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Regeneron to acquire Decibel Therapeutics in deal worth up to $213m

Regeneron Pharmaceuticals has entered into a definitive agreement to acquire hearing loss specialist Decibel Therapeutics in a deal worth as much as $213m. The transaction gives Regeneron access to investigational gene therapy, DB-OTO, which is designed to provide hearing to people with otoferlin-related hearing loss. The candidate is currently in phase 1/2 clinical development. Under the terms of the agreement, Regeneron will pay $4 per share of Decibel common stock, with an additional non-tradeable contingent value right (CVR) for $3.50 apiece, upon achievement of certain clinical development and regulatory milestones for DB-OTO. The deal gives Decibel a total equity value of about $109m, based on the amount payable at closing, though that valuation increases to $213m if the CVR milestones are met. The agreement builds on the existing gene therapy collaboration between Regeneron and Decibel aimed at developing three programmes targeting different forms of congenital, monogenic hearing loss. There are ...
- Source: drugdu
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- August 14, 2023
Galera Lays Off 70% of Staff After FDA Rejection in Severe Oral Mucositis

Pictured: FDA sign in its headquarters/iStock, Grandbrothers The FDA rejected on Wednesday Galera Therapeutics’ avasopasem manganese, which the company was proposing as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer. Galera shares fell 83% in after-hours trading in response to the FDA’s rejection. In its Complete Response Letter, the regulator said that Galera’s data were “not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.” The FDA noted that it will need results from an additional trial if the company wants to file a resubmission. The New Drug Application for avasopasem manganese included data from the Phase III ROMAN study, topline data from which showed that treatment with Galera’s candidate significantly reduced the incidence of radiotherapy-induced severe oral mucositis (SOM). The company supported these findings with results from the Phase ...
- Source: drugdu
- 124
- August 14, 2023
Thermo Fisher Scientific Selected as the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) for the U.S. National Institute of Allergy and Infectious Diseases

T-SCCC will support initiatives seeking to ensure success of organ transplants for patients WILMINGTON, N.C.–(BUSINESS WIRE)– The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the United States. This center will offer a broad range of support services critical to the design, development, execution and analysis of NIAID transplantation clinical trials and research. According to the United Network for Organ Sharing, the non-profit serving as the nation’s transplant system under contract with the federal government, more than 40,000 organ transplants were performed in 2022, setting an annual record, with total kidney transplants exceeding 25,000 for the first time ever. Meanwhile, the Health Resources & Services Administration within the U.S. Department ...
- Source: drugdu
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- August 14, 2023
【EXPERT Q&A】What might be the reasons for not closing deals despite following up with many clients?

Drugdu.com expert’s response: For foreign trade salespeople, every inquiry received is hard-won and should be treasured. However, inevitably among these inquiries, there will be phishing emails, junk inquiries, and even more seriously, potential scammers. Therefore, upon receiving an email, the immediate response is not advisable. Instead, it’s essential first to discern and analyze. How to handle and reply to inquiries more effectively is the key to success. 1. Determine authenticity: 01 Check the IP: Check the sender’s IP by right-clicking the email, selecting properties-details to view the IP address of the email. Determine its geographical location. Also, cross-reference the IP records in the website counter to observe whether the visitor clicked a link to enter the website or typed in your URL directly. 02 Consider the sending time: Look at the email sending time and account for time zone differences. Generally, no one would send emails in the middle ...
- Source: drugdu
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- August 14, 2023
Foreign Trade Experience
Boston Scientific receives FDA approval for cryoablation system

Dive Brief Boston Scientific on Thursday received approval from the Food and Drug Administration for a new heart ablation device to treat atrial fibrillation, according to a company announcement. The POLARx Cryoablation System can accommodate two balloon sizes in one catheter, which Boston Scientific said allows physicians to tailor care to individual patients. The device has been selling well in Europe and Japan, where it is cleared for use, CEO Mike Mahoney said in an earnings call last month. Boston Scientific has been competing with companies like Johnson & Johnson and Medtronic, which are also bringing new cardiac ablation devices to market. Dive Insight Cryoablation is a minimally invasive procedure that uses a balloon catheter to freeze tissue near the pulmonary vein. Scars then block irregular electric signals that can cause atrial fibrillation. Switching between two balloon sizes, clinicians can adjust the device to a patient’s anatomy during a procedure, ...
- Source: drugdu
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- August 12, 2023
New mechanism discovered for brain repair after ischemic stroke

