Pfizer Reports Fourth-Quarter and Full-Year 2020 Results and Releases 5-Year Pipeline Metrics
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Stanford Chem-H Presentation (PDF)
KiNativ® In situ kinase profiling Stanford University ChEM-H confidential @KiNativPlatform Principle of the KiNativ platform • ATP (or ADP) acyl phosphate binds to, and covalently modifies Lysine residues in the active site • Thus, ATP acyl phosphate with a desthiobiotin tag can be used capture and quantitate kinases in a complex lysate Acyl phosphate Desthiobiotin tag ATP 2 ATP acyl phosphate probe covalently modifies kinase in the active site Lysine 2 Lysine 1 3 ATP acyl phosphate probe covalently modifies kinase in the active site Lysine 2 Lysine 1 4 Samples trypsinized, probe-labeled peptides captured with streptavidin, and analyzed by targeted LC-MS2 Identification Quantitation Explicit determination of peptide Integration of signal from MS2 sequence and probe modification site fragment ions from MS2 spectrum 5 Comprehensive Coverage of Protein and Lipid Kinases Protein kinases Atypical kinases Green: Kinases detected on KiNativ Red: Kinases not detected on KiNativ ~80% of known protein and atypical kinases identified on the platform http://www.kinativ.com/coverage/protein-lipid.html 6 Profiling compound(s) on the KiNativ platform Control sample – add probe Sample: Lysate derived from any cell line or tissue from ANY species Treated sample – add inhibitor followed by probe Inhibited kinase Green: Kinases Blue: Probe Gray: Non-kinases Red: Inhibitor 7 Profiling compound(s) on the KiNativ platform Control sample – add probe MS signalMS Sample: Lysate derived from any cell line or tissue from ANY species Treated sample – add inhibitor -
Essex Hangar Aircrafi: Challenger (Schering Plough) Tail Number: N34CD Flight Time: 50 Minutes
This document is from the collections at the Dole Archives, University of Kansas http://dolearchives.ku.edu ... DRAFT# 1- 8/26/94 ·- Contact: Mo Taggart 703/684-7848 Jo-Anne Coe 703/845-1714 SENATOR DOLE SCHEDULE ~ AUGUST 30, 1994 -NEW YORK TUESDAY. AUGUST 30 .. 1".4 10:35 am DEPART Capitol for National Airport Ori ver: Wilbert 10:50 am ARRIVE National Airport and proceed to departing aircraft PBO: Signature 703/419·8440 10:55 am DEPART Wushington for Morristown, NJ FBO: Essex Hangar Aircrafi: Challenger (Schering Plough) Tail number: N34CD Flight time: 50 minutes Pilots: Curt Barsi John Santucci Seats: 6 Meal: None Manifest: Senator Dole Rob Lively, Schcring Plough Mike Glassner • Mark Miller Contact: Rob Lively 202/463-8809 11:45 am ARRIVE Morristown, NJ FBO: Essex Hangar 201/539-6554 11 :50 am DEPART airport for Shering Plough Headquarters Driver: Mr. Luciano's driver Drive time: 5 minutes J,ocation: l Giralda Fanns Madison, NJ 11 :55 am ARRIVE Schering Plough Headquarters 20 I /822-7440 Page 1 of 48 This document is from the collections at the Dole Archives, University of Kansas http://dolearchives.ku.edu TUESDAY, AUGUSI-.3D .1994 PAGE TWO 12:00 N- ATTEND Lunch with Bob Luciano, Chairman of Schering Plough 1:30 pm 1:30 pm DEPART Schering Plough Headquarters for airport Driver: Mr. Luciano's driver Drive time: 5 minutes 1:35 pm ARRIVE airport and proceed to departing heliocopter FBO: Essex Hangar 201/539-6554 1:40 pm DEPART Morristown, NJ for New York Helo pad: 34th Strecf Helo pad Aircraft: S-76 . -
Confusing Brand Names: Nightmare of Medical Profession
Original Article www.jpgmonline.com Confusing brand names: Nightmare of medical profession Rataboli PV, Garg A Department of Pharma- ABSTRACT cology and Therapeutics, Objective: India has more than 20,000 registered pharmaceutical manufacturers. Consequently, there is a Goa Medical College, Bambolim, Goa 403202, flood of brand names to choose from. We conducted this study to analyse and sort out the multitudinous India brand names thronging the Indian market, and identified those that could create a possible confusion. Materials and Methods: Recent issues of drug formularies like Indian Drug Review, Drug Index, and Monthly Correspondence: Index of Medical Specialities-India were checked and all the brand names given were included. Some other Amit Garg, MD brand names that are available