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Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

19 Oct 2009

FDA approves continuation of the fourth 6-month open label extension of PRX-03140

The FDA has approved a Physician-Sponsored IND and continuation of the fourth 6-month open label extension of PRX-03140, a novel 5HT4 partial agonist for the potential treatment of Alzheimer's Disease. The patient was enrolled initially in a two week Phase 2a study in August 2007 where she received 100 mg per day of PRX-03140 in combination with her normal daily dose of Aricept(10 mg).

19 Oct 2009

Antibiotic resistance to be undesirable consequence of antibiotic abuse is inaccurate, reveals report

The perception that antibiotic resistance is primarily the undesirable consequence of antibiotic abuse or misuse is a view that is simplistic and inaccurate, according to a recent report by the American Academy of Microbiology. The reasons behind the spread of resistance are much more complex, including appropriate antibiotic use, lack of proper sanitation and hygiene, and even the environment.

19 Oct 2009

Government closely monitors swine flu vaccine

The government is closely monitoring the safety of the new H1N1 swine flu vaccine amid people's concerns.

19 Oct 2009

Novel HIV drug to be studied in cell cultures and patients

A $6 million, five-year federal grant to The Children's Hospital of Philadelphia Research Institute will enable researchers to investigate a novel approach in treating HIV infection---a unique class of drugs focused on developing therapies for psychological and neurological effects in AIDS.

19 Oct 2009

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Biogen Idec and Biovitrum AB (STO: BVT) today announced that they plan to advance the companies’ long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B patients.

19 Oct 2009

Exposure to online media increases treatment's awareness and favorability: Study

comScore, Inc. (Nasdaq: SCOR), a leader in measuring the digital world, today released results from its third annual study Online Marketing Effectiveness Benchmarks for the Pharmaceutical Industry, which found that exposure to online media, including a brand's website and online ads, had a significant positive lift on a treatment's awareness and favorability.

19 Oct 2009

Aurora Visiting Nurse Association to suspend its seasonal flu vaccination clinics

Delays in shipments from vaccine manufacturers will force the Aurora Visiting Nurse Association of Wisconsin to suspend its seasonal flu vaccination clinics throughout eastern Wisconsin.

19 Oct 2009

PHARMACIA & UPJOHN COMPANY to pay the largest criminal fine ever imposed in the U.S.

PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer Inc. ("Pfizer") today was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead.

19 Oct 2009

Ruthenium and Osmium compounds show high levels of activity against ovarian cancer

Drugs made using unusual metals could form an effective treatment against colon and ovarian cancer, including cancerous cells that have developed immunity to other drugs, according to research at the University of Warwick and the University of Leeds.

19 Oct 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009

FDA approves Gardasil vaccine usage in boys and men for preventing genital warts

The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

19 Oct 2009

Pfizer acquires Wyeth; begins joint operations

Pfizer and Wyeth announced today that Pfizer has completed its acquisition of Wyeth following the receipt of regulatory approval from all government authorities required by the merger agreement and approval by Wyeth shareholders.

19 Oct 2009

Rituxan drug effective for treating ANCA-associated vasculitis

Researchers have identified that Rituxan, a drug previously approved for the treatment of non-Hodgkin's B cell lymphoma and rheumatoid arthritis, can treat severe ANCA-associated vasculitis as effectively as cyclophosphamide, the current standard therapy.

19 Oct 2009

Recently approved Gleevec drug for cancer treatment

Investigators have identified a drug that is currently approved to treat certain types of cancer, Gleevec, that could provide the first treatment for scleroderma, a chronic connective tissue disease for which a treatment has remained elusive. The news will be presented at the annual meeting of the American College of Rheumatology on October 18 in Philadelphia.

19 Oct 2009

Findings may yield new treatments for COPD

A genetic mutation found in four children born with multiple abnormalities may provide insight into potential treatments for newborn lung distress and chronic obstructive pulmonary disease (COPD).

19 Oct 2009

CK Life Sciences acquires additional voting shares of WEX Pharmaceuticals

CK Life Sciences Int'l., (Holdings) Inc. ("CKLS") of Hong Kong (Hong Kong Stock Exchange Limited Stock Code 0775) and WEX Pharmaceuticals Inc. ("WEX" or the "Company") (TSX:WXI) announced today that CKLS has acquired an additional 116,852,062 restricted voting shares of WEX to bring its holding to 133,179,334 restricted voting shares, or 75.25% of the total outstanding restricted voting shares.

19 Oct 2009

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

19 Oct 2009

Multi-million dollar cooperative agreement for SMA drug development program

Paratek Pharmaceuticals (Boston, MA) and Families of Spinal Muscular Atrophy (Elk Grove Village, IL) announced today that a jointly funded drug development program for Spinal Muscular Atrophy (SMA) has been awarded a multi-million dollar cooperative agreement from the National Institute of Neurological Disorders and Stroke (NINDS).

19 Oct 2009

FDA approves 100th antiretroviral for PEPFAR

HHS recently announced the FDA's 100th approval of an antiretroviral drug for PEPFAR, PharmTech.com reports. Seventy-one of the more than 100 drugs reviewed by FDA for PEPFAR were generic products.

19 Oct 2009

Pharmaceutical News

Rituxan's sBLA receives a Complete Response from the FDA

FDA approves continuation of the fourth 6-month open label extension of PRX-03140

Antibiotic resistance to be undesirable consequence of antibiotic abuse is inaccurate, reveals report

Government closely monitors swine flu vaccine

Novel HIV drug to be studied in cell cultures and patients

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Exposure to online media increases treatment's awareness and favorability: Study

Aurora Visiting Nurse Association to suspend its seasonal flu vaccination clinics

PHARMACIA & UPJOHN COMPANY to pay the largest criminal fine ever imposed in the U.S.

Ruthenium and Osmium compounds show high levels of activity against ovarian cancer

FDA grants marketing approval for Elitek

FDA approves Gardasil vaccine usage in boys and men for preventing genital warts

Pfizer acquires Wyeth; begins joint operations

Rituxan drug effective for treating ANCA-associated vasculitis

Recently approved Gleevec drug for cancer treatment

Findings may yield new treatments for COPD

CK Life Sciences acquires additional voting shares of WEX Pharmaceuticals

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

Multi-million dollar cooperative agreement for SMA drug development program

FDA approves 100th antiretroviral for PEPFAR

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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