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Resource #350932
−This Clinical Resource gives subscribers additional insight related to the Recommendations published in− September 2019 ~ Resource #350932 Anticipated Availability of First-Time Generics ―To help explain the benefits of generic drugs to your patients, the FDA has patient education materials available at https://www.fda.gov/drugs/generic-drugs/patient-education ― Branda Generic Name Generic Manufacturer(s)b,1 Anticipated Availabilityc (Manufacturer) Acanya Benzoyl peroxide 2.5%/ Teva Generic now available (Valeant) Clindamycin phosphate 1.2% Cuprimine Penicillamine capsule Amerigen, Teva Generic now available (Bausch Health) Delzicol Mesalamine delayed-release Teva Generic now available (Warner Chilcott) capsule Diclegis Doxylamine/Pyridoxine Teva Generic now available (Duchesnay) Exjade Deferasirox tablets for oral Teva Generic now available (Novartis) suspension Fareston Toremifene Rising (EirGen Pharma Limited) Generic now available (Kyowa Kirin) Faslodex Fulvestrant Sandoz Generic now available (AstraZeneca) Firazyr Icatibant Teva Generic now available (Shire Orphan Therapies) Gablofen Baclofen 1 mg/mL single dose Mylan Institutional Generic now available (Piramal) vial Hemabate Carboprost tromethamine Dr. Reddy’s Generic now available (Pharmacia & Upjohn) Letairis Ambrisentan Cipla, Mylan, Par, Sigmapharm, Sun, Teva, Generic now available (Gilead) Zydus Lexiva Fosamprenavir Mylan Generic now available (Viv) More. Copyright © 2019 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com ~ nursesletter.therapeuticresearch.com (Clinical Resource #350932: Page 2 of 24) Branda Generic Name Generic Manufacturer(s)b,1 Anticipated Availabilityc (Manufacturer) Lotemax Loteprednol ophthalmic Hi-tech Generic now available (Bausch & Lomb) suspension Lyrica Pregabalin capsule Alembic, Amneal, Ascend (Alkem), Cipla Generic now available (PF Prism CV) (InvaGen), Dr. -
Gilead Sciences, Inc. November 13, 2016
Student Investment Management Gilead Sciences, Inc. November 13, 2016 Gilead Sciences, Inc. NASDAQ: GILD BUY $92.00 The Fisher College of Business Student Investment Management Program is initiating coverage on Gilead Sciences with a BUY rating. Our target price is $92.00. Our implied P/E for 2016E is 7.9x versus consensus 6.5x. Our 2017 and 2018 estimates are 8.8x and 9.5x, respectively. Company overview Gilead Sciences, Inc. is a research-based biopharmaceutical Fund Manager company that discovers, develops and commercializes innovative Royce West, CFA medicines in areas of unmet medical need. Gilead strives to 614-227-2948 transform and simplify care for people with life-threatening illnesses [email protected] around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, liver Analyst diseases, cancer, inflammatory and respiratory diseases, and Andrew Jasen cardiovascular conditions. 301-300-0702 [email protected] 12-Month trading performance 10.0% S&P Current share price: $72.64 7.0% 52 wk range: $71.76 - $108.13 0.0% S5HLTH Market cap: $99.9bn 1.4% P/E: 6.8x (10.0%) XBI (3.0%) Diluted shares out.: 1.3bn Last dividend (9/4/2016): $0.47 (20.0%) GILD Dividend yield: 2.4% (25.5%) Beta: 0.94 (30.0%) EV/EBITDA: 4.8x EV/Sales: 3.1x (40.0%) Nov-15 Jan-16 Mar-16 May-16 Jul-16 Sep-16 Nov-16 Investment thesis We are placing a BUY rating on GILD with a price target of $92.00, a 20.4% upside to the current trading price. -
Amgen-Opinion-Jan-7-2021.Pdf
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELA WARE AMGEN INC. and AMGEN MANUFACTURING, LIMITED, Plaintiffs, v. Civil Action No. 20-0561-CFC HOSPIRA, INC. and PFIZER INC. Defendants. MEMORANDUM ORDER Having considered the merits of Defendants Hospira, Inc. and Pfizer Inc.' s Motion to Stay (D.I. 19) and the briefs filed by the parties in connection with that motion, it is HEREBY ORDERED that Defendants' motion to stay is GRANTED IN PART for the following reasons: 1. Plaintiffs Amgen Inc. and Amgen Manufacturing, Limited make and sell the biologic filgrastim under the brand name Neupogen®. Filgrastim, like many biologics, is a protein. Plaintiffs own two patents generally related to methods of purifying such proteins. These two patents are U.S. Patent Nos. 10,577,392 (the #392 patent), and 9,643,997 (the #997 patent). The #392 patent issued in March of 2020. 