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HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, January 30, 2024: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that the marketing approval of ELUNATE® (fruquintinib) by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). ELUNATE® is a selective oral inhibitor of vascular endothelial growth factor (“VEGF”) receptors -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis. This marks the first medicine to be approved under the new mechanism for registration of new drugs (“1+” mechanism) announced by the Government of the Hong Kong Special Administrative Region (“SAR”) in October last year. The mechanism officially commenced on November 1, 2023. It allows drugs which are beneficial for treatment of life-threatening or severely debilitating diseases to apply for registration for use in Hong Kong, if they have supporting local clinical data and recognition ...
- Source: drugdu
- 125
- February 1, 2024
Rezzayo approved to treat adult patients with invasive candidiasis

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat a fungal infection called invasive candidiasis. Invasive candidiasis is an infection caused by a yeast called Candida. While some common Candida infections (such as thrush) are easily treatable and do not pose a serious risk to health, invasive candidiasis is a severe infection that can affect the blood, heart, brain, eyes and bones and other parts of the body. Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us. We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review. The treatment is administered once a week by a drip into the ...
- Source: drugdu
- 164
- February 1, 2024
FDA rejects Defender Pharma’s motion sickness nasal gel candidate

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. regulator has sent a complete response letter (CRL) to Defender Pharmaceuticals, rejecting DPI-396 for the prevention of nausea and vomiting induced by motion. Barry Feinberg, M.D., the CEO of Defender, a privately held St. Louis company, said in a release that the firm will schedule a meeting with the FDA so it can “understand the issues raised in the CRL so we can develop and implement a comprehensive action plan.” “We remain confident that our intranasal scopolamine is a safe and effective therapy,” Feinberg added. In 2012, the NASA teamed with Irvine, California-based Epiomed Therapeutics to develop a nasal spray version of scopolamine. Astronauts often experience motion sickness in space. Two years later, Defender purchased Epiomed, according to the St. Louis Post-Dispatch. Also working to develop the treatment has ...
- Source: drugdu
- 118
- February 1, 2024
As AstraZeneca gears up for courtroom showdown over IRA, Novo’s case faces separate HHS rebuke

When the Biden administration welcomed the passing of the Inflation Reduction Act (IRA) in August 2022, it marked a rare defeat for the pharmaceutical industry in Washington, D.C. Naturally, drugmakers didn’t lie down without a fight on the controversial topic of Medicare price negotiations. Now, new developments show that the Biden administration is willing to go to the mat in defense of the IRA negotiations. Wednesday, lawyers for AstraZeneca are set to engage in oral arguments against the U.S. Department of Justice in a federal court, according to a September court order and a new report from Bloomberg Law. The British drugmaker aims to challenge the legality of the drug pricing provisions put in place under the IRA, which will allow Medicare to haggle over the prices of some of the costliest drugs it covers starting in 2026. AstraZeneca’s diabetes blockbuster Farxiga ranks among the 10 drugs that were selected ...
- Source: drugdu
- 97
- February 1, 2024
CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13i) Receives Phase III Clinical Trial Summary Report

Recently, CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT vector) (hereinafter referred to as “PCV13i”) has obtained the summary report of the Phase III clinical trial. The report shows that the vaccine has good safety and immunogenicity, and the clinical study has reached the predefined clinical endpoints in the target population. CanSinoBio’s PCV13i adopts the covalent combination of polysaccharide antigen and protein carrier. After the polysaccharide antigen connects to the carrier protein, the polysaccharide can be transformed into T-cell-dependent antigen, which not only induces high specific antibody levels in infants and young children under the age of 2 years, but also generates memory B-cells and produces immune memory. At the same time, the company adopts dual-carrier technology, which can reduce the immunosuppression on immunogenicity caused by co-injection with other vaccines. In terms of production process, CanSinoBio adopts a safer production process, and the fermentation medium adopts medium of no animal ...
- Source: drugdu
- 201
- February 1, 2024
Dual-carrier 13-valent Pneumococcal Conjugate Vaccine Receives Overseas Orders, Signs Sales Contract with Indonesian Partner, and Will Soon Realize First Batch of Exports