with the pharmacists but are not included in these indexes were also included E-mail: [email protected] in the study for analysis. Observations: Potentially confusing brand names were sorted out and categorised according to the severity of damage they can cause if misinterpreted by the pharmacist or the patient. Subgroups were made according to the brand name, the generic name, and the manufacturers of the drug. Conclusion: Several brand names are strikingly identical, similar looking (orthographic), or similar sounding (phonological). Preventing this possible confusion is not the work of any one person involved. We describe the Received : 09-08-04 role of prescribing doctors, dispensing pharmacists, consumer patients, and the manufacturing companies to Review completed : 30-09-04 prevent “wrong prescribing” due to similarities in brand names. Accepted : 22-12-04 PubMed ID : 15793332 J Postgrad Med 2005;51:13-6 KEY WORDS: Identical; look-alike; sound-alike; confusing; brand names rescribing drugs with their brand name is an essential the patients, doctors, pharmacists, and the drug manufacturers were P part of medical practice. -
Pfizer and Mylan Will Own 57% and 43% of the New Company (“Newco”), Respectively
DEAL PROFILE PFIZER | MYLAN VALUES 57% 43% $12.0bn PFIZER SHARE OF NEWCO MYLAN SHARE OF NEWCO NEW DEBT RAISED Pfizer Inc. (NYSE:PFE) Pfizer Inc. (“Pfizer”) is a pharmaceutical company that develops, manufactures, and sells products in internal medicine, vaccines, oncology, inflammation & immunology, and rare diseases. Upjohn, a subsidiary of Pfizer, is composed of Pfizer’s oral solid generics and off-patent drugs franchise, such as Viagra, Lipitor, and Xanax. Upjohn has a strong focus in emerging markets, and is headquartered in Shanghai, China. TEV: $265.4bn LTM EBITDA: $22.5bn LTM Revenue: $55.7bn Mylan N.V. (NASDAQ:MYL) Mylan N.V. (“Mylan”) is a pharmaceutical company that develops, manufactures, and commercializes generic, branded-generic, brand-name, and over-the-counter products. The company focuses in the following therapeutic areas: cardiovascular, CNS and anesthesia, dermatology, diabetes and metabolism, gastroenterology, immunology, infectious disease, oncology, respiratory and allergy, and women’s health. Mylan was founded in 1961 and is headquartered in Canonsburg, PA. TEV: $23.9bn LTM EBITDA: $3.5bn LTM Revenue: $11.3bn Bourne Partners provides strategic and financial advisory services to BOURNE clients throughout the business evolution life cycle. In order to provide PARTNERS the highest level of service, we routinely analyze relevant industry MARKET trends and transactions. These materials are available to our clients and partners and provide detailed insight into the pharma, pharma services, RESEARCH OTC, consumer health, and biotechnology sectors. On July 29, 2019, Pfizer announced the spin-off of its off-patent drug unit, Upjohn, in order to merge the unit with generic drug manufacturer, Mylan. -
JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors
Drugs https://doi.org/10.1007/s40265-020-01261-8 CURRENT OPINION JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors Miguel Nogueira1 · Luis Puig2 · Tiago Torres1,3 © Springer Nature Switzerland AG 2020 Abstract Despite advances in the treatment of psoriasis, there is an unmet need for efective and safe oral treatments. The Janus Kinase– Signal Transducer and Activator of Transcription (JAK–STAT) pathway plays a signifcant role in intracellular signalling of cytokines of numerous cellular processes, important in both normal and pathological states of immune-mediated infamma- tory diseases. Particularly in psoriasis, where the interleukin (IL)-23/IL-17 axis is currently considered the crucial pathogenic pathway, blocking the JAK–STAT pathway with small molecules would be expected to be clinically efective. However, relative non-specifcity and low therapeutic index of the available JAK inhibitors have delayed their integration into the therapeutic armamentarium of psoriasis. Current research appears to be focused on Tyrosine kinase 2 (TYK2), the frst described member of the JAK family. Data from the Phase II trial of BMS-986165—a selective TYK2 inhibitor—in psoriasis have been published and clinical results are encouraging, with a large Phase III programme ongoing. Further, the selective TYK2 inhibitor PF-06826647 is being tested in moderate-to-severe psoriasis in a Phase II clinical trial. Brepocitinib, a potent TYK2/JAK1 inhibitor, is also being evaluated, as both oral and topical treatment. Results of studies with TYK2 inhibitors will be important in assessing the clinical efcacy and safety of these drugs and their place in the therapeutic armamentarium of psoriasis. -
