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    Business Plan: a Medical Affairs perspective

    A business plan is generally considered a process and specifically, a document, that summarizes the operational and financial objectives of a business - independently...

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    Podcast: Trends in The New Value-Based Reimbursement Model

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    Business Plan: a Medical Affairs perspective

    A business plan is generally considered a process and specifically, a document, that summarizes the operational and financial objectives of a business - independently...

    Rare Diseases at Roche: Combining science and alliances to find breakthroughs in rare diseases

    One of the biggest events in the rare disease calendar – the Huntington Disease Society of America annual convention – is taking place this week, the...

    Innovative Trial Designs for Individualizing Oncology Treatments (Part 2 of 2)

    Last month, I looked into adaptive trials for individualizing oncology treatment and moving towards personalized medicine. In part 2 of 2 of this series,...

    Innovative Trial Designs for Individualizing Oncology Treatments (Part 1 of 2)

    In my recent article on personalized medicine in oncology, I touched on the need for more and better clinical trials to make precision medicine...

    Virtual Trials as a Means to Increase Patient Involvement and Reduce Patient Burden

    Virtual trials, sometimes also referred to as “remote” or “site-less” trials are an innovative and emerging trial design. These trials aim to reduce the...

    10 Things I Learned About Digital Health in Brazil

    I wrote this from the perspective of the entrepreneurs I met, currently forging digital health solutions in Brazil, and where I see the opportunities...

    Five Essential Skills for Pharma’s Future Leaders

    By Steve Figman, Syntegrity The recent eyeforpharma ‘19 conference in Philadelphia showcased an impressive array of speakers, with presentations and roundtable discussions from thought leaders...

    “Magic Mushrooms” for Psychotherapy—What Does the Evidence Say?

    What are “Magic Mushrooms”? “Magic mushrooms,” also known as “shrooms” among many other names, are mushrooms containing the hallucinogen psilocybin. This compound is found in...

    Top Tips – Building your ISO Quality Management System

    Top tips for building your ISO Quality Management System for Pharmaceutical Companies A Quality Management System (QMS) is key for pharma companies and should encourage...

    Importance of Patient Engagement and Empowerment for Pharma

    Except for direct participation in clinical trials and post-approval activities such as disease education, patient involvement in the biopharmaceutical development process remains episodic and...

    Connecting in the Digital Age

    Connecting in the Digital Age How Pharmaceutical Companies Can Use Marketing Outreach to Better Engage with Global Consumers By Guillem Vidal, Welocalize Life Sciences, lifesciences.welocalize.com Most companies...

    Why Too Many Clinical Trials Fail

    By Julien Moussalli Market Expansion Lead at IQVIA (LinkedIn: https://www.linkedin.com/in/julien-moussalli-80010349/) A makeover of the $65 billion clinical trials market (1) is well overdue. According to...

    Editor´s Pick

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    AstraZeneca Imfinzi combination fails advanced lung cancer study

    A combination of AstraZeneca's lung cancer drug Imfinzi and an experimental treatment failed to extend the lives of patients with advanced non-small cell lung cancer (NSCLC) and high levels of gene mutations, the drugmaker said on Wednesday.

    Exclusive: Philips, under investigation in U.S. and Brazil, fired whistleblower who warned of graft

    Healthcare giant Philips was warned of suspicious sales of its medical equipment to the Brazilian government, and failed to halt them, nearly a decade before an alleged bribery racket was exposed in the company's Brazil operations last year, Reuters has learned.

    Drugmakers Endo, Allergan agree to $15 million in settlements in major opioid case

    Endo International Plc and Allergan Plc have agreed to pay $15 million to avoid going to trial in October in a landmark case by two Ohio counties accusing various drug manufacturers and distributors of fueling the U.S. opioid epidemic.

    Teva launches generic version of EpiPen for young children

    Teva Pharmaceutical Industries Ltd on Tuesday made its generic version of Mylan's EpiPen for young children available in most retail pharmacies at $300 for a 2-pack.

