CY 2020 CDER Drug and Biologic Calendar Year Approvals As of December 31, 2020
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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. -
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. -
Abstracts from the 9Th Biennial Scientific Meeting of The
International Journal of Pediatric Endocrinology 2017, 2017(Suppl 1):15 DOI 10.1186/s13633-017-0054-x MEETING ABSTRACTS Open Access Abstracts from the 9th Biennial Scientific Meeting of the Asia Pacific Paediatric Endocrine Society (APPES) and the 50th Annual Meeting of the Japanese Society for Pediatric Endocrinology (JSPE) Tokyo, Japan. 17-20 November 2016 Published: 28 Dec 2017 PS1 Heritable forms of primary bone fragility in children typically lead to Fat fate and disease - from science to global policy a clinical diagnosis of either osteogenesis imperfecta (OI) or juvenile Peter Gluckman osteoporosis (JO). OI is usually caused by dominant mutations affect- Office of Chief Science Advsor to the Prime Minister ing one of the two genes that code for two collagen type I, but a re- International Journal of Pediatric Endocrinology 2017, 2017(Suppl 1):PS1 cessive form of OI is present in 5-10% of individuals with a clinical diagnosis of OI. Most of the involved genes code for proteins that Attempts to deal with the obesity epidemic based solely on adult be- play a role in the processing of collagen type I protein (BMP1, havioural change have been rather disappointing. Indeed the evidence CREB3L1, CRTAP, LEPRE1, P4HB, PPIB, FKBP10, PLOD2, SERPINF1, that biological, developmental and contextual factors are operating SERPINH1, SEC24D, SPARC, from the earliest stages in development and indeed across generations TMEM38B), or interfere with osteoblast function (SP7, WNT1). Specific is compelling. The marked individual differences in the sensitivity to the phenotypes are caused by mutations in SERPINF1 (recessive OI type obesogenic environment need to be understood at both the individual VI), P4HB (Cole-Carpenter syndrome) and SEC24D (‘Cole-Carpenter and population level. -
Circulating Biomarkers in Neuromuscular Disorders: What Is Known, What Is New
biomolecules Review Circulating Biomarkers in Neuromuscular Disorders: What Is Known, What Is New Andrea Barp 1,* , Amanda Ferrero 1, Silvia Casagrande 1,2 , Roberta Morini 1 and Riccardo Zuccarino 1 1 NeuroMuscular Omnicentre (NeMO) Trento, Villa Rosa Hospital, Via Spolverine 84, 38057 Pergine Valsugana, Italy; [email protected] (A.F.); [email protected] (S.C.); [email protected] (R.M.); [email protected] (R.Z.) 2 Department of Neurosciences, Drug and Child Health, University of Florence, Largo Brambilla 3, 50134 Florence, Italy * Correspondence: [email protected] Abstract: The urgent need for new therapies for some devastating neuromuscular diseases (NMDs), such as Duchenne muscular dystrophy or amyotrophic lateral sclerosis, has led to an intense search for new potential biomarkers. Biomarkers can be classified based on their clinical value into different categories: diagnostic biomarkers confirm the presence of a specific disease, prognostic biomarkers provide information about disease course, and therapeutic biomarkers are designed to predict or measure treatment response. Circulating biomarkers, as opposed to instrumental/invasive ones (e.g., muscle MRI or nerve ultrasound, muscle or nerve biopsy), are generally easier to access and less “time-consuming”. In addition to well-known creatine kinase, other promising molecules seem to be candidate biomarkers to improve the diagnosis, prognosis and prediction of therapeutic response, such as antibodies, neurofilaments, and microRNAs. However, there are some criticalities that can complicate their application: variability during the day, stability, and reliable performance metrics Citation: Barp, A.; Ferrero, A.; (e.g., accuracy, precision and reproducibility) across laboratories. In the present review, we discuss Casagrande, S.; Morini, R.; Zuccarino, the application of biochemical biomarkers (both validated and emerging) in the most common NMDs R. -
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 -
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. -
Letter Without Tagline