Recently, BIOKANGTAI’s wholly-owned subsidiary, Beijing Minhai Biotechnology, has signed a sales contract with its Indonesian partner, in which a detailed agreement was made on the quantity, unit price, total amount of the order, and shipment date of the world’s first dual-carrier 13-valent pneumococcal conjugate vaccine developed and produced by BIOKANGTAI to be exported to Indonesia. In October 2023, Minhai Biotech obtained the Marketing License for 13-valent Pneumococcal Polysaccharide Conjugate Vaccine issued by the Indonesian Food and Drug Administration, marking that the vaccine has the basic conditions for sale in the local market in Indonesia. The signing of this contract indicates that after years of market expansion, Kangtai’s 13-valent pneumococcal vaccine has formally opened for overseas sales, and as the relevant work continues to progress, this variety will bring new growth points for the company’s 2024 annual results. Dr. Lucia Rizka Andalusia, Acting Head of Indonesia’s Food and Drug Regulatory Agency ...
- Source: drugdu
- 98
- February 1, 2024
【EXPERT Q&A】What documents and certifications are needed, and what are the main processes for exporting pharmaceuticals to Canada?

Drugdu.com expert’s response: Exporting pharmaceuticals to Canada requires adherence to specific processes and regulations. Here are the key steps for exporting pharmaceuticals to Canada: Understanding Canadian Regulations: Before exporting, familiarize yourself with the pharmaceutical regulations and regulatory requirements of Canada. Health Canada is the regulatory authority responsible for formulating and enforcing policies on drug imports. Familiarity with these regulations is essential to ensure that the exported pharmaceuticals comply with Canadian standards. Registration and Approval: Pharmaceuticals must be registered and approved by Health Canada before export. Depending on the type of drug, different application forms and materials may be required. Specific requirements can be found on Health Canada’s official website: https://www.canada.ca/en/health-canada.html Quality Management in Drug Production: Ensure that exported pharmaceuticals meet Canadian Good Manufacturing Practices (GMP). Exporting companies should regularly conduct internal audits to ensure compliance with GMP standards. Product Labeling and Instructions: Pharmaceutical labels and instructions must be prepared according ...
- Source: drugdu
- 233
- February 1, 2024
Pfizer’s layoff campaign ramps back up with dozens of SF-area cuts expected next month

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake.Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act (WARN) alert. That address matches the former headquarters of Global Blood Therapeutics, which Pfizer scooped up for $5.4 billion back in 2022. Along with the deal, Pfizer gained GBT’s marketed sickle cell disease drug Oxbryta. “As previously communicated, Pfizer has launched an enterprise-wide cost realignment program,” a Pfizer spokesperson said via email. The program will “result in some job loss across a number of our locations, including South San Francisco,” the spokesperson said.“Pfizer does not take these changes lightly,” she added. GBT’s Oxbryta won FDA approval in sickle cell disease back in 2019. When Pfizer closed its GBT buyout in October 2022, ...
- Source: drugdu
- 164
- January 31, 2024
Grifols files lawsuit against hedge fund for making ‘false and misleading statements’

Spanish plasma medicines producer Grifols is clapping back at Gotham City Research, filing a lawsuit that accuses the New York hedge fund of “knowingly making false and misleading statements” about the company “to manipulate the value of Grifols’ stock for their own monetary gain.” The complaint, filed in federal court in the Southern District of New York, comes in response to a report from Gotham on Jan. 9 which accused Grifols of wrongful accounting practices.Gotham called Grifols shares “uninvestable,” and over the next several days the report triggered a drop in Grifols shares of more than 30% and a freefall of its market cap from $7.6 billion to $4.6 billion. In reaction to the Gotham report, in a regulatory filing to Spain’s stock market watchdog CNMV, Grifols called it “false information” and “speculation.” The accounting questions raised by Gotham surround Grifols’ 2018 acquisitions of Haema AG and Biotest though its subsidiary Scranton Enterprises. In essence, Gotham said Grifols has underreported ...
- Source: drugdu
- 210
- January 31, 2024
Groundbreaking CRISPR Technology Could Revolutionize Diagnosis of Genetic Diseases

Diagnosing rare genetic diseases presents a significant challenge due to their complex and often hidden nature. These conditions can arise from a diverse array of genetic variations, many of which are uncommon or specific to each individual, complicating the identification of the exact cause of symptoms. Until recently, unraveling these mysteries involved extensive genetic testing and comparing an individual’s genetic profile against established disease patterns. Complicating matters further, many relevant genes are inactive in commonly tested tissues like blood and skin, which makes it difficult to get a clear picture of the genetic basis of these diseases. This complexity not only prolongs the diagnostic process but also extends patient and family uncertainty and delays the initiation of suitable treatments. Now, a new study could mark a significant step forward in the rapid and efficient diagnosis of these complex diseases, which can affect any part of the body. At Aarhus University ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294800054/groundbreaking-crispr-technology-could-revolutionize-diagnosis-of-genetic-diseases.html
- 156
- January 31, 2024

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