Pharmaceuticals News and Research

RSS

Gingrich's health care consulting firm declares bankruptcy

GOP presidential hopeful Newt Gingrich's health care consulting company filed for bankruptcy Thursday. The Center for Health Transformation charged up to $200,000 annually to drugmakers, insurers and hospitals for Gingrich's advice and may have suffered after he stepped down to seek the GOP nomination for president, reports say.

7 Apr 2012

Premier, healthcare providers to create performance improvement collaboratives

The Premier healthcare alliance is working with hospitals, health systems and manufacturers to create performance improvement collaboratives that evaluate which clinical practices result in better outcomes while lowering costs.

7 Apr 2012

No one funding model is sufficient to ensure availability of life-saving drugs

"Trade deals are threatening generic drugs -- we need new ways to incentivize affordable drug development," Daniele Dionisio, head of the research project Geopolitics, Public Health and Access to Medicines (GESPAM) and a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases, writes in this SciDev.Net opinion piece.

7 Apr 2012

Par Pharmaceutical commences shipment of modafinil tablets

Par Pharmaceutical Companies, Inc. today announced that it began shipping all strengths of modafinil tablets, a generic version of Teva's Provigil brand.

7 Apr 2012

Teva's ANDA for Provigil entitled to 180-day exclusivity

Teva Pharmaceutical Industries Ltd. announces that the FDA has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil (modafinil) and therefore Teva's ANDA alone is entitled to 180-day exclusivity.

6 Apr 2012

First Edition: April 6, 2012

Today's early morning highlights from the major news organizations, including the Obama administration's response to a federal court about the Supreme Court's power.

6 Apr 2012

Poultry producers still use FDA-banned antibiotics

In a joint study, researchers at the Johns Hopkins Bloomberg School of Public Health and Arizona State University found evidence suggesting that a class of antibiotics previously banned by the U.S. government for poultry production is still in use. Results of the study were published March 21 in Environmental Science & Technology.

6 Apr 2012

Regeneron, Sanofi announce clinical and regulatory update for ZALTRAP

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review of the Biologics License Application (BLA) for the investigational agent ZALTRAP (aflibercept) concentrate for solution for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen.

6 Apr 2012

Longer looks: Berwick calls for leaders to rise above 'political catechism'; Convincing the healthy to feel sick

Between July 2010 and December 2011, Dr. Donald Berwick was head of the Centers for Medicare and Medicaid Services, the agency that runs the government's health insurance programs. In a sane world, he would be still. But Senate Republicans refused even to let his confirmation come up for a vote ... A pediatrician by training and a widely respected expert in health care policy, Berwick should have been a lock for the CMS job. But he was a backer of Obamacare; a believer in data and science; a proponent of universal health care.

6 Apr 2012

Viewpoints: Support for drug benefit merger; Health reform comes too slowly for some patients; Pinpointing Romney's views on mandate

It seems counterintuitive, but the Federal Trade Commission has just decided that a $29 billion merger of two of the three largest companies that manage pharmaceutical benefits for employers and health plans - Express Scripts and Medco Health Solutions - would not substantially lessen competition. That judgment deserves credence because of the thoroughness of the F.T.C.'s eight-month inquiry and the willingness of the agency to oppose other mergers when the evidence warrants.

6 Apr 2012

Tonix completes TNX-102 pharmacokinetic study on fibromyalgia syndrome

Tonix Pharmaceuticals Holding Corp., a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system completed a pharmacokinetic (PK) study of the first formulation of its lead drug, TNX-102, for the treatment of fibromyalgia syndrome.

6 Apr 2012

Sucampo announces positive results from lubiprostone phase 3 trial on OBD

Sucampo Pharmaceuticals, Inc. today announced positive top-line results from an open-label phase 3 clinical trial designed to evaluate the long-term safety and efficacy of lubiprostone in opioid-induced bowel dysfunction (OBD) patients with chronic, non-cancer-related pain.

6 Apr 2012

Spectrum’s apaziquone Phase 3 trials on bladder cancer do not meet primary endpoint

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the two double blind, randomized, placebo controlled, Phase 3 clinical trials for apaziquone did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms.

6 Apr 2012

TAM protein complex - a potential antibacterial target

Scientists could produce new antibacterial treatments by disarming the molecular pumps bacteria use to bring disease causing molecules in contact with animals and humans.

6 Apr 2012

Akebia completes AKB-6548 Phase 2 study for anemia in CKD patients

Akebia Therapeutics, Inc., a pharmaceutical discovery and development company focused on anemia and vascular disorders, today announced that it has successfully completed a randomized, double-blinded, placebo-controlled Phase 2 dose-ranging study of AKB-6548 in patients with stage 3 and 4 chronic kidney disease (CKD).

6 Apr 2012

African-Americans and Hispanics with MDD less likely to get antidepressants

African-Americans and Hispanics with major depressive disorder are less likely to get antidepressants than Caucasian patients, and Medicare and Medicaid patients are less likely to get the newest generation of antidepressants.

6 Apr 2012

Spectrum signs definitive agreement to acquire Allos

Spectrum Pharmaceuticals and Allos Therapeutics, Inc. today announced that they have signed a definitive agreement under which Spectrum will acquire all of the outstanding shares of Allos for $1.82 per share in cash plus one Contingent Value Right.

6 Apr 2012

Mylan seeks to overturn FDA decision on generic Provigil

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia seeking to overturn a decision by FDA, which awarded Teva sole 180-day exclusivity for the generic version of its affiliate Cephalon's Provigil.

6 Apr 2012

USPTO issues patent to ChromaDex’s pterostilbene

The U.S. Patent and Trademark Office has granted patent #8,133,917 pertaining to the ingredient pterostilbene, which is licensed exclusively to ChromaDex Corp., an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, cosmetic and pharmaceutical industries, and marketer of BluScience, its new line of dietary supplements.

6 Apr 2012

Opportunity for developers and marketers of EGFR inhibitors in Brazil and Mexico

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that patient access to premium-priced targeted cancer treatments in Brazil and Mexico is improving, creating an opportunity for developers and marketers of epidermal growth factor receptor (EGFR) inhibitors.

5 Apr 2012