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March 26, 2013
06:32 EDTJNJ, BMY, TEVA, ACT, GNK, NVS, PFE, GSK, MYLSome justices seem skeptical about payments to generic drug firms, NY Times says
Several Supreme Court justices seemed skeptical about the practice of brand name pharmaceutical companies paying generic companies to keep their cheaper drugs off the market for a longer time, according to The New York Times. Some of the justices appeared to be interested in issuing a narrow ruling in the case they are hearing regarding the issue that would not create a precedent, the newspaper added. Reference Link
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February 26, 2015
08:35 EDTBMYBristol-Myers says BMS-966176 Phase IIa study met primary endpoint
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08:03 EDTJNJJohnson & Johnson forms new health and wellness platform
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06:52 EDTJNJPharmacyclics downgraded to Hold from Buy at WallachBeth
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February 25, 2015
17:26 EDTACTActavis' Avycaz for infections approved by FDA
Actavis' Avycaz has been approved by the FDA for the treatment of adult patients with complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. AVYCAZ received a priority review based on Phase II data from the company's clinical development program and supporting in vitro data, and as such should be reserved for use in patients who have limited or no alternative treatment options. AVYCAZ will be available in Q2.
14:47 EDTJNJPharmacyclics could fetch as much as $19B in sale, FT says
Pharmacyclics (PCYC) is considering a sale that could fetch as much as $19B, reported Financial Times, citing people familiar with the matter who said Johnson & Johnson (JNJ) is exploring a potential deal for the company. The Fly notes that Bloomberg had a similar report, but its report said Pharmacyclics could fetch $17B-$18B in a sale. Reference Link
14:10 EDTJNJ, NVSPharmacyclics downgraded to Hold on lack of upside at Deutsche Bank
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12:54 EDTJNJ, NVSPharmacyclics exploring options including sale, Bloomberg reports
According to sources, Pharmacyclics (PCYC), which develops cancer treatments, is currently exploring options, Bloomberg reports. One option may include a sale of the company, and the sources say Johnson & Johnson (JNJ) and Novartis (NVS) have expressed interest in the company. Pharmacyclics could fetch $17B-$18B in a sale, the sources add. Reference Link
12:53 EDTJNJ, NVSPharmacyclics weighing sale to U.S. drugmaker, Bloomberg reports
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12:13 EDTGSK, NVSGlaxoSmithKline sees Novartis transaction closing next week
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11:24 EDTGSKGlaxoSmithKline announces return of alli to retail stores
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08:36 EDTBMYBristol-Myers announces data from Phase IIb BMS-663068 trial
Bristol-Myers Squibb Company announced data from a Phase IIb trial of investigational compound BMS-663068, designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients. In the study, which compared BMS-663068 to a pharmacoenhanced protease inhibitor, virologic response rates and immunologic reconstitution were similar across the BMS-663068 and Reyataz/ritonavir arms of the trial through 48 weeks. Specifically, 61-82% of BMS-663068 patients had HIV-1 RNA levels <50 c/mL, compared to 71% of Reyataz/ritonavir patients at week 48. HIV-1 RNA levels <50 c/mL typically indicate virus replication is undetectable. Treatment with BMS-663068 resulted in no dose response safety signals, no treatment discontinuations related to adverse events, and no treatment-related serious adverse events over the course of the trial. The most common AEs were headache and abdominal pain. Due to the positive results seen thus far, a Phase III clinical trial of the attachment inhibitor among heavily treatment-experienced patients began on Monday, February 23, 2015. For the purposes of the Phase III trial, heavily treatment-experienced patients are defined as individuals who can no longer formulate a viable regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications. The Phase IIb study results, presented yesterday at the 22nd Conference on Retroviruses and Opportunistic Infections, highlight the novel mechanism of action of the investigational prodrug BMS-663068, which when converted into its active moiety BMS-626529, is designed to bind directly to the HIV gp120 protein, and prevents initial viral attachment to the host CD4+ T cell and entry into the host immune cell.
08:19 EDTACTActavis price target raised to $350 from $315 at Bernstein
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08:07 EDTNVSNovartis' Farydak myeloma drug approved by FDA, to be distributed by Diplomat
Novartis' (NVS) drug Farydak for the treatment of patients with multiple myeloma Diplomat Pharmacy has been approved by the FDA. The drug is now a treatment option for patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. Farydak will be distributed by Diplomat Pharmacy (DPLO).
08:05 EDTTEVATeva says FDA accepts CEP-33237 NDA for review
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07:59 EDTACTActavis 13.2M share Secondary priced at $288.00
The deal size was lowered to $3.8B from $4.2B and but the convertible preferred was up-sized to $4.6B from $4.2B. JPMorgan, Mizuho, Wells Fargo and Morgan Stanley acted as joint book running managers for the offering.
February 24, 2015
16:27 EDTACTActavis confirms generic Uceris patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Budesonide Extended-release Tablets, 9 mg. Actavis' ANDA product is a generic version of Salix Pharmaceuticals' (SLXP) Uceris, which is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
16:19 EDTNVSAratana Therapeutics to pay Elanco up to $3M to regains rights to AT-004
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09:02 EDTTEVATeva announces phase 2b study of TEV-48125 achieved endpoints
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08:07 EDTPFEPfizer announces Trumenba studies met primary objectives
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07:46 EDTBMYJacobs Engineering awarded contract from Bristol-Myers
Jacobs Engineering Group (JEC) announced that it received a contract from Bristol-Myers Squibb Company (BMY) to provide architectural and engineering services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. The facility is being designed to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
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