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Fully Human Domain Antibody Therapeutics: the Best of Both Worlds
Drug Discovery Fully Human Domain Antibody Therapeutics: The Best of Both Worlds By combining the therapeutic benefits of small molecule drugs with those of fully human antibodies, Domain Antibodies are expected to have strong therapeutic and commercial potential. By Robert Connelly at Domantis Robert Connelly is Chief Executive Officer of Domantis. He has over 22 years’ commercial experience of the life science sector, including that gained in the fields of diagnostics, drug discovery technologies and antibody therapeutics. Prior to joining Domantis, he was CEO of Veritas Pharmaceuticals (Los Angeles, USA), an in vivo imaging start-up company. He spent over five years with IGEN International, latterly as Senior Vice President and General Manager, Life Sciences, where he took part in the company’s IPO and financing rounds, raising $130 million. The first 11 years of his career were spent at Abbott Laboratories in sales, marketing and management positions. Domain Antibodies (dAbs) are the smallest functional variable regions of either the heavy (VH) or light (VL) binding units of antibodies. At Domantis, we are chains of human antibodies. Domantis scientists applying our proprietary know-how in dAbs to deliver have used the variable domains sequences of human human therapies that address large, unmet medical antibodies to create a series of large and highly needs in areas such as inflammation, cancer and functional libraries of fully human dAbs, with each autoimmune diseases. Three and a half years after library comprising at least 1010 different dAbs. The opening our laboratories, we have a dozen proprietary dAbs selected from these libraries are both specific therapeutic programmes underway, and an additional for their biological target and are well folded and eight therapeutic programmes with partners. -
Biotech Investing 2020
BIOTECH INVESTING 2020 Bill Cara www.billcara.com [email protected] 647-868-6013 JULY 20, 2020 A. Report Overview This Greenfield Capital (billcara.com) report on the Biotechnology industry is written by a registered investment consultant & portfolio manager, not by a scientist. Our objective is to provide education and information to investors who lack the tools to trade successfully in an industry made vitally important to the world by the coronavirus pandemic of 2020. If we want to live through this pandemic -- and future ones -- where it is possible that hundreds of millions of us could perish because of the lack of diagnostics, vaccines, and therapeutics, then as investors we should be keenly interested in the Biotech industry. News reports state that in just six and a half months, COVID-19, initially called SARS- CoV-2, has killed more people than the number of Americans who die each year from opioid overdose (46,000), traffic accidents (36,500), and gun violence (40,000) combined. But, currently, there is no vaccine for COVID-19, and the treatment options for patients with severe or life-threatening symptoms are limited. As the world struggles to contain the deadly virus, there are, fortunately, over 140 coronavirus vaccines in development. News is breaking every day. At the same time, however, many individuals who are trading in Biotech stocks remain woefully uninformed and are speculating wildly. Some Biotech stocks that have appreciated 100% or more in a few months on hopefulness may have trouble sustaining gains beyond the news peak. Still, for investors who study this industry, there are opportunities right now to buy Biotech stocks that will grow in price well into the future. -
