Merck Provides Update on FDA Review of Supplemental Biologics License Application for VAXNEUVANCE for Use in Infants and Children

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental biologics license application (sBLA) for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in infants and children to July 1, 2022. The FDA requested additional analyses of data from the pediatric studies, which Merck has submitted to the FDA. No new studies have been requested by the FDA.

In December 2021, Merck announced that the FDA accepted the company's application for VAXNEUVANCE for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age and it was granted Priority Review.

"We are confident in the strength of the data from our pediatric studies with VAXNEUVANCE and will continue to work expeditiously with the FDA to bring this important vaccine forward to infants and children in the United States as soon as possible," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

About VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)

VAXNEUVANCE, Merck's 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein. VAXNEUVANCE is indicated for active immunization of adults 18 years of age and older for the prevention of invasive disease caused by the S. pneumoniae serotypes contained in the vaccine. It is currently under investigation in the pediatric population. VAXNEUVANCE previously received Breakthrough Therapy designation and Priority Review from the FDA for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age.

Select Safety Information for VAXNEUVANCE in Adults 18 Years of Age and Older

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection site swelling (21.7%), injection site erythema (15.1%) and arthralgia (12.7%).

The most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection site swelling (15.4%), injection site erythema (10.9%) and arthralgia (7.7%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

About Merck

For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2021 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

Please see Prescribing Information for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdf .

and Patient Information at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_ppi.pdf .

Media:
Melissa Moody
(215) 407-3536

Kimberly Petrillo
(267) 742-2813

Investors:
Peter Dannenbaum
(908) 740-1037

Alexis Constantine
(908) 740-1051

News Provided by Business Wire via QuoteMedia

MRK
The Conversation (0)
Merck Announces First-Quarter 2023 Financial Results

Merck Announces First-Quarter 2023 Financial Results

  • First Quarter 2023 Reflected Continued Strong Underlying Performance Across Key Growth Drivers, Particularly in Oncology and Vaccines
  • Total Worldwide Sales Were $14.5 Billion, a Decrease of 9% From First Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 15%
    • KEYTRUDA Sales Grew 20% to $5.8 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24%
    • GARDASIL/GARDASIL 9 Sales Grew 35% to $2.0 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 43%
    • LAGEVRIO Sales Declined 88% to $392 Million; Excluding the Impact of Foreign Exchange, Sales Declined 87%
  • GAAP EPS Was $1.11; Non-GAAP EPS Was $1.40; GAAP and Non-GAAP EPS Include $0.52 of Charges Related to Acquisition of Imago and Collaboration and Licensing Agreement With Kelun-Biotech
  • Announced Proposed Acquisition of Prometheus Biosciences to Strengthen Immunology Pipeline
  • Presented Compelling Data From Innovative Cardiovascular Pipeline With:
    • Positive Phase 3 Results for Sotatercept
    • Positive Phase 2b Results for MK-0616; Plans to Start Phase 3 Studies in 2023
  • Advanced Oncology Research Efforts, Sharing Notable Progress for Earlier Stages of Disease in Certain Tumor Types, Including:
    • Positive Topline Results From Phase 3 KEYNOTE-671 Trial
    • Positive Detailed Results in Collaboration With Moderna From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial
  • 2023 Financial Outlook
    • Raises and Narrows Expected Full-Year 2023 Worldwide Sales Range To Be Between $57.7 Billion and $58.9 Billion, Including Negative Impact of Foreign Exchange of Approximately 2 Percentage Points; Outlook Includes Approximately $1.0 Billion of LAGEVRIO Sales
    • Lowers and Narrows Expected Full-Year 2023 GAAP EPS Range To Be Between $5.85 and $5.97, Reflecting Zetia Antitrust Litigation Settlement
    • Raises and Narrows Expected Full-Year 2023 Non-GAAP EPS Range To Be Between $6.88 and $7.00, Including Negative Impact of Foreign Exchange of Approximately 4 Percentage Points
    • Outlook Does Not Reflect Any Impact From Proposed Acquisition of Prometheus Biosciences, Which Is Expected to Close in Third Quarter 2023, and Would Result in a One-Time Charge to Both GAAP and Non-GAAP Results of Approximately $10.3 Billion or Approximately $4.00 per Share

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2023.

