Updated-Final List of Pharma Product Patents During 2005-06 to 2009-10
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United States Securities and Exchange Commission Form
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) February 5, 2020 Merck & Co., Inc. (Exact name of registrant as specified in its charter) New Jersey 1-6571 22-1918501 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 2000 Galloping Hill Road, Kenilworth, NJ 07033 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code (908) 740-4000 Not Applicable (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. -
Basic Science of ITP
CHAPTER 1 Basic sc*ience of ITP Editor: John W. Semple 1.1 Megakaryocyte differentiation and platelet produc*tion A.S. Weyrich 1.2 Autoimmune mechanisms and T regula*tory cell disturbances in ITP K. Yazdanbakhsh 1.3 Mouse models o*f ITP J.W. Semple 1.4 Peptide therapy for patients with* ITP S.J. Urbaniak * Basic science of ITP 1.1 Megakaryocyte differen*tiation and platelet production Andrew S. Weyrich CHAPTER 1.1 • Megakaryocyte differentiation and platelet production 1. Introduction Platelets are anucleate cells that circulate in the bloodstream for approximately 10 days. The average adult must produce roughly 1 x 10 11 platelets per day to maintain normal platelet counts, a level of production that increases dramatically in a variety of clinical scenarios (1). In 1906, Wright provided the first evidence that megakaryocytes give rise to blood platelets. Since then, our understanding of the molecular basis of thrombopoiesis has progressed substantially and is arguably in a logarithmic growth phase. This chapter will review our current understanding of thrombopoiesis and highlight how the field is evolving. The history of megakaryocytes and platelets is fairly young. In 1841, Addison first described platelets and in 1882, Bizzozero named and identified platelets in the circulation and determined that they could induce clotting. In 1890, Howell named megakaryocytes, and 16 years later, Wright discovered that these were actually the precursors of platelets. Thus, the late 1880’s and early 1900’s were a period of prolific activity in the elucidation of megakaryocytes. Several discoveries were made about platelets and also about erythropoietin, which implied that a humoral substance also regulated platelet production though its exact nature was not yet known. -
Specialists in Small Molecule Drug Development
Specialists in Small Molecule Drug Development Dr Stephen Parker, Chairman Dr Tim Mitchell, CEO & Co-Founder Dr John Reader, CSO & Co-Founder Final Results for the Year Ending 30 June 2019 October 2019 www.sareum.co.uk Disclaimer The information contained in this document (“Presentation”) is directed at (i) members or creditors of a corporate body within the meaning of Article 43 of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005, as amended ("Order"), (ii) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Order, or (iii) those persons to whom it can otherwise be distributed without contravention of article 21 of the Financial Services and Markets Act 2000 (“FISMA”) or to whom it can lawfully be distributed. This Presentation has been prepared by Sareum Holdings PLC (“Company”) and provided to you for information purposes only. This Presentation is not an invitation or inducement to engage in an investment activity for the purposes of FISMA. This Presentation has not been approved by an Authorised Person (as defined in s31 FISMA), as would be required for financial promotions under s21 FISMA and, for the avoidance of doubt, is not a financial promotion for the purposes of FISMA. If, contrary to the above, this Presentation is deemed to be a financial promotion for the purposes of FISMA, the Company relies on the exemptions set out in Articles 19, 43, 59 and 69 of the Order, which exempts companies admitted to trading on relevant markets making certain communications. Please note that any indication of past performance should not be relied upon as a guide to future performance. -
News Release
News Release ____________________________________________________________________________ FOR IMMEDIATE RELEASE Media Contacts: Tracy Ogden Investor Contacts: Teri Loxam (908) 740-1747 (908) 740-1986 Claire Gillespie Michael DeCarbo (267) 305-0932 (908) 740-1807 Merck Announces First-Quarter 2018 Financial Results First-Quarter 2018 Worldwide Sales Were $10.0 Billion, an Increase of 6 Percent, Including a 3 Percent Positive Impact from Foreign Exchange First-Quarter 2018 GAAP EPS was $0.27, Reflecting a $1.4 Billion Aggregate Charge Related to the Formation of a Collaboration with Eisai; First-Quarter Non-GAAP EPS was $1.05 Company Narrows and Raises 2018 Full-Year Revenue Range to be Between $41.8 Billion and $43.0 Billion, Including an Approximately 2 Percent Positive Impact from Foreign Exchange Company Lowers 2018 GAAP EPS Range to be Between $2.45 and $2.57; Narrows and Raises 2018 Full-Year Non-GAAP EPS Range to be Between $4.16 and $4.28, Including an Approximately 1 Percent Positive Impact from Foreign Exchange Results from Phase 3 KEYNOTE-189 Study Presented at AACR 2018 and Published in The New England Journal of Medicine Showed KEYTRUDA in Combination with Pemetrexed and Platinum Chemotherapy Reduced the Risk of Death by Half Compared with Chemotherapy Alone as a First-Line Treatment for Advanced Nonsquamous NSCLC Data from KEYNOTE-189 is Now Under Review by Regulatory Authorities in the United States, Europe and Japan KENILWORTH, N.J., May 1, 2018 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2018. “Merck had a strong start to the year driven by KEYTRUDA, GARDASIL, BRIDION and Animal Health,” said Kenneth C. -
