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Endo third quarter total revenues increase 23% to $444.1 million

Endo Pharmaceuticals today reported financial results for the third quarter 2010.

1 Nov 2010

Spectrum submits complete response to FDA's CRL for FUSILEV to treat colorectal cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Friday, October 29, 2010 it submitted a complete response to the "Complete Response" letter issued by the U.S. Food and Drug Administration (FDA), regarding its supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.

1 Nov 2010

Biodel receives FDA CRL for Linjeta NDA

Biodel Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) requesting additional information regarding the company's new drug application (NDA) for Linjeta™ (human insulin [rDNA origin]) injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control.

1 Nov 2010

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Vertex Pharmaceuticals Incorporated today announced new data from its Phase 3 studies of people with genotype 1 chronic hepatitis C who have not been treated previously. In these studies, the majority of people achieved superior sustained viral response (SVR or viral cure) rates with a telaprevir-based combination regimen, compared to current therapies, regardless of race/ethnicity or stage of liver fibrosis (factors known to limit response to current hepatitis C treatments).

1 Nov 2010

FDA new approvals, antibiotic and neurological drugs

Two new drugs have gained approval from the US Food and Drug Administration (FDA) – one is an antibiotic from Forest Labs and the other a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals. Another waiting for approval is Biodel's fast-acting insulin Linjeta. On the other hand seven new drugs got rejected including a diabetes drug from Amylin Pharmaceuticals and weight-loss drugs from Arena Pharmaceuticals and Vivus, respectively.

31 Oct 2010

NeoPharm enters merger agreement with Insys Therapeutics

NeoPharm, Inc. a biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced it has entered into a merger agreement with Insys Therapeutics, a Phoenix-based drug development company focused on pain and oncology.

30 Oct 2010

MannKind third quarter operating expenses decreases from $42.8 million to $42.5 million

MannKind Corporation today reported financial results for the third quarter ended September 30, 2010.

29 Oct 2010

MAP Pharmaceuticals to present FREEDOM-301 Phase 3 trial data for migraine at EHMTIC Congress

MAP Pharmaceuticals, Inc. today announced new data from the FREEDOM-301 Phase 3 trial of its investigational LEVADEX orally inhaled migraine therapy showing low recurrence rates with LEVADEX. Eight additional analyses from the LEVADEX program also will be presented during the 2010 European Headache and Migraine Trust International Congress (EHMTIC) in Nice, France.

29 Oct 2010

Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

Shire plc the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.

29 Oct 2010

VIVUS receives FDA CRL for QNEXA NDA

VIVUS, Inc. announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

29 Oct 2010

Tenofovir gel to prevent HIV transmission nearing approval

Anti HIV drug Tenofovir in its gel form is to be fast-tracked for approval by the US FDA. The announcement was made by Conrad, a nonprofit scientific organization based in Arlington, Virginia that works with reproductive health.

28 Oct 2010

POZEN reports net loss of $8.6M for third quarter 2010 vs. net income of $6.7M for third quarter 2009

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

28 Oct 2010

Celgene third quarter non-GAAP total revenue increases 31% to $908 million

Celgene Corporation announced non-GAAP net income of $349.9 million, or non-GAAP diluted earnings per share of $0.75 for the quarter ended September 30, 2010.

28 Oct 2010

Cell Therapeutics 2010 third quarter total net operating expense decreases 52% to $13.0 million

Cell Therapeutics, Inc. today reported recent accomplishments and financial results for the third quarter ended September 30, 2010.

28 Oct 2010

EpiCept, FDA reach agreement on regulatory path forward for Ceplene

EpiCept Corporation today announced that it has reached an agreement on all outstanding issues with the U.S. Food and Drug Administration (FDA) on a regulatory path forward for Ceplene® (histamine dihydrochloride), the Company's lead product for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission. Ceplene® is approved in the European Union for this indication and is marketed there by Meda AB.

28 Oct 2010

Reuters examines development progress of microbicide gel to prevent HIV

Reuters reports that the developers of a vaginal microbicide gel containing the antiretroviral tenofovir, which has been found to reduce "HIV infections in women by 39 percent," said the FDA last week granted fast-track approval designation to the gel.

28 Oct 2010

US FDA cracks down on importation of unapproved new drugs for personal use

The United States Food and Drug Administration (“FDA”) is cracking down on the importation of unapproved new drugs with regards to personal use. Import Alert #66-41, “Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.” (“IA 66-41”) was most recently published on September 23, 2010. IA 66-41 contains a Red List, a list of importers whose products are automatically detained for FDA violations, of over 400 firms on the charge of importing misbranded unapproved new drugs. Benjamin England, founder of FDAImports.com, LLC and former FDA Compliance Officer, attorney, and Food and Drug Law expert states that “This Import Alert has been expanded to include importers and products of drugs imported strictly for personal use rather than just targeting foreign shippers, which is FDA's normal M.O.”

27 Oct 2010

Cipher reports net revenue of $1.1 million for 2010 third quarter

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

27 Oct 2010

ARIAD prices common stock public offering

ARIAD Pharmaceuticals, Inc. announced today the pricing of an underwritten public offering of 16,000,000 shares of its common stock at $3.70 per share. The offering is expected to close on or about October 29, 2010, subject to customary closing conditions. In addition, ARIAD has granted the underwriters a 30-day option to purchase up to 2,400,000 shares of common stock to cover over-allotments, if any.

27 Oct 2010

Keryx completes randomization of last patient in Zerenex Phase 3 study for hyperphosphatemia

Keryx Biopharmaceuticals reported today the randomization of the last patient in its short-term study component of its Phase 3 registration program of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

26 Oct 2010

New Drug Application News and Research

Endo third quarter total revenues increase 23% to $444.1 million

Spectrum submits complete response to FDA's CRL for FUSILEV to treat colorectal cancer

Biodel receives FDA CRL for Linjeta NDA

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

FDA new approvals, antibiotic and neurological drugs

NeoPharm enters merger agreement with Insys Therapeutics

MannKind third quarter operating expenses decreases from $42.8 million to $42.5 million

MAP Pharmaceuticals to present FREEDOM-301 Phase 3 trial data for migraine at EHMTIC Congress

Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

VIVUS receives FDA CRL for QNEXA NDA

Tenofovir gel to prevent HIV transmission nearing approval

POZEN reports net loss of $8.6M for third quarter 2010 vs. net income of $6.7M for third quarter 2009

Celgene third quarter non-GAAP total revenue increases 31% to $908 million

Cell Therapeutics 2010 third quarter total net operating expense decreases 52% to $13.0 million

EpiCept, FDA reach agreement on regulatory path forward for Ceplene

Reuters examines development progress of microbicide gel to prevent HIV

US FDA cracks down on importation of unapproved new drugs for personal use

Cipher reports net revenue of $1.1 million for 2010 third quarter

ARIAD prices common stock public offering

Keryx completes randomization of last patient in Zerenex Phase 3 study for hyperphosphatemia

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