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The best articles from selected authors of the pharma community.

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    Brexit Checklist for the Pharma Industry

    by John Cahill Director/Snr Consultant, Quality and Compliance A disorderly Brexit is moving from a possibility to a probability. While governments pass last minute legislation over the...

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    Podcast: Trends in The New Value-Based Reimbursement Model

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    this month featured authors

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    A Pharmaceutical Launch Opportunity:​ Science, Art or Alchemy?

    A publisher friend recently suggested I write down what I knew about launching pharmaceutical brands, to help new marketers who may have been handed...

    Biologics and Biosimilars in Oncology

    With many patents about to expire in coming years, the field of biologics in oncology is about to change dramatically. Biologics are predicted to...

    How you can add value to your self-inspection programme

    by Lorraine Lyons. Pharmaceutical Quality Consultant and Qualified Person (QP) with over 16 years’ experience in the Pharmaceutical Industry. Self-inspections support an organisation in accomplishing its...

    Improving The Communication Between Drug Reps and Doctors

    What does it mean to be a drug rep / medical representative? What is this magical profession about, that forces all managers, executives and...

    Change Medical Reps Status from ‘Unwelcomed’​ to ‘Most Welcome’​

    Just a decade ago, the job of a pharma sales rep was much desired among pharma professionals. DTC advertising did most of the heavy...

    Addition by Subtraction

    Addition by Subtraction? Sounds paradoxical? Unbelievable? Consider what Lao Tzu, the great Chinese philosopher said 2,500 years ago. Here is the essence of what he said: To attain knowledge, add things everyday. To attain wisdom, subtract things everyday. Profit comes from what is there, and usefulness comes from what is not there.

    Real-world Evidence (RWE) for Regulatory and Reimbursement Decisions

    We have previously discussed the potential roles of real-world data (RWD) and real-world evidence (RWE) for drug access. However, the precise roles of RWE...

    Is there a way of safeguarding the supply of medicines in the case of a ‘no deal’ Brexit?

    By Dr. Jonathan Trethowan, Vice President Regulatory and Scientific Policy at PharmaLex Every month, there are 45 million patient packs of medicines transported from the...

    Barriers to Personalized Medicine in Oncology

    Did you know that the top 10 highest grossing drugs in the United States only help between 4-25% of patients who take them? In...

    Bionics and Exoskeleton Components for Patient Assistance

    What is Bionics and Why Should You Care? Bionics – also known as biomechatronics – is the study of mechanical systems that function like living...

    Artificial Intelligence in Pharma

    Artificial intelligence, or AI for short, is one of the most highly anticipated digital healthcare technologies. While the concept of AI may still seem futuristic...

    Gene Editing in the UK Parliament

    Published on November 22, 2018 Pic: From right to left: Ms Nunzia Florio (External Affairs Manager at BIVDA); Lord Warner (Crossbench, Minister of Health from 2005 to 2007); yours truly;...

    Everything you need to know about MOA 3D Medical Videos

    Looking at ways on taking your Medical Communication to the next level? Mechanisms of Action Videos, also known as MOA videos, are videos that visually...

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    Editor´s Pick

    Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD

    INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA...

    Diagnostics Data Analytics Company Diaceutics to List on London Stock Exchange

    PARSIPPANY, N.J.--(BUSINESS WIRE)--Diaceutics plc, a revenue-generating and profitable diagnostics data analytics and implementation services company which services the global pharmaceutical industry, today announces that...

    Amarin’s Vascepa cuts occurrence of serious heart problems 30 percent: study

    A high dose of Amarin Corp's Omega-3 drug Vascepa significantly reduced the occurrence of first and subsequent heart attacks, strokes and other serious heart problems in high-risk patients already taking cholesterol medication by even more than initially reported, according to data presented on Monday.

    Apple Watch detects irregular heart beat in large U.S. study

    The Apple Watch was able to detect irregular heart pulse rates that could signal the need for further monitoring for a serious heart rhythm problem, according to data from a large study funded by Apple Inc , demonstrating a potential future role for wearable consumer technology in healthcare.

    Researchers Use Algorithm from Netflix Challenge to Speed Up Biological Imaging

    WASHINGTON--(BUSINESS WIRE) Researchers have repurposed an algorithm originally developed for Netflix’s 2009 movie preference prediction competition to create a method for acquiring classical Raman...

    Antibacterial Drugs Market Expansion to be Persistent During 2026

    The Global Antibacterial Drugs Market size was valued at US$ 43,791.2 million in 2017, and is expected to exhibit a CAGR of 1.4% over...

