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Stock Market & Financial Investment News

News Breaks
May 20, 2014
08:15 EDTAHS, GILD, ARRY, QSII, EXEL, SGEN, MNK, CGIXUBS to hold a conference
2014 Global Healthcare Conference to be held in New York on May 19-21 with webcasted company presentations to begin on May 20 at 8 am; not all company presentations may be webcasted. Webcast Link
News For ARRY;CGIX;EXEL;GILD;MNK;QSII;AHS;SGEN From The Last 14 Days
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November 14, 2014
09:38 EDTGILDActive equity options trading
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November 13, 2014
13:32 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
10:44 EDTMNKMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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10:29 EDTQSIIQuality Systems management to meet with Oppenheimer
Meeting to be held in Texas on November 18 hosted by Oppenheimer.
08:20 EDTMNKMallinckrodt could be down $6-$8 on FDA reclassification, says UBS
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07:24 EDTAHSSunTrust to hold a conference
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06:11 EDTMNKMallinckrodt responds to FDA expected reclassification of methylphenidate ER
Mallinckrodt has been informed by the FDA that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release, or ER, tablets, USP may not be therapeutically equivalent to the category reference drug Concerta. As a result, the agency indicated that it has reclassified Mallinckrodt’s ANDA 202608 for methylphenidate ER dosage strengths of 27mg, 36 mg and 54 mg from AB to BX. The agency said that this change was based on the application of its new Draft Guidance for determining bioequivalence of methylphenidate hydrochloride products just published on November 6, 2014. Although the Draft Guidance has an open comment period through January 5, 2015, the agency nevertheless confirmed that this change would be reflected on November 13, 2014 in the on-line Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Mallinckrodt strongly believes its methylphenidate ER products are safe and effective when used in accordance with the approved labels. Mark Trudeau, president and CEO of Mallinckrodt stated, “We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients." Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA, and in the 21 months since launch more than 88M doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug to the company’s methylphenidate ER products.
November 12, 2014
11:17 EDTSGENLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:13 EDTARRYBoston Biotech to hold a conference
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07:53 EDTSGEN, GILDLeerink to hold a tour
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07:22 EDTCGIXAssociation of Molecular Pathology is holding annual meeting
2014 Annual Meeting of AMP is being held in National Harbor, Maryland on November 12-15.
November 11, 2014
16:14 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including JAK inhibitors, novel Jakafi combinations for Myelofibrosis and developing compounds on an Analyst/Industry conference call to be held on November 17 at 10 am.
16:01 EDTGILDOptions Update; November 11, 2014
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15:43 EDTSGENLeerink major pharma & biotech analysts hold analyst/industry conference call
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11:35 EDTGILDUBS holds a conference call with Gilead Sciences
UBS Biotech Analyst Roden, along with Dr. Bischofberger of Gilead Sciences, discuss the recently-held AASLD Meeting and the outlook of several GILD pipeline programs on a conference call to be held on November 13 at 4:30 pm.
08:07 EDTGILDGilead announces results from Phase 2 and 3 studies evaluating Harvoni
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08:05 EDTGILDGilead announces data from Phase 2 Sofosbuvir plus GS-5816 studies
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07:56 EDTCGIXCancer Genetics receives second patent for FHACT
Cancer Genetics announced that it has received a second U.S. patent covering its proprietary FISH-based HPV-Associated Cancer Test, or FHACT, for cervical cancer detection in patients. FHACT is designed to assess change across four biomarkers indicating HPV-associated pre-cancers and cancers. Critically, FHACT can help prevent unnecessary colposcopies and cervical biopsies, reducing costs and complications associated with these invasive procedures.
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