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News Breaks
March 24, 2014
06:19 EDTBMY, RHHBY, MRK, AZNBristol-Myers, Roche, working on possible blockbusters for melanoma, WSJ says
Bristol-Myers (BMY), Roche (RHHBY) and Merck (MRK) are all working to launch potential blockbuster drugs in the next 18 months that would treat advanced melanoma, the Wall Street Journal reports. The companies' drugs could be launched later this year or in late 2015 if approved. AstraZeneca (AZN) also has an earlier-stage candidate that it's developing. Reference Link
News For BMY;RHHBY;MRK;AZN From The Last 14 Days
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September 15, 2014
13:30 EDTMRKMerck announces data from pivotal Phase 3 study for odanacatib
Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.
07:27 EDTAZNPfizer acquisition could drive shares higher, says JPMorgan
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September 12, 2014
10:32 EDTAZNPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
September 10, 2014
16:00 EDTMRKOptions Update; September 10, 2014
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15:21 EDTAZNAstraZeneca has a conference call hosted by JPMorgan
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13:04 EDTRHHBYRoche unit receives orphan status for lung cancer mutation drug
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September 8, 2014
16:00 EDTMRKOptions Update; September 8, 2014
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14:13 EDTAZNConnecticut AG tells FDA to speed up generic Nexium
A news release from the Connecticut Attorney General George Jepsen, dated September 4, says: In comments to a Citizen Petition filed with the FDA, Attorney General George Jepsen called on the federal agency to expeditiously end several years of delays preventing the sale of a generic form of the drug esomeprazole magnesium , esomeprazole, currently marketed under the brand name Nexium. Nexium is the second highest-selling pharmaceutical drug in the United States, and delays in approving generic versions have cost consumers and government healthcare payers billions of dollars. In his comments, Attorney General Jepsen alleges that an agreement between drug manufacturers Ranbaxy (RBXLY) and AstraZeneca Pharmaceuticals (AZN), Nexium’s brand-name manufacturer, has prevented other drug-makers from launching a generic version of the drug, ultimately harming all consumers by artificially inflating prices. Ranbaxy was first-to-file with the FDA for approval of a generic form of Nexium. AstraZeneca sued Ranbaxy for patent infringement, and the dispute was settled by an agreement that provided financial incentives for Ranbaxy to delay entry of its generic into the consumer market. Reference Link
07:15 EDTRHHBYIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
07:02 EDTAZNAstraZeneca announces availability of Bydureon pen 2mg
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September 5, 2014
16:45 EDTMRK, BMYMarket ends week little changed after mixed economic data
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13:07 EDTRHHBYRoche has a conference call hosted by JPMorgan
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11:17 EDTMRK, BMYBristol-Myers files patent infringement suit against Merck
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08:39 EDTMRKMerck Keytruda sales to reach $5B in 2018, says BMO Capital
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September 4, 2014
17:15 EDTAZNAstraZeneca granted orphan status for EFGR non-small cell lung cancer treatment
The FDA posted on its website that AstraZeneca has been granted orphan status for its treatment of epidermal growth factor receptor, or EFGR, mutation-positive non-small cell lung cancer. Reference Link
15:16 EDTMRKMerck receives accelerated approval of Keytruda
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09:02 EDTMRKMerck's relebactam granted QIDP, fast track designations by FDA
Merck announced that the U.S. Food and Drug Administration has designated relebactam -- previously known as MK-7655 -- the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product with designated Fast Track status. The QIDP and Fast Track designations apply to intravenous use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Relebactam is an investigational, class A and C, beta-lactamase inhibitor that is being evaluated in combination with imipenem/cilastatin in ongoing Phase 2 clinical trials for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. In preclinical studies, relebactam administered in combination with imipenem/cilastatin demonstrated antibacterial activity against a broad range of Gram-negative and beta-lactam-resistant pathogens. Merck plans to initiate Phase 3 studies with relebactam in combination with imipenem/cilastatin in 2015.
08:02 EDTBMYTeva launches generic Baraclude in U.S.
Teva (TEVA) announces the launch of the generic equivalent to Baraclude tablets in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Baraclude is marketed by Bristol-Myers Squibb (BMY).
07:23 EDTAZNAstraZeneca called for inversion clamp down as part of defense, WSJ says
Amid its defense against an unsolicited takeover bid from rival Pfizer (PFE), AstraZeneca (AZN) hired advisers with close ties to the Obama administration, who made calls to senior administration officials urging a clamp down on tax inversions, said The Wall Street Journal, citing people familiar with the previously undisclosed calls. Reference Link
07:21 EDTMRKMedidata can obtain major new platform customers, says Stifel
Noting that Medidata (MDSO) partners with Veeva, Stifel believes that a number of Veeva (VEEV) customers could become Medidata platform customers, especially if they already use Medidata for R&D and clinical trial solutions. The firm identifies Merck (MRK), Gilead (GILD), and Teva (TEVA) as companies that may become platform clients for Medidata. Stifel keeps a $55 price target and Buy rating on Medidata.
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