Stem Cell/Wnt
Inhibitors, Agonists, Screening Libraries www.MedChemExpress.com Stem Cell/Wnt Stem cells are required for continuous tissue maintenance within diverse organs, stem cell activity is often externally dictated by the microenvironment (the niche) so that stem cell output is precisely shaped to meet homeostatic needs or regenerative demands. Several key signaling pathways have been shown to play essential roles in this regulatory capacity. Specifically, the JAK/STAT, Hedgehog, Wnt, Notch, Smad, PI3K/phosphatase and tensin homolog, and NK-κB signaling pathways have all been shown experimentally to mediate various stem cell properties, such as self-renewal, cell fate decisions, survival, proliferation, and differentiation. Recent studies mainly focus on cancer stem cell, induced pluripotent stem cell, neural stem cell and maintenance of embryonic stem cell pluripotency. Cancer stem cells (CSCs) have been believed to be responsible for tumor initiation, growth, and recurrence. Numerous agents have been developed to specifically target CSCs by suppressing the expression of pluripotency maintaining factors Nanog, Oct-4, Sox-2, and c-Myc and transcription of GLI. Induced pluripotent stem cells (iPSCs) have the capacity to differentiate into various types of cells, and a self-renewing resource, and scientists can experiment with an unlimited number of pluripotent cells to perfect the process of targeted differentiation, transplantation, and more, for personalized medicine. Novel pathological mechanisms have been elucidated, new drugs originating from iPSC screens are in the pipeline and the first clinical trial using human iPSC-derived products has been initiated. References: [1] Clevers H, et al. Science. 2014 Oct 3;346(6205):1248012. [2] Matsui WH. Medicine (Baltimore). -
Pfizer's Bourla
No. 3985 December 13, 2019 line success and business development. “In the next two years, we need to see how the pipeline is delivering,” he said. Bourla has been outspoken that when it comes to business development, he doesn’t see a mega-merger on the hori- zon. Instead, he said he is looking to bring in mid-stage clinical development assets to complement the internal pipeline. It sounds like investors can expect the company to be active on the business development front within those guard- rails. “I want to double it,” he said of the pipeline, which includes 92 projects right now. “And, we are going to double it by bringing in a lot of innovation to comple- ment what we distribute.” The company is focusing business de- velopment on six core therapeutic areas Pfizer’s Bourla: “I Think We Forgot as well, but Bourla indicated the company will be actively building out those areas both through internal investment and What It Looks Like To Grow” external collaboration. “We’re going to be JESSICA MERRILL [email protected] active because Pfizer is a very big plane and it cannot fly with one engine,” he said. fizer Inc. CEO Albert Bourla took in July it will merge the Upjohn business Bourla highlighted Pfizer’s recent acqui- over the top leadership spot from with Mylan NV to form a new generic drug sition of the cancer specialist Array Bio- PIan Read a year ago, but has quickly company to be called Viatris GMBH. Pharma for $11.4bn as an example of the executed on big changes poised to make The resulting Pfizer will be significantly kinds of deals the company will be pursu- Pfizer significantly smaller and faster smaller, with a 2020 annual revenue base ing. -
Health Industry Business Communications Council