2. Defendants manufacture and sell a biosimilar version Neupogen® called Nivestym®. Nivestym® has been available since 2018 and is the third biosimilar version ofNeupogen® launched in the United States since Neupogen® became available almost thirty years ago. 3. Both the #392 patent and #997 patent have been asserted against the Defendants-albeit in different actions-for the manufacture ofNivestym®. The #392 patent has been asserted in this case (C.A. 20-0561 ), which was filed on April 24, 2020. The #997 patent has been asserted in the related case Amgen Inc. et al. v. Hospira, Inc. et al., No. 18-cv-1064-CFC-CJB (D. Del. 2018). That case is scheduled for a jury trial to begin on May 17, 2021. -
In the Supreme Court of the United States ACORDA THERAPEUTICS, INC., Petitioner
NO. 181280 In the Supreme Court of the United States ACORDA THERAPEUTICS, INC., Petitioner, v. ROXANE LABORATORIES, INC., MYLAN PHARMACEUTICALS, INC., and TEVA PHARMACEUTICALS USA, INC., Respondents. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit BRIEF OF AMICUS CURIAE BOSTON PATENT LAW ASSOCIATION IN SUPPORT OF NEITHER PARTY SOPHIE F. WANG COUNSEL OF RECORD BRYANA T. MCGILLYCUDDY NATALIA SMYCHKOVICH CHOATE HALL & STEWART LLP TWO INTERNATIONAL PLACE BOSTON, MA 02110 (617) 248-5000 [email protected] MAY 8, 2019 COUNSEL FOR AMICUS CURIAE SUPREME COURT PRESS ʕ (888) 958-5705 ʕ BOSTON, MASSACHUSETTS i TABLE OF CONTENTS Page TABLE OF AUTHORITIES ....................................... ii INTEREST OF THE AMICUS CURIAE ................... 1 SUMMARY OF ARGUMENT .................................... 1 ARGUMENT ............................................................... 3 I. THE FEDERAL CIRCUIT’S DECISION CREATES SIGNIFICANT UNCERTAINTY CONCERNING THE SCOPE AND APPLICABILITY OF THE BLOCKING PATENT DOCTRINE. ............................................ 3 A. Clarification Is Needed as to the Definition of a “Blocking Patent.” .............. 3 B. Clarification Is Also Needed as to Whether and How the Blocking Patent Doctrine Should Be Applied to Objective Indicia of NonObviousness. ...................... 8 II. ABSENT CLARIFICATION, THE EXPANDED BLOCKING PATENT DOCTRINE HAS A CHILLING EFFECT ON INNOVATION AND INVESTMENT. .................. 11 A. Improvement Innovations Are Critical and Require Significant Investment. ....... 11 B. Objective Indicia Matter. .......................... 13 CONCLUSION .......................................................... 16 ii TABLE OF AUTHORITIES TABLE OF AUTHORITIES Page CASES Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310 (Fed. Cir. 2018) ......... passim Apple v. ITC, 725 F.3d 1356 (Fed. Cir. 2013) ......................... 14 Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) ............................................. 6 Galderma Labs., L.P. -
Views Expressed in This Publication by Any Contributor Are Not Necessarily Those of the Publisher
THOMSON REUTERS Expansion of the blocking-patent doctrine By Ha Kung Wong, Esq., and Michael Scerbo, Esq., Venable LLP APRIL 13, 2020 In 2005 the U.S. Court of Appeals for the Federal Circuit first Therefore, the law considers two factors to be probative of articulated the blocking-patent doctrine in Merck & Co. v. Teva whether or not an invention would have been obvious: evidence Pharmaceuticals USA Inc., 395 F.3d 1364 (Fed. Cir. 2005), or of (1) commercial success, and (2) a causal nexus between the Merck I. invention and commercial success of a product embodying it.4 The Federal Circuit said that under the doctrine courts may reduce The Federal Circuit in Merck I explained that the district court’s the weight given to evidence of commercial success where an finding of commercial success should be given only minimal earlier patent blocked market entry by others. weight because Merck had both (1) a preexisting patent covering the administration of alendronate sodium (a bisphosphonate) to The appellate court later explained in Acorda Therapeutics treat osteoporosis, and (2) exclusive marketing rights granted by Inc. v. Roxane Laboratories Inc., 903 F.3d 1310 (Fed. Cir. 2018), the Food and Drug Administration. that a patent is a blocking patent “where the practice of a later invention would infringe the earlier patent.” ”Because market entry by others was precluded on those bases, the inference of nonobviousness … from evidence of commercial The rationale behind the doctrine was that where others are legally success … is weak.”5 barred from commercializing a purportedly obvious idea due to a preexisting patent, the court may conclude that the inference of In the years after the Federal Circuit’s decision in Merck I, the court nonobviousness from evidence of commercial success is weak. -