    The Family That Profited From the Opioid Crisis

    The Sacklers, one of the richest families in America, gained much of their wealth from sales of the powerful painkiller OxyContin. Will they now...

    European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Adults with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

    KENILWORTH, N.J.--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24MRK&src=ctag" target="_blank"gt;$MRKlt;/agt; lt;a href="https://twitter.com/hashtag/MRK?src=hash" target="_blank"gt;#MRKlt;/agt;--European Commission Approves Merck’s KEYTRUDA in Combination with Chemotherapy for First-Line Treatment of Adults with Metastatic Squamous...

    U.S. court rejects Alvogen’s patent challenge for Celgene’s cancer drug

    The U.S. patent office on Thursday rejected a filing by Alvogen Pine Brook Llc for a review challenging patents on Celgene Corp's blockbuster myeloma drug Revlimid.

    California jury awards $29 million to woman with cancer who used J&J talc

    A California jury on Wednesday awarded $29 million to a woman who said that asbestos in Johnson & Johnson's talcum-powder-based products caused her cancer.

    FDA Grants Purdue Pharma’s Nalmefene HCl Injection Fast Track Designation for the Emergency Treatment of Known or Suspected Opioid Overdose

    STAMFORD, Conn.--(BUSINESS WIRE)--FDA Grants Purdue Pharma’s Nalmefene HCl Injection Fast Track Designation for the Emergency Treatment of Known or Suspected Opioid...
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    Look Who’s On the Move!

    ArunA Bio Appoints Al Medwar as Executive Vice President, Corporate and Commercial Development

    ATHENS, Ga--(BUSINESS WIRE)--ArunA Bio Appoints Al Medwar as Executive Vice President, Corporate and Commercial Development http://www.businesswire.com/news/home/20190318005261/en/ArunA-Bio-Appoints-Al-Medwar-Executive-Vice/?feedref=JjAwJuNHiystnCoBq_hl-bQQCakZDujohEJegUyaJwquReQ0P23MrIoWkrUSV24ZevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxbNWfZlBntHS6jpH5ROLXsTFMkl05DM8ABqeyBleEmzJA==

    LivaNova Announces Trui Hebbelinck as Chief Human Resources Officer

    LONDON--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24LIVN&src=ctag" target="_blank"gt;$LIVNlt;/agt;--LivaNova announced Trui Hebbelinck has been appointed Chief Human Resources Officer for the Company. http://www.businesswire.com/news/home/20190318005011/en/LivaNova-Announces-Trui-Hebbelinck-Chief-Human-Resources/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

    California Life Sciences Association (CLSA) Appoints Andrew Setikas as Senior Vice President of Business...

    SAN FRANCISCO & SAN DIEGO--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/AndrewSetikas?src=hash" target="_blank"gt;#AndrewSetikaslt;/agt;--California Life Sciences Association (CLSA) Appoints Andrew Setikas as Senior Vice President of Business Development and Strategy...

    Fractyl Expands Management Team as Company Initiates U.S. Clinical Trial in Type 2 Diabetes

    LEXINGTON, Mass.--(BUSINESS WIRE)--Fractyl Laboratories Inc. today announced the hiring of Margaret Borys as Chief Commercial Officer (CCO) and Juan Carlos Lopez-Talavera, M.D. http://www.businesswire.com/news/home/20190318005140/en/Fractyl-Expands-Management-Team-Company-Initiates-U.S./?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

    Bicycle Therapeutics Appoints Pierre Legault as New Director and Board Chairman

    CAMBRIDGE, England & BOSTON, Mass.--(BUSINESS WIRE)--Bicycle Therapeutics announced today the appointment of Pierre Legault, MBA, CPA, as a Director and Chairman of the Board...

    Dr Joshua Dunaief MD, Renowned Age-Related Macular Degeneration Clinician and Researcher, Joins Mperia Therapeutics...

    MONTREAL--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/amorchem?src=hash" target="_blank"gt;#amorchemlt;/agt;--Dr. Joshua Dunaief, PhD, MD, the Adele Niessen Professor of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, USA, joins the Clinical Advisory...

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    Research and Development

    Boston Heart Diagnostics Publishes Randomized Trial

    FRAMINGHAM, Mass.--(BUSINESS WIRE)--Boston Heart Diagnostics, one of the leading disease management laboratories in the United States, today announced the publication of a new research...

    miR Scientific Presents a New Non-invasive Test for Identifying Clinically...

