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FDA accepts Labopharm's response for its novel trazodone formulation

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug Administration (FDA) has accepted Labopharm's response regarding its novel formulation of the antidepressant trazodone as complete and designated it as a Class 2 resubmission. The FDA has assigned Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010.

26 Aug 2009

Sabril (vigabatrin) Oral Solution receives approval from FDA

Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months.

26 Aug 2009

Glaxosmithkline affirms safety of Alli

GSK stands firmly behind the safety and efficacy of alli. Our primary priority is patient health, and we want people to know that there is no evidence that alli causes liver damage.

26 Aug 2009

FDA issues warning letters to eight companies for selling illegal OTC ibuprofen drugs

The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

26 Aug 2009

Gloucester Pharmaceuticals raises funds for the development of romidepsin

Gloucester Pharmaceuticals today announced that it has raised $29 million in a Series D financing. The proceeds will be used to support the ongoing development of romidepsin, a novel histone deacetylase (HDAC) inhibitor for the treatment of T-cell lymphomas and other hematologic malignancies.

26 Aug 2009

Profectus BioSciences to conduct proof-of-concept studies with its rVSV vector technology

Profectus BioSciences, Inc. (Profectus), a clinical stage biopharmaceutical company focused on the development of novel vaccine candidates for serious chronic infections, announced today it has entered into a research collaboration agreement with the PATH Malaria Vaccine Initiative (MVI) to conduct proof-of-concept studies with its proprietary, recombinant vesicular stomatitis virus (rVSV) vector technology as a preventative malaria vaccine.

26 Aug 2009

Hiberix receives accelerated approval from FDA to overcome nationwide shortage

The U.S. Food and Drug Administration today approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, N.C. and Philadelphia.

26 Aug 2009

ParagonRx's CEO recommends techniques to effectively manage the FDA-mandated REMS program

While many pharmaceutical and biologics companies are getting accustomed to FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs for many new and old drugs, most are not adequately preparing for the equally mandatory program evaluations beginning just 1-1/2 years after each REMS is put into effect.

25 Aug 2009

Cytrx’s study offers a better perception of arimoclomol's mechanism of action in induced animal stroke

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that study results demonstrated that arimoclomol exhibited both statistically significant neuroprotective and neuroregenerative effects in brain cells of animals induced with stroke, offering important insights into this drug candidate’s mechanism of action.

25 Aug 2009

Bavarian Nordic begins negotiations with U.S. to secure a contract to develop a freeze-dried version of smallpox vaccine

Bavarian Nordic A/S (OMX: BAVA) announced today that the US authorities have initiated negotiations for a new contract to develop a freeze-dried version of the IMVAMUNE(R) smallpox vaccine.

25 Aug 2009

FDA accepts for filing Salix Pharmaceuticals' NDA for rifaximin tablets

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the Food and Drug Administration (FDA) has accepted for filing and designated for Priority Review the Company’s New Drug Application (NDA) for rifaximin tablets 550 mg for the maintenance of remission of hepatic encephalopathy (HE). Additionally, the FDA has informed the Company of its plan to schedule an Advisory Committee meeting in late February 2010 to discuss the application.

25 Aug 2009

Portola Pharmaceuticals' investigational antiplatelet drug elinogrel featured at the ESC Congress 2009

Portola Pharmaceuticals, Inc. today announced two oral presentations at the European Society of Cardiology (ESC) Congress 2009 in Barcelona, Spain, that will feature its investigational antiplatelet drug elinogrel, a P2Y12 ADP receptor antagonist that is currently in Phase II clinical development with Novartis, Portola's development and commercialization partner.

25 Aug 2009

Blue Spoon outlines a new strategy for pharmaceutical industries

Blue Spoon Consulting Group, LLC, today published a white paper that frames a new innovation space for strategy in the pharmaceutical industry. As momentum grows for performance-based contracting, connected health, and collaborative business models, drug companies will need to rethink their value proposition in a broader context.

