New Drug Application News and Research

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FDA issues Lux Biosciences Complete Response letter for Luveniq NDA

Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration's Center of Drug Evaluation and Research has issued a Complete Response letter regarding the New Drug Application (NDA) for Luveniq™ (oral voclosporin) for the treatment of non-infectious uveitis.

5 Aug 2010

Par Pharmaceutical second-quarter total net revenues decrease 37% to $255.5 million

Par Pharmaceutical Companies, Inc. today reported results for the second quarter ended June 30, 2010.

4 Aug 2010

NCI panel recommends Celsion's Phase III ThermoDox HEAT Study as Priority Clinical Trial for HCC

Celsion Corporation announced today that the consensus recommendations of the National Cancer Institute (NCI) Clinical Trials Planning Meeting (CTPM) for Hepatocellular Carcinoma have been released and published in the August 2010 issue of Journal of Clinical Oncology, the official publication of American Society of Clinical Oncology (ASCO). In addition to evaluating the current standard of care, the NCI panel also recommended Celsion's Phase III ThermoDox ® HEAT Study as a Priority Clinical Trial for HCC.

4 Aug 2010

Arena reports lower net loss of $28.80M for second-quarter 2010

Arena Pharmaceuticals, Inc. today reported financial results for the second quarter ended June 30, 2010, and recent developments, including the successful Pre-Approval Inspection, or PAI, of the company's Swiss drug product manufacturing facility by the US Food and Drug Administration, or FDA.

4 Aug 2010

Akorn second-quarter consolidated revenue increases 24% to $20.2 million

Akorn, Inc., a niche generic pharmaceutical company, today reported financial results for the second quarter ended June 30, 2010.

4 Aug 2010

MAP Pharmaceuticals reports net loss of $12.5M for second-quarter 2010

MAP Pharmaceuticals, Inc. today announced financial results for the second quarter ended June 30, 2010.

3 Aug 2010

POZEN reports $16.2M net income for second-quarter 2010

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the second quarter ended June 30, 2010.

3 Aug 2010

Acorda second-quarter net loss decreases to $6.8 million

Acorda Therapeutics, Inc. today announced its financial results for the second quarter of 2010.

3 Aug 2010

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

ArQule, Inc. and Daiichi Sankyo Co., Ltd. today announced that they will move forward with a Phase 3 clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC). In connection with this decision, the sponsor company, Daiichi Sankyo, will file a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo.

3 Aug 2010

Oxygen Biotherapeutics collaborates with U.S. Navy to develop treatment for DCS

Oxygen Biotherapeutics, Inc. today announced it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC) to conduct preclinical trials to assess the safety and efficacy of Oxygen Biotherapeutics' proprietary Oxycyte perfluorocarbon emulsion (PFCE) for the prevention and treatment of decompression sickness and related injuries.

3 Aug 2010

FDA approves N30 Pharma's NDA for N6022 GSNOR

N30 Pharmaceuticals, LLC today announced the approval of its Investigational New Drug Application for N6022 by the U.S. Food and Drug Administration. N6022, a first-in-class inhibitor of s-nitrosoglutathione reductase (GSNOR), has the potential to be an important new treatment for acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD).

3 Aug 2010

Perrigo files ANDA for butoconazole nitrate vaginal cream

Perrigo Company announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for butoconazole nitrate vaginal cream, 2% and that is has notified KV Pharmaceutical Company, the owner of the New Drug Application as well as FemmePharma, the listed owner of the patent, of its ANDA filing. KV is a licensee under the patent. Perrigo believes it is first-to-file on this product.

31 Jul 2010

Endo Pharmaceuticals total revenues for second-quarter 2010 increase 6% to $396.5 million

Endo Pharmaceuticals today reported financial results for the second quarter 2010. Total revenues during the second quarter of 2010 increased 6 percent to $396.5 million, compared with $373.1 million in the same quarter of 2009. Net income for the three months ended June 30, 2010 was $51.5 million, compared with $30.0 million in the comparable 2009 period.

