PharmaFocus Today – Page 226 – media

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
- 140
- 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
- 118
- 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
- 247
- 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
- 116
- 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
- 185
- 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
- 312
- 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
- 185
- January 31, 2024
Hengrui Medicine’s immunosuppressant tacrolimus sustained-release capsules were approved for marketing in the United States

Recently, Chengdu Shengdi Medical Company Co., Ltd.., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, U.S. generic drug application) for tacrolimus extended-release capsules has been approved for marketing in the U.S.. This product is suitable for use in combination with other immunosuppressants to prevent graft rejection after adult kidney transplantation. The company’s tacrolimus sustained-release capsules are the first generic drug approved by the U.S. FDA for marketing, and are also the first domestic generic products. They have been approved for marketing in China in June 2022. Tacrolimus is the core basic immunosuppressant after transplantation [1]. It is a calcineurin inhibitor (CNI). Its mechanism is to inhibit the activity of calcineurin, thereby inhibiting the production of various cytokines. Expression and/or production, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., ultimately inhibit T lymphocyte activation and ...
- Source: drugdu
- 156
- January 31, 2024
FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo’s Enhertu for HER2+ Solid Tumors

Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 Enhertu is a HER2-directed antibody-drug conjugate (ADC) with approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction (GEJ) adenocarcinoma. “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. ...
- Source: https://www.pharmexec.com/authors/pharmaceutical-executive-editorial-staff
- 179
- January 31, 2024
EMA to support establishment of the African Medicines Agency

EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors. The European Commission’s Directorate-General for International Partnerships has signed an agreement with EMA marking the official launch of the project.AMA will be a specialised agency of the African Union (AU) dedicated to improving equitable access to quality, safe and effective medical products in Africa. To date, 27 countries have ratified the AMA treaty, and more AU members are expected to complete the process in the coming months. The creation of AMA is a unique opportunity to facilitate the regulation and oversight of key medicines at continental level, promoting collaboration among African countries and regions. Cooperation and collaboration are in the DNA of the European medicines ...
- Source: drugdu
- 130
- January 31, 2024

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