In the United States District Court for the District of Delaware
Case 1:20-cv-00561-UNA Document 1 Filed 04/24/20 Page 1 of 27 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE AMGEN INC. and AMGEN MANUFACTURING, LIMITED, C.A. No. ________ Plaintiffs, v. HOSPIRA, INC. and PFIZER INC., DEMAND FOR JURY TRIAL Defendants. COMPLAINT Plaintiffs Amgen Inc. and Amgen Manufacturing, Limited (collectively, “Plaintiffs”), by and through their undersigned attorneys, for their Complaint against Defendants Hospira, Inc. and Pfizer Inc. (collectively, “Defendants”) hereby allege as follows: THE PARTIES 1. Amgen Inc. is a corporation existing under the laws of the State of Delaware, with its principal place of business at One Amgen Center Drive, Thousand Oaks, California, 91320. Amgen Inc. discovers, develops, manufactures, and sells innovative therapeutic products based on advances in molecular biology, recombinant DNA technology, and chemistry. Founded in 1980, Amgen Inc. is a pioneer in the development of biological human therapeutics. Today, Amgen Inc. is one of the largest biotechnology companies in the world, fueled in part by the success of NEUPOGEN® (filgrastim). 2. Amgen Manufacturing, Limited (“AML”) is a corporation existing under the laws of Bermuda with its principal place of business in Juncos, Puerto Rico. AML manufactures and sells biologic medicines for treating particular diseases in humans. AML is a wholly-owned subsidiary of Amgen Inc. Case 1:20-cv-00561-UNA Document 1 Filed 04/24/20 Page 2 of 27 PageID #: 2 3. On information and belief, Hospira, Inc. (“Hospira”) is a corporation existing under the laws of the State of Delaware, with its principal place of business at 275 North Field Drive, Lake Forest, Illinois 60045. -
Percutaneous Endoscopic Gastrostomy in Pediatric Patients
3 Percutaneous Endoscopic Gastrostomy in Pediatric Patients Omar I. Saadah Department of Pediatrics, Faculty of medicine, King Abdulaziz University Saudi Arabia 1. Introduction Adequate nutrition is important in the management of children with chronic illnesses. Patients who are unwilling or unable to eat will starve. Starvation depletes tissue stores, and ultimately leads to impaired organ function and tissue structure. Appropriate caloric intake enables growth, promotes tissue repair, and improve immune function. Access to the intestinal tract may be via a nasal tube or by the percutaneous route, with delivery to the stomach or jejunum. Nasogastric tubes are employed for short- term feeding, usually up to four weeks. In children requiring long term tube feeding, nasogastric feeding may be uncomfortable, disfiguring and often traumatic. Percutaneous access is usually by either endoscopic or radiological techniques. Percutaneous gastrostomy is basically a sutureless approximation of the stomach to the abdominal wall. The percutaneous endoscopic gastrostomy (PEG) becomes the most popular technique nowadays. The first PEG was performed in the pediatric operating room of University Hospitals of Cleveland on June 12, 1979 on a four-and-half-month-old child with inadequate oral intake. The procedure was performed under sedation and local anesthesia. The child did remarkably well. However, because the initial tube used was a 12F catheter with small mushroom head, external migration ensued after 3 weeks. The catheter was changed under direct visualization, using a small laparotomy (Gauderer, 2002). Since then the procedure has been adopted worldwide for both children and adults. Because the procedure is considered minimally invasive, rapid, and associated with low risk of complications, and short hospital stay, it has become the preferred method for delivering nutritional support in vulnerable pediatric patients. -
ANALYSIS of AGREEMENT CONTAINING CONSENT ORDERS to AID PUBLIC COMMENT in the Matter of Pfizer Inc
