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BioDiem presents positive findings of their eye disease drug at international conference

Australian infectious disease therapy and vaccine development company BioDiem Ltd (ASX: BDM) today announced positive results from formal studies of its BDM-E eye disease drug, presented over 21 – 22 July at the International Society for Eye Research (ISER) meeting in Berlin, Germany. The ISER convenes leading researchers and clinicians in the area of eye disease.

22 Jul 2012

Kyprolis for multiple myeloma receives FDA approval under accelerated approval program

The U.S. Food and Drug Administration today approved Kyprolis (carfilzomib) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy. A form of blood cancer that arises from plasma cells, multiple myeloma usually grows in bone marrow, the soft, spongy tissue found inside most bones.

21 Jul 2012

FDA's approval of Kyprolis offers hope to myeloma patients, says IMF

The International Myeloma Foundation (IMF) - the oldest and largest foundation dedicated to improving the life and care of myeloma patients - says today's Food and Drug Administration approval of Onyx's Kyprolis (carfilzomib) offers hope to myeloma patients who have run out of options when available therapies have stopped working.

21 Jul 2012

When checks and balances in the pharmaceutical marketplace fall short

The Washington Post explores how a trio of very expensive anemia drugs became "superstars" in the marketplace. Also, The Wall Street Journal tracks the process by which certain fake cancer drugs found their way into the United States.

21 Jul 2012

Janssen-Cilag receives positive opinion from EMA CHMP for DACOGEN

Janssen-Cilag International NV announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of DACOGEN (decitabine) for Injection.

21 Jul 2012

Researchers discover reason why breast cancer cells become drug resistant

Breast cancer treatments such as Herceptin that target a marker called HER2 have dramatically improved outcomes for women with this type of cancer. But nearly half of these cancers are resistant to Herceptin from the start and almost all of them will eventually become resistant.

21 Jul 2012

Pfizer receives positive opinion from EMA CHMP for crizotinib to treat ALK-positive NSCLC

Pfizer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that crizotinib be granted conditional marketing authorization in the European Union (EU), for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

21 Jul 2012

New WHO guidance recommends use of ARVs for HIV prevention

WHO has issued its first guidance to countries that are considering offering HIV medications, known as antiretrovirals (ARVs), to protect people who do not have the virus but who are at high risk of HIV infection.

21 Jul 2012

Marshall University faculty member receives $426,000 NIH grant for lung cancer study

A Marshall University faculty member has been awarded a three-year, $426,000 grant by the National Institutes of Health (NIH) to further her lung cancer research.

21 Jul 2012

Cipla, DNDi to develop ARV combination therapy for children with HIV/AIDS

On the eve of the XIX International AIDS Conference in Washington, DC, the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, announces a new collaboration with Indian drug manufacturer Cipla to develop and produce an improved first-line antiretroviral (ARV) combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV/AIDS.

21 Jul 2012

FDA grants accelerated approval to Onyx's Kyprolis for treatment of multiple myeloma

Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Kyprolis (carfilzomib) for Injection, a proteasome inhibitor, indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

21 Jul 2012

uniQure receives positive recommendation from EMA CHMP for Glybera

uniQure announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion that recommends marketing authorization of Glybera (alipogene tiparvovec) as a treatment for lipoprotein lipase deficiency (LPLD) under exceptional circumstances.

21 Jul 2012

Onyx receives FDA approval for Kyprolis to treat multiple myeloma

The Multiple Myeloma Research Foundation (MMRF) today announced that its partner, Onyx Pharmaceuticals, Inc., received U.S. Food and Drug Administration (FDA) approval for Kyprolis (carfilzomib) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including Velcade (bortezomib) for Injection and an immunomodulatory agent, such as Thalomid (thalidomide) or Revlimid (lenalidomide), and have demonstrated disease progression on or within 60 days of completion of the last therapy.

21 Jul 2012

Novartis receives FDA approval for Afinitor to treat HER2-negative breast cancer

The U.S. Food and Drug Administration today approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

21 Jul 2012

New class of chemically produced antimicrobial agents could become future infection treatment alternative

The World Health Organization (WHO) has named antimicrobial resistance one of the most important threats to human health. We therefore need to find new compounds that can be used as future alternatives to conventional antibiotics.

20 Jul 2012

UNAIDS releases report highlighting gains, gaps in global HIV/AIDS response

Ahead of the XIX International AIDS Conference next week, UNAIDS on Wednesday launched a new report, titled "Together we will end AIDS", "that shows that a record eight million people are now receiving antiretroviral therapy [ARVs], and that domestic funding for HIV has exceeded global investments," the U.N. News Centre reports.

20 Jul 2012

ARV drug resistance levels steady in low-, middle-income countries, WHO report says

More widespread use of antiretroviral drugs (ARVs) to treat HIV infection has led to drug resistance in low- and middle-income countries, but the level "is not steep enough to cause alarm, said a survey released by the World Health Organization on Wednesday," Agence France-Presse reports.

20 Jul 2012

Top 5 Pharma selects Certara’s PKS Online for PK/PD analysis

Certara, a leading provider of scientific software and consulting services to improve productivity and decision-making from drug discovery through drug development, announced that a Top 5 Pharma selected PKS Online as the platform of choice to support their regulatory compliant NCA analysis for clinical pharmacology.

20 Jul 2012

Novation, UPPI partner to offer both low and high PET radiopharmaceuticals

United Pharmacy Partners (UPPI) is pleased to announce the signing of a 5-year agreement with Novation, a leading health care supply chain expertise and contracting company, to offer both low and high (PET) radiopharmaceuticals.

20 Jul 2012

Vitamin D may modify damaging effects of smoking on lung function

Vitamin D deficiency is associated with worse lung function and more rapid decline in lung function over time in smokers, suggesting that vitamin D may have a protective effect against the effects of smoking on lung function, according to a new study from researchers in Boston.

20 Jul 2012

Pharmaceutical News

BioDiem presents positive findings of their eye disease drug at international conference

Kyprolis for multiple myeloma receives FDA approval under accelerated approval program

FDA's approval of Kyprolis offers hope to myeloma patients, says IMF

When checks and balances in the pharmaceutical marketplace fall short

Janssen-Cilag receives positive opinion from EMA CHMP for DACOGEN

Researchers discover reason why breast cancer cells become drug resistant

Pfizer receives positive opinion from EMA CHMP for crizotinib to treat ALK-positive NSCLC

New WHO guidance recommends use of ARVs for HIV prevention

Marshall University faculty member receives $426,000 NIH grant for lung cancer study

Cipla, DNDi to develop ARV combination therapy for children with HIV/AIDS

FDA grants accelerated approval to Onyx's Kyprolis for treatment of multiple myeloma

uniQure receives positive recommendation from EMA CHMP for Glybera

Onyx receives FDA approval for Kyprolis to treat multiple myeloma

Novartis receives FDA approval for Afinitor to treat HER2-negative breast cancer

New class of chemically produced antimicrobial agents could become future infection treatment alternative

UNAIDS releases report highlighting gains, gaps in global HIV/AIDS response

ARV drug resistance levels steady in low-, middle-income countries, WHO report says

Top 5 Pharma selects Certara’s PKS Online for PK/PD analysis

Novation, UPPI partner to offer both low and high PET radiopharmaceuticals

Vitamin D may modify damaging effects of smoking on lung function

Exploring the nanoscale: How AFM is transforming cosmetic science

Innovating Texture and Culture in Plant-Based Foods

Advancing brain microphysiological systems (bMPS)

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