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Merck’s 21-Valent Pneumococcal Conjugate Vaccine Granted FDA Priority Review

Pharmaceutical Executive Editorial Staff Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a single dose for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The BLA has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. “Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press release. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed ...
- Source: drugdu
- 181
- December 25, 2023
Glass specialist Schott Pharma touts 2023 sales growth, Serbia expansion and hiring plans

Following an IPO and ahead of its fiscal 2023 earnings release next month, German drug containment and delivery specialist Schott Pharma is trumpeting its recent momentum. Over the course of its 2023 fiscal year, Schott Pharma charted a 9% year-over-year revenue boost to €899 million (about $986 million), the company said Tuesday. For comparison, the company pulled down €821 million in fiscal year 2022. Schott credited the gains to the expansion of its production capabilities, especially as they pertain to drug delivery systems and new production lines for prefillable polymer syringes in Germany. Schott partners with a range of drugmakers in the biopharma industry. The company and its products are involved in several significant trends, such as the GLP-1 treatments from Novo Nordisk and Eli Lilly, plus mRNA vaccines from Moderna. Schott’s revenue win comes more than a year after the company set out on its own. Back in August ...
- Source: drugdu
- 208
- December 25, 2023
Deerfield Agency names Sam Cannizzaro as first chief creative officer

Deerfield Agency has named its first chief creative officer. Sam Cannizzaro has ended a two-year stint at Elevate Healthcare Marketing to take up the position at a fast-growing agency that is carving out a niche serving small to midsize pharmaceutical companies. Pennsylvania-based Deerfield is a full-service agency specializing in healthcare. Last year, the acquisition of Verge Scientific, a company that supports brand strategy and public relations, helped the agency to grow its sales by 40% and increase its headcount from 88 to 141. Deerfield has navigated its rise without a chief creative officer. Now, Deerfield is filling that gap by hiring Cannizzaro, a person whose CV features highlights related to the initiation of omnichannel campaigns, work on telehealth solutions and immersive technologies, use of voice-based health assistants and launch of AstraZeneca’s first digital detailing solutions. In a statement, Frank Burrell, managing partner at Deerfield, said Cannizzaro will “lead creative visioning ...
- Source: drugdu
- 236
- December 25, 2023
Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F

Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells FasTCAR-T GC012F has demonstrated a favorable safety profile in clinical investigator-initiated trials in 60 patients with multiple myeloma and B-cell non-Hodgkin lymphoma SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared Gracell’s Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE). Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate ...
- Source: drugdu
- 113
- December 25, 2023
Midterm report on 2025 network strategy highlights good progress during critical period of the pandemic

The European medicines regulatory network is on track to meet its strategic goals and objectives covering availability and accessibility of medicines; data analytics, digital tools, and digital transformation; innovation; antimicrobial resistance and other emerging health threats; supply-chain challenges; sustainability of the network and operational excellence, according to the midterm report of the network strategy. “Despite the unprecedented challenges presented by the COVID-19 pandemic and the resource that has been deployed across the medicines regulatory network in response, a lot of progress has been made in the six priority focus areas of our network strategy,” says Emer Cooke, EMA’s Executive Director. “The end of the public health emergency and the lifting of the business continuity planning means we will once again be in a position to focus more fully on delivering patient-relevant medicines and digital transformation while continuing to deal with health threats and supply issues.” The network strategy was published ...
- Source: drugdu
- 239
- December 25, 2023
Shanghai RAAS Cancels Limited Payment Scope of Medical Insurance for Some Products

According to the official website of the State Medical Insurance Bureau, in order to further improve the level of medication protection for the insured, in accordance with the Interim Measures for the Administration of Medicines for Basic Medical Insurance and the Requirements of the Work Program for Adjustment of the National Drug Catalogs for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance for the Year of 2023, the State Medical Insurance Bureau and the Ministry of Human Resources and Social Security have organized to adjust and formulate the “Drug Catalog (2023)” for the National Drug Catalog (2023)”, which was officially implemented from January 1, 2024 onwards. This catalog includes human albumin, IVIG (intravenous human immunoglobulin), human fibrinogen, human plasminogen complex, human coagulation factor VIII, human coagulation factor IX, human immunoglobulin, tetanus human immunoglobulin, human rabies immunoglobulin, and recombinant human coagulation factor VIIa, recombinant human coagulation factor VIII, and recombinant ...
- Source: drugdu
- 125
- December 25, 2023
“National Key Laboratory for R&D of New Vaccines for Emerging Infectious Diseases” was launched!