    NEW YORK--(BUSINESS WIRE)--miR Scientific LLC, a precision bioscience company focused on comprehensive disease detection and management, announced today a poster presentation at the 34th...

    QxMD Adds Mobile-First Continuing Medical Education (CME) Programming to Its...

    VANCOUVER, British Columbia--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/CME?src=hash" target="_blank"gt;#CMElt;/agt;--In addition to earning CME credits for literature searches, busy HCPs can now also acquire credits through mobile learning...

    First Sub-Analyses from the DECLARE-TIMI 58 Trial Further Support the...

    WILMINGTON, Del.--(BUSINESS WIRE)--Positive results from a pre-specified sub-analysis of the Phase III DECLARE-TIMI 58 trial showed that FARXIGA (dapagliflozin) reduced the relative risk of...

    Dr. Stefan Büttner to Present Clinical Trial Results of ExThera’s...

    MARTINEZ, Calif.--(BUSINESS WIRE)--Dr. Stefan Büttner will present clinical trial results of ExThera Medical's Seraph® pathogen-removing filter at ISICEM in Brussels. http://www.businesswire.com/news/home/20190318005163/en/Dr.-Stefan-B%C3%BCttner-Present-Clinical-Trial-Results/?feedref=JjAwJuNHiystnCoBq_hl-bQQCakZDujohEJegUyaJwquReQ0P23MrIoWkrUSV24ZevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxbNWfZlBntHS6jpH5ROLXsTFMkl05DM8ABqeyBleEmzJA==

    NantKwest Chairman & CEO Dr. Patrick Soon-Shiong to Present Vision...

    SAN DIEGO & CULVER CITY, Calif.--(BUSINESS WIRE)--NantKwest (Nasdaq:NK), a leading clinical-stage, natural killer cell based therapeutics company, today announced that the company’s Chairman &...

    AUGUSTUS Demonstrates Favorable Safety Results of Eliquis® Versus Vitamin K...

    PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24BMY&src=ctag" target="_blank"gt;$BMYlt;/agt;--AUGUSTUS Demonstrates Favorable Safety Results of Eliquis® Versus Vitamin K Antagonists in Non-Valvular Atrial...

    Mogrify Awarded $555,000 USD (£420,000 GBP) Innovate UK Funding to...

    CAMBRIDGE, England--(BUSINESS WIRE)--Cell Mogrify Ltd (Mogrify), a UK company aiming to transform the future development of cell therapies, today announced that it has been...

    Impella RP Post-Approval Study Data Presented at ACC 2019

    NEW ORLEANS, La.--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/heartrecovery?src=hash" target="_blank"gt;#heartrecoverylt;/agt;--Impella RP Post-Approval Study Data Presented at ACC 2019. Data demonstrates survival benefit with the Impella RP Recover Right...

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    Regulatory Affairs

    Takeda Receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK), (“Takeda”) today announced that the United States Food and Drug Administration (FDA) has approved...

    Puma Biotechnology’s Licensing Partner Specialised Therapeutics Asia Receives Regulatory Approval...

    LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology’s licensing partner Specialised Therapeutics Asia received regulatory approval to commercialize NERLYNX® (neratinib) in Australia. http://www.businesswire.com/news/home/20190318005250/en/Puma-Biotechnology%E2%80%99s-Licensing-Partner-Specialised-Therapeutics-Asia/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

    Vizient Endorses Legislation to Support Competition and Biosimilar Adoption to...

    IRVING, Texas--(BUSINESS WIRE)--Vizient announces its support for the FAST Generics Act of 2019 and the Biologic Patent Transparency Act of 2019. http://www.businesswire.com/news/home/20190318005150/en/Vizient-Endorses-Legislation-Support-Competition-Biosimilar-Adoption/?feedref=JjAwJuNHiystnCoBq_hl-bQQCakZDujohEJegUyaJwquReQ0P23MrIoWkrUSV24ZevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxbNWfZlBntHS6jpH5ROLXsTFMkl05DM8ABqeyBleEmzJA==

    Adamis Pharmaceuticals Announces FDA Acceptance for Review of the New...

    SAN DIEGO--(BUSINESS WIRE)--Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the company’s New...

