PharmaFocus Today – Page 233 – media

After missing out on FDA voucher, bluebird quickly raises funds to support gene therapy launches

Despite bluebird bio winning a recent FDA nod for its much-anticipated sickle cell disease gene therapy Lyfgenia, the regulatory triumph left something to be desired for the company because the agency didn’t grant a lucrative priority review voucher (PRV). That came as a surprise to bluebird, which had previously inked a deal to sell a potential PRV to Novartis for $103 million. Now, bluebird is hurrying to raise millions of dollars—through two separate avenues—to fund the launch of its new sickle cell disease gene therapy and others. In one fundraising approach, bluebird said it reached an agreement to hand over future gene therapy revenues to Alterna Capital Solutions in exchange for up-front funding. The deal covers a maximum credit of $100 million for bluebird, the company said in an SEC filing (PDF). Additionally, bluebird is working with Goldman Sachs and J.P. Morgan Securities to sell $150 million in new shares. ...
- Source: drugdu
- 109
- December 21, 2023
Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent

A German court has dealt the first blow against CureVac amid the company’s heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. The German Federal Patent Court ruled that one of eight CureVac patents involved in the litigation is invalid, the company said in a Tuesday release. The patent in question covers a process that improves the expression of mRNA in cells, Juve Patent reports. The ruling came as a surprise to CureVac, which noted that the court in April issued a preliminary opinion in favor of the patent’s validity. Still, CureVac believes its “pioneering role in mRNA technology and continuing innovation in the field made essential contributions to safe and efficacious COVID-19 vaccines,” CEO Dr. Alexander Zehnder said in a statement. The company will “continue to defend our claim for recognition and fair compensation and will take appropriate action by appealing this decision,” Zehnder added. CureVac’s appeal ...
- Source: drugdu
- 119
- December 21, 2023
Signing ceremony between the Municipality of Bogotá, Colombia and SINOVAC for the official launch of the joint venture BogotáBio

On December 18th, local time in Colombia, a signing ceremony was held between the Municipality of Bogotá and SINOVAC. Claudia López Hernández, Mayor of Bogota, and Weidong Yin, Chairman, President and CEO of SINOVAC, signed the cooperation agreement on behalf of the two parties for the Bogota Vaccine Plant Project and announced the official launch of BogotáBio, a joint venture company jointly funded by the two parties. The Bogotá Vaccine Factory project will promote the localized production of a variety of vaccines in Colombia as well as the research and development of new vaccines and innovations, thereby enhancing the local capacity to respond to infectious diseases and prepare for the next pandemic. The signing ceremony was attended by Colombian Foreign Minister Álvaro Leyva Durán, Chinese Ambassador to Colombia Zhu Jingyang, Colombian Deputy Minister of Trade, Industry and Tourism Quintero, and nearly 60 guests from the Colombian central government, Bogota city ...
- Source: drugdu
- 157
- December 21, 2023
The First Da Vinci Xi Surgical Robot Made in China Officially “Onboarded”, Making High-Quality Medical Resources More Accessible

On December 18, the start-up ceremony of the Da Vinci surgical robot was successfully held in Gansu Hospital, Affiliated Cancer Hospital of Sun Yat-sen University. This marks that the first domestic Da Vinci Xi surgical robot has officially settled in Gansu Hospital of Sun Yat-sen University Cancer Hospital, helping the construction of the national regional medical center, bringing more efficient, accurate and safer surgical treatments to the majority of patients, and marking the commercialization of the domestic Da Vinci surgical robot into the era. After the launching ceremony, the Da Vinci Xi surgical robot was formally “on duty” in the operating room of Gansu Hospital, Affiliated Cancer Hospital of Sun Yat-sen University. With the assistance of the surgical robot, Executive Director Prof. Liu Zhuowei’s team successfully performed “robot-assisted partial nephrectomy” for the patient. Prof. Liu Zhuowei introduced that the surgical robot makes the surgical incision smaller, less painful, shortens the ...
- Source: drugdu
- 115
- December 21, 2023
Smartwatches prove effective in detecting heart arrhythmias in children

A recent study published in the journal Communications Medicine discusses how smartwatches can facilitate the diagnosis of arrhythmias in children. Background Smartwatches and other wearable devices are becoming increasingly popular and allow users to constantly monitor their health, leading to their value for medical diagnosis becoming well-recognized. While the utility of these devices for adults has been widely researched, including for cardiac health monitoring and reducing the time needed to detect symptomatic rhythms, little is known about how they can be used to monitor child health indicators. Palpitations and abnormalities in cardiac rhythms are a leading cause of referrals in pediatric cardiology. However, existing non-invasive methods like patch rhythm monitors are not always effective in diagnosing arrhythmias, as symptoms often present infrequently, and children cannot wear monitors for as long as adults. Invasive methods such as implantable loop monitors (ILR) allow long-term monitoring. However, this approach may not be ideal ...
- Source: drugdu
- 132
- December 20, 2023
Fluorescence Microscopy Combined with AI Enables Detection of Tumors at Early Stage

