Posts Tagged: "leukemia"

$1.5 billion Celator purchase buoys the financial future of Jazz Pharmaceuticals’ oncology division

Of particular interest in this deal is a drug in Celator’s pipeline is Vyxeos (cytarabine:daunorubicin), an injectable liposomal treatment for blood cancers, especially acute myeloid leukemia (AML). The treatment, which has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for fast-tracked approval, recently achieved positive results in a Phase 3 trial. Patients with high-risk, or secondary, AML who received Vyxeos injections saw a significant increase in overall survival rates, 41.5 percent for Vyxeos-treated patients versus 27.6 percent for other patients in a year’s time.

Bolder initiatives needed to take next steps in fight against cancer

February 4 is World Cancer Day… There has been steady progress made in the history of treating cancers of many types since the administration of former U.S President Richard Nixon, according to Dr. Boris Pasche, the Director of the Wake Forest Baptist Medical Center’s Comprehensive Cancer Center. “In my opinion, government should embark on bold new initiatives in cancer treatment,” Pasche said. He did note that, while what President Obama says as a statesman doesn’t change the humbling reality that many cancers have so far stumped medical scientists. Nevertheless, increased investments into cancer research have dramatically impacted survival rates. Over the past decade, most cancers show a better outcome than they did ten years ago. “Bolder initiatives with disruptive approaches to cancer are in order if we want to make leaps forward more quickly,” Pasche said.

Hybrigenics gets Orphan Drug designation for the treatment of Acute Myeloid Leukemia

Hybrigenics (ALHYG), a French bio-pharmaceutical company with a focus on research and development of new treatments against proliferative diseases, has announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to inecalcitol for the treatment of acute myeloid leukemia (AML) in the United States. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation allows the company receiving the designation to leverage a wide range of financial and regulatory benefits, including government and institutional grants, and waiver of FDA user fees for the potential submission of a New Drug Application.

Global IP Reaction to India’s Rejection of the Novartis Drug Patent

India’s booming $26 billion generic drug industry and public health sector rejoiced over the Indian Supreme Court’s recent decision to reject a patent filed by the Swiss pharmaceutical giant, Novartis for their landmark leukemia drug, Gleevec. Novartis received a patent for an earlier variation of Gleevec in 40 countries including Russia, China, and Taiwan. However, India’s troubled IP regime applies an ambiguous standard to patentability, the so-called “enhanced efficacy” for new forms of known substances. India only applies their “efficacy” requirement to the chemical and pharmaceutical drug industry as a protectionist measure. India codified the efficacy requirement in section 3(d) of their patent code and this may contravene with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) as set forth by the World Trade Organization (WTO).

St. Jude Children’s Research Hospital Gets Patent for Genetically Modified Human Immune Cells for Cancer Therapy

As the patent community waits to see whether the United States Supreme Court will deal a significant, perhaps fatal blow, to the patenting of many genetic related innovations in Association of Molecular Pathology v. Myriad Genetics, announcement came this morning of a newly issued U.S. patent. This patent was issued to St. Jude Children’s Research Hospital. The invention relates to compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults.

Patent Granted on Long-Acting Drug for Multiple Sclerosis

The conjugates covered by this patent could enable less frequent and better tolerated dosing of one of the most widely used treatments worldwide for relapsing-remitting multiple sclerosis, interferon-beta-1b. The invention described in the European Patent relates to methods for the preparation of conjugates of poly(ethylene glycol), and derivatives thereof, with interferon-beta-1b. Compared to the corresponding unconjugated bioactive components, the conjugates of the invention have increased stability (i.e., longer shelf life and longer half-lives in vivo). In addition, compared to conjugates of the same bioactive component prepared with polymer chains that are attached randomly to solvent-accessible sites along the polypeptide chains, the conjugates of the invention have increased receptor-binding activity and increased potency.

US Oncologists Report Crucial Cancer Drug Shortages

The mantra of the anti-patent community is nearly in unison on the issue of patented drugs. Of course, everyone wants drugs to be developed, but no one wants to pay the exorbitant prices charged for blockbuster, patented drugs. You can add me to that list of individuals who doesn’t like the prices, but at least there is a benefit. Without appropriate financial incentives in place drugs would not be patented, but then again they wouldn’t be developed either. But what is the justification for scarcity and exorbitant prices of old drugs that are off patent?