Tue, Feb. 3, 5:30 PM
Thu, Jan. 22, 3:45 AM
- After lawyers for both companies made final presentations on Wednesday, Johnson & Johnson's (NYSE:JNJ) multibillion-dollar trial with Boston Scientific (NYSE:BSX) over its purchase of device maker Guidant now lies in the hands of a federal judge.
- As Guidant’s successor, J&J is seeking more than $7.2B in damages and interest from Boston Scientific for violating clauses included under their agreement to combine in 2004.
- Previously: J&J, Boston Scientific $5B trial to begin Thursday (Nov. 19 2014)
Thu, Jan. 15, 9:06 AM
Thu, Jan. 8, 12:24 PM
Wed, Jan. 7, 10:24 AM
Dec. 12, 2014, 9:31 AM
- In a retrospective study of 213 patients at 13 medical centers, Boston Scientific's (NYSE:BSX) Precision Spectra Spinal Cord Stimulator (SCS) System demonstrated sustained relief of low back pain 12 months after implantation.
- On a 0 - 10 numeric rating scale (NRS), the 7.17 average baseline score for overall pain dropped to an average of 2.96 at month 12 (n=178). In patients with only low back pain (n=73), the average baseline pain score dropped from 7.21 to 3.17. In patients with severe low back pain (n=41), the average score dropped from 8.60 to 2.87. The cohort will followed for another 12 months.
- Lead investigator Dr. Salim Hayek says, "Treating low back pain has been challenging because so many therapies have had mixed results. These results demonstrate that the Precision Spectra System can provide effective, long-term relief for patients suffering from the difficult-to-treat condition."
- The results will presented at the North American Neuromodulation Society meeting in Las Vegas this weekend.
Dec. 12, 2014, 8:14 AM
- U.S. District Court Joseph Goodwin took the unusual step of advising C.R. Bard (NYSE:BCR) to settle more than 12,000 vaginal mesh lawsuits it faces in light of the large verdicts to date. "I can't imagine a corporation facing potentially billions of dollars in verdicts wouldn't find it advisable to try to achieve a settlement for a much lesser sum," he says. "I base that billions of dollars business on some of the rather large verdicts that we've had." The judge is overseeing all federal court litigation involving the products. More than 30,000 cases have been consolidated before him.
- Women who have had the products implanted for the treatment of incontinence or to support internal organs claim that the devices erode over time causing organ damage and pain. Jury decisions so far have found the devices defectively designed or the manufacturers failed to adequately warn physicians and patients of the risks.
- In October, Bard agreed to settle 500 suits for $21M. In August, the company lost a case in West Virginia and was ordered to pay a woman $2M in damages.
- Bard is not the only company mired in litigation. Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX) have recently lost jury verdicts. In September, a jury in West Virginia ordered JNJ to pay $3.27M to a woman who received the implant. Juries in Texas and Florida ordered BSX to pay $45.2M to eight women and $73M to one woman, respectively.
- The FDA ordered the three manufacturers to study the rates of organ damage and complications linked to the devices.
- Previously: Boston Sci loses first federal case over vaginal mesh product (Nov. 14, 2014)
Nov. 19, 2014, 2:44 AM
- Johnson & Johnson's (NYSE:JNJ) multibillion-dollar trial with Boston Scientific (NYSE:BSX) is set to begin Thursday, as a NY federal court judge decides whether Guidant, through its successor Boston Scientific, should be held liable for breaching a contract.
- J&J is seeking in excess of $5B in damages and interest from Boston Scientific, claiming that Guidant violated clauses included under their agreement to combine in 2004.
Nov. 14, 2014, 10:08 AM
- Jurors in a Miami federal court find Boston Scientific (BSX) responsible for the injuries suffered by four women who used the company's Pinnacle vaginal mesh inserts due to the defective design of the product and the firm's failure to properly warn the doctors and patients about the device's risks. The award is $26.7M.
- The case is the first on the federal level and he first to combine more than one plaintiff.
- University of Richmond law school faculty member Carl Tobias says, "Boston Scientific better start giving serious consideration to doing a global settlement of these vaginal mesh cases." This may be sound advice considering the ~23,000 cases facing the company in various courts in the U.S., Canada and U.K.
- Previously: Boston Scientific due in federal court for mesh lawsuits
Nov. 10, 2014, 10:49 AM
- The Japanese Ministry of Health, Labour and Welfare approves Medtronic's (MDT +0.1%) Evera SureScan implantable cardioverter-defibrillator (ICD) for magnetic resonance imaging (MRI) scans positioned on any region of the body. The commercial launch is underway.
- Evera MRI is available in both single chamber and dual chamber ICDs.
- Until the availability of MR-Conditional ICDs, patients with the devices had been contraindicated from receiving MRI scans because of the potential interactions between the MRI and device function.
- Evera MRI is not yet approved in the U.S.
- Related tickers: (STJ +0.7%)(BSX +1.6%)
Nov. 3, 2014, 5:12 AM
- Boston Scientific (NYSE:BSX) is due to face its first federal trials in courts in West Virginia and Miami today over claims that the company's transvaginal mesh devices caused injuries to the women who used them.
- Boston Scientific has been slapped with over 23,000 suits in U.S. state and federal courts over the past six years. The company has faced three trials in state courts, two that it won and one that it lost and for which it was ordered to pay $34M.
- Other companies that have been dealing with similar problems include J&J and C.R. Bard.
Oct. 27, 2014, 11:41 AM
- The FDA approves St. Jude Medical's (STJ -0.3%) TactiCath Quartz irrigated ablation catheter. The product gives physicians a real-time objective measure of the force that the catheter applies to a patient's heart wall during an ablation procedure. The technology is associated with a reduction in the rate of atrial fibrillation recurrence when optimal treatment measures are used.
- Related tickers: (BCR +1.2%)(MDT -0.1%)(JNJ +0.9%)(BSX +0.8%)(HNSN +2.1%)(ABT -0.6%)
Oct. 22, 2014, 7:23 AM
- Boston Scientific (NYSE:BSX) Q3 results ($M): Total Revenues: 1,846 (+6.4%); Gross Profit: 1,296 (+5.8%); Operating Expenses: 953 (+8.9%); Operating Income: 64 (-37.9%); Net Income: 43 (+960.0%); EPS: $0.03; Quick Assets: 246 (+13.4%).
- Segment Revenues: Cardiovascular: 731 (+8.5%), Interventional Cardiology: 514 (+8.4%); Peripheral Interventions: 217 (+8.5%); Rhythm Management: 536 (+7.2%), CRM: 482 (+3.7%), Electrophysiology: 54 (+54.3%); MedSurg: 593 (+4.8%), Endoscopy; 340 (+6.6%), Urology and Women's Health: 138 (+5.3%), Neuromodulation: 115 (-0.9%).
- 2014 Guidance: Revenues: $7.37B - 7.42B from $7.325B - 7.425B; GAAP EPS: $0.22 - 0.24 from $0.28 - 0.32; non-GAAP EPS: $0.81 - 0.83 from $0.79 - 0.83.
- Q4 Guidance: Revenues: $1.875B - 1.925B, GAAP EPS: $0.09 - 0.11; non-GAAP EPS: $0.20 - 0.22.
Oct. 22, 2014, 7:02 AM
Oct. 21, 2014, 5:30 PM
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
BSX vs. ETF Alternatives
Other News & PR