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    Why Pharma Needs to Care About Global Warming

    A version of this article was previously published on Pharmaphorum. Barely a day goes by without global warming or climate change (now more appropriately termed...

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    Podcast: Trends in The New Value-Based Reimbursement Model

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    Why Pharma Needs to Care About Global Warming

    A version of this article was previously published on Pharmaphorum. Barely a day goes by without global warming or climate change (now more appropriately termed...

    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...

    Editor´s Pick

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    Israel’s Healthy.io raises $60 million, gets FDA ok for urine test

    Israel's Healthy.io said on Thursday it raised $60 million in funding and received clearance from the U.S. Food and Drug Administration for its smartphone-based urine albumin test to aid in diagnosing chronic kidney disease.

    U.S. judge approves novel framework for opioid settlement talks

    A federal judge on Wednesday approved the substance of a proposal by lawyers representing cities and counties suing drug companies over the U.S. opioid epidemic that would bring every state and municipality in the country into their settlement talks.

    Purdue Pharma reaches tentative opioid settlement with some: sources

    OxyContin maker Purdue Pharma LP reached a tentative agreement with some plaintiffs to resolve litigation over its alleged role in fueling the U.S. opioid crisis and plans to tussle with states opposing the settlement offer in bankruptcy proceedings as soon as next week, people familiar with the matter said.

    Purdue OxyContin settlement would rank among largest in pharma history

    OxyContin maker Purdue Pharma LP has reached a tentative multibillion-dollar agreement with some plaintiffs aimed at settling thousands of lawsuits over its alleged role in the U.S. opioid crisis, Reuters reported on Wednesday, citing people familiar with the matter.

    Sanofi to pay Lexicon $260 million for terminated partnership

    Lexicon Pharmaceuticals Inc said on Tuesday France's Sanofi SA will pay the drugmaker $260 million for the termination of their partnership to develop diabetes drug Zynquista.

    Female pediatricians paid 76 cents for every $1 paid to men

    (Reuters Health) - Women in pediatrics still earn less than men even with similar levels of experience and even after accounting for the disproportionate amount of time they devote to unpaid work at home, two new studies suggest.

    Teens with illnesses want role in decision-making

    (Reuters Health) - Teens with chronic illnesses would like to have a say in decisions such as switching to a new medicine, but they often feel left out of the conversation, a small study suggests.

    Juul warned by FDA over marketing practices

    The U.S. Food and Drug Administration warned Juul Labs Inc on Monday for marketing its e-cigarettes as safer than traditional cigarettes, the latest move by the agency to curb the use of vaping devices that have become extremely popular among teens.

    AstraZeneca’s Imfinzi prolongs survival in aggressive lung cancer

    AstraZeneca's cancer treatment Imfinzi has been shown to prolong survival in a particularly aggressive type of lung cancer by close to three months, as the British drugmaker holds its ground in a crowded field against rival immunotherapy drugs.

    Novartis CEO promises to speed data integrity disclosures

    Novartis Chief Executive Vas Narasimhan, facing an uproar over data manipulation involving $2.1 million gene therapy Zolgensma, pledged on Monday to tell regulators quickly if credible questions emerge in future over data integrity.

    Neurotrope shares crash after Alzheimer’s drug fails in trial

    Drug developer Neurotrope Inc's shares tumbled nearly 80% on Monday after the company said its experimental treatment for Alzheimer's disease did not meet the main goal of a mid-stage study.

    Slovakian biotech firm signals tentative Alzheimer’s drug hope

    An Alzheimer's vaccine developed by a privately held Slovakian biotech firm showed early signs of efficacy in a mid-stage trial, a rare step forward in the fight against the brain-wasting disease, the company said on Monday.

    Lilly’s targeted RET drug shrinks tumors in lung cancer trial

    Eli Lilly and Co's LOXO-292, a experimental cancer drug the company acquired in January as part of its $8 billion takeover of Loxo Oncology, shrank tumors in nearly 70% of advanced lung cancer patients whose tumors carried specific abnormalities in the RET gene.

    Look Who’s On the Move!

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    Kraig Biocraft Laboratories Selects Finalists for Expanded Board of Directors

    ANN ARBOR, Mich.--(BUSINESS WIRE)--Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) (“Company”), the leading developer of spider silk based fibers, announces today that it has narrowed...

