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Revolutionary Disease Awareness Tests Launched

SQI Diagnostics Inc. and Microdrop LLC announced a commercial agreement to serve the rapidly growing direct-to-consumer healthcare diagnostic testing market.

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AcelRx resubmits New Drug Application for DSUVIA

Specialty pharmaceutical company AcelRx Pharmaceuticals Inc. announced the resubmission of the New Drug Application (NDA) for DSUVIA with the U.S. FDA.

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Lipocine Receives Complete Response Letter for TLANDO From U.S. Food and Drug Administration

Lipocine Inc. announced that the specialty pharmaceutical company received a Complete Response Letter (“CRL”) from the FDA regarding its New Drug Application for TLANDO, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

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Ned Russell Joins MDC Partners as Managing Partner, Healthcare

In this newly created role, Russell is working with MDC’s agency partners to bring modern offerings to the healthcare industry and drive category growth globally.

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FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

Regeneron Pharmaceuticals and Sanofi announced that the U.S. Food and Drug Administration accepted for priority review the Biologics License Application for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.

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Amneal, Impax Receive FTC Clearance For Business Combination

Amneal Pharmaceuticals LLC and Impax Laboratories Inc. announced that the U.S. Federal Trade Commission cleared the companies’ business combination, subject to their agreement to divest certain products.

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Endo to Acquire Somerset Therapeutics and Business of Affiliate Wintac Limited

Endo International plc announced that it has reached definitive agreements to acquire Somerset Therapeutics LLC, a New Jersey based specialty pharmaceutical company that develops and markets sterile injectable and ophthalmic drugs for the U.S. marketplace, and the business of its India-based affiliate Wintac Limited, which operates as Somerset Therapeutics’ contract developer and manufacturer.  

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Boehringer Ingelheim, Lilly Announce Academic Collaboration With University Of Oxford

Boehringer Ingelheim and Eli Lilly announced an academic collaboration with the University of Oxford to investigate the effects of Jardiance on the progression of kidney disease and the occurrence of cardiovascular death, in adults with established chronic kidney disease with and without diabetes.

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FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine

Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals.

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FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

The U.S. Food and Drug Administration permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.

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Dave Sonderman Joins The Shipyard as Chief Creative Officer

The Shipyard announced the appointment of David Sonderman to the role of Chief Creative Officer.

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The Bloc Welcomes Industry Leader, Ane Jones, to Lead New Oncology and Rare Disease Franchise

Leading health creative agency The Bloc added industry leader Ane Jones to its management team.

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Outcome Health Announces Initiative With WomenHeart To Bring Cardiovascular Information To Minority Groups

Outcome Health, which provides health education at the moment of care to improve patient outcomes, announced today an initiative with WomenHeart: The National Coalition for Women with Heart Disease, the first national patient-centered organization solely focused on women’s heart disease.

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Eisai Submits Fycompa Pediatric Indications to FDA

Eisai Inc. submitted a supplemental New Drug Application for priority review to the U.S. FDA for the company’s antiepileptic drug Fycompa (perampanel) CIII as monotherapy and adjunctive use.

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Outcome Health And The Colorectal Cancer Alliance Announce Campaign To Support Patient Education

Outcome Health, a technology company that provides health education at the moment of care to improve patient outcomes, announced a partnership with the Colorectal Cancer Alliance to make patients aware of the signs and symptoms of colorectal cancer.

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Omnicom Health Group acquires Elsevier’s Pharma Communications business in Japan

Omnicom Health Group announced that it has entered into a definitive agreement to acquire the Pharma Communications business in Japan of Elsevier, part of RELX Group.

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FDA approves Toujeo Max SoloStar

The U.S. Food and Drug Administration approved Sanofi’s Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the market.

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Brite Media Group Acquires Mesmerize Marketing

Brite Media Group, a leading out-of-home advertising company, announced the acquisition of Mesmerize Marketing.

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Phase III data in The Lancet show Novartis siponimod significantly improved outcomes in patients with secondary progressive MS

Novartis announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis were published in the peer-reviewed journal The Lancet.

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Novartis drug Tasigna approved by FDA to treat children with rare form of leukemia

Novartis announced that the U.S. Food and Drug Administration expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.

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April 2018 Focus: Agency Profiles, Manny Awards and Annual Review


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