30 Jul 2010

Orexigen's Contrave COR-I trial results published online in journal Lancet

Orexigen® Therapeutics, Inc. announced that results from its COR-I trial of Contrave® were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug Administration. Results show that patients taking Contrave were two to three times more likely to lose at least 5% or 10% of their body weight compared to those taking placebo, on both an intent-to-treat (ITT) and completers basis.

30 Jul 2010

Safeguard Scientifics second-quarter aggregate revenue of partner companies increase 47% to $91.6 million

Safeguard Scientifics, Inc., a holding company that builds value in growth-stage life sciences and technology companies, today announced that aggregate revenue of its partner companies for the three months ended June 30, 2010 was $91.6 million, up 47% from $62.3 million for the same partner companies in the same period of 2009. For the six months ended June 30, 2010, the aggregate partner company revenue was $176.9 million, up 45% from $121.8 million for the same partner companies for the same period of 2009.

29 Jul 2010

U.S. Court of Appeals rules against Eli Lily's claims in Gemzar patent lawsuit

Sun Pharma today announced that the U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the U.S. District Court for the Eastern District of Michigan against Eli Lily and Co. finding certain claims of U.S. Patent No. 5,464,826 ("'826 patent") invalid. The appeal arose out of a lawsuit that Eli Lilly filed against Sun Pharma in connection with Sun Pharma's submission of an Abbreviated New Drug Application (ANDA) for a generic version of Gemzar®.

29 Jul 2010

FDA Advisory Committee recommends approval of AstraZeneca's ticagrelor for Acute Coronary Syndromes

AstraZeneca today announced that the US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee recommended the FDA approve AstraZeneca's investigational drug ticagrelor for the reduction of thrombotic events in patients with Acute Coronary Syndromes.

29 Jul 2010

Pain Therapeutics second-quarter collaboration revenue decreases to $0.1 million

Pain Therapeutics, Inc., a biopharmaceutical company, today reported second quarter financial results. Net loss for the quarter ended June 30, 2010 was $0.8 million, or $0.02 per share, compared to net loss of $34,000, or $0.00 per share, for the second quarter of 2009. Pain Therapeutics had cash, cash equivalents and marketable securities of $176.2 million, or about $4.14 cash per share, and no debt as of June 30, 2010.

28 Jul 2010

Cipher Pharmaceuticals second-quarter net revenues increase to $2.2 million

Cipher Pharmaceuticals Inc. today announced its financial and operational results for the three and six months ended June 30, 2010.

28 Jul 2010

FDA accepts for filing Cladribine Tablets NDA for MS

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS).

28 Jul 2010

New Drug Application News and Research

FDA issues Lux Biosciences Complete Response letter for Luveniq NDA

Par Pharmaceutical second-quarter total net revenues decrease 37% to $255.5 million

NCI panel recommends Celsion's Phase III ThermoDox HEAT Study as Priority Clinical Trial for HCC

Arena reports lower net loss of $28.80M for second-quarter 2010

Akorn second-quarter consolidated revenue increases 24% to $20.2 million

MAP Pharmaceuticals reports net loss of $12.5M for second-quarter 2010

POZEN reports $16.2M net income for second-quarter 2010

Acorda second-quarter net loss decreases to $6.8 million

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

Oxygen Biotherapeutics collaborates with U.S. Navy to develop treatment for DCS

FDA approves N30 Pharma's NDA for N6022 GSNOR

Perrigo files ANDA for butoconazole nitrate vaginal cream

Endo Pharmaceuticals total revenues for second-quarter 2010 increase 6% to $396.5 million

Orexigen's Contrave COR-I trial results published online in journal Lancet

Safeguard Scientifics second-quarter aggregate revenue of partner companies increase 47% to $91.6 million

U.S. Court of Appeals rules against Eli Lily's claims in Gemzar patent lawsuit

FDA Advisory Committee recommends approval of AstraZeneca's ticagrelor for Acute Coronary Syndromes

Pain Therapeutics second-quarter collaboration revenue decreases to $0.1 million

Cipher Pharmaceuticals second-quarter net revenues increase to $2.2 million

FDA accepts for filing Cladribine Tablets NDA for MS

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