Health Industry Business Communications Council Registered Labelers: Accredited Auto-ID Labeling Standards Argentina New MedTek Devices Pty Ltd Oxavita SRL Norseld Pty Ltd. Novadien Healthcare Pty Ltd The following companies Odontit S.A. (and/or their subsidiaries/ PAMPAMED S.R.L. Numedico Technologies Pty Ltd divisions) have applied PATEJIM SRL Opto Global Pty. Ltd. for a Labeler Identification Orthocell Limited Code (LIC) assignment with Austria Prolotus Technologies Pty Ltd HIBCC*. By doing so, they afreeze GmbH Red Milawa Pty Ltd dba Magic Mobility have demonstrated their AMI GmbH SDI Limited commitment to patient safety Bender Medsystems GmbH Signostics Ltd. and logistical efficiency for BHS Technologies GmbH Sirtex Medical Pty Ltd their customers, the industry Metasys Medizintechnik GmbH Smith & Nephew Surgical Pty. Ltd. and the public at large. PAA Laboratories GmbH Staminalift International Limited Safersonic Medizinprodukte Handels The Pipette Company Pty. Ltd. Any organization that is GmbH Thermo Electron Corporation interested in using the HIBC W & H Dentalwerk Burmoos GmbH Vush Pty Ltd uniform labeling system may apply for the assignment of VUSH STIMULATION Australia one or more LICs. William A Cook Australia Pty. Ltd. Adv. Surgical Design & Manufacture, Ltd. Last updated 9-21-2021 AirPhysio Pty Ltd Belgium Annalise-AI Pty Ltd 3M Europe Apollo Medical Imaging Technology Pty Advanced Medical Diagnostics SA/NV Ltd Analis SA/NV Benra Pty Ltd dba Gelflex Laboratories Baxter World Trade Bioclone Australia Pty. Ltd. Bio-Rad RSL Candelis, Inc. Bio-Rad Lab Inc Clinical Diag. Group DePuy Australia Pty. Ltd. Biosource Europe SA For more information, please dorsaVi Ltd Cilag NV contact the HIBCC office at: EC Certification Service GmbH Coris Bioconcept Fink Engineering Pty Ltd Fuji Hunt Photographic Chemicals NV 2525 E. -
022450Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022450Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) CLINICAL PHARMACOLOGY REVIEW NDA 22-450 Submission Dates 05/13/2009 Brand Name - Generic Name IV acetaminophen Reviewer Ping Ji, Ph.D. Team Leader Suresh Doddapaneni, Ph.D. PM Primary Reviewers Ping Ji. Ph.D. PM Team Leader Yaning Wang, Ph.D. OCP Division Division of Clinical Pharmacology-II OND Division Division of Anesthesia, Analgesia, and Rheumatology Products Sponsor Cadence Pharmaceuticals, Inc. Relevant IND(s) 58,362 Submission Type; Code 505 (b) (2) P Formulation; Strength(s) Sterile solution for intravenous infusion, 1000 mg/vial Indication Treatment of acute pain and fever Proposed Dosing Regimen Single or repeated dose via a 15-minute intravenous infusion. The dose administered varied depending on age and body weight. Table of Contents Table of Contents.................................................................................................................1 1. Executive Summary.....................................................................................................2 1.1. Recommendations............................................................................................ 2 1.2. Phase IV Commitments................................................................................... 2 2. Question-Based Review...............................................................................................9 2.1. General Attributes........................................................................................... -
Eli Lilly and Company
Merrimack College Merrimack ScholarWorks Honors Senior Capstone Projects Honors Program Spring 2021 Eli Lilly and Company Alyssa Ardai Follow this and additional works at: https://scholarworks.merrimack.edu/honors_capstones Part of the Business Commons Ardai 1 Written Assignment #4 Eli Lilly and Company Alyssa Ardai Bus 4402W: Strategic Analysis and Decision Making Professor Herrmann April 30, 2021 Ardai 2 Abstract Eli Lilly and Company is a pharmaceutical company that has the goal of creating new products. Eli Lilly’s products are seen in hospitals and pharmacies around the US, with the hopes of growing internationally. By having a large number of drugs in their pipeline, they can be a key player in improving multiple types of illnesses as well as help aid the aging population. The healthcare sector is always one that is high-performing. Ardai 3 Eli Lilly and Company is positioned