    Xencor Appoints Celia Eckert as Vice President, General Counsel and Corporate Secretary

    MONROVIA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic...

    Vifor Pharma Appoints New Chief Medical Officer and Announces Changes to Executive Committee

    ST GALLEN, Switzerland--(BUSINESS WIRE)--Regulatory News: Vifor Pharma today announced changes to its management. Dr Klaus Henning Jensen will join the company as Chief Medical...

    Xellia Pharmaceuticals Appoints Peter Baker as Chief Commercial Officer, Xellia North America

    COPENHAGEN, Denmark & BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Xellia Pharmaceuticals (‘Xellia’), a global leader in the manufacturing of specialty anti-infective treatments, has appointed Peter Baker as...

    Mark Beaudouin to Retire as Waters General Counsel; Company Promotes Keeley Aleman

    MILFORD, Mass.--(BUSINESS WIRE)--Waters Corporation (NYSE: WAT) today announced Mark T. Beaudouin is retiring as Senior Vice President, General Counsel and Corporate Secretary after 16...

    Immunomic Therapeutics Appoints Harvard’s Brain Tumor Expert, Dr. E. Antonio Chiocca, to its Scientific...

    ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company, announced today that it has appointed brain tumor expert E. Antonio ‘Nino’...

    Cerevel Therapeutics Appoints Biotechnology Leader Tony Coles, M.D., as Chief Executive Officer

    BOSTON--(BUSINESS WIRE)--Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced the appointment of renowned biotechnology...

    More Emerging Biopharma and CROs Adopting Veeva Vault CDMS

    PHILADELPHIA--(BUSINESS WIRE)--2019 Veeva R&D Summit — An increasing number of emerging biopharma companies and leading contract research organizations (CROs) are adopting Vault CDMS from...

    BlackThorn Therapeutics Appoints Healthcare Technology Innovator, Monique Levy, as Chief Strategy Officer

    SAN FRANCISCO--(BUSINESS WIRE)--BlackThorn Therapeutics, Inc., a clinical-stage, neurobehavioral health company pioneering next-generation artificial intelligence (AI) technologies to advance targeted therapeutics, today announced the appointment...

    Oncternal Further Expands Executive Team; Appoints Gunnar Kaufmann, Ph.D., as Chief Scientific Officer and...

    SAN DIEGO--(BUSINESS WIRE)--Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biotechnology company developing potential first-in-class product candidates for cancers with critical unmet medical needs, today...

    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!

    Genentech’s Satralizumab Significantly Reduced Relapse Risk in Second Positive Phase...

    SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today full pivotal Phase III study results...

    Moderna Announces Positive Interim Results from Phase 1 Cytomegalovirus (CMV)...

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

    Moderna Announces Positive Phase 1 Results for the First Systemic...

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

    Concert Pharmaceuticals Announces CTP-543 Phase 2 Alopecia Areata Data Selected...

    LEXINGTON, Mass.--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it will present results from its recently completed Phase 2 trial of CTP-543 in...

    First Patient Enrolled in Cook Regentec’s Clinical Trial of Investigational...

    INDIANAPOLIS--(BUSINESS WIRE)--Cook Regentec today announced enrollment of the first patient in an international clinical trial evaluating the HemaTrate® Blood Filtration System to treat patients...

    RDMD Co-Founders to Participate in Upcoming Rare Disease and Health...

    SAN FRANCISCO--(BUSINESS WIRE)--RDMD, a healthcare technology company dedicated to accelerating research for patients with rare diseases, today announced key leadership members will be participating...

    Rocket Pharmaceuticals Announces Publication of Data from Phase 1/2 Trial...

    NEW YORK--(BUSINESS WIRE)--Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (“Rocket”), a leading U.S.-based multi-platform clinical-stage gene therapy company, today announces the publication of long-term data from...

    Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab)...

    PRINCETON, N.J.--(BUSINESS WIRE)--<a href="https://twitter.com/search?q=%24BMY&src=ctag" target="_blank">$BMY</a> <a href="https://twitter.com/hashtag/BMS?src=hash" target="_blank">#BMS</a>--BMS Announces Pooled Five-Year Survival Results for Opdivo in Previously-Treated Advanced Non-Small Cell Lung...