CH D Press release DONGBAO TO ACQUIRE FERRING’S MALMÖ MANUFACTURING OPERATION Saint Prex, Switzerland and Shanghai, China, Friday 17 November, 2006 – Ferring Pharmaceuticals and Shanghai Dongbao Biopharmaceutical Company announced today the signing of an agreement by which Dongbao Biopharmaceutical will purchase Ferring’s manufacturing operation at Malmö in Sweden. Earlier this year, Ferring informed staff of its plan to cease manufacturing at Malmö by the end of March 2008. However, the acquisition by Dongbao Biopharmaceutical has secured the jobs of around 50 members of staff. The agreement will become effective on 1 January, 2007. “From the very beginning, our aim has been to find a solution which would maintain the Malmö production site,” commented Ferring Pharmaceuticals Chief Operating Officer, Michel Pettigrew. “This agreement is a boost for the local community and has secured the long-term future of the factory for around 50 employees, whose experience will be invaluable to Dongbao Biopharmaceutical.” “We see great potential for the manufacturing centre at Malmö,” added Dr George Li, President of Dongbao Biopharmaceutical. “The site is technically very developed and the current team, who will be an important part of our future business development, offer a lot of knowledge and competencies.” Ends Ferring International Center S.A., Chemin de la Vergognausaz 50, 1162 Saint‐Prex, Switzerland Tel: +41 58 301 00 00, Fax: +41 58 301 00 10, www.ferring.com CH About Ferring: Ferring is a Swiss-based research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology. -
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, -
Triptorelin Pamoate (Subcutaneous Injection) for Prostate Cancer NIHRIO (HSRIC) ID: 20540 NICE ID: 9841
NIHR Innovation Observatory Evidence Briefing: May 2018 Triptorelin pamoate (subcutaneous injection) for prostate cancer NIHRIO (HSRIC) ID: 20540 NICE ID: 9841 LAY SUMMARY Prostate cancer is cancer of the prostate gland (a small organ in a man’s pelvis) and is the second most common cancer in the UK. There are three stages: localised, locally‐advanced and advanced (or metastatic) prostate cancer. The symptoms of prostate cancer may vary depending on the stage of cancer but can include pain, tiredness, problems emptying the bladder and the bowels. About half of men diagnosed with locally‐advanced prostate cancer will see their cancer spread to other body organs (i.e. becoming metastatic). Triptorelin is being developed as an injection under the skin (subcutaneous) for the treatment of locally advanced or metastatic prostate cancer. It is already marketed for this condition but is given by injection deep into the muscles (intramuscular). Triptorelin is an artificial analogue of natural gonadotropin‐releasing hormone that acts to slowly reduce the level of testosterone in the body. The first administration of triptorelin stimulates an increase in testosterone levels but prolonged administration leads to a fall in plasma testosterone or oestradiol to castrate levels which is maintained for as long as the product is administered. Triptorelin as a subcutaneous injection formulation has the potential advantage of improved safety and local tolerability when compared to intramuscular injection formulation. This briefing reflects the evidence available at the time of writing. A version of the briefing was sent to the company for a factual accuracy check. The company was available to provide comment. -
Manufacturers with Signed Rebate Agreements February 1 , 2011
Wisconsin Medicaid Pharmacy Data Table Manufacturers with Signed Rebate Agreements February 1 , 2011 NEWLABELER NAME START END SC NEW LABELER NAME START END SC 00002 ELI LILLY AND COMPANY 1/1/1991 Y 00126 COLGATE ORAL PHARMACEUTICAL 1/1/1991 Y 00003 E R SQUIBB AND SONS INC. 1/1/1991 Y 00131 SCHWARZ PHARMA, INC. 1/1/1991 Y 00004 HOFFMANN LAROCHE INC 1/1/1991 00132 C B FLEET COMPANY INC. 1/1/1991 00005 LEDERLE LABORATORIES 1/1/1991 Y 00135 SMITHKLINE BEECHAM 1/1/1995 Y 00006 MERCK SHARP & DOHME 1/1/1991 Y 00143 WEST-WARD PHARMACEUTICAL C 1/1/1991 Y 00007 SMITHKLINE BEECHAM CORPORATI 1/1/1991 Y 00145 STIEFEL LABORATORIES INC. 1/1/1991 Y 00008 WYETH AYERST LABORATORIES 1/1/1991 Y 00149 PROCTER & GAMBLE PHARMACEU 1/1/1991 Y 00009 PHARMACIA AND UPJOHN 1/1/1991 Y 00168 E FOUGERA AND CO, DIV OF ALTAN 1/1/1991 Y 00013 PHARMACIA AND UPJOHN 1/1/1991 Y 00169 NOVO NORDISK PHARMACEUTICAL 1/1/1991 Y 00015 INVAMED, INC 1/1/1991 Y 00172 ZENITH LABORATORIES, INC 1/1/1991 Y 00023 ALLERGAN INC. 1/1/1991 Y 00173 GLAXOSMITHKLINE 1/1/1991 Y 00024 SANOFI SYNTHELABO 1/1/1991 Y 00178 MISSION PHARMACAL COMPANY 1/1/1991 Y 00025 PHARMACIA CORPORATION 1/1/1991 Y 00182 GOLDLINE LABORATORIES INC 1/1/1991 Y 00026 BAYER CORP PHARMACEUTICAL DI 1/1/1991 Y 00185 EON LABS MANUFACTURING, INC. 1/1/1991 Y 00028 NOVARTIS PHARMACEUTICALS 1/1/1991 Y 00186 ASTRAZENECA LP 1/1/1991 Y 00029 SMITHKLINE BEECHAM CORPORATI 1/1/1991 Y 00187 ICN PHARMACEUTICALS INC. -
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.