as a pharmaceutical company, with the goal of creating high-quality medicine for every need or to take a preexisting medicine and make it better. For the past 140 years, they have been creating medicine for various causes, but are now focusing their efforts on antibody treatments for the COVID-19 pandemic, as well as different cancers and autoimmune diseases. Everything that the company does should follow its core values: integrity, excellence, and respect for people (Eli Lilly and Company - A). Eli Lilly is found in the US, Japan, Europe, and hopes to expand to the rest of the world soon. They are broken down into Endocrinology, Oncology, Immunology, Neuroscience, & Other. The company has increased revenues from $23,832.8 - $25,925.3, a consistent tax rate of 15%, expenses increasing $300k a year, accounts receivable, or a/r, decreasing as they pay less in patents and drugs go generic, consistent inventory of $120k - $140k, showing they do not keep a lot on hand, a weighted average cost of capital, or WACC, of 5.9% showing it does not hold a lot of debt, and a long term growth rate of 2.3%, showing a healthy but stable growth (Bloomberg LP, CapitalIQ 2021). -
Eople on the Move Eople on the Move
eopleeople onon PPthethe movemove Pierre Cloutier Sylvie Denis Gilles Fortin Nicolas Gauvin Bernard Michaud Anna Kratochvil Abbott Abbott Abbott Abbott Abbott Abbott Laboratories Laboratories Laboratories Laboratories Laboratories Laboratories Gary Schmid Alison Shore Eric Bergey Kal Dreisziger Lidia Krupka Abbott Abbott L’Académie- Allard-Johnson Allard-Johnson Laboratories Laboratories Ogilvy Communications Communications (Montreal) (Montreal) Pierre Cloutier, formerly Business Nicolas Gauvin, formerly Senior Alison Shore, formerly Product Unit Manager, Oncology, Product Manager, GI, has been Manager, has been promoted to Pharmaceutical Products Division, promoted to Marketing Manager, GI, Senior Product Manager, Metabolic has been promoted to Director, Pharmaceutical Products Division, at (Meridia), Pharmaceutical Products Customer Relations (Corporate), at Abbott Laboratories. Division, at Abbott Laboratories. Abbott Laboratories. Bernard Michaud, formerly Senior Eric Bergey, formerly International Sylvie Denis, formerly Business Unit Product Manager, Anti-infectives, has OTC Product Manager at World Manager, Cardiovascular & been promoted to Marketing Headquarters of Pharmacia & Metabolic, has been promoted to Manager, Anti-infectives, Upjohn in Sweden and, most Director of Sales, Primary Care, Pharmaceutical Products Division, at recently, Account Supervisor at Jeffrey Pharmaceutical Products Division, at Abbott Laboratories. Simbrow Associates (Montreal), has Abbott Laboratories. been appointed Account Director at Anna Kratochvil, -
Statements Contained in This Release As the Result of New Information Or Future Events Or Developments
Pfizer and BioNTech Provide Update on Booster Program in Light of the Delta-Variant NEW YORK and MAINZ, GERMANY, July 8, 2021 — As part of Pfizer’s and BioNTech’s continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies are providing an update on their comprehensive booster strategy. Pfizer and BioNTech have seen encouraging data in the ongoing booster trial of a third dose of the current BNT162b2 vaccine. Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant, which are 5 to 10 times higher than after two primary doses. The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA, EMA and other regulatory authorities in the coming weeks. In addition, data from a recent Nature paper demonstrate that immune sera obtained shortly after dose 2 of the primary two dose series of BNT162b2 have strong neutralization titers against the Delta variant (B.1.617.2 lineage) in laboratory tests. The companies anticipate that a third dose will boost those antibody titers even higher, similar to how the third dose performs for the Beta variant (B.1.351). Pfizer and BioNTech are conducting preclinical and clinical tests to confirm this hypothesis. While Pfizer and BioNTech believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants including Delta, the companies are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant.