Regeneron Pharmaceuticals Inc
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Prostate Cancer in Focus
PROSTATE CANCER IN FOCUS Current Developments in the Management of Prostate Cancer Section Editor: Andrew J. Armstrong, MD Prostate Cancer Prostate PSMA-Targeted Therapy in Prostate Cancer Scott T. Tagawa, MD, MS Professor of Medicine and Urology Weill Cornell Medicine New York, New York H&O What is prostate-specific membrane agent such as a monoclonal antibody might be able to antigen (PSMA), and what makes it a good target target a tumor without binding to other PSMA-positive for the treatment of prostate cancer? sites owing to its large size and physical inability to reach luminal sites of expression that are separated from the ST PSMA is a cell surface antigen that is expressed to vasculature by tight junctions. a limited degree on certain normal cells in the body but generally is highly overexpressed in the setting of prostate H&O How is PSMA positivity established? cancer. Normal cells that express PSMA are located in the prostate, salivary, and lacrimal glands; the proximal part ST Imaging and biopsy are the main ways to establish of the small intestine; the proximal renal tubules; and PSMA positivity. Multiple imaging modalities are avail- some ganglia. In the setting of prostate cancer, PSMA able worldwide. The agent indium In 111 capromab expression generally increases along with the cancer grade, pendetide (ProstaScint) has been approved for years in and it also increases following hormonal therapy. In addi- the United States, and the US Food and Drug Adminis- tion, PSMA expression tends to be higher in metastatic tration (FDA) approved the use of gallium Ga 68 PSMA- sites than in primary tumors. -
Telaprevir (Incivek)
© Hepatitis C Online PDF created September 25, 2021, 4:19 pm Telaprevir (Incivek) Discontinued. This treatment has been discontinued. Table of Contents Telaprevir Incivek Summary Drug Summary Adverse Effects Class and Mechanism Manufacturer for United States FDA Status Indications Dosing Clinical Use Cost and Medication Access Resistance Key Drug Interactions Full Prescribing Information Figures Drug Summary Although telaprevir was a promising direct-acting antiviral agent that had impact in the hepatitis C treatment field during 2011 to 2013, it was subsequently replaced by newer direct-acting antiviral agents that were more effective, better tolerated, and more convenient. Based on the dwindling role of telaprevir after newer direct-acting antiviral agents were approved, Vertex pharmaceuticals discontinued the sales and distribution of telaprevir in the United States in October 2014. Telaprevir does have some current importance since persons who previously failed a telaprevir-based regimen may have developed resistant associated variants, which could potentially impact subsequent therapy. Adverse Effects The most significant adverse effects reported in the main registration trials and in post-marketing experience were rash, anorectal complaints, and anemia. When comparing triple therapy of telaprevir, peginterferon, and ribavirin with dual therapy of peginterferon and ribavirin alone significant differences were noted with rash (56% versus 34%), anemia (36% versus 17%), and anorectal complaints that include anorectal discomfort, anal pruritus, and hemorrhoids (29% versus 7%). In most cases, the rash that develops is eczematous or maculopapular in character and mild to moderate in severity; the rash is typically manageable with good skin care and topical emollients or corticosteroids. In some instances, however, telaprevir has caused serious skin Page 1/5 rashes, including Steven's Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN). -
AMGEN INC. V. SANOFI