Merck & Co., Inc
As filed with the Securities and Exchange Commission on February 25, 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2020 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth New Jersey 07033 (908) 740-4000 New Jersey 22-1918501 (State or other jurisdiction of incorporation) (I.R.S Employer Identification No.) Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2021: 2,530,315,668. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2020 based on closing price on June 30, 2020: $195,461,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. -
Biocentury 8.15.16
WEEK OF AUGUST 15, 2016 6 PRODUCT DEVELOPMENT: NO ANTIGEN LEFT BEHIND Amgen has added to its immuno-oncology arsenal with its deal for Advaxis’ pan- epitope neoantigen vaccine platform. SERVING RETURNS 9 EMERGING COMPANY PROFILE: RESTRAINING TRANSLATION BY STEVE EDELSON, SENIOR EDITOR Bantam is developing small molecule eIF4E inhibitors to treat a range of cancers, China’s Ally Bridge Group hit the investment world’s starting with B cell malignancies. radar in 2015 with its audacious move to take CRO WuXi PharmaTech Inc. private. If the firm and its partners can engineer the first fruits of that move with REGULATION: the listing of WuXi’s biologics unit in Hong Kong this 10 year, the question is what will be its next moves to ADAPTING FOR THE REAL WORLD generate outsized returns for its investors. EMA says better strategies for real-world evidence and more patient and payer involvement are necessary Ally Bridge, which has a about $1.5 billion under next steps for its adaptive pathway initiative. management across three funds and an international base of LPs, thinks its returns and continued visibility will come from a handful of public and private portfolio companies with transformative data events, the first of EBB & FLOW: 13 which should come this half. LION’S SHARE OF THE WORK Aslan’s validating event. Plus: Cutting a check The firm also says it is working on new private equity to Cleave; and Ironwood’s operating leverage. deals that will rival WuXi in terms of size and impact. Ally Bridge is keeping its private equity plans under wraps, and does not disclose names of investments in its Asia hedge fund. -
Merck & Co., Inc
As filed with the Securities and Exchange Commission on February 26, 2020 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2019 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth New Jersey 07033 (908) 740-4000 New Jersey 22-1918501 (State or other jurisdiction of incorporation) (I.R.S Employer Identification No.) Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2020: 2,536,268,760. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2019 based on closing price on June 30, 2019: $215,106,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. -
Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Inc
Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Gathering Momentum Company Overview Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops and markets prescription and non-prescription pharmaceutical products that make a meaningful difference in patients’ lives. Valeant’s primary focus is principally in the areas of dermatology and neurology. The Company’s growth strategy is to acquire, develop and commercialize new products through strategic partnerships, and build on the company’s strength in dermatology and neurology. Valeant plans to strategically expand its pipeline by adding new compounds or products through product or company acquisitions and will maximize its pipeline through strategic partnering to optimize its research and development assets and strengthen ongoing internal development capabilities. Valeant’s strategic markets are primarily in the United States, Canada, Central and Eastern Europe, Latin America, Australia and South East Asia. Headquartered in Montreal, Quebec, Valeant has approximately 7,000 employees worldwide. FORWARD-LOOKING Statements In addition to current and historical information, this Annual Report contains forward-looking statements, including, without limitation, statements regarding our strategy, expected future revenue, the prospects for approval of product candidates and the timing of regulatory approvals, and the growth and future development of the company, its business units and its products. Words such as “expects,” “anticipates,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or “continue” or similar language identify forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties. Our actual results may differ materially from those contemplated by the forward-looking statements. -