    Nano Discovery Inc. Launches a New Blood Test for Cattle...

    ORLANDO, Fla.--(BUSINESS WIRE)--Nano Discovery Inc. announced today that it has launched a new blood test to the market for cattle immune health testing. Cattle...

    Clinical Innovations’ Ken Reali to Deliver Keynote at APEC forum

    SALT LAKE CITY--(BUSINESS WIRE)--Ken Reali, president and CEO of Clinical Innovations, will share his vision for ethical business conduct as a keynote speaker at...

    ACADIA Pharmaceuticals Announces Pivotal Phase 3 HARMONY Trial Stopped Early...

    SAN DIEGO--(BUSINESS WIRE)--ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that its Phase 3 HARMONY study, a double-blind, placebo-controlled relapse prevention trial evaluating pimavanserin for...

    Aptorum Group Announces the Development of Microbiome Drug Candidate Targeting...

    NEW YORK--(BUSINESS WIRE)--Aptorum Group Limited (Nasdaq: APM) (“Aptorum Group”), a biopharmaceutical company focused on the development of novel therapeutics to address global unmet medical...

    Regulatory Affairs

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    Pharma Guide Website

    Your industry meeting point. Add your business for free!

    Pharma Jobs Site

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

    Checkpoint Surgical Receives FDA Breakthrough Designation for Nerve Regeneration Device

    CLEVELAND--(BUSINESS WIRE)--Checkpoint Surgical received FDA Breakthrough Designation for its nerve regeneration device, an adjunct to surgery following nerve injury. ...

    Puma Biotechnology Announces U.S. FDA Acceptance of Supplemental New Drug...

    LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its...

    FDA Confirms Omeros’ Schedule for Rolling Review of the Company’s...

    SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) announced that the United States Food and Drug Administration (FDA) agreed with the company’s proposed schedule for the rolling...

    Former FDA Commissioner Set to Speak at PCCA International Seminar...

    HOUSTON--(BUSINESS WIRE)--<a href="https://twitter.com/hashtag/CompoundingPharmacy?src=hash" target="_blank">#CompoundingPharmacy</a>--Former FDA Commissioner Dr. Scott Gottlieb will address more than 400 representatives of the compounding industry at PCCA...

    Axonics® Announces U.S. Food & Drug Administration Approval for its...

    IRVINE, Calif.--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable...

    Acceleron Receives FDA Orphan Drug Designation for Sotatercept in Pulmonary...

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat...

    Horizon Therapeutics plc Announces the FDA has Granted Priority Review...

    DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc announces the FDA has granted priority review of the teprotumumab BLA for the treatment of active thyroid...

    Astex Pharmaceuticals Announces That Its Novel, Oral Hypomethylating Agent ASTX727...

    PLEASANTON, Calif.--(BUSINESS WIRE)--Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, announces that the...

    FDA Grants Orphan Drug Designation to Puma Biotechnology’s NERLYNX® for...

    LOS ANGELES--(BUSINESS WIRE)--The FDA has granted "orphan drug designation" to Puma Biotechnology's NERLYNX for the treatment of breast cancer patients with...

    Ra Pharmaceuticals Receives Orphan Drug Designation from the U.S. FDA...

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ra Pharmaceuticals, Inc. (Nasdaq:RARX) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to...

    Tricida Announces Submission of New Drug Application for Veverimer for...

    SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Tricida Announces Submission of New Drug Application for Veverimer for the Treatment of Metabolic Acidosis in Patients...

    Magenta Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation...

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more...

    European Commission Approves Expanded Use of Janssen’s STELARA® (ustekinumab) for...

    BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved the expanded use of ustekinumab...

    Inotrem Announces Fast Track Designation Granted by U.S. FDA to...

    PARIS--(BUSINESS WIRE)--<a href="https://twitter.com/hashtag/TREM1?src=hash" target="_blank">#TREM1</a>--Inotrem announces FDA granted Fast Track designation to its lead compound nangibotide for the treatment of septic shock....

    Emalex Biosciences Receives FDA Fast Track Designation for Ecopipam for...

    CHICAGO--(BUSINESS WIRE)--Emalex Biosciences Receives FDA Fast Track Designation for Ecopipam for the Treatment of Patients with Tourette Syndrome ...

    Kyowa Kirin Announces FDA Approval of NOURIANZ™ (istradefylline) for Use...

