Pharmaceutical News

RSS

ZEVALIN treatment for Non-Hodgkin lymphoma becomes simpler with removal of bioscan requirement

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, received approval from the U.S. Food and Drug Administration (FDA) on November 18, 2011 to remove the pre-treatment biodistribution evaluation requirement using Indium-111 ZEVALIN imaging dose followed by a gamma scan before administering the ZEVALIN therapeutic dose.

21 Nov 2011

ICON selected as CRO for Tasly's Dantonic pill global Phase III studies for chronic stable angina pectoris

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been selected by Tasly Pharmaceuticals for the company's global Phase III T89 trial. T89, also known as Dantonic pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States.

21 Nov 2011

Almac collaborates with Alexion for packaging and distribution of Soliris during German E. coli outbreak

Almac, a leading provider of contract services to the global pharmaceutical and biotech industries, responded earlier this year to an urgent request from their client partner, Alexion Pharmaceuticals, Inc., a global biotechnology company, for packaging and distribution of Soliris (eculizumab) for patients with STEC-HUS during the E. coli outbreak in Germany earlier this year.

21 Nov 2011

Avidocin protein could prevent or treat E. coli O157:H7-induced diarrhea

A novel antibacterial protein targeted against E. coli O157:H7 may offer a way to prevent or treat serious food-borne bacterial infections, as demonstrated in a study published in the December issue of Antimicrobial Agents and Chemotherapy.

21 Nov 2011

Switching or adding antidepressants does not exacerbate side effects

Patients with major depression who fail to see improvement after taking an antidepressant often have their initial medication switched or combined with a second drug. Many clinicians weigh the possibility of adverse side effects when deciding between strategies. New research in the latest issue of General Hospital Psychiatry now suggests one strategy may not be any more likely to be harmful than the other.

19 Nov 2011

Omega-3 linked with reduced joint pain and cognitive side effects of breast cancer therapy

"I know I need this medicine to help lower my chance of cancer recurrence, but it makes my joints ache and stiff. It makes me feel old and I am not sure I can take this medication much longer."

19 Nov 2011

New class of malaria drugs could be used as both prevention, treatment, study shows

"A group of researchers led by Novartis AG have discovered novel malaria compounds that may prove to be more efficient than currently available treatments and could be used as a prophylactic," the Wall Street Journal reports.

19 Nov 2011

Avastin drug not safe and effective for breast cancer patients: FDA Commissioner

FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency's approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

19 Nov 2011

FDA approves EUSA's orphan drug ERWINAZE for acute lymphoblastic leukemia

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that the US Food and Drug Administration (FDA) has approved its orphan drug ERWINAZE (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase.

19 Nov 2011

Shire, Shionogi enter agreement to co-develop and co-commercialize ADHD medicines in Japan

Shire plc, the global specialty biopharmaceutical company, announces that it has entered into an agreement with Shionogi & Co. Ltd. of Japan to co-develop and co-commercialize certain of Shire's Attention Deficit Hyperactivity Disorder (ADHD) medicines in Japan.

19 Nov 2011

FAMEDS founder condemns FDA decision on Avastin for metastatic breast cancer

Breast cancer patients, their families and advocates expressed extreme disappointment at today's Food and Drug Administration (FDA) decision to remove the anti-cancer drug Avastin from the approved medication list for treatment of late stage breast cancer.

19 Nov 2011

FDA revokes approval of Avastin for breast cancer

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling in an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.

19 Nov 2011

FDA approves EYLEA for treatment of wet Age-related Macular Degeneration

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams every four weeks for the first 12 weeks, followed by 2 mg every eight weeks.

19 Nov 2011

Regeneron receives FDA approval for Eylea to treat wet AMD

The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.

18 Nov 2011

EUSA Pharma receives FDA approval for Erwinaze to treat ALL

The U.S. Food and Drug Administration today approved Erwinaze to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

18 Nov 2011

H2S plays a major role in protecting bacteria from effects of different antibiotics

Although scientists have known for centuries that many bacteria produce hydrogen sulfide (H2S) it was thought to be simply a toxic by-product of cellular activity. Now, researchers at NYU School of Medicine have discovered H2S in fact plays a major role in protecting bacteria from the effects of numerous different antibiotics.

18 Nov 2011

Multi-drug resistant bacteria widespread in Europe, report says

Multi-drug resistant bacteria "are increasing their grip in Europe with rates of drug resistance in one type of bacteria reaching 50 percent in the worst-hit countries, health officials said Thursday," Reuters reports.

18 Nov 2011

VSL#3 classified as refrigerated medical food for three GI conditions

As clinical studies continue to validate the use of probiotics to help promote general gastrointestinal health, a growing U.S. market for probiotics indicates that the U.S. healthcare community and consumers alike are recognizing the value of these beneficial microorganisms. However, because most probiotics are classified as dietary supplements, directing patients to the best probiotic for their individual needs can be challenging.

18 Nov 2011

IDSA supports 'Get Smart About Antibiotics Week'

With antibiotic-resistant infections increasingly common, and a dangerous lack of new infection fighters in the drug development pipeline, it's more important than ever to use existing antibiotics appropriately. This week, infectious disease experts are helping to educate consumers, health care providers, and policymakers about when antibiotics can help, when misuse of these lifesaving drugs can do more harm than good, and the tremendous need for new antibiotics to protect patients.

18 Nov 2011

South African public health experts urge countries to use TRIPS to produce generic drugs, IPS reports

South African public health experts from Medecins San Frontieres (MSF) South Africa and the Treatment Action Campaign (TAC) "are calling on governments to use legally available mechanisms to promote the production or import of generic drugs in their countries," Inter Press Service reports.

18 Nov 2011

Pharmaceutical News

ZEVALIN treatment for Non-Hodgkin lymphoma becomes simpler with removal of bioscan requirement

ICON selected as CRO for Tasly's Dantonic pill global Phase III studies for chronic stable angina pectoris

Almac collaborates with Alexion for packaging and distribution of Soliris during German E. coli outbreak

Avidocin protein could prevent or treat E. coli O157:H7-induced diarrhea

Switching or adding antidepressants does not exacerbate side effects

Omega-3 linked with reduced joint pain and cognitive side effects of breast cancer therapy

New class of malaria drugs could be used as both prevention, treatment, study shows

Avastin drug not safe and effective for breast cancer patients: FDA Commissioner

FDA approves EUSA's orphan drug ERWINAZE for acute lymphoblastic leukemia

Shire, Shionogi enter agreement to co-develop and co-commercialize ADHD medicines in Japan

FAMEDS founder condemns FDA decision on Avastin for metastatic breast cancer

FDA revokes approval of Avastin for breast cancer

FDA approves EYLEA for treatment of wet Age-related Macular Degeneration

Regeneron receives FDA approval for Eylea to treat wet AMD

EUSA Pharma receives FDA approval for Erwinaze to treat ALL

H2S plays a major role in protecting bacteria from effects of different antibiotics

Multi-drug resistant bacteria widespread in Europe, report says

VSL#3 classified as refrigerated medical food for three GI conditions

IDSA supports 'Get Smart About Antibiotics Week'

South African public health experts urge countries to use TRIPS to produce generic drugs, IPS reports

Exploring the nanoscale: How AFM is transforming cosmetic science

Innovating Texture and Culture in Plant-Based Foods

Advancing brain microphysiological systems (bMPS)

Latest News