PharmaFocus Today – Page 201 – media

Bayer wins latest Roundup cancer trial, ending losing streak

Dec 23 (Reuters) – Bayer has won a trial in a lawsuit brought by a California man who said he developed cancer from exposure to its Roundup weedkiller, ending what had been a five-trial losing streak for the company in trials over similar claims. The verdict was handed down on Friday by a jury in San Benito County, California Superior Court, Bayer announced. The company said in a statement that the verdict was “consistent with the evidence in this case that Roundup does not cause cancer and is not responsible for the plaintiff’s illness.” Lawyers for plaintiff Bruce Jones did not immediately respond to requests for comment. Like most plaintiffs in Roundup lawsuits, Jones alleged that the product caused him to develop a form of cancer called non-Hodgkin lymphoma. Around 165,000 claims have been made against the company for personal injuries allegedly caused by Roundup, which Bayer acquired as part ...
- Source: drugdu
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- December 28, 2023
US FDA warns about counterfeit versions of Novo’s diabetes drug Ozempic

Dec 21 (Reuters) – The U.S. Food and Drug Administration on Thursday warned consumers not to use counterfeit versions of Novo Nordisk’s (NOVOb.CO) diabetes drug Ozempic that have been found in the country’s drug supply chain. The health regulator said it will continue to investigate counterfeit Ozempic 1 milligram injections and has seized thousands of units, but flagged that some may still be available for purchase. Danish drugmaker Novo Nordisk and the FDA are testing the seized products and do not yet have information about the drugs’ identity, quality or safety, the agency said. Novo said the seizures took place in warehouses outside the company’s authorized supply chain. The agency said the needles from the seized injections are counterfeit and their sterility cannot be confirmed, which presents an additional risk of infection for patients. Other confirmed counterfeit components from the seized products include the pen label and accompanying information about ...
- Source: drugdu
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- December 28, 2023
AstraZeneca to buy China’s Gracell Biotechnologies in $1.2 billion deal

Dec 26 (Reuters) – AstraZeneca (AZN.L) said on Tuesday it will buy Gracell Biotechnologies (GRCL.O) for up to $1.2 billion as the Anglo-Swedish pharma company furthers its cell therapy ambitions and boosts its presence in China, the world’s second-largest pharmaceuticals market. The cash deal, which adds several experimental therapies to AstraZeneca’s portfolio, values Gracell at $2 per ordinary share, or $10 per American Depository Share, of Gracell, representing a premium of 61.6% from its last close on Dec. 22. The shareholders will also receive a non-tradable contingent value right of $0.30 per ordinary share, if certain regulatory milestones are met. Shares of China-headquartered Gracell surged 60% in premarket trading in the United States. Gracell’s CAR-T cell therapy works by extracting disease-fighting white blood cells known as T-cells from a patient, re-engineered to attack cancer and infused back into the body. H.C. Wainwright analyst Emily Bodnar said this could be AstraZeneca’s ...
- Source: drugdu
- 180
- December 28, 2023
BMS agrees to acquire Karuna Therapeutics for $14bn

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of all outstanding shares of common stock of biopharmaceutical company Karuna Therapeutics for an equity value totalling $14bn in cash. The new strategic merger deal is part of BMS’ strategy to bolster its neuroscience portfolio. Karuna focuses on the discovery and development of therapies for psychiatric and neurological ailments. Through the transaction, BMS will gain access to Karuna’s lead asset KarXT (xanomeline-trospium). It is a potential antipsychotic therapy for patients with schizophrenia and Alzheimer’s disease psychosis. KarXT possesses a new mechanism of action with varied distinguished efficacy and safety profiles. The US Food and Drug Administration (FDA) recently has accepted Karuna’s new drug application (NDA) for KarXT to treat adult patients with an approval decision anticipated on 26 September next year under the Prescription Drug User Fee Act (PDUFA). The antipsychotic is currently being analysed in registrational clinical ...
- Source: drugdu
- 206
- December 28, 2023
Completion of Phase I Clinical Trial for GLP-1/GIP Dual Receptor Agonist (Injectable THDBH120) with First Subject Enrolled

Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as “the Company” or “Tonghua Dongbao”), a wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., received the approval notice for the clinical trial of injectable THDBH120 (GLP-1/GIP dual receptor agonist) from the National Medical Products Administration Drug Evaluation Center. The company has initiated the Phase I clinical trial and recently completed the enrollment of the first subject. After the approval for clinical use of injectable THDBH120, the company completed the enrollment of the first subject in the Phase I clinical trial in just around half a month, showcasing the company’s accelerated progress in the research and development of innovative products, as well as its ability and determination to transition into an innovative pharmaceutical enterprise. The company will further explore and uncover the potential of injectable THDBH120 in other indications such as obesity, continually opening up new therapeutic areas to maximize the value ...
- Source: drugdu
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- December 28, 2023
Hengrui’s Innovative Drug Pyrotinib Combined Therapy for HER2-Positive Metastatic Breast Cancer Featured in the Sub-journal of ‘Nature’

Recently, the “Pyrotinib Combined with Docetaxel as First-Line Treatment for HER2-Positive Metastatic Breast Cancer: An Open, Multicenter Phase II Clinical Study (PANDORA)” led by Professor Wang Xiaojia from the Affiliated Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) was officially published in the internationally renowned journal “Nature Communications,” a sub-journal of ‘Nature’ (Impact Factor: 16.6). The research results indicate that the combination therapy of pyrotinib and docetaxel demonstrates excellent anti-tumor activity and brings about progression-free survival (PFS) benefits. Research Background: Dual-targeted therapy with trastuzumab combined with taxanes has established the first-line standard treatment for HER2-positive advanced breast cancer [Progression-Free Survival (PFS): 18.7m vs. 12.4m, P<0.001; 8-year Overall Survival (OS) rate: 37% vs. 23%, P<0.001]. However, the inclusion of trastuzumab in the Cleopatra study in a population with prior trastuzumab (referred to as “H”) treatment was only 11%, and it may no longer fully guide current ...
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- December 28, 2023
Moderna and Merck’s Novel Cancer Vaccine, Keytruda Combo Cuts Risk of Skin Cancer Death, Recurrence by Half

Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
- Source: drugdu
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- December 27, 2023
Orthofix has positive spine stimulation tech data

BY SEAN WHOOLEY rthofix Medical (Nasadaq: OFIX)+ today announced new data investigating pulsed electromagnetic field (PEMF) stimulation with lumbar spinal fusion. Lewisville, Texas-based Orthofix evaluated PEMF stimulation as an adjunct to lumbar spinal fusion procedures in patients at risk for pseudoarthrosis. Patients treated with the SpinalStim bone growth device demonstrated a high rate of successful fusion. They also showed significant improvements in pain, function and quality of life, despite having risk factors for pseudoarthrosis. SpinalStim, an FDA-approved bone growth stimulation therapy, offers an adjunct treatment for lumbar spinal fusion. It also functions as a nonsurgical treatment for spinal pseudoarthrosis. The device utilizes PEMF technology that provides 360 degrees of treatment coverage around the fusion site. Orthofix says its system has an overall success rate of 92% in treating spinal fusion surgery patients. Researchers published their data evaluating the SpinalStim system in the International Journal of Spine Surgery. Lead author Dr. ...
- Source: drugdu
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- December 27, 2023
With FDA approval, Ionis and AstraZeneca gear up to launch rare disease drug Wainua

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. More specifically, the agency signed off on the ligand-conjugated antisense oligonucleotide (LICA) drug to treat polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (ATTRv-PN), a rare and often fatal disease that affects 40,000 people globally, the companies said in a press release. The nod was backed by phase 3 data showing Wainua’s ability to provide “consistent and sustained” benefit in outcomes measures, including serum transthyretin concentration and neuropathy impairment, as well as improvements in quality of life. Crucially, Wainua comes in an auto-injector form that patients can administer themselves once a month. That gives the treatment a convenience edge against the competition, including Alnylam’s Onpattro, which is delivered subcutaneously at treatment centers. Despite the Alnylam option, the unmet need for the genetic disease remains ...
- Source: drugdu
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- December 27, 2023
Big Pharma reworks China strategy, and job cuts are part of it

Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
- Source: drugdu
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- December 27, 2023

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