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FDA grants BioSante Orphan Drug designation for Melanoma Cancer Vaccine

BioSante Pharmaceuticals, Inc. today announced the receipt of Orphan Drug designation for its Melanoma Cancer Vaccine in the treatment of stage IIb to IV melanoma, from the FDA's Office of Orphan Products Development. Melanoma is the most deadly form of skin cancer.

25 Jan 2011

First Edition: January 25, 2011

Today's health policy headlines include speculation about what President Barack Obama will say during tonight's State of The Union address and how the GOP will respond to it.

25 Jan 2011

Regulatory changes needed to protect public health from exposure to toxicants

Americans are exposed to hundreds, if not thousands, of suspected toxic substances every day, substances that affect the development and function of the brain, immune system, reproductive organs or hormones. Children are the most vulnerable. But no public health law requires product testing of most chemical compounds before they enter the marketplace.

25 Jan 2011

Sanofi-aventis acquires world-wide license for ADC products

Oxford BioTherapeutics today announces that sanofi-aventis has acquired an exclusive world-wide license to one of OBT's internal preclinical antibody programs.

25 Jan 2011

Male celebrities admit to undergoing hair restoration surgery

An interesting statistic: more than half of hair loss sufferers would be more inclined to consider having a hair transplant if celebrities or public figures were more open about hair restoration surgery, and men are more likely to be influenced than women.

25 Jan 2011

RRD enters partnership with NIH Therapeutics for Rare and Neglected Diseases program

RRD International, a strategy-driven biotech and pharmaceutical product development company, announced today that it has entered into a partnership with the National Institutes of Health (NIH) Therapeutics for Rare and Neglected Diseases (TRND) program as a regulatory support and development partner.

25 Jan 2011

Fixed Phage to develop products based on Strathclyde's technology for tackling infections

A new company has been launched to commercialise an award-winning technology, developed at the University of Strathclyde in Glasgow, for tackling bacterial infection and contamination, including superbugs such as MRSA.

25 Jan 2011

FDA approves Matrix's generic Protonix DR Tablets ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-release (DR) Tablets USP, 20 mg (base) and 40 mg (base), the generic version of Wyeth's Protonix® DR Tablets, a treatment for the irritation of the esophagus caused by gastroesophageal reflux disease (GERD).

25 Jan 2011

FedEx launches Deep Frozen Shipping Solution for temperature-sensitive healthcare products

FedEx Corp. today announced the launch of FedEx Deep Frozen Shipping Solution, which offers an innovative end-to-end service for the shipping of temperature-sensitive healthcare products around the world.

24 Jan 2011

BMJ News examines ongoing investigation of WHO's handling of H1N1

BMJ News reports on the ongoing external investigation of the WHO's handling of the 2009 H1N1 (swine flu) pandemic, following recent statements to the WHO's executive board meeting by review committee chairman, Harvey Fineberg.

24 Jan 2011

PediatRx announces first-ever revenues and successful launch of GRANISOL

PediatRx Inc.is pleased to provide an update on activities for the fiscal third quarter. Among its achievements, the hospital specialty pharmaceutical company reported its first-ever revenues and successfully launched GRANISOL™, the company's first commercial entry.

24 Jan 2011

Digital Assent closes $2 million Series A equity financing round

Atlanta-based Digital Assent, provider of the PatientPad self-service patient check-in and patient education solution, announces the closing of a $2 million Series A round of equity financing led by Imlay Investments, Fulcrum Equity Partners and BLH Venture Partners.

24 Jan 2011

Furiex's MuDelta for diarrhea-predominant irritable bowel syndrome receives FDA Fast Track designation

Furiex Pharmaceuticals, Inc. today announced that its novel diarrhea-predominant irritable bowel syndrome treatment called MuDelta, now in Phase II clinical trials, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

24 Jan 2011

Viewpoints: Reps. Ryan, kind on repeal; Opinions on what's next for health reform

The health-care law enacted by the last Congress is enormous—more than 2,000 pages—and full of provisions that will expand government control of health care and limit what individuals and employers can do. ... in the end the Senate, House, and White House will have to come together and agree on some health-care changes.

24 Jan 2011

Threshold reports positive results from TH-302 Phase 1/2 clinical trial in pancreatic cancer

Threshold Pharmaceuticals, Inc. today announced updated Phase 1/2 clinical trial results related to the Company's clinical stage hypoxia-activated prodrug, TH-302. The results were presented at the ASCO Gastro Intestinal Cancers Symposium that took place in San Francisco from January 20-22, 2011.

24 Jan 2011

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Alexza Pharmaceuticals, Inc. announced today that the British Journal of Psychiatry, a publication of the Royal College of Psychiatrists, has published the results of the pivotal Phase 3 study evaluating AZ-004 (inhaled or Staccato® loxapine) for the rapid treatment of agitation in patients with schizophrenia, in its January 2011 edition (198:51-58).

24 Jan 2011

FDA accepts Optimer's fidaxomicin NDA for filing

Optimer Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI.

24 Jan 2011

Spectrum submits Post Approval Supplement for removal of bioscan requirement for Indium-111 ZEVALIN

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Thursday, January 20, 2011, it submitted a Post Approval Supplement containing data supporting the removal of the Indium-111 ZEVALIN® pre-treatment imaging evaluation, more commonly referred to as the "bioscan" requirement.

24 Jan 2011

Raptor completes enrollment in DR Cysteamine Phase 3 clinical trial in cystinosis

Raptor Pharmaceutical Corp., today announced it has completed enrollment in its Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

24 Jan 2011

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

Immune Network, a company in the business of development and commercialization of immune therapies, announced today that its newly acquired business, Immunitor, has published interim data from the ongoing Phase IIb imm01 clinical trial of V5 in tuberculosis conducted at its second site in Ukraine.

24 Jan 2011

Pharmaceuticals News and Research

FDA grants BioSante Orphan Drug designation for Melanoma Cancer Vaccine

First Edition: January 25, 2011

Regulatory changes needed to protect public health from exposure to toxicants

Sanofi-aventis acquires world-wide license for ADC products

Male celebrities admit to undergoing hair restoration surgery

RRD enters partnership with NIH Therapeutics for Rare and Neglected Diseases program

Fixed Phage to develop products based on Strathclyde's technology for tackling infections

FDA approves Matrix's generic Protonix DR Tablets ANDA

FedEx launches Deep Frozen Shipping Solution for temperature-sensitive healthcare products

BMJ News examines ongoing investigation of WHO's handling of H1N1

PediatRx announces first-ever revenues and successful launch of GRANISOL

Digital Assent closes $2 million Series A equity financing round

Furiex's MuDelta for diarrhea-predominant irritable bowel syndrome receives FDA Fast Track designation

Viewpoints: Reps. Ryan, kind on repeal; Opinions on what's next for health reform

Threshold reports positive results from TH-302 Phase 1/2 clinical trial in pancreatic cancer

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

FDA accepts Optimer's fidaxomicin NDA for filing

Spectrum submits Post Approval Supplement for removal of bioscan requirement for Indium-111 ZEVALIN

Raptor completes enrollment in DR Cysteamine Phase 3 clinical trial in cystinosis

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

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