Case: 20-1074 Document: 159 Page: 1 Filed: 06/21/2021 NOTE: This order is nonprecedential. United States Court of Appeals for the Federal Circuit ______________________ AMGEN INC., AMGEN MANUFACTURING, LIMITED, AMGEN USA, INC., Plaintiffs-Appellants v. SANOFI, AVENTISUB LLC, FKA AVENTIS PHARMACEUTICALS INC., REGENERON PHARMACEUTICALS INC., SANOFI-AVENTIS U.S. LLC, Defendants-Appellees ______________________ 2020-1074 ______________________ Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-01317-RGA, 1:14-cv- 01349-RGA, 1:14-cv-01393-RGA, 1:14-cv-01414-RGA, Judge Richard G. Andrews. ______________________ JEFFREY A. LAMKEN, MoloLamken LLP, Washington, DC, filed a petition for rehearing en banc for plaintiffs-ap- pellants. Also represented by SARAH JUSTINE NEWMAN, MICHAEL GREGORY PATTILLO, JR.; SARA MARGOLIS, New York, NY; EMILY JOHNSON, ERICA S. OLSON, STEVEN TANG, STUART WATT, WENDY A. WHITEFORD, Amgen Inc., Thou- sand Oaks, CA; KEITH HUMMEL, Cravath Swaine & Moore LLP, New York, NY; WILLIAM G. GAEDE, III, McDermott Case: 20-1074 Document: 159 Page: 2 Filed: 06/21/2021 2 AMGEN INC. v. SANOFI Will & Emery LLP, Menlo Park, CA; CHRISTOPHER B. MEAD, Schertler Onorato Mead & Sears LLP, Washington, DC; JAMES L. HIGGINS, MELANIE K. SHARP, Young, Cona- way, Stargatt & Taylor, LLP, Wilmington, DE. Plaintiff- appellant Amgen Inc. also represented by SARAH CHAPIN COLUMBIA, McDermott, Will & Emery LLP, Boston, MA; LAUREN MARTIN, Quinn Emanuel Urquhart & Sullivan LLP, Boston, MA. MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP, Washington, DC, filed a response for defendants-appellees. Also represented by VICTORIA REINES; DAVID K. BARR, DANIEL REISNER, New York, NY; DEBORAH E. -
Refreshing the Biologic Pipeline 2020
news feature Credit: Science Lab / Alamy Stock Photo Refreshing the biologic pipeline 2020 In the absence of face-to-face meetings, FDA and industry implemented regulatory workarounds to maintain drug and biologics approvals. These could be here to stay. John Hodgson OVID-19 might have been expected since 1996) — a small miracle in itself “COVID-19 confronted us with the need to severely impair drug approvals (Fig. 1 and Table 1). to better triage sponsors’ questions,” says Cin 2020. In the event, however, To the usual crop of rare disease and Peter Marks, the director of the Center for industry and regulators delivered a small genetic-niche cancer treatments, 2020 Biologics Evaluation and Research (CBER) miracle. They found workarounds and also added a chimeric antigen receptor at the FDA. “That was perhaps the single surrogate methods of engagement. Starting (CAR)-T cell therapy with a cleaner biggest takeaway from the pandemic related in January 2020, when the outbreak veered manufacturing process and the first to product applications.” Marks says that it westward, the number of face-to face approved blockbuster indication for a became very apparent with some COVID- meetings declined rapidly; by March, small-interfering RNA (siRNA) — the 19-related files that resolving a single they were replaced by Webex and Teams. European Medicines Agency’s (EMA) issue can help a sponsor enormously and (Secure Zoom meeting are to be added registration of the RNA interference accelerate the development cycle. Before this year.) And remarkably, by 31 December, (RNAi) therapy Leqvio (inclisiran) for COVID-19, it was conceivable that a small the US Food and Drug Administration cardiovascular disease. -
ARK GENOMIC REVOLUTION MULTI SECTOR ETF (ARKG) HOLDINGS As of 09/27/2021
ARK GENOMIC REVOLUTION MULTI SECTOR ETF (ARKG) HOLDINGS As of 09/27/2021 Company Ticker CUSIP Shares Market Value($) Weight(%) 1 TELADOC HEALTH INC TDOC 87918A105 3,937,797 531,208,815.30 6.99 2 EXACT SCIENCES CORP EXAS 30063P105 3,971,013 381,296,668.26 5.01 3 PACIFIC BIOSCIENCES OF CALIF PACB 69404D108 13,696,148 350,347,465.84 4.61 4 VERTEX PHARMACEUTICALS INC VRTX 92532F100 1,722,281 316,228,014.41 4.16 5 FATE THERAPEUTICS INC FATE 31189P102 4,825,395 312,926,865.75 4.12 6 IONIS PHARMACEUTICALS INC IONS 462222100 8,572,965 310,341,333.00 4.08 7 REGENERON PHARMACEUTICALS REGN 75886F107 430,742 275,201,063.80 3.62 8 TWIST BIOSCIENCE CORP TWST 90184D100 2,237,350 250,829,308.50 3.30 9 TAKEDA PHARMACEUTIC-SP ADR TAK UN 874060205 13,592,076 229,570,163.64 3.02 10 ACCOLADE INC ACCD 00437E102 5,268,242 226,850,500.52 2.98 