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Mothers can play a key role in convincing college-aged women to receive HPV vaccine

Even after young women reach adulthood, their mothers can play a key role in convincing them to receive the human papillomavirus vaccine, new research suggests.

3 Jan 2011

SinoFresh, Green Valley Drug enter marketing relationship for Homeopathic Antiseptic Nasal Spray

SinoFresh® HealthCare, Inc., is pleased to announce that its marketing division has secured an agency marketing relationship with Green Valley Drug, the largest medical supplier in Southern Nevada with a significant pharmacy and medical customer base in the western U.S.

3 Jan 2011

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

FDA grants orphan drug status for Senesco's SNS01-T in treatment of multiple myeloma

Senesco Technologies, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company's lead drug candidate SNS01-T for treatment of multiple myeloma.

3 Jan 2011

Labopharm monetizes future royalty payment stream for RYZOLT through subsidiary

Labopharm Inc. today announced that, through its wholly owned subsidiary, Labopharm Europe Limited, it has monetized the expected future royalty payment stream for RYZOLT(TM) (once-daily tramadol).

3 Jan 2011

Akorn-Strides joint venture enters purchase agreement with Pfizer for ANDAs

Akorn, Inc., a niche generic pharmaceutical company, today reported that its Akorn-Strides LLC joint venture has entered into a purchase agreement with Pfizer Inc. to sell 16 Abbreviated New Drug Approvals (ANDAs) and 6 filed ANDAs. For its portion, Akorn, Inc. will receive $35 million in cash. Akorn-Strides LLC will continue to manufacture and distribute the approved products until April 30, 2011.

30 Dec 2010

Heart researchers find no evidence of toxicity in Longevinex

It was Paracelsus, the Renaissance physician who first said "the dose makes the poison." So, you can drink too much wine, or ingest too much resveratrol, but in an unprecedented study, heart researchers report they couldn't find a toxic dose for Longevinex-, a resveratrol-based dietary supplement.

30 Dec 2010

Omega-3 fatty acids may reduce inflammation, disease symptoms and cartilage degeneration

Omega-3 fatty acids from seafood may reduce inflammation, symptoms of gum disease and risk of abnormal heartbeats early after cardiac surgery. One type of omega-3, DHA (docosahexaenoic acid), may also have lasting benefits in visual function for years in children whose mothers consume sufficient prenatal DHA.

30 Dec 2010

FDA approves Impax's ANDA for generic Doryx 75 and 100mg tablets

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application for the generic version of Doryx® (doxycyline hyclate delayed-release) 75 and 100mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

29 Dec 2010

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.

29 Dec 2010

FDA approves Endo's FORTESTA Gel for low testosterone

Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

29 Dec 2010

FDA stops pain drug trial over safety concerns

Johnson & Johnson revealed Tuesday this week that a clinical trial of its experimental pain drug, fulranumab, has been stopped after the Food and Drug Administration expressed concerns that patients taking the drug could suffer increased joint damage.

29 Dec 2010

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

Patients unresponsive to anti-anemia drug have higher risk of cardiovascular disease, death

Patients with diabetes, kidney disease and anemia who don't respond to treatment with an anti-anemia drug have a higher risk of cardiovascular disease or death, researchers at UT Southwestern Medical Center have found.

28 Dec 2010

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Cephalon, Inc. today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.

28 Dec 2010

King Pharmaceuticals resubmits NDA for REMOXY

King Pharmaceuticals®, Inc. and Pain Therapeutics®, Inc. today announced that King has resubmitted a New Drug Application for REMOXY® to the U.S. Food and Drug Administration in response to a Complete Response letter received by Pain Therapeutics in December 2008.

28 Dec 2010

NDA resubmitted for DURECT's ORADUR technology based REMOXY

DURECT Corporation today reported that King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. have announced that King has resubmitted a New Drug Application (NDA) for REMOXY® to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle.

28 Dec 2010

Study sheds light on how bacteria developed resistance to antibiotics

Studying how bacteria incorporate foreign DNA from invading viruses into their own regulatory processes, Thomas Wood, professor in the Artie McFerrin Department of Chemical Engineering at Texas A&M University, is uncovering the secrets of one of nature's most primitive immune systems.

27 Dec 2010

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Transition Therapeutics Inc. today announced that the Company and Elan Corporation, plc have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005.

27 Dec 2010

60% of type 2 diabetics who use insulin would switch to a less expensive biosimilar insulin if available

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that 60 percent of surveyed type 2 diabetes patients in the U.S. who currently use insulin indicate they would request that their doctor switch them to a less expensive biosimilar insulin if such an agent became available.

24 Dec 2010

Pharmaceutical News

Mothers can play a key role in convincing college-aged women to receive HPV vaccine

SinoFresh, Green Valley Drug enter marketing relationship for Homeopathic Antiseptic Nasal Spray

FDA approves 200 mg formulation of INTELENCE for HIV-1

FDA grants orphan drug status for Senesco's SNS01-T in treatment of multiple myeloma

Labopharm monetizes future royalty payment stream for RYZOLT through subsidiary

Akorn-Strides joint venture enters purchase agreement with Pfizer for ANDAs

Heart researchers find no evidence of toxicity in Longevinex

Omega-3 fatty acids may reduce inflammation, disease symptoms and cartilage degeneration

FDA approves Impax's ANDA for generic Doryx 75 and 100mg tablets

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

FDA approves Endo's FORTESTA Gel for low testosterone

FDA stops pain drug trial over safety concerns

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Patients unresponsive to anti-anemia drug have higher risk of cardiovascular disease, death

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

King Pharmaceuticals resubmits NDA for REMOXY

NDA resubmitted for DURECT's ORADUR technology based REMOXY

Study sheds light on how bacteria developed resistance to antibiotics

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

60% of type 2 diabetics who use insulin would switch to a less expensive biosimilar insulin if available

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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