    TOKYO--(BUSINESS WIRE)--Kyowa Kirin Announces FDA Approval of NOURIANZ™ (istradefylline) for Use in Parkinson’s Disease ...

    Industry News

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    Global Medicines Company Collaborates With Coursera to Power Innovation Through...

    MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Coursera, the world’s leading online learning platform, today announced a global collaboration with Novartis, a leading global medicine company. Novartis will...

    Innovative Industrial Properties Acquires California Property Portfolio and Enters into...

    SAN DIEGO--(BUSINESS WIRE)--Innovative Industrial Properties, Inc. (IIP), the first and only real estate company on the New York Stock Exchange (NYSE: IIPR) focused on...

    Veracyte Announces Publication of Clinical and Analytical Validation Data for...

    SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT) today announced the publication of new data demonstrating the clinical and analytical validity of its Afirma®...

    Endospan Enters Into Strategic Distribution Agreement With CryoLife

    HERZLIYA, Israel--(BUSINESS WIRE)--Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, today announced it has entered into strategic distribution and credit facility...

    CroíValve Secures €4M in Additional Funding to Initiate Clinical Trials

    DUBLIN--(BUSINESS WIRE)--€4 million in additional financing has been secured by CroíValve, a high potential start-up (HPSU) supported by Enterprise Ireland developing a treatment for...

    Vertex Announces New Access Agreement with Scottish Government for ORKAMBI®...

    LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that eligible cystic fibrosis patients living in Scotland will now have access to ORKAMBI® (lumacaftor/ivacaftor) and...

    MedtechWomen Announces Lisa Earnhardt as Recipient of 2019 Ferolyn Powell...

    MENLO PARK, Calif.--(BUSINESS WIRE)--MedtechWomen today announced that Lisa Earnhardt, executive vice president, medical devices, at Abbott, has been named the recipient of the fifth...

    CureDuchenne Helps Duchenne Families Make Informed Decisions About Durable Medical...

    NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Finding the right mobility equipment for Duchenne muscular dystrophy patients can be a time-intensive and frustrating process. To help take the...

    Tubulis and Glycotope Announce Research and Feasibility Agreement for the...

    MUNICH & BERLIN--(BUSINESS WIRE)--Tubulis, a company developing uniquely matched protein drug conjugates, and Glycotope, a clinical-stage immuno-oncology company today announced that they have signed...

    Atomwise and Atropos Launch Joint Venture to Discover Senescence Modulating...

    SAN FRANCISCO & BELMONT, Calif.--(BUSINESS WIRE)--Atomwise Inc., a leader in artificial intelligence (AI) for drug discovery, and Atropos Therapeutics, Inc., a senescence platform discovery...

    NanoView Biosciences and Quantum Design Korea Enter Into Distribution Agreement

    BOSTON--(BUSINESS WIRE)--NanoView Biosciences, Inc., and Quantum Design Korea, a subsidiary of Quantum Design International, today announced an exclusive distribution agreement for NanoView’s ExoView™ platform...

    Merz and Oncotec Make Major Investments in Dessau BioPharmaPark

    FRANKFURT & DESSAU-ROSSLAU, Germany--(BUSINESS WIRE)--Merz, a global leader in aesthetics and neurotoxins, today celebrated the official opening of its new filler plant in BioPharmaPark,...

    Avalon Ventures and COI Pharmaceuticals Announce Acquisition of Sitari Pharmaceuticals...

    SAN DIEGO--(BUSINESS WIRE)--Avalon Ventures today announced that it entered into a definitive agreement with GlaxoSmithKline (GSK) for the acquisition of Sitari Pharmaceuticals by GSK....

    BIA Separations Introduces Cornerstone AAV Process Development Service to Accelerate...

    AJDOVŠČINA, Slovenia--(BUSINESS WIRE)--BIA Separations, a leading bio-chromatography development and manufacturing company, today announced the introduction of CORNERSTONE AAV Process Development Service, a program of...

    McKesson and TrakCel Launch Innovative Collaboration to Support Commercialization of...

    IRVING, Texas & CARDIFF, Wales--(BUSINESS WIRE)--McKesson, a leading provider of third-party logistic (3PL) services, patient access support and specialty pharmacy solutions, and TrakCel, the...

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