The Top 100 November, 2016 a List of Stocks Topping Our Custom 'Torpedo’ Screen
The Top 100 November, 2016 A list of stocks topping our custom 'torpedo’ screen. Updated monthly. GPRO GoPro, Inc. Class A Consumer Discretionary TSLA Tesla Motors, Inc. Consumer Discretionary UA Under Armour, Inc. Class A Consumer Discretionary CRC California Resources Corp Energy CRZO Carrizo Oil & Gas, Inc. Energy CWEI Clayton Williams Energy, Inc. Energy FANG Diamondback Energy, Inc. Energy GST Gastar Exploration, Inc. Energy MPLX MPLX LP Energy RSPP RSP Permian, Inc. Energy SLCA U.S. Silica Holdings, Inc. Energy AAC AAC Holdings, Inc. Health Care ABEO Abeona Therapeutics, Inc. Health Care ACAD ACADIA Pharmaceuticals Inc. Health Care ADMP Adamis Pharmaceuticals Corporation Health Care ADMS Adamas Pharmaceuticals, Inc. Health Care ADXS Advaxis, Inc. Health Care AIMT Aimmune Therapeutics Inc Health Care AKBA Akebia Therapeutics, Inc. Health Care ALDR Alder Biopharmaceuticals, Inc. Health Care ARDM Aradigm Corporation Health Care ARDX Ardelyx, Inc. Health Care ARLZ Aralez Pharmaceuticals Inc. Health Care ATRA Atara Biotherapeutics Inc Health Care BCRX BioCryst Pharmaceuticals, Inc. Health Care BLUE bluebird bio, Inc. Health Care CARA Cara Therapeutics Inc Health Care CDNA CareDx, Inc. Health Care CEMP Cempra, Inc. Health Care CERS Cerus Corporation Health Care CFMS ConforMIS Inc Health Care CLVS Clovis Oncology, Inc. Health Care COLL Collegium Pharmaceutical, Inc. Health Care CORI Corium International, Inc. Health Care CRMD CorMedix Inc. Health Care CSU Capital Senior Living Corporation Health Care DERM Dermira Inc Health Care DVAX Dynavax Technologies Corporation Health Care DXCM DexCom, Inc. Health Care EPZM Epizyme, Inc. Health Care FOLD Amicus Therapeutics, Inc. Health Care HRTX Heron Therapeutics Inc Health Care ICPT Intercept Pharmaceuticals, Inc. -
05/01/02 Louisiana Medicaid Management
APPENDIX C 05/01/02 LOUISIANA MEDICAID MANAGEMENT INFORMATION SYSTEM PAGE 1 DEPT OF HEALTH AND HOSPITALS - BUREAU OF HEALTH SERVICES FINANCING LOUISIANA MEDICAID PHARMACY BENEFITS MANAGEMENT UNIT ONLY THESE COMPANIES PRODUCTS ARE COVERED AND ONLY THOSE DOSAGE FORMS LISTED IN APPENDIX A. MEDICAID DRUG FEDERAL REBATE PARTICIPATING PHARMACEUTICAL COMPANIES LABELER PHARMACEUTICAL COMPANY EFFECTIVE END DATE CODE DATE 00002 ELI LILLY & CO 04/01/91 00003 E.R.SQUIBB & SONS,INC 04/01/91 00004 HOFFMAN-LA ROCHE,INC 04/01/91 00005 LEDERLE LABORATORIES AMERICAN CYANAMID 04/01/91 00006 MERCK SHARP & DOHME 04/01/91 00007 SMITHKLINE BEECHAM CORPORATION 04/01/91 00008 WYETH LABORATORIES 04/01/91 00009 THE UPJOHN COMPANY 04/01/91 00011 BECTON DICKINSON MICROBIOLOGY SYSTEMS 10/01/91 07/01/98 00013 ADRIA LABORATORIES DIV.OF ERBAMONT,INC 04/01/91 00014 G.D.SEARLE & CO 04/01/91 01/01/01 00015 MEAD JOHNSON & COMPANY 04/01/91 00016 KABI PHARMACIA 04/01/91 00021 REED & CARNRICK 10/01/96 01/01/97 00023 ALLERGAN,INC 04/01/91 00024 WINTHROP PHARMACEUTICALS 04/01/91 00025 G.D.SEARLE & CO 04/01/91 00026 MILES INC.,PHARMACEUTICAL DIVISION 04/01/91 00028 GEIGY PHARMACEUTICALS 04/01/91 00029 SMITHKLINE BEECHAM CORPORATION 04/01/91 00031 ROBINS,A.H. 04/01/91 00032 SOLVAY PHARMACEUTICALS 04/01/91 00033 SYNTEX 04/01/91 00034 THE PURDUE FREDERICK COMPANY 04/01/91 00037 CARTER-WALLACE,INC 04/01/91 00038 STUART PHARMACEUTICALS,ICI AMERICAS INC 04/01/91 07/01/01 00039 HOECHST-ROUSSEL PHARMACEUTICALS INC 04/01/91 00043 SANDOZ CONSUMER CORPORATION 04/01/91 00044 KNOLL PHARMACEUTICALS -