    Sarepta shares sink 14% after shock FDA rejection

    Shares of Sarepta Therapeutics Inc plunged 14% on Tuesday after the U.S. health regulator, in an unexpected move, declined to approve the drugmaker's newest treatment for a muscle-wasting disorder that mainly affects young boys.

    Expert panel updates advice on BRCA cancer gene screening

    (Reuters Health) - Mutations in the BRCA1 and BRCA2 genes are associated with increased risks for breast, ovarian, and other cancers, but only certain women stand to benefit from genetic testing, according to updated recommendations from the U.S. Preventive Services Task Force (USPSTF).

    Drugmaker Endo to pay $10 million to settle opioid case ahead of trial

    Endo International Plc on Tuesday said it had agreed to pay $10 million to avoid going to trial in October in a landmark case by two Ohio counties accusing various drug manufacturers and distributors of fueling the U.S. opioid epidemic.

    Teva to launch generic version of EpiPen for young children

    Teva Pharmaceutical Industries Ltd said on Tuesday its generic version of Mylan's EpiPen for young children will be available in most retail pharmacies at a price of $300 for a 2-pack.

    AstraZeneca diabetes drug shows promise in heart failure

    AstraZeneca made strides on Tuesday toward its goal of adding heart failure to the conditions that can be treated by its diabetes drug Farxiga, putting it ahead of a rival medicine from Eli Lilly.

    FDA declines to approve Sarepta’s second Duchenne treatment

    Sarepta Therapeutics Inc said on Monday the U.S. Food and Drug Administration declined to approve its newest treatment for Duchenne muscular dystrophy (DMD), citing safety concerns including the risk of infection and kidney toxicity.

    Who is next in big pharma’s merger spree?

    Consolidation in the U.S. healthcare industry, which has already witnessed a string of multi-billion dollar deals, is expected to remain a major theme for the rest of 2019.

    Roche taps Lilly executive Garraway as chief medical officer

    Swiss drugmaker Roche Holding on Monday named Eli Lilly executive Levi Garraway to succeed Sandra Horning as chief medical officer and head of global product development.

    UK’s Johnson slams ‘mumbo-jumbo’ about vaccines after measles rates rise

    Britons should get vaccinated against measles and ignore online "mumbo-jumbo" about dangers of the jabs, Prime Minister Boris Johnson said on Monday after a resurgence of the disease.

    Look Who’s On the Move!

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    Roche taps Lilly executive Garraway as chief medical officer

    Swiss drugmaker Roche Holding on Monday named Eli Lilly executive Levi Garraway to succeed Sandra Horning as chief medical officer and head of global product development.

    Mary Lynne Hedley Joins Veeva Board of Directors

    PLEASANTON, Calif.--(BUSINESS WIRE)--Veeva Systems (NYSE:VEEV) today announced the appointment of Mary Lynne Hedley to the company’s Board of Directors. Dr. Hedley brings 23 years...

    PredictImmune Appoints Tim Rea of BGF as Non-Executive Director

    CAMBRIDGE, England--(BUSINESS WIRE)--PredictImmune, developers of pioneering prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated diseases, is delighted to welcome Tim...

    Millendo Therapeutics Appoints Tamara Joseph as General Counsel and Ryan Zeidan as Chief Development...

    ANN ARBOR, Mich.--(BUSINESS WIRE)--Millendo Therapeutics, Inc. (Nasdaq: MLND), a clinical-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases with significant...

    California Life Sciences Association Adds Substantial Depth to Board with Several New Appointments

    SAN FRANCISCO & SAN DIEGO--(BUSINESS WIRE)--California Life Sciences Association (CLSA), the trade association representing California’s life sciences sector, today announced the appointment of several...

    Merz Announces Key Governance Changes

    FRANKFURT, Germany--(BUSINESS WIRE)--Merz, a global leader in medical aesthetics and specialty neurology, announced today that Philip Burchard will be appointed Chairman of the company’s...