�Inspired by our commitment to bring bold science forward to address critical unmet patient needs, we began 2023 with significant advancements across our innovative pipeline," said Robert M. Davis, chairman and chief executive officer, Merck. "Our first-quarter results are a reflection of the focused execution of our science-led strategy, strong performance across our key growth drivers, continued momentum commercially and operationally, and most importantly the collective and dedicated efforts of our colleagues around the world. I'm proud of the progress we've made, and we will continue to move with speed and agility to deliver value for patients and shareholders, now and well into the future."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Spectrum Pharmaceuticals, Inc. , BELLUS Health Inc , Prometheus Biosciences, Inc. , Univar Solutions Inc.

BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Spectrum Pharmaceuticals, Inc. , BELLUS Health Inc , Prometheus Biosciences, Inc. , Univar Solutions Inc.

Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ( jbrodsky@brodskysmith.com ) or Marc Ackerman ( mackerman@brodskysmith.com ) at 855-576-4847. There is no cost or financial obligation to you.

Spectrum Pharmaceuticals, Inc. (Nasdaq – SPPI)

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
OTC:BCTXF

BriaCell Announces Grant to Investigator Dr. Saveri Bhattacharya at Sidney Kimmel Cancer Center – Jefferson Health

Highlights:

  • Grant awarded to Dr. Saveri Bhattacharya, Principal Investigator of the Phase I/IIa combination study of Bria-IMT™ with KEYTRUDA® (by Merck) in advanced breast cancer at Thomas Jefferson University.
  • Merck to provide KEYTRUDA® for use in the combination study.
  • The Investigator Grant validates and will build on the encouraging preliminary data from BriaCell’s combination study of Bria-IMT™ with KEYTRUDA® (Link).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, today announced that Dr. Saveri Bhattacharya, a board-certified medical oncologist and recognized expert in breast cancer treatment at the Sidney Kimmel Cancer Center – Jefferson Health in Philadelphia, PA, has been selected to receive support from the Merck Investigator Studies Program (“MISP”). The Investigator Grant is a highly coveted award granted by Merck & Co., Inc. (“Merck”) (NYSE: MRK) to leading investigators with highly innovative clinical studies.

Keep reading...Show less

Merck Announces Q4 and Full-Year 2019 Financial Results

Merck (NYSE:MRK) reported quarterly worldwide sales at US$11.9 billion in Q4 in its financial results for the fourth quarter of 2019 and its full fiscal 2019 year.

As quoted in the press release:

Keep reading...Show less
OTC:BCTXF

BriaCell’s Clinical Data Accepted to be Presented at the Annual Symposium of Society of Surgical Oncology 2020 in Boston

Safety and early efficacy data to be presented from clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer:

  • Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc.);
  • Bria-IMT™ in combination with INCMGA00012 (by Incyte Corporation).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce that the data of its clinical studies with its lead product candidate, Bria-IMT™, will be presented the at the Annual Symposium of Society of Surgical Oncology (SSO) 2020 – International Conference on Surgical Cancer Care taking place March 25-28 in Boston, MA.

Keep reading...Show less
Blank pill bottle spilling a variety of pharmaceutical pills and capsules.

5 Biggest Pharmaceutical ETFs in 2024

The global pharmaceutical market reached a total value of US$1.6 trillion in 2023, according to Statista, up significantly from the US$888 billion seen just over a decade earlier in 2010.

Experienced and novice investors alike may want to consider pharmaceutical exchange-traded funds (ETFs) as a way to gain exposure to the top pharma companies. Like all ETFs, pharmaceutical ETFs are a good option for those who want to trade a set of assets in the pharmaceutical industry instead of focusing solely on individual pharmaceutical stocks.

The main advantage of a pharmaceutical ETF is the fact that it can provide exposure to an overarching sector, but still trades like a stock. Pharma ETFs also offer less market volatility and lower fees and expenses.

Keep reading...Show less
Pill spelling "big pharma."

