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News Breaks
August 21, 2014
15:16 EDTMNK, ACT, TEVA, ABBVDEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
News For TEVA;MNK;ABBV;ACT From The Last 14 Days
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December 11, 2014
07:24 EDTTEVATeva to host conference call
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07:12 EDTTEVATeva sees FY15 Copaxone sales $3.5B-$3.7B
Sees FY15 Treanda sales $670M-$750M. Sees FY15 ProAir family sales $470M-$580M, Azilect sales $350M-$400M and Nuvigil sales $300M-$330M. Erez Vigodman, President & CEO of Teva, said, "Generics remain at the heart of our business, both as the cornerstone of the Company, but also as an area that has great impact on society. At the same time, we anticipate four specialty product approvals and five submissions in 2015 which we believe will improve treatment options for patients, and add value for all of our stakeholders." The company expects 2015 generic revenues in the United States to be $4.2B-$4.6B, $2.6B-$3.0B in Europe and $2.0B-$2.3B in its ROW markets. Results of its specialty segment are expected to be impacted by the introduction of two AB-rated generic competitors to Copaxone in the U.S. beginning in September 2015, which is a modeling assumption only, as well as by increased competition from oral products for the treatment of multiple sclerosis. In addition, the company is expecting to invest in a significant number of product launches and in its specialty pipeline. "All of these will result in lower profit and profitability, as we focus on generating growth over the next few years," Teva said.
07:08 EDTTEVATeva sees FY15 gross profit 59.5%-61.5%
Teva sees FY15 cash flow from operations $4.3B-$4.7B and free cash flow $3.5B-$3.7B.
07:07 EDTTEVATeva sees spending $1B-$1.2B on share buybacks in 2015
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07:02 EDTTEVATeva sees FY15 EPS $5.00-$5.30, consensus $5.06
Sees FY15 revenue $19B-$19.4B, consensus $20.07B.
06:29 EDTABBVShire CEO sees no immediate need to spend break-up fee, Reuters reports
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06:20 EDTABBVAbbVie downgraded to Equal Weight from Overweight at Morgan Stanley
December 10, 2014
11:40 EDTACTActavis management to meet with Sterne Agee
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09:33 EDTACTActavis launches generic version of Celebrex
Actavis (ACT) announced that it has launched a generic version of Celebrex 50 mg, 100 mg, 200 mg and 400 mg capsules, as part of a settlement agreement with Pfizer (PFE). Celebrex is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. For the 12-month period ending June 30, 2014, Celebrex had U.S. sales of approximately $2.4 billion, according to IMS Health data.
08:31 EDTTEVATeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
December 9, 2014
14:22 EDTMNKAetna updates clinical policy for H.P. Acthar Gel
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09:31 EDTACTZoetis drops after report of Valeant abandoning growth by acquisitions strategy
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07:44 EDTTEVA, ABBVAmerican Association for Cancer Research to hold a symposium
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06:14 EDTACTAllergan price target raised to $245 from $210 at Citigroup
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December 8, 2014
12:25 EDTACTAntibiotic makers rise after Merck agrees to buy Cubist
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11:30 EDTACT, TEVALeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:21 EDTTEVAMerck says looked at all risks, including patent litgation, before Cubist deal
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06:47 EDTTEVAArena says Teva files marketing authorization of Belviq in Israel
Arena Pharmaceuticals (ARNA) disclosed late Friday that Teva Pharmaceutical's (TEVA) local Israeli subsidiary, Abic Marketing Limited, has filed for marketing authorization of Belviq in Israel. In connection with the filing, Arena will receive a milestone payment of $250K.
December 5, 2014
16:49 EDTACTAdvisory Committee recommends approval Of Actavis' ceftazidime-avibactam
Actavis announced that the Anti-Infective Drugs Advisory Committee convened by the U.S. Food and Drug Administration has voted to recommend approval of Actavis' New Drug Application for ceftazidime-avibactam, an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative pathogens. The committee found the scientific and clinical evidence submitted by Cerexa, a wholly owned subsidiary of Actavis, adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of the proposed cIAI and cUTI indications. The committee voted not to recommend approval of the combination for hospital-acquired bacterial pneumonia /ventilator-associated bacterial pneumonia and bacteremia.The Advisory Committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for ceftazidime-avibactam during the first quarter of 2015.
07:54 EDTTEVALannett names Michael Bogda as president, effective December 1
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