NASDAQ Stock Market
Nasdaq Stock Market Friday, December 28, 2018 Name Symbol Close 1st Constitution Bancorp FCCY 19.75 1st Source SRCE 40.25 2U TWOU 48.31 21st Century Fox Cl A FOXA 47.97 21st Century Fox Cl B FOX 47.62 21Vianet Group ADR VNET 8.63 51job ADR JOBS 61.7 111 ADR YI 6.05 360 Finance ADR QFIN 15.74 1347 Property Insurance Holdings PIH 4.05 1-800-FLOWERS.COM Cl A FLWS 11.92 AAON AAON 34.85 Abiomed ABMD 318.17 Acacia Communications ACIA 37.69 Acacia Research - Acacia ACTG 3 Technologies Acadia Healthcare ACHC 25.56 ACADIA Pharmaceuticals ACAD 15.65 Acceleron Pharma XLRN 44.13 Access National ANCX 21.31 Accuray ARAY 3.45 AcelRx Pharmaceuticals ACRX 2.34 Aceto ACET 0.82 Achaogen AKAO 1.31 Achillion Pharmaceuticals ACHN 1.48 AC Immune ACIU 9.78 ACI Worldwide ACIW 27.25 Aclaris Therapeutics ACRS 7.31 ACM Research Cl A ACMR 10.47 Acorda Therapeutics ACOR 14.98 Activision Blizzard ATVI 46.8 Adamas Pharmaceuticals ADMS 8.45 Adaptimmune Therapeutics ADR ADAP 5.15 Addus HomeCare ADUS 67.27 ADDvantage Technologies Group AEY 1.43 Adobe ADBE 223.13 Adtran ADTN 10.82 Aduro Biotech ADRO 2.65 Advanced Emissions Solutions ADES 10.07 Advanced Energy Industries AEIS 42.71 Advanced Micro Devices AMD 17.82 Advaxis ADXS 0.19 Adverum Biotechnologies ADVM 3.2 Aegion AEGN 16.24 Aeglea BioTherapeutics AGLE 7.67 Aemetis AMTX 0.57 Aerie Pharmaceuticals AERI 35.52 AeroVironment AVAV 67.57 Aevi Genomic Medicine GNMX 0.67 Affimed AFMD 3.11 Agile Therapeutics AGRX 0.61 Agilysys AGYS 14.59 Agios Pharmaceuticals AGIO 45.3 AGNC Investment AGNC 17.73 AgroFresh Solutions AGFS 3.85 -
CDER – Redi: Focus on CGMP & FDA Inspections – Participant List
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Eileen Zhou Michael Channing A B M Mahfuz ul Alam Research Associate Group Chief - Positron Emission General Manager, Quality Operations Neuralstem Tomography Department ACI HealthCare Limited Germantown, MD, United States NIH Dhaka, Non-US, Bangladesh [email protected] Bethesda, MD, United States [email protected] [email protected] Abe Wong ABHIJEET GUJAR Adam Ebbinghouse CCO Chief Operating Officer QC Associate Gmpsigma SETHU KP Pharmaceutical Technology, Inc. Seattle, WA, United States Porvorim Goa, Non-US, India Bloomington, IN, United States [email protected] [email protected] [email protected] Adil Gatrad Adiseshu Modugula Aditiben Patel Director, Quality Systems RA Regulatory Specialist Actavis MSN USAMMDA Parsippany, NJ, United States Hyderabad, Non-US, India Frederick, MD, United States [email protected] [email protected] [email protected] Adriana de la Cruz ahsanul haque Aimee Gogarty Manager CSO Quality Coordinator Laboratorios Pisa SA de CV FDA Mallinckrodt Jalisco, Non-US, Mexico silver spring, MD, United States Port Allen, LA, United States [email protected] [email protected] [email protected] Aislyn Fronzak Ajay Deshmukh Ajay Khedkar QC Manager QA manager Regulatory Affair PL Developments Ingenus Pharmaceutical Umedica Laboratories Pvt Ltd Clinton, SC, United States Navi mumbai, Non-US, India Mumbai, Non-US, India [email protected] -
1 United States District Court for the Southern District