25 Aug 2009

Nutra Pharma submits final packaging and labeling for Cobroxin drug for FDA approval

Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has successfully submitted final packaging and labeling to the Food and Drug Administration (FDA) to begin selling Cobroxin, an over-the-counter (OTC) treatment for stage 2 (moderate to severe) chronic pain.

25 Aug 2009

Lpath achieves one of the four Phase 1 objectives by demonstrating its optimized fermentation process

Lpath, Inc., the category leader in lipidomics-based therapeutics, demonstrated commercially acceptable yields in its optimized fermentation process. In doing so, Lpath achieved one of four Phase 1 objectives established by Merck Serono, the exclusive worldwide licensee of ASONEP and Lpath's development partner, and will receive a milestone payment according to the terms of the Merck Serono license agreement.

25 Aug 2009

Pharmacy Times serves as a go-to resource for pharmacists on OTC products

Consumers overwhelmed by options when considering over-the-counter (OTC) medications can now find out which products are most recommended by pharmacists through Pharmacy & Healthcare Communications' OTC Recommendations Survey.

25 Aug 2009

FDA issues final approval for manufacturing and marketing Ranbaxy's Glycopyrrolate tablets

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Glycopyrrolate Tablets USP, 1 mg and 2 mg.

25 Aug 2009

Thyretain TSI Reporter BioAssay test for detecting auto-antibodies attains the FDA clearance

Diagnostic HYBRIDS announces the FDA clearance, for marketing under the 510(k) pre-notification process, of the Thyretain TSI Reporter BioAssay. Thyretain is an in vitro diagnostic use test that specifically detects auto-antibodies called thyroid stimulating immunoglobulins (TSI) in patient serum.

25 Aug 2009

Myoderm expands its portfolio to include drug procurement, management and distribution services

Myoderm, a leading global pharmaceutical supplier of comparator drugs for clinical research and clinical trials, has expanded its portfolio to include Distribution Management Services. This new capability provides their clients with an efficient solution for sourcing, managing, and distributing off-the-shelf, commercial drugs used in clinical trials.

25 Aug 2009

UCB and sanofi-aventis U.S. receive FDA's approval for XYZAL to treat allergies in children

UCB and sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved XYZAL(R) (levocetirizine dihydrochloride) for children age six months and older for the relief of symptoms of perennial allergic rhinitis (indoor allergies) and chronic idiopathic urticaria (chronic hives) and for children age two years and older for symptoms of seasonal allergic rhinitis (outdoor allergies).

25 Aug 2009

Pharmaceutical News

FDA accepts Labopharm's response for its novel trazodone formulation

Sabril (vigabatrin) Oral Solution receives approval from FDA

Glaxosmithkline affirms safety of Alli

FDA issues warning letters to eight companies for selling illegal OTC ibuprofen drugs

Gloucester Pharmaceuticals raises funds for the development of romidepsin

Profectus BioSciences to conduct proof-of-concept studies with its rVSV vector technology

Hiberix receives accelerated approval from FDA to overcome nationwide shortage

ParagonRx's CEO recommends techniques to effectively manage the FDA-mandated REMS program

Cytrx’s study offers a better perception of arimoclomol's mechanism of action in induced animal stroke

Bavarian Nordic begins negotiations with U.S. to secure a contract to develop a freeze-dried version of smallpox vaccine

FDA accepts for filing Salix Pharmaceuticals' NDA for rifaximin tablets

Portola Pharmaceuticals' investigational antiplatelet drug elinogrel featured at the ESC Congress 2009

Blue Spoon outlines a new strategy for pharmaceutical industries

Nutra Pharma submits final packaging and labeling for Cobroxin drug for FDA approval

Lpath achieves one of the four Phase 1 objectives by demonstrating its optimized fermentation process

Pharmacy Times serves as a go-to resource for pharmacists on OTC products

FDA issues final approval for manufacturing and marketing Ranbaxy's Glycopyrrolate tablets

Thyretain TSI Reporter BioAssay test for detecting auto-antibodies attains the FDA clearance

Myoderm expands its portfolio to include drug procurement, management and distribution services

UCB and sanofi-aventis U.S. receive FDA's approval for XYZAL to treat allergies in children

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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