Biotechs Ahead of Pharma in '08 New Drug Approvals s the dog days of summer come to a close, it has yet to be seen whether 2008 will be a dog of a year for drug approvals, as was 2007, with only 16 new molecular entities (NME) and two new biologics approved last year - the lowest number of...
Biotechs Ahead of Pharma in '08 New Drug Approvals s the dog days of summer come to a close, it has yet to be seen whether 2008 will be a dog of a year for drug approvals, as was 2007, with only 16 new molecular entities (NME) and two new biologics approved last year - the lowest number of...
BioDelivery Sciences Anticipates First Half 2009 Approval of BEMA Fentanyl (ONSOLIS) RALEIGH, N.C.--(BUSINESS WIRE)--Aug.28, 2008 - BioDelivery Sciences International, Inc.
(Nasdaq:BDSI) today announced receipt of a Complete Response letter from the U.S.
Food and Drug Administration (FDA) regarding the Company's New...
USPTO Backlog Impacts Biopharma Industry Unless Situation Is Resolved, Investment in New Candidates May Be Delayed or Withheld Anthony Tridico Jim Kastenmayer Ali Kargbo Large pharmaceutical companies are increasingly turning to smaller biotechnology and pharmaceutical companies to...
Somaxon Pharmaceuticals to Present at the Thomas Weisel 2008 Healthcare Conference and NewsMakers in the Biote SAN DIEGO-- (BUSINESS WIRE) -- Somaxon Pharmaceuticals, Inc.(NASDAQ:SOMX) today announced that Richard Pascoe, the companys recently named president and chief executive officer, will present a company update at the Thomas Weisel 2008...
FDA Grants IND For Pro-Pharmaceuticals' DAVANAT® To Treat Breast Cancer Patient NEWTON, Mass.--(BUSINESS WIRE)--Pro-Pharmaceuticals, Inc.(Amex: PRW), today announced that the U.S.
Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of DAVANAT in combination with 5-FU...
Somaxon Pharmaceuticals to Present at the Thomas Weisel 2008 Healthcare Conference and NewsMakers in the Biote SAN DIEGO--(BUSINESS WIRE)--Somaxon Pharmaceuticals, Inc.(NASDAQ:SOMX - News) today announced that Richard Pascoe, the companys recently named president and chief executive officer, will present a company update at the Thomas Weisel 2008...
FDA Grants IND for Pro-Pharmaceuticals' DAVANAT to Treat Breast Cancer Patient Pro-Pharmaceuticals, Inc.has been granted an Investigational New Drug (IND) application by the FDA for use of DAVANAT in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Kentucky.
DAVANAT...
IDM PHARMA INC EPS Estimated At -1.33: Current Recommendation is Buy Company: IDM PHARMA INC Report Headline: 'Mifamurtide NDA Amendment Expected 1Q:08 Following FDA's Not Approvable Letter' Report Date: August 27, 2007 Current FY EPS Estimate [FY2007]: -1.33 Previous EPS Estimate for Current FY [FY2007...
IDM PHARMA INC EPS Estimated At -1.33: Current Recommendation is Buy Company: IDM PHARMA INC Report Headline: 'Mifamurtide NDA Amendment Expected 1Q:08 Following FDA's Not Approvable Letter' Report Date: August 27, 2007 Current FY EPS Estimate [FY2007]: -1.33 Previous EPS Estimate for Current FY [FY2007...
Novartis to take $235 million charge as Aurograb fails Novartis says that it is ending development of the antibacterial Aurograb after it failed to show efficacy in mid-stage trials.The lack of efficacy was revealed following a review of a Phase II study of Aurograb, an add-on therapy to...
Napo Pharmaceuticals H1 loss widens as co says funding essential to survive LONDON (Thomson Financial) - Napo Pharmaceuticals Inc.(News) reported deepening losses for the first half of 2008 and said that, unless it raises more funds, its future is in jeopardy.
The group, which focuses on bringing proprietary...
Napo Pharmaceuticals H1 loss widens as co says funding essential to survive LONDON (Thomson Financial) - Napo Pharmaceuticals Inc.reported deepening losses for the first half of 2008 and said that, unless it raises more funds, its future is in jeopardy.
The group, which focuses on bringing proprietary products...
Pain Therapeutics, King Pharma develop abuse-resistant pain medication Pain Therapeutics, Inc.and King Pharmaceuticals, Inc.
announced they are developing a new abuse-resistant prescription pain medication called PTI-721.
Like Remoxy (controlled-release oxycodone), PTI-721's patented formulation is...
FDA Asks for More Information Before Sanctioning J&JPRDs Drug for Hospital-Acquired Pneum Johnson & Johnson Pharmaceutical Research & Development(J&JPRD) reports that the FDA requires additional data to approve Doribax for hospital-acquired pneumonia, or nosocomial pneumonia (NP), including ventilator...
Somaxon Pharmaceuticals to Present at the Thomas Weisel 2008 Healthcare Conference and NewsMakers in the - Somaxon Pharmaceuticals, Inc.(NASDAQ:SOMX) today announced that Richard Pascoe, the company's recently named president and chief executive officer, will present a company update at the Thomas Weisel 2008 Healthcare Conference on...
Barr receives U.S. approval for generic Razadyne tablets Barr Pharmaceuticals, Inc.today announced that its subsidiary, , received final approval from the U.S.
Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne (galantamine...
FDA grants IND for Davanat to treat breast cancer patient Pharmaceutical News Pro-Pharmaceuticals, Inc.has announced that the U.S.
Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of Davanat in combination with 5-FU to treat a breast cancer...
POZEN, Inc. Q2 2008 Earnings Call Transcript Including our inability to know with certainty what standards the FDA will use to evaluate drug candidates and how that may change or evolve over time, how the FDA evaluates data, what the results of future trials may be, whether those...
BioDelivery Sciences Anticipates First Half 2009 Approval of BEMA(TM) Fentanyl (ONSOLIS(TM)) RALEIGH, N.C.--(BUSINESS WIRE)--BioDelivery Sciences International, Inc.(Nasdaq:BDSI - News) today announced receipt of a Complete Response letter from the U.S.
Food and Drug Administration (FDA) regarding the Companys New Drug...
NexMed Shares Fall Hard as Novartis Nixes NDA Stock Drops More Than 80 Percent NexMed Inc.shares plummeted 81.6 percent Wednesday on news that its partner, Novartis AG, has decided that, for now, it will not file a new drug application for a topical nail fungus product that uses...
NexMed Shares Fall Hard as Novartis Nixes NDA NexMed Inc.shares plummeted 81.6 percent Wednesday on news that its partner, Novartis AG, has decided that, for now, it will not file a new drug application for a topical nail fungus product that uses NexMed's drug delivery technology.
FDA Grants IND for Pro-Pharmaceuticals' DAVANAT(R) to Treat Breast Cancer Patient Pro-Pharmaceuticals, Inc.(PRW), today announced that the U.S.
Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of DAVANAT in combination with 5-FU to treat a breast cancer patient at...
FDA Grants IND for Pro-Pharmaceuticals' DAVANAT(R) to Treat Breast Cancer Patient , 7:00 AM EST News source: Business Wire Pro-Pharmaceuticals, Inc.(Amex: PRW), today announced that the U.S.
Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of DAVANAT(R) in...
FDA Grants IND for Pro-Pharmaceuticals' Davanat to Treat Breast Cancer Patient - Pro-Pharmaceuticals, Inc.(Amex: PRW), today announced that the U.S.
Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of DAVANAT(R) in combination with 5-FU to treat a breast cancer...
