transaction, Silverback will be renamed ARS Pharmaceuticals, Inc. and will be headquartered in San Diego, California. Richard Lowenthal, M.S., MBA, will serve as chief executive officer and president of the combined company. The merger agreement provides that the Board of Directors of the combined company will be comprised of ten members, including seven from ARS and three from Silverback. The merger agreement has been approved by the Board of Directors of each company, and the transaction is expected to close in the fourth quarter of 2022, subject to approvals by the stockholders of each company and other customary closing conditions. About Silverback Therapeutics, Inc. Silverback Therapeutics, Inc. is a biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Silverback Therapeutics is located in Seattle, Washington.

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BUSINESS INSIGHTS

Amylyx Pharmaceuticals Announces ALBRIOZA™ is Now Available in Canada for the Treatment of ALS

Amylyx Pharmaceuticals, Inc | August 01, 2022

Amylyx Pharmaceuticals, Inc. announced that ALBRIOZA™ is now commercially available in Canada for people living with amyotrophic lateral sclerosis. ALBRIOZA is an oral fixed-dose combination therapy that may reduce neuronal cell death as a stand-alone therapy or when added to existing treatments. In a clinical trial, ALBRIOZA significantly slowed disease progression and loss of functional decline in people living with ALS. “We have remained steadfast in our commitment to ensure ALBRIOZA would be available in Canada as quickly as possible following Health Canada’s decision to approve ALBRIOZA, with conditions, in June,” said Margaret Olinger, Chief Commercial Officer at Amylyx. “We are pleased that starting this week, we are ready to fill prescriptions for ALBRIOZA.” Amylyx filed reimbursement submissions to the Canadian Agency for Drugs and Technologies and Institut national d’excellence en santé et en services sociaux in Quebec as part of an aligned Health Technology Assessments (HTA) review with Health Canada in parallel with the regulatory process to reduce the timelines required for patient access. The Company is continuing to work with the pan-Canadian Pharmaceutical Alliance, Federal, Provincial, and Territorial public drug plans, and private insurers to expeditiously achieve listing and reimbursement, so that eligible Canadians living with ALS can have access to ALBRIOZA as quickly and efficiently as possible. “In Canada, prescription drugs undergo a thorough and often long review and approval process across regulatory, HTA, pricing negotiations, and formulary listing with public drug plans. In addition, private insurers have their own review and listing processes. We continue to work diligently to navigate reimbursement processes to pursue broad and equitable access to ALBRIOZA across all provinces in Canada.” Chris Aiello, General Manager and Head of Canada at Amylyx “Market availability is an important milestone in the available treatment options for people living with ALS,” said Tammy Moore, CEO of the ALS Society of Canada. “As we look forward, we do not want to see coverage decisions become a barrier to access, and we urge the decision-makers throughout the drug access and reimbursement process to work expeditiously to provide equitable access for all eligible Canadians living with ALS who are in desperate need.” As part of Amylyx’ continued commitment to the ALS community, through the Amylyx Care Team Support Program, Amylyx provides insurance navigation, treatment coordination and educational support for people living with ALS who have been prescribed ALBRIOZA in Canada and their caregivers. Eligibility and enrollment into the ACT Support Program can be discussed with prescribing health care professionals. About ALBRIOZA™ ALBRIOZA™ is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada and with marketing applications pending in the United States and European Union. The combination of sodium phenylbutyrate and taurursodiol may reduce neuronal cell death, hypothesized to occur by simultaneously mitigating endoplasmic reticulum stress and mitochondrial dysfunction. ALBRIOZA is also being explored for the potential treatment of other neurodegenerative diseases. About Amylyx Pharmaceuticals Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA.

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