There may be someone on the dark side of the Moon that hasn’t heard about the Senate vote for the 21st Century Cures Act, but everyone else certainly has. One might have expected the reaction to the Cures bill to be split, but the degree to which the reaction on both sides has been hyperbolic is perhaps surprising even to the veterans of the Twitterverse. What seems to be lacking is a level-headed examination of what this legislation will and will not accomplish. Dare anyone argue that H.R 34’s net effect will drop squarely into that plump, bourgeois, middle...

PERTH, Australia – Drug and device companies in Australia may soon be able to bring their products to market more quickly via a new priority review designation. Health Minister Susan Ley introduced legislation to Parliament on Dec. 1 that would speed the approval of drugs and devices by providing Australia's Therapeutic Goods Administration (TGA) with new priority review mechanisms. TGA spokeswoman Kay McNiece told Medical Device Daily that the bill is the first tranche of legislation to support the recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation, as agreed by the...

A liquid biopsy company that spun out of Illumina Inc. in January to search for what it considers the holy grail of oncology – a blood test capable of detecting cancer at the earliest, most curable, stages – recently took a big first step toward that end. Grail Inc., of Menlo Park, Calif., launched a study that will eventually include up to four-dozen U.S. sites tasked with analyzing blood and tissue samples from 10,000 patients in an effort to characterize the landscape of cell-free DNA profiles in both cancer and non-cancer patients using a...

Wayne, Pa.-based, Teleflex Inc. is set to acquire Minneapolis-based Vascular Solutions Inc. in a transaction valued at about $1 billion. Teleflex's offer of $56 per Vascular Solutions share represents a premium of 1.6 percent to the stock's Thursday close. Upon news of the pending merger, shares of Teleflex (NYSE:TFX) jumped as much as 6.2 percent to $155.09, the biggest intraday percent gain since February. Shares closed at $152.64. Founded in 1997, Vascular Solutions (NASDAQ:VASC) develops clinical solutions for minimally invasive coronary and peripheral vascular procedures. Its product line consists of more than 90 proprietary products...

In a week dotted with big news for the life science industries, the passage of 21st Century Cures legislation in the House of Representatives is perhaps the biggest. Investors and industry are understandably enthused at the development, but opponents, including Senate Democrat Elizabeth Warren of Massachusetts, are blasting the legislation as a grab bag for industry that exposes patients to greater risk. (See story this issue.) The 21st Century Cures Act of 2016 requires FDA reviewers to engage in formal training regarding the least burdensome standard for review of drugs and devices, but the volume...

President-elect Donald Trump has offered two nominees for positions in his administration, naming Rep. Tom Price (R-Georgia) as the nominee for Secretary of Health and Human Services. Price's support of a repeal of the medical device tax is a matter of record, but there is little to indicate whether Price is on board with Trump's stated willingness to require that Medicare negotiate prices with drug makers. For the CMS administrator's post, Trump nominated Seema Verma, president and founder of SVC Inc., a health care consultancy in Indianapolis. According to the SVC website, Verma has consulted...

The FDA final guidances for point-of-care (POC) and home-use glucose monitors might not have given industry everything it wanted compared to the draft guidances, but the agency said in a webinar that the accuracy goals for POC systems will be substantially eased from what some saw as unattainable accuracy benchmarks. The agency published both final guidances in October after hearing from industry that the draft guidances flew against some recognized standards, including an ISO standard for glucose meter reading ranges. Another subject of some concern was the CLIA status of POC test units, but the...

Becton Dickinson & Co. (BD) is developing a wearable insulin patch pump, which would help the Franklin Lakes, N.J.-based company expand its $1 billion diabetes care division. The device would take BD's current diabetes offerings beyond insulin syringes, pen needles and lancets. Last week, the company revealed the product during analyst day. BD said it hopes to launch its insulin patch pump for patients with type 2 diabetes in its 2018 fiscal year. Diabetes continues to be a huge burden and a growing market. The company said that direct medical costs from diabetes are more...

Pump thrombosis has been such a well-established shortcoming of left ventricular assist devices (LVADs), that one heart surgeon went so far as to borrow Winston Churchill's phraseology to describe it as "a riddle, wrapped in a mystery, inside an enigma" for the title of his September 2014 article in the Annals of Cardiothoracic Surgery. But St. Jude Medical Inc. may have unraveled that riddle with its Heartmate 3 LVAD system. According to short-term results of the company's U.S. pivotal study, MOMENTUM 3, there were no cases of pump thrombosis in patients implanted with the...

The election of real estate mogul Donald Trump to the presidency of the U.S. may or may not have upended the Washington establishment, but the policy implications of the election for the life sciences are as yet unknown. John Manthei of Latham & Watkins said on a Nov. 9 conference call that one important issue to device makers, the lag time between device approval and Medicare coverage known as the Valley of Death, may be tackled in legislation used to reauthorize the user fee programs. Manthei remarked at the outset of the conference call that...