Smiths Group (LON:SMIN) said yesterday that it’s spiking merger talks with ICU Medical (NSDQ:ICUI) after rejecting a nearly $4 billion offer earlier this month. The British company and San Clemente, Calif.-based ICU revealed negotiations in May about a possible union with Smiths Medical. Smiths, said to be eyeing the exit door last month, reportedly rejected a cash-and-stock offer […]
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DarioHealth raises $10m in private offering
DarioHealth (NSDQ:DRIO) said today that it closed a private placement offering with institutional and private investors, bringing in roughly $10.3 million for the Israel-based company. As part of the private placement, DarioHealth issued 4,266,800 shares of common stock at 90¢ apiece and 1,806,923 shares of Series D convertible preferred stock at $3.60 apiece. The company also offered […]
FDA to review Regeneron’s Eylea for diabetic retinopathy
Regeneron Pharmaceuticals (NSDQ:REGN) said today that the FDA plans to review the supplemental biologics license application for Regeneron’s Eylea aflibercept injection for the treatment of diabetic retinopathy. The U.S. agency plans to make a decision about the blockbuster drug by May 13, 2019. Regeneron’s Eylea is dosed using a two-milligram intravitreal injection and is already approved […]
Mylan launches generic Brevibloc heart injection
Mylan (NSDQ:MYL) said today that it launched a generic version of Baxter‘s (NYSE:BAX) Brevibloc heart drug in the U.S. The company’s injectable product, esmolol hydrochloride in sodium chloride, will be offered in single-dose plastic bags, according to Mylan. The FDA approved Mylan’s drug for the short-term treatment of control of ventricular rate in supraventricular tachycardia, including […]
FDA pushes back decision date for Acorda’s Parkinson’s drug
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions […]
PCI Pharma Services to buy Sherpa Clinical Packaging
PCI Pharma Services has agreed to acquire clinical supply services provider Sherpa Clinical Packaging, the companies announced today. Financial terms of the deal were not disclosed. San Diego–based Sherpa is a provider of clinical trial material management services for clinical studies phases I through IV, with expertise in packaging, labeling, distribution, storage and returns and […]
Siga lands $629m BARDA contract to stockpile smallpox treatment
Siga Technologies (NSDQ:SIGA) said today that it signed a multi-year contract with the Biomedical Advanced Research & Development Authority to provide oral and intravenous versions of Siga’s Tpoxx smallpox treatment to the Strategic National Stockpile. The contract, which is valued at up to $629 million, also includes funding for advanced development of the the drug’s IV […]
Insulet promotes COO to corner office as CEO Sullivan sets retirement date
Insulet (NSDQ:PODD) announced this week that president & COO Shacey Petrovic will succeed CEO Patrick Sullivan after he retires at the end of the year. Petrovic plans to stay on as president of the Billerica, Mass.-based company. Sullivan will retire from Insulet’s board effective Jan. 1, 2019 and will hold a consulting role with the company […]
Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan
Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent […]
Boston Scientific launches trial for drug-eluting peripheral stent
Boston Scientific (NYSE:BSX) said last week that it enrolled the first patient in a pivotal trial to evaluate its below-the-knee drug-eluting stent in patients with critical limb ischemia. The peripheral stent is the first of its kind to undergo the FDA’s breakthrough device program, according to the medtech giant. Roughly 17 million people in the U.S. […]