Case 1:07-cv-12141-PBS Document 18-3 Filed 11/28/07 Page 1 of 167 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF IOWA, CENTRAL DIVISION THE STATE OF IOWA, Plaintiff, v. ABBOTT LABORATORIES, INC., AGOURON PHARMACEUTICALS, INC., JURY TRIAL REQUESTED ALPHARMA, INC., ALZA CORPORATION, AMGEN, INC., ASTRAZENECA L.P., ASTRAZENECA PHARMACEUTICALS, LP., AVENTIS BEHRING L.L.C., COMPLAINT BARR LABORATORIES, INC., BAXTER INTERNATIONAL, INC., BAXTER HEALTHCARE CORPORATION, BAYER CORPORATION, BAYER PHARMACEUTICALS CORPORATION, BEN VENUE LABORATORIES, INC., BOEHRINGER INGELHEIM CORPORATION, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., BRISTOL-MYERS SQUIBB COMPANY, CENTOCOR, INC., CHIRON CORPORATION, DERMIK LABORATORIES, INC., DEY, INC., DEY, L.P., ELI LILLY AND COMPANY, EMD, INC., ENDO PHARMACEUTICALS, INC., ETHEX CORPORATION, ETHICON, INC., FOREST LABORATORIES, INC., FOREST PHARMACEUTICALS, INC. GENEVA PHARMACEUTICALS, GLAXOSMITHKLINE, PLC, GLAXOWELLCOME, INC., GREENSTONE, LTD., HOECHEST MARION ROIUSSEL, INC., HOFFMAN-LAROCHE, INC., 1 Case 1:07-cv-12141-PBS Document 18-3 Filed 11/28/07 Page 2 of 167 IMMUNEX CORPORATION, IVAX CORPORATION, IVAX PHARMACEUTICALS, INC., JANSSEN PHARMACEUTICA PRODUCTS, LP, JOHNSON & JOHNSON, KING PHARMACEUTICALS, INC., KING RESEARCH AND DEVELOPMENT, MCNEIL-PPC, INC., MEDIMMUNE, INC., MERCK & CO., INC., MONARCH PHARMACEUTICALS, INC., MYLAN LABORATORIES, INC., MYLAN PHARMACEUTICALS, INC., NOVARTIS PHARMACEUTICALS CORPORATION, NOVOPHARM USA, INC., ONCOLOGY THERAPEUTICS NETWORK CORP., ORTHO-MCNEIL PHARMACEUTICAL, INC., -
Update Covers C1-C4 Iss2 2005.Indd
In Compliance and In Court by John B. Reiss, Ph.D., and William M. Janssen his article examines various fraud and abuse cases is the simultane- violated the Anti-Kickback Statute. Tlegal issues facing the medical ous fi ling of False Claims Act charges. Under the government’s theory, these device, pharmaceutical, and biologics Because the False Claims Act permits inducements resulted in an illegal use industries; court decisions or settle- fi nes of up to three times the amount of the drugs, and claims fi led for these ments over the past year; and suggested of the claim—and penalties of between uses were thus false. Also brought actions. New guidelines set standards $5,500 and $11,000 per claim—penal- into focus by this case were the False that industry leaders should consider as ties can add up quickly to billions of Claims Act’s qui tam provisions, which they plan product development, sales, dollars, giving the government an enor- allow whistleblowers to participate in and marketing strategies. mous “hammer” with which to exact up to 25% of the government’s recov- settlements. ery. A majority of the recent cases have Fraud and Abuse and the The complexity of the application resulted from whistleblower fi lings. False Claims Act of these laws is demonstrated by the TAP Pharmaceuticals made an Fraud and abuse issues dominated Warner-Lambert case.1 The primary $875 million payment in October 2001, the headlines during 2004. The U.S. allegation involved the company’s partly as the result of its guilty plea for Attorney and the Department of Health off-label marketing of its epilepsy violating the Prescription Drug Market- and Human Services (DHHS) Offi ce of drug, Neurontin®, in violation of the ing Act.2 The government also alleged Inspector General (OIG) continued a Federal Food, Drug, and Cosmetic Act manipulation of the average wholesale high level of activity, and states’ attor- (FDCA). -