2018 Medicines in Development for Skin Diseases
2018 Medicines in Development for Skin Diseases Acne Drug Name Sponsor Indication Development Phase ADPS topical Taro Pharmaceuticals USA acne vulgaris Phase II completed Hawthorne, NY www.taro.com AOB101 AOBiome acne vulgaris Phase II (topical ammonia oxidizing bacteria) Cambridge, MA www.aobiome.com ASC-J9 AndroScience acne vulgaris Phase II (androgen receptor degradation Solana Beach, CA www.androscience.com enhancer) BLI1100 Braintree Laboratories acne vulgaris Phase II completed Braintree, MA www.braintreelabs.com BPX-01 BioPharmX acne vulgaris Phase II (minocycline topical) Menlo Park, CA www.biopharmx.com BTX1503 Botanix Pharmaceuticals moderate to severe acne vulgaris Phase II (cannabidiol) Plymouth Meeting, PA www.botanixpharma.com CJM112 Novartis Pharmaceuticals acne vulgaris Phase II (IL-17A protein inhibitor) East Hanover, NJ www.novartis.com clascoterone Cassiopea acne vulgaris Phase III (androgen receptor antagonist) Lainate, Italy www.cassiopea.com Medicines in Development: Skin Diseases ǀ 2018 Update 1 Acne Drug Name Sponsor Indication Development Phase CLS001 Cutanea acne vulgaris Phase II (omiganan) Wayne, PA www.cutanea.com DFD-03 Promius Pharma acne vulgaris Phase III (tazarotene topical) Princeton, NJ www.promiuspharma.com DMT310 Dermata Therapeutics moderate to severe acne vulgaris Phase II (freshwater sponge-derived) San Diego, CA www.dermatarx.com finasteride Elorac severe nodulocystic acne Phase II (cholestenone 5-alpha Vernon Hills, IL www.eloracpharma.com reductase inhibitor) FMX101 Foamix moderate to severe -
FDA Listing of Authorized Generics As of July 1, 2021
FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc. -
Drug Discovery Chemistry
Save up to $200! Final Agenda Register by February 23 COVER CHI’s 13th Annual CONFERENCE AT-A-GLANCE PLENARY KEYNOTES SHORT COURSES Drug Discovery AGENDA Plenary April 3-4 Conferences »» Protein-Protein Interactions Keynotes »» Inflammation»&»Autoimmune» Inhibitors Chemistry »» Kinase»Inhibitor»Chemistry Optimizing Small Molecules for Tomorrow's Therapeutics »» GPCR-Targeted Drug Design »» Fragment-Based»Drug» Activity-Based April 2-6, 2018 | San Diego, CA | Hilton San Diego Bayfront Discovery Proteomics: April 4-5 Conferences Protein and »» Ubiquitin»Proteasome»System» Ligand Discovery Inhibitors on a Global Scale CONFERENCE PROGRAMS »» Small»Molecules»for»Cancer» Benjamin F. Cravatt, Immunotherapy PhD, Professor and APRIL 3-4 APRIL 4-5 APRIL 6 Co-Chair, Department »» Macrocyclics»&»Constrained» of Molecular Peptides Medicine, The Protein-Protein Ubiquitin Proteasome Biophysical Approaches »» Targeting»Complex» Scripps Research Membrane»Proteins Institute Interactions System Inhibitors for Drug Discovery April 6 Symposia »» Biophysical»Approaches»for» Lead Optimization Inflammation & Small Molecules for Drug»Discovery for Drug Metabolism Autoimmune Inhibitors Cancer Immunotherapy »» Lead»Optimization»for»Drug» & Safety Metabolism»&»Safety » Targeting Ras » Blood-Brain»Penetrant» Kinase Inhibitor Macrocyclics & Blood-Brain Inhibitors and MYC for the Treatment of Chemistry Constrained Peptides Penetrant Inhibitors HOTEL & TRAVEL Cancer Stephen Fesik, SPONSORSHIP PhD, Professor GCPR-Targeted Targeting Complex Plus Short Courses & EXHIBIT -
2019 Analyst Day
2019 Analyst Day March 12, 2019 NASDAQ: LGND 2 Safe Harbor Statement The following presentation contains forward-looking statements by Ligand and its partners that involve risks and uncertainties and reflect Ligand's and it’s partners’ judgment as of the date of this presentation. Words such as “plans,” “believes,” “expects,” “projects,” “could,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, financial projections, expectations regarding research and development programs, potential uses of capital, including any potential dividend or share repurchase program, and the timing of the initiation or compilation of preclinical studies and clinical trials by Ligand and its partners. Actual events or results may differ from Ligand’s expectations due to risks and uncertainties inherit in Ligand’s business, including: Ligand has wide discretion on its use of capital and may choose not to engage in any share repurchases, declare any dividends or pursue acquisitions or internal develop programs; Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline;, drug development program benefits may not be realized; Ligand will achieve its guidance in 2019 or thereafter; third party research summarized herein may not be correct or complete; Kyprolis®, EVOMELA® and Zulresso™ may not perform as expected, Ligand relies on collaborative partners for milestone and royalty payments,