    Bioasis Strengthens Senior Management Team with Appointment of Caroline Dircks, Ph.D. as Chief Operating...

    GUILFORD, Conn.--(BUSINESS WIRE)--BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI), ), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3 TM platform technology for the delivery of...

    AVROBIO Appoints Georgette Verdin as Chief Human Resources Officer

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVROBIO, Inc. (NASDAQ: AVRO) (“AVROBIO” or the “Company”), a Phase 2 clinical-stage gene therapy company, today announced the appointment of Georgette Verdin...

    SpringWorks Therapeutics Announces Appointment of Frank Perier as Chief Financial Officer

    STAMFORD, Conn.--(BUSINESS WIRE)--SpringWorks Therapeutics, Inc. a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced...

    AmerisourceBergen Appoints New Chief Strategy Officer

    VALLEY FORGE, Pa.--(BUSINESS WIRE)--AmerisourceBergen, a global healthcare solutions leader, announces the appointment of Leslie E. Donato to its executive team as Executive Vice President...

    M2Gen® Appoints Dr. Helge Bastian President and Chief Executive Officer

    TAMPA, Fla.--(BUSINESS WIRE)--M2Gen, a health informatics solutions company focused on accelerating the discovery, development and delivery of precision medicine, announced today the appointment of...

    Research and Development

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    Pharma Jobs Site

    Here, worldwide, recruiters will be able to post their jobs and job seekers will be able to seek them.

    Pharma Guide Website

    Your industry meeting point. Add your business for free!

    Fremanezumab Data in The Lancet Demonstrate Clinically Meaningful Reduction in...

    JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that results from the Phase IIIb FOCUS study, which examined fremanezumab versus placebo...

    Clinical Study Published in Prenatal Diagnosis Further Validates PerkinElmer’s Vanadis...

    WALTHAM, Mass.--(BUSINESS WIRE)--PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that its Vanadis® fully automated non-invasive prenatal testing...

    Aimmune Enrolls First Patient in Phase 2 Trial of AR201...

    BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that it has randomized its first...

    OKYO Pharma Announces Collaboration with Prof. Pedram Hamrah to Evaluate...

    LONDON--(BUSINESS WIRE)--OKYO Pharma Limited (LSE: OKYO), a biotechnology company developing targeted drugs for inflammatory dry eye diseases and chronic pain, is pleased to announce...

    Mary Lynne Hedley Joins Veeva Board of Directors

    PLEASANTON, Calif.--(BUSINESS WIRE)--Veeva Systems (NYSE:VEEV) today announced the appointment of Mary Lynne Hedley to the company’s Board of Directors. Dr. Hedley brings 23 years...

    PredictImmune Appoints Tim Rea of BGF as Non-Executive Director

    CAMBRIDGE, England--(BUSINESS WIRE)--PredictImmune, developers of pioneering prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated diseases, is delighted to welcome Tim...

    Synlogic Discontinues Development of SYNB1020 to Treat Hyperammonemia

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Synlogic, Inc., (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, today announced that...

    Aerie Pharmaceuticals Initiates First-in-Human Clinical Trial of AR-13503 Sustained Release...

    DURHAM, N.C.--(BUSINESS WIRE)--Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment...

    FARXIGA Met Primary Endpoint in Landmark Phase III DAPA-HF Trial...

    WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that FARXIGA (dapagliflozin) met the primary composite endpoint...

    Landos Biopharma Announces First Patient Dosed in Global Phase 2...

    BLACKSBURG, Va.--(BUSINESS WIRE)--Landos Biopharma, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases today announced...

    Intralink-Spine, Inc. Expands Clinical Studies in Australia

    LEXINGTON, Ky.--(BUSINESS WIRE)--Intralink-Spine, Inc. (ILS) announces the expansion of clinical trials in Australia for their patented medical device for the treatment of low back...

    Stoke Therapeutics Enrolls First Patient in an Observational Study of...

    BEDFORD, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company that is pioneering a new way to treat the underlying cause of genetic diseases...

