Medical Tidbits, FDA Approves World’s Smallest Pacemaker for U.S. Patients

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Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of the world’s smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart -providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).  read more

Johnson & Johnson Launches a New Global Public Health Strategy in Africa

You can innovate and create groundbreaking new treatments to help fight infectious diseases, and then work to make those drugs accessible and affordable in the world’s poorest nations. But if you can’t address the full spectrum of obstacles preventing you from getting such medicines to patients, you’re “missing a piece of the puzzle,” says Jaak Peeters, Head of Johnson & Johnson’s global public health organization. read more

Mylan Launches Generic Epivir® Tablets

HERTFORDSHIRE, England and PITTSBURGH, April 6, 2016 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Lamivudine Tablets USP, 150 mg and 300 mg, which is the generic version of ViiV Healthcare’s Epivir® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Lamivudine Tablets is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection.(1) read more

Allergan and Heptares Announce Global R&D and Commercialization Partnership for Novel Treatments in Alzheimer’s and Other Neurological Disorders

DUBLIN and LONDON, April 6, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Heptares Therapeutics, the wholly-owned subsidiary of Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), today announced that Allergan’s wholly-owned subsidiary, Allergan Pharmaceuticals International Limited and Heptares have entered into a definitive agreement under which Allergan will license exclusive global rights to a broad portfolio of novel subtype-selective muscarinic receptor agonists in development for the treatment of major neurological disorders, including Alzheimer’s disease. read more

With Two Acquisitions, Adavium Medical Becomes the Largest Brazilian Medical Equipment and Diagnostics Company

PALO ALTO, Calif.–(EON: Enhanced Online News)–Adavium Medical today announced the acquisitions of Alka Tecnologia and Hemogram Industria e Comercio, two of the largest clinical diagnostic companies in Brazil, transforming the company into the largest Brazilian medical equipment and diagnostics company as measured by sales and number of customers across both specialties. read more

Phase 2b Data on Inhaled Levodopa CVT-301 Featured in Invited Science Session at American Academy of Neurology (AAN) Annual Meeting

Acorda to present additional posters on CVT-301 at AAN

ARDSLEY, N.Y.–(EON: Enhanced Online News)–Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that data from a Phase 2b clinical trial of CVT-301 in Parkinson’s disease (PD) will be featured during the Movement Disorders Invited Science Session at the upcoming 68th Annual Meeting of the American Academy of Neurology, being held in Vancouver, Canada. Invited Science Sessions are intended to highlight cutting-edge research in selected therapeutic categories. read more

Giotrif® (afatinib) approved in Europe as new oral treatment option for patients with squamous cell carcinoma of the lung

  • Approval provides a new oral treatment option for patients with the second largest sub-type of non-small cell lung cancer (NSCLC), representing approximately 20-30% of NSCLC cases
  • Approval of Giotrif® is based on results of the LUX-Lung 8 study, which showed significantly improved overall survival and progression-free survival compared to Tarceva® (erlotinib) in patients with squamous cell carcinoma of the lung
  • Afatinib is already approved in more than 60 countries for the treatment of patients with EGFR mutation-positive NSCLC* read more

Former CEO of Novartis-Sandoz (South Africa) to Lead AAT Research’s Global Expansion

SAN GWANN, Malta–(BUSINESS WIRE)–AAT Research, a research firm that designs and develops quality medical solutions in the neuroscience space, today announced that it has appointed pharmaceutical and medical industry veteran Wolfgang Storf as its new chief executive officer. read more

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