Lilly to Acquire Imclone Systems in $6.5 Billion Transaction
Lilly to Acquire ImClone Systems in $6.5 Billion Transaction Creates a Global Leader in Oncology Biopharmaceuticals Boosts Oncology Pipeline With Up to Three Promising Targeted Therapies in Phase III in 2009 INDIANAPOLIS and NEW YORK, Oct 06, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Eli Lilly and Company (NYSE: LLY) and ImClone Systems Inc. (Nasdaq: IMCL) today announced that the boards of directors of both companies have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion. The offer represents a premium of 51 percent to ImClone's closing stock price on July 30, 2008, the day before an acquisition offer for ImClone was made public. ImClone's board recommends that ImClone's shareholders tender their shares in the tender offer. Additionally, certain entities associated with ImClone's chairman, Carl C. Icahn, holding approximately 14 percent of ImClone's outstanding common stock, have agreed to tender their shares in the tender offer. This strategic combination will create one of the leading oncology franchises in the biopharmaceutical industry, offering both targeted therapies and oncolytic agents along with a pipeline spanning all phases of clinical development. The combined oncology portfolio will target a broader array of solid tumor types including lung, breast, ovarian, colorectal, head and neck, and pancreatic, positioning Lilly to pursue treatments of multiple cancers. Combining with ImClone will further strengthen Lilly's growing portfolio of first-in-class and best-in-class pharmaceutical products, enabling Lilly to better support oncologists, with the ultimate goal of delivering better outcomes for cancer patients. -
Bio/Pharmaceutical Outsourcing Report: November 2016
Volume 21, Number 11, November 2016 Bio/Pharmaceutical Outsourcing Report Part of PharmSource STRATEGIC ADVANTAGE Business Conditions 1 Business Conditions 1 PE-Owned Companies in Line to Change Hands PE-Owned Companies in Line to Change Hands 2 Commercial Dose Manufacturing and Mergers and acquisitions are a hot topic in the contract services industry these Packaging days, and there is a lot of curiosity about which companies are likely to change 2 New Manufacturing Deal, Temporary hands. Of course, any company is a target at any time, especially when the price is Closures and Recall for Patheon right, but insight to likely acquisition candidates can be gained by looking at the list 3 Commercial Dose Manufacturing and Packaging in Brief 3 Clinical Dose Manufacturing and leastof companies four years owned ago are by likelyprivate targets equity in (PE) the nextfirms. year On oraverage, two. PE firms tend to hold Packaging onto their investments for about five years, so companies that were acquired at 3 Marken to be Acquired by UPS The table on page 2 lists 23 CMC services companies that are PE-owned; the list 5 Clinical Dose Manufacturing and was derived from the PharmSource Strategic Advantage database “Search by Packaging in Brief Ownership” feature. It is sorted by the year each company was acquired, and 6 Side Effects: Impacts of Key Events on suggests that at least 13 CMOs and CDMOs are ripe for a transaction in the foresee- CMOs and CROs able future. 7 API — Large Molecule The sale of one company, Marken (Durham, N.C., USA), was announced just this 7 Samsung BioLogics Completes IPO month (see news item, Page 3); another, Capsugel (Morristown, N.J., USA), has been 8 API — Large Molecule in Brief mentioned in the business press as being prepared for an ownership change. -
