News & Analysis as of

Biotechnology Medical Devices

Boom Predicted in Biodegradable Stent Market

Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

A Chinese healthcare boom

by Hogan Lovells on

Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

by McDermott Will & Emery on

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Medical Device Investor Forum - Oct. 27-28 in Irvine, CA - Knobbe Medical

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016,...more

GSK and Verily Partnering to Form New Bioelectronic Medicine Firm

GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million...more

Med Device M&A Values Jump Nearly 50% in 1st Half of 2016

According to MergerMarket, the value of mergers and acquisitions in the medical device area jumped by nearly 50% to $74.5 billion in the first half of 2016 (H1 2016) compared with the first six months of 2015.  The 45.5%...more

[Event] Do Not Enter: Privacy & Security for Life Sciences Companies - Regulatory Roundtable Immersion Series - Session #7 - Jan....

by Cooley LLP on

Cooley's Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant...more

3D Printing Partnership: 3D Medical Limited to Acquire Mach7 Technologies

3D Medical Limited (ASX: 3DM) recently announced that it has entered into a binding Heads of Agreement (HOA) to purchase 100% of shares issued in Mach7 Technologies. According to the agreement, 3D Medical will issue 460...more

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2015

by Bergeson & Campbell, P.C. on

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

by Bergeson & Campbell, P.C. on

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

by Reed Smith on

This white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles – explores the legal ramifications and risks of the rapidly increasing use of 3D printing of medical devices. 3D...more

The Upcoming Implementation of the Italian Patent Box Regime

by McDermott Will & Emery on

Several press articles in recent weeks have anticipated the upcoming enactment of the Ministerial Decree which will eventually implement the Italian Patent Box regime. The Ministry of Economics and Finance announced on 29...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

by Morgan Lewis on

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Össur Announces First Mind-Controlled Prosthetic Lower Limbs

In a recent press release, Össur announced that two amputees are the first people in the world able to control their prosthetic legs with their thoughts. According to the press release, tiny implanted myoelectric sensors...more

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

by Dechert LLP on

Publicly Traded Life Sciences Companies in the United States Are an Increasingly Popular Target of Securities Fraud Class Action Lawsuits - The past year was particularly noteworthy with respect to the relative number...more

Sophisticated Hackers Target Insider Information

by King & Spalding on

A security consulting firm has discovered a sophisticated hacking campaign that has targeted more than 100 public companies, investment banks and law firms. In a report released December 1, cybersecurity firm FireEye...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2014. ...more

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

by Epstein Becker & Green on

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

Inside M&A - Summer 2014

by McDermott Will & Emery on

“Commercially Reasonable Efforts” Diligence Obligations in Life Science M&A" - More than 80 percent of all deals in the pharmaceutical, medical device and biotech industries include an earnout structure that provides...more

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