The FDA awarded 510(k) clearance to a couple of medtech companies this week while others received tax breaks and incentives, including a local tax break for a $154 million Stryker R&D facility planned in Michigan. Here are some medtech stories we missed this week but thought were worth mentioning. 1. FirstRay wins FDA 510(k) clearance […]
Legal News
Opioid treatment implant-maker Braeburn secretly funded advocacy group fronted by Gingrich
Opioid treatment implant-maker Braeburn Pharmaceuticals said in a regulatory filing last month that it has made charitable donations to an advocacy group fronted by Newt Gingrich and Patrick Kennedy known as Advocates for Opioid Recovery. The group lobbies for more government funding and insurance coverage for opioid maintenance treatments. Former Republican House speaker Gingrich and former […]
Orthofix’s foreign corruption woes: Here’s what you can learn
Marc Alain Bohn, Miller & Chevalier Orthofix International in January entered into its second Foreign Corrupt Practices Act (FCPA) settlement in less than 5 years, resolving allegations with the U.S. Securities and Exchange Commission that the company’s Brazilian subsidiary made improper payments to doctors at government-owned hospitals in Brazil to increase sales. Orthofix consented to the entry […]
Baxter reveals DoJ probe of Tisseel, Artiss sealants
Baxter (NYSE:BAX) this week said it received a civil investigative demand from the US Dept. of Justice’s Commercial Litigation Branch related to its Tisseel and Artiss products. The Deerfield, Ill.-based company said the inquiry relates to contingent discount arrangements and other promotions for the 2 sealant products, and that it was cooperating with the DoJ on […]
Pfizer appeals $107m fine for anti-epilepsy drug prices in UK
Pfizer (NYSE:PFE) and Flynn Pharma have appealed the record $107 million (£84.2 million) and $6.5 million (£5.2 million) fines imposed by the U.K. Competition & Markets Authority in December for the companies’ massive price hikes to their unbranded versions of anti-epilepsy drug Epanutin. In its appeal, Pfizer claims that the regulator did not consider market realities when […]
Valeant, Ackman agree to split costs in shareholders class action
Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) and William Ackman’s hedge fund Pershing Square Capital Management reportedly agreed to split litigation costs in a class action lawsuit brought on by shareholders over an alleged insider trading scheme in Allergan (NYSE:AGN)’s 2014 takeover bid. In June 2014, Valeant offered a tender bid for Allergan, which was followed by a 7 […]
Federal investigators subpoena Biogen over MS drug prices
Biogen (NSDQ:BIIB) said on Thursday that it received a subpoena in December last year from federal investigators about the prices of its top-selling multiple sclerosis drugs, Tecfidera, Avonex, Tysabri and Plegridy. In its annual regulatory filing, the company wrote that the investigators inquired about “government price reporting, rebate payments and Biogen’s co-pay assistance programs.” While Cambridge, Mass.-based Biogen said […]
Mylan hit with antitrust lawsuit over EpiPen device
Mylan (NSDQ:MYL) said on Monday that it is undergoing an antitrust probe by the Federal Trade Commission into the company’s commercial practices regarding its EpiPen device. The Canonsburg, Pa.-based company reportedly responded to the allegations that it improperly fought off competition, saying “any suggestion that Mylan took any inappropriate or unlawful actions to prevent generic competition […]
Patent board invalidates RainDance patent for obviousness
The Patent Trial and Appeal Board invalidated a RainDance Technologies patent earlier this week for obviousness. The patent, which covers a method for manipulating the size of liquid droplets used in microfluidic diagnostic tests, was challenged by manufacturer 10X Genomics Inc. The panel, after conducting an inter partes review, found that the technique’s characteristics, which […]
Allergan pays $15m for failing to disclose Actavis ‘white knight’ offer
The SEC said yesterday that Allergan (NYSE:AGN) will pay a $15 million fine for failing to disclose its 2014 merger talks with Actavis. In June 2014, Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) offered a tender bid for the Irvine, Calif.-based company which was followed by a 7 month-long hostile pursuit by Valeant and co-bidder Pershing Square Capital Management. In November […]