11 INTELLIA THERAPEUTICS INC NTLA 45826J105 1,508,421 224,965,907.94 2.96 12 VEEVA SYSTEMS INC-CLASS A VEEV 922475108 741,198 222,307,516.14 2.92 13 CAREDX INC CDNA 14167L103 3,433,475 220,978,451.00 2.91 14 CRISPR THERAPEUTICS AG CRSP H17182108 1,804,041 210,044,493.63 2.76 15 INCYTE CORP INCY 45337C102 2,893,385 199,643,565.00 2.63 16 INVITAE CORP NVTA 46185L103 6,059,066 182,135,523.96 2.40 17 ADAPTIVE BIOTECHNOLOGIES ADPT 00650F109 4,888,391 178,377,387.59 2.35 18 BEAM THERAPEUTICS INC BEAM 07373V105 1,849,698 175,110,909.66 2.30 19 SIGNIFY HEALTH INC -CLASS A SGFY 82671G100 8,107,683 160,937,507.55 2.12 20 UIPATH INC - CLASS A PATH 90364P105 2,955,628 155,761,595.60 2.05 21 CASTLE BIOSCIENCES INC CSTL 14843C105 2,130,211 -
Vertex Pharmaceuticals Global Medical Affairs Pharmd Fellowship Program 2020 Message from Global Medical Affairs Leadership
Vertex Pharmaceuticals Global Medical Affairs PharmD Fellowship Program 2020 Message from Global Medical Affairs Leadership Dear Candidates, Vertex Pharmaceuticals in collaboration with Northeastern University is privileged to host and expand the PharmD Fellowship Program. We are excited to work with our fellows as integral members of our team and facilitate in-depth exposure to a range of functional areas, offering them the critical opportunity to gain extensive experience in the biopharmaceutical industry. In addition to fostering each individual’s personal and professional growth, the program’s primary goal is to extend the visibility of valuable contributions that a Doctor of Pharmacy can bring to the pharmaceutical industry. At Vertex, our Global Medical Affairs fellows are highly encouraged to take on immersive projects, allowing them to work across departments with leaders in the industry. We advocate for them to partake in truly unique, impactful work that develops their skills, sparks curiosity, and drives the science. Vertex’s open and innovative culture allows the fellows to ask questions, challenge the status quo, and explore their interests across multiple expertise areas. As a pharmacist, I am extremely proud of the establishment of the Vertex PharmD Fellowship program in Global Medical Affairs and excited to welcome our future fellows. Vertex is an ideal place for fellows to start their professional career, and we are dedicated to the development of the next generation of pharmacist leaders in the biopharmaceutical industry. As Vertex continues to grow and evolve into a company in multiple disease areas, I am confident that our fellows will be an essential part of moving the needle to deliver on our commitment to patients. -
VIRTUS ZEVENBERGEN INNOVATIVE GROWTH STOCK FUND SCHEDULE of INVESTMENTS (Unaudited) MARCH 31, 2021
VIRTUS ZEVENBERGEN INNOVATIVE GROWTH STOCK FUND SCHEDULE OF INVESTMENTS (Unaudited) MARCH 31, 2021 ($ reported in thousands) Shares Value Shares Value Footnote Legend: (1) Non-income producing. COMMON STOCKS—99.0% Industrials—3.9% Communication Services—9.3% Desktop Metal, Inc. (1) Country Weightings† Coursera, Inc.(1) 7,100 $ 320 Class A 359,800 $ 5,361 (1) Uber Technologies, United States 87% Netflix, Inc. 84,500 44,080 (1) Snap, Inc. Class A(1) 586,650 30,676 Inc. 897,900 48,944 Canada 7 Zillow Group, Inc. 54,305 Brazil 5 Class C(1) 434,335 56,307 Israel 1 Information Technology—43.9% Total 100% 131,383 (1) Coupa Software, Inc. 78,450 19,964 † (1) % of total investments as of March 31, 2021. Consumer Discretionary—25.3% fuboTV, Inc. 315,350 6,976 (1) NVIDIA Corp. 107,000 57,131 Airbnb, Inc. Class A 91,100 17,121 (1) Amazon.com, Inc.(1) 15,200 47,030 Okta, Inc. 235,575 51,928 (1) Paylocity Holding Chegg, Inc. 322,325 27,610 (1) (1) Corp. 110,750 19,916 Chewy, Inc. Class A 340,400 28,835 (1) Fiverr International PayPal Holdings, Inc. 198,850 48,289 Ltd.(1) 27,650 6,005 QUALCOMM, Inc. 204,050 27,055 RingCentral, Inc. Lululemon Athletica, (1) (1) Class A 129,800 38,665 Inc. 41,690 12,787 (1) (1) ServiceNow, Inc. 78,325 39,171 MercadoLibre, Inc. 48,225 70,994 (1) Peloton Interactive, Inc. Shopify, Inc. Class A 78,200 86,528 (1) Snowflake, Inc. Class A 336,850 37,876 (1) Tesla, Inc.(1) 162,740 108,699 Class A 110,700 25,381 Sprout Social, Inc. -