Comparison of Oral Contraceptives and Non-Oral Alternatives
PL Detail-Document #290305 −This PL Detail-Document gives subscribers additional insight related to the Recommendations published in− PHARMACIST’S LETTER / PRESCRIBER’S LETTER March 2013 Comparison of Oral Contraceptives and Non-Oral Alternatives —More information about the use of contraceptives is available in our PL Detail-Document, Hormonal Contraception— Productsa Manufacturerb Estrogen Progestin LOW-DOSE MONOPHASIC PILLS Aviane-28 Teva EE 20 mcg Levonorgestrel 0.1 mg Falmina Novast Lessina Teva Lutera Actavis Orsythia Qualitest Sronyx Actavis Gildess Fe 1/20 Qualitest EE 20 mcg Norethindrone acetate Junel 1/20 Teva 1 mg Junel Fe 1/20 Teva Loestrin-21 1/20 Warner Chilcott/Teva Loestrin Fe 1/20 Warner Chilcott/Teva Microgestin 1/20 Actavis Microgestin Fe 1/20 Actavis Generess Fe chewable Actavis EE 25 mcg Norethindrone 0.8 mg Altavera Sandoz EE 30 mcg Levonorgestrel 0.15 mg Kurvelo Lupin Levora Actavis Marlissa Glenmark Nordette-28 Duramed/Teva Portia-28 Teva Cryselle-28 Teva EE 30 mcg Norgestrel 0.3 mg Elinest Novast Low-Ogestrel-21 Actavis Low-Ogestrel-28 Actavis Lo/Ovral-28 Wyeth Gildess Fe 1.5/30 Qualitest EE 30 mcg Norethindrone acetate Junel 1.5/30 Teva 1.5 mg Junel Fe 1.5/30 Teva Loestrin 1.5/30-21 Warner Chilcott/Teva Loestrin Fe 1.5/30 Warner Chilcott/Teva Microgestin 1.5/30 Actavis Microgestin Fe 1.5/30 Actavis More. Copyright © 2013 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com -
11/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 20:25:21 Report Id 2794D051 Page: 01
MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 11/09/2016 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 20:25:21 REPORT ID 2794D051 PAGE: 01 NUMERIC COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 01/01/2017 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 00002 ELI LILLY AND COMPANY 00145 STIEFEL LABORATORIES, INC, 00003 E.R. SQUIBB & SONS, LLC. 00149 WARNER CHILCOTT PHARMACEUTICALS INC. 00004 HOFFMANN-LA ROCHE 00168 E FOUGERA AND CO. 00006 MERCK & CO., INC. 00169 NOVO NORDISK, INC. 00007 GLAXOSMITHKLINE 00172 IVAX PHARMACEUTICALS, INC. 00008 WYETH LABORATORIES 00173 GLAXOSMITHKLINE 00009 PFIZER, INC 00178 MISSION PHARMACAL COMPANY 00013 PFIZER, INC. 00182 GOLDLINE LABORATORIES, INC. 00015 MEAD JOHNSON AND COMPANY 00185 EON LABS, INC. 00023 ALLERGAN INC 00186 ASTRAZENECA LP 00024 SANOFI-AVENTIS, US LLC 00187 VALEANT PHARMACEUTICALS NORTH AMERICA 00025 PFIZER, INC. 00206 LEDERLE PIPERACILLIN 00026 BAYER HEALTHCARE LLC 00224 KONSYL PHARMACEUTICALS, INC. 00029 GLAXOSMITHKLINE 00225 B. F. ASCHER AND COMPANY, INC. 00032 SOLVAY PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 00037 MEDA PHARMACEUTICALS, INC. 00245 UPSHER-SMITH LABORATORIES, INC. 00039 SANOFI-AVENTIS, US LLC 00258 FOREST LABORATORIES INC 00046 AYERST LABORATORIES 00259 MERZ PHARMACEUTICALS 00049 PFIZER, INC 00264 B. BRAUN MEDICAL INC. 00051 UNIMED PHARMACEUTICALS, INC 00281 SAVAGE LABORATORIES 00052 ORGANON USA INC. 00299 GALDERMA LABORATORIES, L.P. 00053 CSL BEHRING 00300 TAP PHARMACEUTICALS INC 00054 ROXANE LABORATORIES, INC. 00310 ASTRAZENECA LP 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00327 GUARDIAN LABS DIV UNITED-GUARDIAN INC 00062 ORTHO MCNEIL PHARMACEUTICALS 00338 BAXTER HEALTHCARE CORPORATION 00064 HEALTHPOINT, LTD. 00378 MYLAN PHARMACEUTICALS, INC.