    Spectrum Pharmaceuticals Provides BLA Filing Update for ROLONTIS® (eflapegrastim)

    HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals Provides BLA Filing Update for ROLONTIS® (eflapegrastim) http://www.businesswire.com/news/home/20190315005110/en/Spectrum-Pharmaceuticals-BLA-Filing-Update-ROLONTIS%C2%AE-eflapegrastim/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

    Advicenne Announces Submission of European Marketing Authorization Application (MAA) for...

    NÎMES, France--(BUSINESS WIRE)--Regulatory News: Advicenne (Paris:ADVIC) (Euronext: ADVIC – FR0013296746), specializing in the development of adult and pediatric therapeutic products for the treatment of...

    Aerie Pharmaceuticals Announces U.S. FDA Approval of Rocklatan™ (netarsudil and...

    DURHAM, N.C.--(BUSINESS WIRE)--Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization...

    FDA Grants Purdue Pharma’s Nalmefene HCl Injection Fast Track Designation...

    STAMFORD, Conn.--(BUSINESS WIRE)--FDA Grants Purdue Pharma’s Nalmefene HCl Injection Fast Track Designation for the Emergency Treatment of Known or Suspected Opioid...

    Celgene Submits Application to EMA for Ozanimod for the Treatment...

    SUMMIT, N.J.--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/MS?src=hash" target="_blank"gt;#MSlt;/agt;--Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a Marketing Authorization Application to the European...

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    Industry News

    QxMD Adds Mobile-First Continuing Medical Education (CME) Programming to Its...

    VANCOUVER, British Columbia--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/CME?src=hash" target="_blank"gt;#CMElt;/agt;--In addition to earning CME credits for literature searches, busy HCPs can now also acquire credits through mobile learning...

    Kyowa Kirin Asia Pacific Announces Establishment of Subsidiary in Australia

    TOKYO--(BUSINESS WIRE)--Kyowa Kirin Asia Pacific Pte. Ltd. (President: Chikakuni Kotani, Kyowa Kirin Asia Pacific), a wholly owned subsidiary of Kyowa Hakko Kirin Co., Ltd....

    SpeeDx Distribution Network Expands to the Middle East

    SYDNEY--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/PlexPCR?src=hash" target="_blank"gt;#PlexPCRlt;/agt;--SpeeDx sign Al Zahrawi to distribute ResistancePlus and PlexPCR tests in the GCC - bringing Resistance Guided Therapy to more patients...

    China National Biotec Group (CNBG) and ImmunoBiology Ltd Enter Licensing...

    CAMBRIDGE, England--(BUSINESS WIRE)--Cambridge Based Vaccine Company ImmBio has entered a licensing agreement with the largest vaccine producer in China, CNBG to Co-Develop ImmBio’s Pnu...

    Exactech Acquires XpandOrtho

    GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech, a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip announced today, that...

    NanoView Biosciences Opens UK Office for Sales and Application Support

    BOSTON--(BUSINESS WIRE)--NanoView has established a new administrative and demonstration facility near Birmingham, UK. http://www.businesswire.com/news/home/20190312005284/en/NanoView-Biosciences-Opens-UK-Office-Sales-Application/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

    Anika to Showcase Commercial and Pipeline Portfolio at 2019 AAOS...

    BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid...

    BioTime Announces Closing of Acquisition of Asterias Biotherapeutics Creating Leading...

    ALAMEDA, Calif.--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24BTX&src=ctag" target="_blank"gt;$BTXlt;/agt; lt;a href="https://twitter.com/hashtag/AMD?src=hash" target="_blank"gt;#AMDlt;/agt;--BIOTIME ANNOUNCES CLOSING OF ACQUISITION OF ASTERIAS BIOTHERAPEUTICS CREATING LEADING CELL THERAPY COMPANY http://www.businesswire.com/news/home/20190311005200/en/BioTime-Announces-Closing-Acquisition-Asterias-Biotherapeutics-Creating/?feedref=JjAwJuNHiystnCoBq_hl-c_SXB-bY2T43rxUBWxEIvSqcp-o_pnudlUwsb5apQ1S4gUE65BTfjH3-pSuqdv0gW3cb3F4oTIgUqCPafFkgu61_izUl0FZkbDFZ7ZhSEmC

    Seres Therapeutics Announces Microbiome Immuno-Oncology Focused Collaboration with AstraZeneca

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Seres Therapeutics announces a three-year research collaboration with AstraZeneca focused on cancer immunotherapy. http://www.businesswire.com/news/home/20190311005498/en/Seres-Therapeutics-Announces-Microbiome-Immuno-Oncology-Focused-Collaboration/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

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