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Zerva acquires Acer Therapeutics to bolster rare disease portfolio

Zerva Therapeutics, formerly KemPharm, has announced a strategic acquisition of Acer Therapeutics to expand its rare therapies portfolio. The biggest Acer assets include the marketed rare therapy Olpruva (sodium phenylbutyrate formulation), and late-stage drug celiprolol. The acquisition is expected to be worth up to $91m in stock and cash payments, of which $76m is contingent upon milestone-based payments for Olpruva and celiprolol. Additionally, Zerva purchased Acer’s secured debt of more than $17m at a discounted value of $16.5m from its creditor, Nantahala Capital. The news caused Acer’s stock to skyrocket by 140% when the markets opened on 31 August. Zerva has a market cap of $165.25m, with a reported Q1 2023 revenue of $2.9m, as per the company’s financial report. Whilst Acer reported a loss of $8.1m in Q2 2023, as per the company’s Q2 financials. Olpruva is an oral suspension approved for the treatment of urea cycle disorders by ...
- Source: drugdu
- 105
- September 4, 2023
HHS calls for easing restrictions on marijuana, sending cannabis stocks higher

The U.S. Department of Health and Human Services has recommended reclassifying marijuana as a lower-risk drug, which would in turn ease restrictions on the budding business, a spokesperson for the Drug Enforcement Administration told CNBC on Wednesday. Marijuana is currently a Schedule I drug under the Controlled Substances Act, meaning it’s deemed to have no currently accepted medical use and a high potential for abuse. Despite being legalized for recreational use in nearly half of states, marijuana’s federal classification alongside drugs such as heroin and LSD has hindered the industry’s growth. After enjoying a sales surge during the Covid-19 pandemic, the industry is in free fall as investors turn away and capital dries up. The industry has also been barred from accessing most banking services, or from being traded across state lines, resulting in a glut of cannabis in many states and a drop in prices. A federal reclassification could ...
- Source: drugdu
- 100
- September 4, 2023
International survey reveals varying effects of oral medicines for Parkinson’s

An international survey conducted by Parkinson’s Europe, developed in partnership with STADA, has revealed that people taking oral medications for Parkinson’s disease experience varying effects. The survey, financially supported by STADA’s affiliate Brittania Pharmaceuticals, involved 992 participants with advanced Parkinson’s across 53 countries. It revealed that more than 96% of respondents said that they took medication for their condition, two-thirds of which were receiving oral levodopa or another single oral therapy. Parkinson’s disease is a neurodegenerative disease that progressively damages parts of the brain. Symptoms of advanced Parkinson’s are more complex and have a stronger effect on day-to-day life. The study revealed that 65% of respondents reported varying effects; 42% reported a partial response without the usual resolution of motor symptoms; 40% reported a delayed onset of effect; and 60% reported that they ‘regularly’ or ‘often’ experienced the effect of a medication wearing off before the next dose. It also ...
- Source: drugdu
- 103
- September 4, 2023
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

Dive Brief Medtech trade groups have voiced support for the Centers for Medicare and Medicaid Services’ plan to accelerate reimbursement of certain breakthrough devices. In letters sent on the same day, AdvaMed and the Medical Device Manufacturers Association (MDMA) urged CMS to quickly finalize the program, while also naming changes they want the centers to make. The trade groups recommended changes including the expansion of the CMS program to cover breakthrough diagnostics, products authorized in the previous three years and medical devices that are nearing approval. Dive Insight In June, CMS released a draft version of the Transitional Coverage for Emerging Technologies (TCET) pathway for consultation. The path could fill a gap created by the repeal of the contentious Medicare Coverage for Innovative Medical Technologies plan and address industry calls to cut the gap between device approval and reimbursement. AdvaMed and MDMA submitted feedback on the new proposal to CMS ...
- Source: drugdu
- 149
- September 1, 2023
Man-made antibody successfully prevents organ rejection after transplantation

A man-made antibody successfully prevented organ rejection when tested in primates that had undergone a kidney transplant, Duke Health researchers report. The finding clears the way for the new monoclonal antibody to move forward in human clinical trials. Results of the study appear online Aug. 30 in the journal Science Translational Medicine. Imran J. Anwar, (M.D., lead author, surgical research fellow in Duke’s Department of Surgery) said, “Current medications to prevent organ rejection are good overall, but they have a lot of side effects. These therapies suppress the immune system, putting patients at risk of infections and organ damage, and many cause non-immune complications such as diabetes and high blood pressure. The push over the last 30 to 40 years has been to develop new, less toxic drugs. We are hopeful this antibody moves us closer to that goal.” Anwar and colleagues, including co-senior author Allan Kirk, M.D., Ph.D., chair ...
- Source: drugdu
- 119
- September 1, 2023
Pfizer, BioNTech Challenge Moderna’s COVID-19 Patents with USPTO