    Regulatory Affairs

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    Moderna Receives FDA Fast Track Designation for Zika Vaccine mRNA-1893

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a...

    Q-Sera’s Innovative Blood Clotting Technology Granted Patent in US

    MELBOURNE, Australia--(BUSINESS WIRE)--Medical device company Q-Sera Pty Ltd today announces that it has received a Notice of Allowance from the United States Patent &...

    Alfasigma USA Announces ZELNORM™ (tegaserod) Now Available for Treatment of...

    BEDMINSTER, N.J.--(BUSINESS WIRE)--Alfasigma USA announces ZELNORM US availability ...

    European Medicines Agency Validates Marketing Application for Filgotinib for the...

    FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the Marketing Authorization...

    Concept Medical Granted “Breakthrough Device Designation” by FDA for MagicTouch...

    TAMPA, Fla.--(BUSINESS WIRE)--<a href="https://twitter.com/hashtag/BreakthroughDeviceDesignation?src=hash" target="_blank">#BreakthroughDeviceDesignation</a>--Concept Medical Granted “Breakthrough Device Designation” by FDA for MagicTouch PTA Sirolimus Coated Balloon ...

    CALQUENCE® (acalabrutinib) Granted US Breakthrough Therapy Designation for Chronic Lymphocytic...

    WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for CALQUENCE® (acalabrutinib) as a...

    Neuropore Receives Orphan Drug Designation for NPT520-34 for the Treatment...

    SAN DIEGO--(BUSINESS WIRE)--Neuropore Therapies, Inc. announced today that it has received orphan drug designation for NPT520-34 for the treatment of amyotrophic lateral sclerosis or...

    Verdeca Receives USDA Approval of HB4® Drought Tolerant Soybeans

    ROSARIO, Argentina--(BUSINESS WIRE)--Bioceres Crop Solutions Corp. (NYSE American: BIOX), announced today that Verdeca, a joint venture between BCS Holding Inc., a...

    Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25%...

    WATERTOWN, Mass.--(BUSINESS WIRE)--Kala Pharmaceuticals, Inc. (NASDAQ:KALA), today announced that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA)...

    TURALIO™ (pexidartinib), FDA Approved Treatment of TGCT, Available at Biologics...

    CARY, N.C.--(BUSINESS WIRE)--Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, was selected by Daiichi Sankyo, Inc. as the...

    NinePoint Medical Announces FDA Clearance for Pancreatic and Biliary Applications...

    BEDFORD, Mass.--(BUSINESS WIRE)--<a href="https://twitter.com/hashtag/OCT?src=hash" target="_blank">#OCT</a>--NinePoint Medical adds pancreas, bile duct to esophageal applications for their state-of-the-art Optical Coherence Tomography (OCT) imaging...

    Perfuze Receives Breakthrough Device Designation Status from U.S. Food and...

    GALWAY, Ireland--(BUSINESS WIRE)--Perfuze Receives Breakthrough Device Designation Status from U.S. Food and Drug Administration (FDA) for Millipede CIS (Clot Ingestion System)...

    Gilead Sciences Statement on U.S. Food and Drug Administration Advisory...

    FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food...

    NextFlex’s Technology Hub Complies With FDA Standards for Manufacturing of...

    SAN JOSE, Calif.--(BUSINESS WIRE)--<a href="https://twitter.com/hashtag/AdvancedManufacturing?src=hash" target="_blank">#AdvancedManufacturing</a>--NextFlex's technology hub now complies with FDA standards for manufacturing of medical devices ...

    Stoke Therapeutics Granted FDA Orphan Drug Designation for STK-001, an...

    BEDFORD, Mass.--(BUSINESS WIRE)--<a href="https://twitter.com/hashtag/dravet?src=hash" target="_blank">#dravet</a>--Stoke Therapeutics, Inc., (Nasdaq: STOK), a biotechnology company pioneering a new way to treat the underlying cause...

    Akebia Therapeutics® Announces Settlement of Auryxia® Patent Litigation with Par...

