FDA approves 1st Type 2 diabetes drug | Wall Street Beat

MassDevice.com Wall Street Beat

The FDA approved a 1st-of-its-kind treatment for Type 2 diabetes, Johnson & Johnson‘s (NYSE:JNJ) Invokana, with the federal watchdog agency citing it as a pioneer in a new class of diabetes drug.

Invokana is a potential blockbuster drug that acts by reducing the amount of blood sugar that’s normally stored in the liver, instead causing the body to excrete the excess sugar in urine.

The FDA gave Invokana the green light based on 9 clinical studies involving some 10,000 patients that showed the drug helped control blood sugar levels along and alongside other drugs, according to Minnesota Public Radio.

Sign up to get our free newsletters delivered straight to your inbox

JNJ shares were up 0.3% today, the 1st trading day since news of the approval broke late last week, to $81.78 apiece as of about 1:20 p.m.

 TriReme Medical inks Chinese distribution deal
Vascular device maker TriReme Medical said it inked a distribution deal in China with Weihai Weigao Medical Devices, part of "TriReme’s strategy of focusing on Asia, the fastest-growing market in interventional cardiology," according to a press release.
Read more

 Hansen Medical applies for 30 new robotic surgery patents
Hansen Medical (NSDQ:HNSN) said it filed 30 new patent applications with the U.S. Patent & Trademark Office cover technology for flexible medical robotics, based on its research & development program.
Read more

 Covidien OKs new $3B share buyback
Covidien (NYSE:COV) said its board approved a new share buyback program worth up to $3 billion, on top of the $425 million remaining from an existing $2 billion stock repurchasing program. The Mansfield, Mass.-based medical device company said it’s returned more than $1.75 billion to shareholders in dividends and share repurchases, "representing nearly 100% of its free cash flow" according to a press release.
Read more

 PLC Systems swings to Q4 black, raises $4M
PLC Systems (PINK:PLCSF) posted 4th-quarter black ink and drummed up $4 million from an equity funding round.

The Milford, Mass.-based medical device company posted profits of $3.0 million, or 9¢ per share, on sales of $485,000 for the 3 months ended Dec. 31, 2012. That compares with losses of 1.0 million, or 3¢ per share, on sales of $189,000 during Q4 2011.

PLC Systems also said it grossed more than $4.0 million from the sale of 26.9 million shares of stock at 15¢ apiece, plus another 26.3 million shares worth of 5-year warrants at an exercise price of 20¢ each. PLC said it plans to use the cash to fund U.S. pivotal trials of its RenalGuard treatment.

PLCSF shares were up 37.5% to 22¢ each today as of about 1:25 p.m.
Read more

 Analysts’ ups and downs

RSS From Medical Design & Outsourcing

  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]
  • MasterControl’s CEO talks EQMS software and new partnerships
    MasterControl offers a quality and compliance software that helps device companies speed time to market and improve their bottom lines. Under Jon’s leadership, the company has blossomed into a market leader and has a unique corporate culture that fosters growth, excellence and quality. In this podcast, MasterControl’s CEO, Jon Beckstrand, will discuss electronic quality management […]
  • BIT Group launches white label IVD solutions
    BIT Group has launched a product line of customizable IVD white label instruments. During recent years, BIT has invested capital and resources developing customizable, ready-to-use IVD systems to address a growing demand. “The IVD market is challenging for our clients,” said Marius Balger, CEO at BIT. “OEM’s must adhere to a growing number of evolving IVD […]
  • Toshiba expands line-up of ARM Cortex-M-based microcontrollers
    Toshiba announced that it has enhanced its current “TX Family” of ARM core-based microcontrollers and started to develop three series of microcontrollers, “TXZ0 series,” “TXZ3 series” and “TXZ4 series,” as part of the “TXZTM Family.” The TXZTM Family is a new collection of flash microcontrollers that support low-power consumption and high-speed operation for IoT and M2M […]
  • Parker Hannifin consolidates, layoffs ahead
    Parker Hannifin plans to consolidate a number of internal divisions, close 2 facilities and expand its Mexican operations, according to an internally distributed letter from Andy Ross, Parker’s engineered materials group president. The company has confirmed the letter was authentic, but has not disclosed how many employees will be affected by the new plans or […]
  • 3-phase current transducer from PEM delivers all-in-one convenience
    The new RCTrms 3-ph current transducer from Power Electronic Measurements (PEM) delivers a convenient, safe and accurate solution for measuring current in three phases. It features a thin, clip-around, flexible sensor coil and provides accurate true rms measurement with 4-20 mA or 0-5 V output, enabling simple installation with PLC’s, SCADA systems or automation equipment. […]
  • Safety alert: Recall on two IV solutions from Baxter
    Baxter International announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital and user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to […]

Leave a Reply