By Tristan Manalac Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis Pfizer and German partner BioNTech on Monday asked the U.S. Patent and Trademark Office to reconsider, and ultimately invalidate, Moderna’s patents over core technologies of the COVID-19 vaccine, Reuters reported. In an 87-page document, the partner companies argued that the Moderna patents are “unimaginably broad” and seek to claim ownership of knowledge that had existed long before its asserted priority date of 2015. Pfizer and BioNTech contend that using injecting mRNA into cells to produce a protein—and in turn leveraging this process to produce vaccines that prime immune protection—had been demonstrated and documented in the scientific literature as early as the 1990s. Moderna’s patent claims over any mRNA sequence encoding any betacoronavirus spike protein or its subunit, as well as a lipid-based formulation for delivery, is an “attempt to coopt and entire field of mRNA technology,” Pfizer and BioNTech argued ...
- Source: drugdu
- 111
- September 1, 2023
Novo Bolsters Obesity Pipeline with Potential $500M Embark Biotech Buy

By Kate Goodwin Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Novo participated in the seed round for Embark in 2017 when the biotech spun out from Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen. The company said it was founded on the discovery of a “novel target that suppresses appetite increases energy expenditure and enhances insulin sensitivity.” The acquisition announced Wednesday gives Novo full rights to develop and commercialize Embark Biotech’s lead metabolic program, currently in preclinical stages. Included is a three-year R&D collaboration with Embark Laboratories, a new company being formed by the biotech’s team to develop therapies for obesity and related conditions, with ...
- Source: drugdu
- 210
- September 1, 2023
Amid shortage, FDA clears several generics of Takeda’s popular ADHD drug Vyvanse

After 16 years on the market, Takeda’s blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. The med, which is also approved for binge-eating disorder, has been in short supply since June due to a “manufacturing delay compounded by increased demand,” the company said in a statement earlier this summer. Now, generics may soon help ease the supply situation. On Aug. 25, the FDA cleared many copycats of the drug. The now-approved generics range in dosage from 10 mg to 70 mg and come in capsule and chewable forms. Manufacturers such as Teva, Sun Pharmaceutical, Actavis, Mylan, Hikma and others have cleared the agency’s regulatory bar with their generics. It’s not clear whether any of the companies have actually launched their copycats in the U.S. Takeda’s patents on its branded version expired Aug. 24. Whenever they debut, the generics will surely be welcomed by patients. A 100-day ...
- Source: drugdu
- 129
- September 1, 2023
FDA shuns Outlook Therapeutics with wet AMD drug BLA rejection

It is a bleak view for Outlook Therapeutics’ wet age-related macular degeneration (AMD) treatment plans after the US Food and Drug Administration (FDA) rejected a biologic licence application (BLA) for the company’s bevacizumab-vikg candidate. Shares in Outlook Therapeutics fell a hefty 80% when the market opened on 30 August. Prior to the FDA’s complete response letter (CRL), a GlobalData consensus estimated Outlook to potentially earn $989m in 2029 if the drug was approved. GlobalData is the parent company of Pharmaceutical Technology. Despite ONS-5010 (bevacizumab-vikg) demonstrating positive results in a trial – meeting safety and efficacy endpoints, the agency noted several manufacturing issues and the need for additional confirmatory clinical data. In a conference call on 30 August, Outlook Therapeutics’ CEO Russell Trenary said: “We are disappointed, and we were certainly not expecting to receive a CRL back from the FDA.” He added that the company believes the chemistry, manufacturing, and ...
- Source: drugdu
- 109
- September 1, 2023
Merck receives EC approval for Keytruda combination in gastric cancer

Merck & Co – known as MSD outside the US and Canada – has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the European Commission (EC) as part of a combination treatment for certain gastric cancer patients. The therapy is now approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Patients eligible for the Keytruda regimen will also have tumours that express PD-L1 with a combined positive score of one or more, the company outlined. Gastric cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of cancer death worldwide, with nearly 1.1 million new cases diagnosed and more than 768,000 deaths from the disease globally in 2020. Most gastric cancers are adenocarcinomas, which develop from cells in the innermost lining of the stomach. As the disease ...
- Source: drugdu
- 107
- September 1, 2023

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