Doctor of Pharmacy Fellowship Program
2021-2022 Doctor of Pharmacy Fellowship Program Accelerate your career with one of our 1-year fellowship programs Transformative Therapies Targeting Cancer Seagen Inc. is a global biotechnology company dedicated to discovering, developing, and commercializing transformative YEARS: In oncology for 23+ years cancer medicines to make a meaningful difference in people’s lives. SIZE: Largest biotechnology company ADCETRIS® (brentuximab vedotin) and PADCEV® (enfortumab vedotin-ejfv) use based in the Pacific Northwest the company’s industry-leading antibody-drug conjugate (ADC) technology. ADCETRIS is approved in certain CD30-expressing lymphomas, and PADCEV is EMPLOYEES: 2,200+ employees approved in certain metastatic urothelial cancers. TUKYSA® (tucatinib), a small mole- worldwide cule tyrosine kinase inhibitor, is approved in certain HER2-positive metastatic breast cancers. The company is headquartered in Seattle, Washington area, with loca- PASSION: Helping people with cancer tions in California, Switzerland and the European Union. Beyond our approved prod- ucts, the company has established a pipeline of novel targeted therapies at various stages of clinical testing. OUR MISSION OUR VALUES To discover, develop, and Passion for helping patients commercialize transformative cancer Revolutionizing therapies for people medicines to make a meaningful living with cancer difference in people’s lives. Integrity Honesty, respect and trust guide us Scientific excellence Premier science empowers our passion We have built a strong Diversity, teamwork, and corporate culture around our mutual respect mission and values. Seagen Shared dedication and diverse embodies an entrepreneurial perspectives drive successful spirit that advances collaborations breakthrough therapies, Innovation which is why we are the Entrepreneurial spirit advances leader in antibody-drug breakthrough therapies conjugate technology. -
BIOGEN INTERNATIONAL GMBH, Plaintiff-Appellant
Case: 20-1373 Document: 41 Page: 1 Filed: 04/21/2020 United States Court of Appeals for the Federal Circuit ______________________ BIOGEN INTERNATIONAL GMBH, Plaintiff-Appellant v. BANNER LIFE SCIENCES LLC, Defendant-Appellee ______________________ 2020-1373 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:18-cv-02054-LPS, Chief Judge Leonard P. Stark. ______________________ Decided: April 21, 2020 ______________________ JAMES B. MONROE, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, for plaintiff-ap- pellant. Also represented by PAUL WILLIAM BROWNING, J. MICHAEL JAKES, LAURA POLLARD MASUROVSKY, JASON LEE ROMRELL. KYLE MUSGROVE, Parker Poe Adams & Bernstein LLP, Charlotte, NC, for defendant-appellee. Also represented by JOHN WORTHINGTON BATEMAN, ELIZABETH CROMPTON, SCOTT A. CUNNING, II, Washington, DC. ______________________ Case: 20-1373 Document: 41 Page: 2 Filed: 04/21/2020 2 BIOGEN INTERNATIONAL GMBH v. BANNER LIFE SCIENCES LLC Before LOURIE, MOORE, and CHEN, Circuit Judges. LOURIE, Circuit Judge. Biogen International GmbH (“Biogen”) appeals from a judgment of the United States District Court for the Dis- trict of Delaware that Banner Life Sciences LLC (“Banner”) does not infringe the extended portion of U.S. Patent 7,619,001 (the “’001 patent”), extended under the patent term restoration provisions of the Hatch-Waxman Act, Pub. L. No. 98-417, § 201, 98 Stat. 1585, 1598 (as codified at 35 U.S.C. § 156 (2018)). Biogen Int’l GmbH v. Banner Life Scis. LLC, No. 18-2054-LPS, 2020 WL 109499 (D. Del. Jan. 7, 2020) (“Decision”). Because the scope of a patent term extension under 35 U.S.C. -
FTIF - Franklin Global Growth Fund August 31, 2021
