Jeffrey Brewer faced the biggest challenge of his life when his 7-year-old son Sean received a diabetes diagnosis in 2002: Diabetes became the new focus for Brewer’s energy. In his role as CEO at JDRF (formerly the Juvenile Diabetes Research Foundation) between 2011 and 2014, Brewer forged financial partnerships with industry to drive the development […]
Pharmaceuticals
Pavmed registers for $20m rights offering
Pavmed (NSDQ:PAVM) said today that it filed a preliminary prospectus with the SEC for an offering of the rights to buy a new unit in exchange for each share of outstanding common stock. The medical device company plans to offer the rights to purchase up to 9 million units at $2.25 apiece on May 21, valuing […]
Medical device recalls significantly increase during Q1
The medical device and pharmaceutical industries saw a significant spike in product recalls during the first quarter of 2018, according to the U.S. Recall Index released by Stericycle Expert Solutions. There was a 126% increase in medical device recalls in Q1 — the most in a quarter since 2005. Software problems made up about 22.7% […]
Takeda reaches $62B deal to buy Shire
After a series of offers, Takeda (TYO:4502) said today that it reached an agreement with Shire (NSDQ:SHPG) to acquire the U.S.-based company in a deal valued at $62 billion. The merger was approved by both companies’ boards of directors, according to Takeda, and is slated to close in the first half of 2019. Takeda investors are wary […]
OncoSec to combine ImmunoPulse device with Merck’s immunotherapy in breast cancer trial
OncoSec Medical (NSDQ:ONCS) expanded its relationship with Merck (NYSE:MRK) today, announcing a deal to combine its ImmunoPulse IL-12 device with Merck’s anti-PD-1 therapy, Keytruda, in a Phase II trial of patients with triple negative breast cancer. The trial is slated to study the drug-device combination in patients with inoperable locally advanced or metastatic cancer who have failed […]
J&J’s Janssen touts Ph3 data for antidepressant nasal spray
Johnson & Johnson‘s (NYSE:JNJ) Janssen revealed data today from two Phase III trials of its investigational esketamine nasal spray in patients with treatment-resistant depression. The Titusville, N.J.-based company said that if approved by the FDA, esketamine would represent one of the first new approaches designed to treat refractory major depressive disorder in the last 50 […]
Common Sensing, Haselmeier ink deal to develop connected injection pen
Swiss-based manufacturer Haselmeier inked a deal with Common Sensing to develop a smart, connected drug-delivery device for people who use injectable medications. The companies plan to combine Haselmeier’s subcutaneous injection technology with Common Sensing’s Gocap injector monitor. The product, which will be sold by Haselmeier, will record the time and dose of every injection and […]
FDA chief suggests kickback law could be used to rein in drug prices
Drug rebates paid between pharmaceutical companies and pharmacy benefit managers enjoy safe harbor status under federal kickback law, leaving them immune from legal scrutiny. But that could change, FDA chief Dr. Scott Gottlieb suggested yesterday at the FDA Law Institute’s annual meeting. The commissioner reportedly hinted that reinterpreting the law could help lower drug prices. […]
Insulet sales grow 22% in Q1
Insulet (NSDQ:PODD) topped estimates on Wall Street yesterday with its first-quarter results, topping analysts’ sales expectations by $1.9 million. The Billerica, Mass.-based company reeled in its losses, posting a net loss of -$6.6 million, or -11¢ per share, on sales of $123.6 million for the 3 months ended March 31, for bottom-line growth of 34.2% on […]
Fresenius fires back at Akorn with counterclaims following failed merger
Fresenius (ETR:FRE) filed counterclaims against generic drugmaker Akorn Inc. (NSDQ:AKRX) this week in Delaware Chancery Court, alleging that Akorn tried to defraud the FDA with falsified testing data. Akorn filed suit against Fresenius one day after the company walked away from a $4.75 billion deal to acquire Akorn. Fresenius cited an investigation that found material breaches of […]