Detecting cancer in the body or monitoring it during therapy is typically a time-consuming process, often conducted in later phases when signs become obvious. Researchers engaged in cancer research are continuously seeking reliable and sensitive techniques to detect a developing tumor at a very early stage and to closely monitor the success or failure of cancer therapy. Therefore, a breakthrough in early cancer diagnosis is a significant advancement. Researchers have now achieved a breakthrough with the development of a test for early diagnosis of cancer. Researchers at the Paul Scherrer Institute (Würenlingen, Switzerland) have demonstrated that changes in the organization of the cell nucleus of certain blood cells can reliably indicate the presence of a tumor in the body. Using fluorescence microscopy, the team examined the chromatin of these blood cells – DNA packaged into a complex structure. They analyzed about 200 different characteristics, including the external texture, the packing ...
- Source: drugdu
- 122
- December 20, 2023
Illumina’s Antitrust Battles to End With Divestiture of Cancer Test Maker Grail

Illumina has decided against further appeals of U.S. and European antitrust litigation challenging its acquisition of liquid biopsy company Grail. Illumina expects to have terms of the divestiture set by the end of the second quarter of 2024. By FRANK VINLUAN Illumina is done fighting in the courts to keep cancer-detection company Grail. The gene-sequencing giant had previously pledged to divest Grail if it did not win either the U.S. or European appeals of anti-trust cases challenging the acquisition. A U.S. appeals court came down against the Federal Trade Commission’s case on Friday, but in a narrow way that hardly handed Illumina a clear victory. After reviewing the decision, Illumina said Sunday that it has decided against further litigation. The company will divest Grail. The planned divestiture is the latest step in a journey that started within Illumina. Grail began as research within the San Diego company. Grail spun out ...
- Source: drugdu
- 117
- December 20, 2023
Point Bio Prostate Cancer Therapy Meets Phase 3 Goal, But Results Still Disappoint

Despite achieving its Phase 3 study’s main goal, the results for Point Biopharma’s therapy are short of what Novartis radiopharmaceutical Pluvicto achieved in a similarly designed clinical trial. Nevertheless, the data readout should clear the way for Eli Lilly to complete its $1.4 billion acquisition of Point. By FRANK VINLUAN A Point Biopharma Global cancer therapy key to a $1.4 billion Eli Lilly M&A deal has met the main goal of its pivotal clinical trial in prostate cancer. But the results raise questions about how well the drug will match up against a radiopharmaceutical marketed by Novartis. The Point drug, PNT2002, is also a radiopharmaceutical. It offers targeted delivery of a radioactive particle by linking it to a ligand that targets PSMA, a protein abundant on the surface of prostate cancer cells. The open-label Phase 3 study evaluated the Point radiopharmaceutical in patients with cases of prostate cancer that has ...
- Source: drugdu
- 122
- December 20, 2023
Chilean President Gavriel Borich Meets with Yin Weidong, Chairman, President and CEO of SINOVAC

On December 12, 2023, local time, Chilean President Gavriel Borich met with Yin Weidong, Chairman, President and CEO of SINOVAC, and his delegation at the Presidential Palace. The two sides reached an agreement on the localization of vaccine production and cooperation in the research and development of health products, and the Chilean government will strongly support SINOVAC’s project promotion in the region. President Borich began by recalling his successful visit to China not long ago, emphasizing that when he met with President Xi Jinping, they jointly identified the need to further deepen cooperation in the health sector among the many bilateral cooperation between China and Chile. He also indicated that the Chilean government has set the strategic goal of developing vaccine R&D and industrialization in Chile. Chairman Yin Weidong responded, “His Excellency the President’s visit to China was indeed a great success, and the charisma you displayed attracted many Chinese ...
- Source: drugdu
- 112
- December 20, 2023
CanSino Bio and SPIMACO Signed a Cooperation Agreement on Innovative Vaccines, Continuing to Deepen the Comprehensive Strategic Partnership

Recently, China-Saudi Arabia Investment Conference was held in Beijing. As a representative of China’s innovative vaccine enterprises, CanSino Bio signed a vaccine cooperation framework agreement with SPIMACO, a Saudi Arabian pharmaceutical manufacturing company, at the Major Investment Collective Signing Ceremony, in which the two parties will cooperate in the commercialization of innovative vaccines, joint R&D and clinical research, as well as localized production. According to the agreement, the cooperation will focus on promoting the entry of CanSino Bio’s quadrivalent conjugate vaccine Manhexin® into Saudi Arabia and other markets in the Middle East and North Africa region. In Saudi Arabia, the quadrivalent conjugate vaccine has been included in the country’s childhood immunization program, and there is a strong demand for a quadrivalent conjugate vaccine with longer-lasting immunoprotection effect and higher safety in the local market. Post-marketing data shows that Mannhexin®, a quadrivalent conjugate vaccine from CanSino Bio, has a very impressive ...
- Source: drugdu
- 123
- December 20, 2023

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