On December 20, the kick-off meeting of “National Key Laboratory for R&D of New Vaccines for New Emerging Infectious Diseases” and the first meeting of the first Academic Committee were held at Sinopharm China Biologicals. Deng Jindong, Vice General Manager of Sinopharm and Chairman of China Bio, and Yang Xiaoming, Chief Scientist and Chief Engineer of Sinopharm, Chief Scientist of China Bio, and Director of the National Key Laboratory for R&D of Novel Vaccines for Newly Emerging Infectious Diseases, formally launched the “National Key Laboratory for R&D of Novel Vaccines for Newly Emerging Infectious Diseases”. Academician Zhao Jia, Academician Chen Xiangmei, Academician Li Zaikun, and Academician Wang Junzhi of the Chinese Academy of Engineering attended the launching meeting. After the launching meeting, the National Key Laboratory of New Vaccine Development for Emerging Infectious Diseases held the first meeting of the first academic committee. The Academic Committee listened to and passed ...
- Source: drugdu
- 130
- December 25, 2023
Apple to pause US sales of smartwatches with pulse oximetry

Dive Brief Apple will pause selling models of the Apple Watch in the U.S. that have blood oxygen monitoring functions, beginning this week, the company told the website 9to5Mac. The move comes nearly two months after the U.S. International Trade Commission (USITC) ordered Apple to stop importing and selling its watches with the pulse oximetry feature in response to a patent infringement complaint brought by patient monitoring company Masimo. Apple, in a statement carried by 9to5Mac, said that it was “preemptively” taking steps to comply with the USITC ruling while it awaits the outcome of a presidential review of the order. The time period for President Joe Biden to review the decision is set to expire on Dec. 25. Dive Insight Masimo, which sells a competing medical watch, accused the tech giant of stealing its trade secrets and incorporating its patented technology for measuring blood oxygen saturation into some Apple ...
- Source: drugdu
- 229
- December 22, 2023
Accurate Blood Markers for Identifying AKI Could Eliminate Need for Invasive Kidney Biopsies

Acute Kidney Injury (AKI) is a condition characterized by intense inflammation, leading to sudden kidney function loss. AKI affects an estimated 15% to 20% of hospitalized patients, increasing their risk of in-hospital death and possibly leading to chronic kidney disease requiring dialysis or transplant. Clinicians have long sought markers to detect AKI without resorting to invasive kidney biopsies. Now, researchers have used cells from kidney biopsies to make progress in the search for more accurate and easier-to-obtain markers that can predict, manage, and assess the treatment of AKI. This new study by investigators at Johns Hopkins University (Baltimore, MD, USA) focused on noninvasive assessments of what is termed maladaptive proximal tubule (PT) repair, a process that occurs in response to AKI and is marked by excessive inflammation. This PT maladaptation process offers an opportunity to identify noninvasive markers in blood or urine that could greatly aid in predicting AKI, managing ...
- Source: drugdu
- 236
- December 22, 2023
FDA Grants Priority Review to Genentech’s sBLA for Xolair to Treat Food Allergies

Pharmaceutical Executive Editorial Staff If approved by the FDA, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure, including peanut, milk, and egg allergies. The FDA has granted Priority Review to Genentech’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of allergic reactions, such as anaphylaxis, that may result from an accidental exposure to one or more foods in patients aged 1 year and older with a food allergy. If the FDA approves the application, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure. Roche said it expects the FDA to decide on the approval in the first quarter of 2024. “Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global ...
- Source: drugdu
- 148
- December 22, 2023

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