FTIF - Franklin Global Growth Fund August 31, 2021 FTIF - Franklin Global Growth August 31, 2021 Fund Portfolio Holdings The following portfolio data for the Franklin Templeton funds is made available to the public under our Portfolio Holdings Release Policy and is "as of" the date indicated. This portfolio data should not be relied upon as a complete listing of a fund's holdings (or of a fund's top holdings) as information on particular holdings may be withheld if it is in the fund's interest to do so. Additionally, foreign currency forwards are not included in the portfolio data. Instead, the net market value of all currency forward contracts is included in cash and other net assets of the fund. Further, portfolio holdings data of over-the-counter derivative investments such as Credit Default Swaps, Interest Rate Swaps or other Swap contracts list only the name of counterparty to the derivative contract, not the details of the derivative. Complete portfolio data can be found in the semi- and annual financial statements of the fund. Security Security Shares/ Market % of Coupon Maturity Identifier Name Positions Held Value TNA Rate Date G6095L109 APTIV PLC 70,000 $10,653,300 3.09% N/A N/A 045327103 ASPEN TECHNOLOGY INC 58,000 $7,511,000 2.18% N/A N/A BRIGHT HORIZONS FAMILY SOLUTIONS 109194100 49,000 $7,142,240 2.07% N/A N/A INC BROADRIDGE FINANCIAL SOLUTIONS 11133T103 46,000 $7,922,120 2.30% N/A N/A INC 124765108 CAE INC 360,000 $10,394,547 3.01% N/A N/A CHARLES RIVER LABORATORIES 159864107 27,000 $11,984,220 3.47% N/A N/A INTERNATIONAL -
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): June 17, 2005 VERTEX PHARMACEUTICALS INCORPORATED (Exact name of registrant as specified in its charter) MASSACHUSETTS 000-19319 04-3039129 (State or other jurisdiction of (Commission File Number) (IRS Employer Identification incorporation) No.) 130 Waverly Street Cambridge, Massachusetts 02139 (Address of principal executive offices) (Zip Code) (617) 444-6100 Registrant’s telephone number, including area code: 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 (see General Instruction A.2. below): o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 8.01. Other Events. On June 17, 2005, Vertex Pharmaceuticals Incorporated and Merck & Co., Inc. issued a joint press release that announced the initiation of an additional Phase I study with VX-680, a small molecule inhibitor of Aurora kinases. A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Item 9.01. -
Human Sequencing Resource with UK Biobank
January 8, 2018 Regeneron Forms Consortium of Leading Life Sciences Companies to Accelerate Largest Widely-Available 'Big Data' Human Sequencing Resource with UK Biobank By end of 2019, Regeneron plans to sequence the exomes of all 500,000 people within the UK Biobank resource, all with associated health records, creating an unprecedented resource linking human genetic variations to human biology and disease AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer will join Regeneron to co-fund one of the industry's most ambitious 'pre-competitive' research efforts Exome sequencing data and findings will be openly available to other researchers TARRYTOWN, N.Y., Jan. 8, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), along with new collaborators AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer Inc., today announced the formation of a major 'pre-competitive' consortium to fund the generation of genetic exome sequence data from the 500,000 volunteer participants who make up the UK Biobank health resource. The newly announced collaborators will each commit $10 million to enable a dramatic acceleration of sequencing timelines, and additional companies are considering joining the consortium. Regeneron will conduct the sequencing effort. The sequencing data will be paired with detailed, de-identified medical and health records within the UK Biobank resource, including enhanced measures such as brain, heart and body imaging, to create an unparalleled resource for linking human genetic variations to human biology and disease. It was originally planned that sequencing of all 500,000 samples in the UK Biobank would be completed by 2022, with the first 50,000 people sequenced during 2017 with funding from Regeneron and GlaxoSmithKline.