Patients often experience functional decline after an ischemic stroke, especially due to the brain’s resistance to regenerate after damage. Yet, there is still potential for recovery as surviving neurons can activate repair mechanisms to limit and even reverse the damage caused by the stroke. How is it triggered though? In a study published recently in Neuron, researchers from Tokyo Medical and Dental University (TMDU) provided new insights regarding this question by identifying a new mechanism. They discovered that neurons surrounding the area of cell death secrete lipids that can trigger brain-autonomous neural repair after ischemic brain injury. An ischemic stroke occurs when the blood supply to the brain is blocked and results in the death of brain cells. This condition is life-threatening, and patients will likely develop functional disabilities. Although the adult brain can self-repair, the underlying mechanisms need further clarification. Inflammation of the brain contributes to the effects of ...
- Source: drugdu
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- August 12, 2023
Pfizer faces whistleblower lawsuit from former compliance manager who says he flagged possible fraud in China

After Pfizer allegedly fired a compliance manager for raising the flag on potential fraud activity in China, the former employee is hitting back. Frank Han, the former director of global compliance analytics at Pfizer, has filed a civil complaint against the drugmaker. In the California lawsuit, Han claims he was terminated for identifying potential Foreign Corrupt Practices Act (FCPA) issues within the company. Han worked for Pfizer from May 2017 to November 2022, according to the court documents. Back in 2021, Han says he discovered that Pfizer had spent “over ten times the amount of money” on potentially influential government officials (PIGOs) in China than the company had spent on those officials in other countries, the court documents state. Specifically, Pfizer spent $168 million on PIGOs in China between the second quarter of 2019 and the third quarter of 2021, Han’s work found. That compared to $12 million in the ...
- Source: drugdu
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- August 12, 2023
Novo Nordisk spends $1bn to acquire weight loss drug developer Inversago.

Amongst fierce competition in the obesity space, Novo Nordisk has spent $1bn to acquire Inversago Pharma to shore up its weight loss treatment portfolio. The acquisition is expected to be completed by the end of 2023 and will hit the billion-dollar mark, subject to developmental and commercial milestones. The deal, which comes a month after Eli Lilly acquired Versanis and its lead weight loss candidate, bimagrumab, in a $1.9bn deal, will include Inversago’s lead asset INV-202, an oral cannabinoid receptor type-1 (CB1) inverse agonist. Novo Nordisk said it intends to use the candidate for patients with obesity and obesity-related complications. Canada-based Inversago demonstrated the weight loss potential of the candidate in a Phase Ia trial by blocking the CB1 receptor, which plays an important role in appetite regulation and metabolism. INV-202 is currently in a Phase II trial for diabetic kidney disease (NCT05514548). Prior to the 10 August announcement, Novo ...
- Source: drugdu
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- August 12, 2023
JCVI announces advice for autumn COVID-19 booster vaccine eligibility

The Joint Committee on Vaccination and Immunisation (JCVI) has announced its advice in relation to details surrounding the eligibility of this autumn’s COVID-19 booster vaccine. As the UK COVID-19 vaccination programme enters its third autumn season, the Committee has advised offering the booster to those at high risk of serious disease and who are therefore more likely to benefit from the vaccination. This includes all adults aged 65 years and older, residents in care homes for older adults, those aged six months to 64 years in a clinical risk group, those aged 16 to 64 years who are carers and staff working in care homes for adults. The COVID-19 booster vaccine helps to protect against severe illness, hospitalisations and deaths from COVID-19. Dr Mary Ramsay, director of public health programmes at the UK Health Security Agency, said the COVID-19 virus is “circling more widely over the winter months, with the ...
- Source: drugdu
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- August 12, 2023
Novartis shares promising phase 3 results for BTK inhibitor in chronic hives

Novartis has shared positive top-line results from two late-stage studies evaluating its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines. Affecting 40 million people worldwide, CSU is a debilitating and unpredictable condition characterised by the occurrence of itchy hives and/or deep tissue swelling that lasts for six weeks or longer. H1-antihistamines are the first-line treatment for the condition; however, approximately 60% of patients are inadequately controlled by these alone and continue to live with the distressing symptoms of CSU. Novartis’ remibrutinib works by blocking the cascade of BTK, an enzyme central to the release of histamine and, when spontaneously activated, plays a critical role in the symptoms associated with CSU. The ongoing phase 3 REMIX-1 and REMIX-2 trials met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at week 12, demonstrating clinically ...
- Source: drugdu
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- August 12, 2023

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