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced that its wholly-owned subsidiary, Keryx Biopharmaceuticals, Inc., and its licensor Panion &amp;...

    Industry News

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    Debbie McCune Davis to be honored with AZBio Public Service...

    CHANDLER, Ariz.--(BUSINESS WIRE)--The Arizona Bioindustry Association (AZBio) today announced that the Honorable Debbie McCune Davis, Executive Director of The Arizona Partnership for Immunization will...

    Avivagen Announces Approval for OxC-beta™ Livestock (“OxC-beta”) in Mexico.

    OTTAWA, Ontario--(BUSINESS WIRE)--Avivagen Inc. (TSXV:VIV) (“Avivagen” or the “Corporation”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and...

    The Pfizer Foundation Invests in 20 Organizations Tackling Infectious Diseases...

    NEW YORK--(BUSINESS WIRE)--The Pfizer Foundation announced today 20 grants* to help non-governmental organizations (NGOs), non-profits and social enterprises address critical health challenges related to...

    Paragon Biosciences Announces the Formation of Paragon Health Capital

    CHICAGO--(BUSINESS WIRE)--Paragon Biosciences LLC – the Chicago-based life science innovator that invests in, builds, and advises bioscience companies – is announcing the formation of...

    Advanced BioNutrition and GreenLight Biosciences Announce Collaboration

    MEDFORD, Mass. & COLUMBIA, Md.--(BUSINESS WIRE)--Advanced BioNutrition (ABN) and GreenLight Biosciences (GreenLight) announce today a collaboration to develop high stability RNA products for specific...

    Perspectum and ProPath Announce Partnership

    DALLAS--(BUSINESS WIRE)--Combining the best in imaging and pathology—Europe’s fastest-growing life science company, Perspectum, joins forces with a premier provider of pathology services, ProPath. This...

    GeneCentric Therapeutics Acquires Select ImmunoGenomics

    DURHAM, N.C.--(BUSINESS WIRE)--GeneCentric Therapeutics, Inc. today announced that it has acquired Select ImmunoGenomics, LLC, a Chapel Hill, NC-based provider of advanced immunogenomic, data analysis...

    Purdue Pharma L.P. and the National Center for Wellness &...

    STAMFORD, Conn. & TULSA, Okla.--(BUSINESS WIRE)--Purdue Pharma L.P. (“Purdue”) and the National Center for Wellness & Recovery (the “Center”) at Oklahoma State University today...

    Cyrus Biotechnology Significantly Expands Customer Engagement through Biotherapeutic Partnerships and...

    SEATTLE--(BUSINESS WIRE)--Cyrus Biotechnology, Inc., a Seattle-based biotech software company specializing in the use and commercialization of Rosetta, the world's leading computational protein design platform,...

    Baxter and COSMED Announce Partnership to Bring Next-generation Indirect Calorimetry...

    DEERFIELD, Ill. & ROME--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition, and COSMED srl, a worldwide leader in the design...

    2019 Edogawa NICHE Prize Awarded to Dr. Steven Rosenberg for...

    TOKYO--(BUSINESS WIRE)--The Edogawa NICHE Committee today announced that the 2019-Edogawa NICHE Prize (www.edogawanicheprize.org) has been awarded to Dr. Steven A. Rosenberg, for his pioneering...

    IQVIA Launches Patient Portal to Transform the Clinical Trial Experience

    DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--IQVIA™ (NYSE:IQV) announces its launch of the IQVIA Patient Portal, a global web-based solution built on a...

    Agilent Introduces Revolutionary Real-Time Cell Analyzer

    SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today introduced a multimode real-time cell analyzer (RTCA)—the first of its kind—combining the best of non-invasive...

    CTD Announces New Data Presented at Annual Gathering of Patients...

    ALACHUA, Fla.--(BUSINESS WIRE)--CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical...

    AtriCure Completes Acquisition of SentreHEART

    MASON, Ohio--(BUSINESS WIRE)--AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced that...

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