ANALYSIS OF AGREEMENT CONTAINING CONSENT ORDERS TO AID PUBLIC COMMENT In the Matter of Pfizer Inc. and Hospira, Inc. File No. 151-0074 The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) from Pfizer Inc. (“Pfizer”) and Hospira, Inc. (“Hospira”) that is designed to remedy the anticompetitive effects resulting from Pfizer’s acquisition of Hospira. Under the terms of the proposed Consent Agreement, the parties are required to divest all of Pfizer’s rights and assets related to generic acetylcysteine inhalation solution and all Hospira’s rights and assets related to clindamycin phosphate injection, voriconazole injection, and melphalan hydrochloride injection to Alvogen Group, Inc. (“Alvogen”). The proposed Consent Agreement has been placed on the public record for thirty days for receipt of comments from interested persons. Comments received during this period will become part of the public record. After thirty days, the Commission will again evaluate the proposed Consent Agreement, along with the comments received, to make a final decision as to whether it should withdraw from the proposed Consent Agreement or make final the Decision and Order (“Order”). Pursuant to an Agreement and Plan of Merger executed on February 5, 2015, Pfizer proposes to acquire Hospira for approximately $16 billion (the “Proposed Acquisition”). The Commission alleges in its Complaint that the Proposed Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. § 45, by lessening current competition in the markets for generic acetylcysteine inhalation solution and clindamycin phosphate injection and future competition in the markets for voriconazole injection and melphalan hydrochloride injection in the United States. -
Annual Report
ANNUAL REPORT 2019 MARCH 2020 To Our Shareholders Alex Gorsky Chairman and Chief Executive Officer By just about every measure, Johnson & These are some of the many financial and Johnson’s 133rd year was extraordinary. strategic achievements that were made possible by the commitment of our more than • We delivered strong operational revenue and 132,000 Johnson & Johnson colleagues, who adjusted operational earnings growth* that passionately lead the way in improving the health exceeded the financial performance goals we and well-being of people around the world. set for the Company at the start of 2019. • We again made record investments in research and development (R&D)—more than $11 billion across our Pharmaceutical, Medical Devices Propelled by our people, products, and and Consumer businesses—as we maintained a purpose, we look forward to the future relentless pursuit of innovation to develop vital with great confidence and optimism scientific breakthroughs. as we remain committed to leading • We proudly launched new transformational across the spectrum of healthcare. medicines for untreated and treatment-resistant diseases, while gaining approvals for new uses of many of our medicines already in the market. Through proactive leadership across our enterprise, we navigated a constant surge • We deployed approximately $7 billion, of unique and complex challenges, spanning primarily in transactions that fortify our dynamic global issues, shifting political commitment to digital surgery for a more climates, industry and competitive headwinds, personalized and elevated standard of and an ongoing litigious environment. healthcare, and that enhance our position in consumer skin health. As we have experienced for 133 years, we • And our teams around the world continued can be sure that 2020 will present a new set of working to address pressing public health opportunities and challenges. -
Managing Complications of Percutaneous Tracheostomy and Gastrostomy
5330 Review Article on Interventional Pulmonology in the Intensive Care Unit Managing complications of percutaneous tracheostomy and gastrostomy Aline N. Zouk, Hitesh Batra Division of Pulmonary, Allergy, and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA Contributions: (I) Conception and design: Both authors; (II) Administrative support: Both authors; (III) Provision of study materials or patients: Both authors; (IV) Collection and assembly of data: Both authors; (V) Data analysis and interpretation: Both authors; (VI) Manuscript writing: Both authors; (VII) Final approval of manuscript: Both authors. Correspondence to: Aline N. Zouk, MD. Division of Pulmonary, Allergy, and Critical Care Medicine, The University of Alabama at Birmingham, 1900 University Blvd, THT 422, Birmingham, AL 35294, USA. Email: [email protected]. Abstract: Percutaneous tracheostomy and