Big Pharma Stocks Eli Lilly, AbbVie and Pfizer Share Q3 Results

Major pharmaceutical players Eli Lilly (NYSE:LLY), AbbVie (NYSE:ABBV) and Pfizer (NYSE:PFE) reported mixed Q3 results, with each company facing distinct market forces, ranging from supply issues to financial constraints.

In its latest quarterly report, released on Wednesday (October 30), Eli Lilly missed on sales expectations for Zepbound, its popular weight-loss drug, and Mounjaro, its diabetes medication. Despite growing US demand for these products, supply chain management issues impacted the company’s ability to meet Wall Street's expectations.

According to Reuters, Eli Lilly dropped 8 percent on the news, reducing its market valuation by nearly US$70 billion.

Keep reading...Show less
Canada maple leaves on left and pharmaceutical pills in red and blue on right.

4 Best-performing Canadian Pharma Stocks of 2024

From established players to up-and-coming firms, Canada's pharmaceutical company is diverse and dynamic.

Canadian pharma companies are working to discover and develop major innovations amidst an increasingly competitive global landscape. Rising technologies such as artificial intelligence are playing a role in the landscape as well.

Here the Investing News Network lists the top Canadian pharma stocks on the TSX, TSXV and CSE by year-to-date gains. All data was compiled on October 28, 2024, using TradingView’s stock screener, and the companies considered had market caps above C$10 million at that time. Read on to learn about what's been driving their share prices.

Keep reading...Show less
US flag with orange pill bottle on top and white pills spilling out.

Harris vs. Trump: The 2024 US Election, Drug Prices and Healthcare

The exorbitant cost of pharmaceutical drugs in the US has been a contentious issue for years, with the Republican and Democrat parties overtly at odds on the best way to lower drug prices.

Despite the best efforts of lawmakers on both sides of the aisle, prescription drug prices are still on the rise. Figures from the US Department of Health and Human Services show a 15.2 percent increase in the cost of prescription drugs from 2022 to 2023, with an average of US$590 per drug.

In the lead up to the 2024 US general election, the pharmaceutical industry is buttering its bread on both sides with nearly equal contributions to both parties. Citing data from OpenSecrets, KFF Health News reported in late August that drug companies had donated US$4.89 million to Democrats’ coffers and US$4.35 million to Republicans.

Keep reading...Show less
Pills and Australian dollars.

InhaleRx Pens AU$38.5 Million Funding Agreement with Clendon Biotech Capital

Australian healthcare company InhaleRx (ASX:IRX) has entered into a AU$38.5 million funding facility with Melbourne-based Clendon Biotech Capital to cover clinical trial costs for its key projects.

InhaleRx currently has two main projects: its pain asset IRX-211 and its mental health asset IRX-616a.

According to the company, IRX-211 is designed to target breakthrough cancer pain, while IRX-616a focuses on offering fast and effective relief for individuals suffering from panic disorder.

Keep reading...Show less

Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer

  • If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant treatment with Kisqali ® (ribociclib) in combination with an aromatase inhibitor 1

  • Recommendation is based on the Phase III NATALEE trial, where Kisqali added to endocrine therapy (ET) significantly reduced the risk of recurrence by 25% versus ET alone across a broad population of patients with HR+/HER2- early breast cancer 2

  • People with stage II or III HR+/HER2- EBC face significant risk of recurrence – often as incurable metastatic disease – despite adjuvant ET and regardless of nodal involvement 3,4

  • In September, Kisqali was approved by the FDA in this setting 5 ; at ESMO 2024, an updated analysis from NATALEE was presented, showing a deepening invasive disease-free survival benefit 6

Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Kisqali ® (ribociclib) for the adjuvant treatment of adults with hormone receptor-positivehuman epidermal growth factor receptor 2-negative (HR+HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease 1 .

"One-third of people diagnosed with stage II breast cancer and more than half of those diagnosed with stage III will unfortunately experience a return of their cancer in the long term, often as metastatic disease," said Peter A. Fasching , M.D., Professor of Translational Medicine, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator. "If approved, Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient population, particularly for patients who currently have limited treatment options, including those with high-risk node-negative disease."

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×