gastrostomy are some of the most commonly performed procedures at bedside in the intensive care unit. While they are generally considered safe, they can be associated with numerous short and long-term complications, many of which can occur long after their placement and cause significant morbidity. Performers of these procedures should possess a comprehensive understanding of procedural indications and contraindications, and know how to recognize and manage complications that may arise. In this review, we highlight complications of percutaneous tracheostomy and describe strategies for their prevention and management, with a special focus on post-tracheostomy -
12Th KEPAN CONGRESS ABSTRACTS
DOI: 10.5152/ClinSciNutr.2021.080321 12th KEPAN CONGRESS ABSTRACTS Selected Abstracts for Oral Presentation NUTRITION 12th KEPAN CONGRESS ABSTRACTS SS01 Predictive Effect of a New Screening Tool for Nutritional Risk in Neonatal Intensive Care Unit Nadir Yalçın1, Hasan Tolga Çelik2, Kutay Demirkan1, Şule Yiğit2 1Hacettepe University, Faculty of Pharmacy, Department of Clinical Pharmacy, Ankara, Turkey 2Hacettepe University, Faculty of Medicine, Neonatology Unit, Department of Child Health and Diseases, Ankara, Turkey Objective: Hospitalized newborns are at increased risk of malnutrition and especially preterm infants often experience postnatal growth failure.1 It was aimed to evaluate the predictive effect of malnutrition risk on the initiation of parenteral nutrition (PN) and length of stay (LOS) while patients were admitted to neonatal intensive care unit (NICU) within 24 hours. Methods: Neonatal Nutritional Screening Tool (NNST) was prospectively applied to all infants in the NICU within 24 hours of their hospitalization. The predictive effects of NNST and birth weight on LOS and PN administration were evaluated with Poisson regres- sion analysis. The study protocol was approved by the local Ethics Committee. Results: Total of 303 patients with a mean gestational age of 35 weeks and 2 days and a mean birth weight of 2552 g were prospec- tively included in the study. According to the NNST, 27 (8.9%) of the patients had a high risk, 70 (23.1%) had a moderate risk, and 206 (68.0%) had a low nutritional risk. However, PN treatment was initiated in 118 (38.9%) of the patients. Even though, the mean LOS was 14 days for all patients, LOS was 2.7 times higher in patients with a high nutritional risk compared to patients with a low nutritional risk (p<0.001). -
Adverse Events of Upper GI Endoscopy
GUIDELINE Adverse events of upper GI endoscopy This is one of a series of statements discussing the use of lications rely on self-reporting, and most reported data GI endoscopy in common clinical situations. The Stan- collected only from the immediate periprocedure period, dards of Practice Committee of the American Society for thus the rate of late adverse events and mortality may be Gastrointestinal Endoscopy (ASGE) prepared this text. underestimated.8,9 Major adverse events related to diag- In preparing this document, a search of the medical liter- nostic UGI endoscopy are rare and include cardiopulmo- ature was performed by using PubMed. Additional refer- nary adverse events, infection, perforation, and bleeding. ences were obtained from the bibliographies of the identi- Adverse events of ERCP and EUS are discussed in separate fied articles and from recommendations of expert ASGE documents.10,11 consultants. When few or no data exist from well-designed prospective trials, emphasis is given to results of large series and reports from recognized experts. This document is ADVERSE EVENTS ASSOCIATED WITH based on a critical review of the available data and expert DIAGNOSTIC UGI ENDOSCOPY consensus at the time that the document was drafted. Further controlled clinical studies may be needed to clar- Cardiopulmonary adverse events ify aspects of this document. This document may be re- Most UGI procedures in the United States and Europe vised as necessary to account for changes in technology, are performed with patients under sedation (moderate or 12 new data, or other aspects of clinical practice. deep). Cardiopulmonary adverse events related to seda- This document is intended to be an educational device tion and analgesia account for as much as 60% of UGI 1-4,7 to provide information that may assist endoscopists in endoscopy adverse events.