Roche reports positive Phase II results for experimental eye drug

30 08 2013

New Drug Approvals


Roche reports positive Phase II results for experimental eye drug
Lampalizumab, an experimental eye drug from Roche, has helped slow down the progression of an advanced form of age-related macular degeneration (AMD) in a Phase II study, the company announced this week.



Lampalizumab effective in Phase II clinical trial for macular degeneration

Roche’s new drug for age-related macular degeneration, lampalizumab, showed effective in slowing the progression of AMD in patients with advanced disease, shrinking the area of geographic atrophy by 20%. Read More >>


Lampalizumab (INN) is a humanized monoclonal antibody designed for the treatment of geographic atrophy secondary to age-related macular degeneration. It binds to CFD.[1][2]

This drug was developed by Genentech/Roche.


  1. ^World Health Organization (2012). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 107” (PDF). WHO Drug…

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FDA grants priority review to Pharmacyclics drug

30 08 2013

New Drug Approvals


FDA grants priority review to Pharmacyclics drug

Pharmacyclics is getting a priority review of its blood cancer treatment by federal regulators. A priority review shortens a drug evaluation by the U.S. Food and Drug Administration from 10 months to six. The acceptance of the application triggers a $75 million milestone payment to Pharmacyclics from Johnson & Johnson’s Janssen unit.

Ibrutinib (USAN[1]), also known as PCI-32765, is an experimental drug candidate for the treatment of various types of cancer. It is an orally-administered, selective and covalent inhibitor of the enzyme Bruton tyrosine kinase (Btk).[2][3][4] Ibrutinib is currently under development by Pharmacyclics, Inc and Johnson & Johnson’s Janssen Pharmaceutical division for B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, diffuse large B-cell lymphoma, and multiple myeloma.[6][7][8]. Ibrutinib was first designed and synthesized at Celera Genomics by Zhengying Pan, who along with a team of chemists and…

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Breakthrough Therapy Designation for Firdapse to treat Lambert-Eaton Myasthenic Syndrome (LEMS)

28 08 2013

TGI: Thrive Health

Recently, Catalyst Pharmaceutical Partners Received Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS.

Company announced that its investigational product Firdapse(TM) (amifampridine phosphate) has received “Breakthrough Therapy Designation” by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse(TM) is Catalyst’s investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.

“We are very pleased to have received Breakthrough Therapy Designation for Firdapse(TM) and we are excited by the FDA’s decision to place our product in a category that may enable expedited development and review for patients with LEMS,” said Patrick McEnany, President and Chief Executive Officer of Catalyst. “With no approved or effective symptomatic treatment currently available for LEMS, Firdapse(TM) has the potential to be the first-line treatment option for patients with this rare condition.”

Breakthrough Therapy…

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Clinical trial design and clinical trial site selection considerations

28 08 2013

April 26, 2013 | By Márcio Barra


When planning a clinical trial, the question that the sponsor wishes to address is the starting point, and where the rest of the trial planning hangs. While the objective of the trial is often obvious to the investigator designing the trial, the question itself can be phrased poorly. Thus, writing a scientific, clear research question is a most valuable action when starting and establishing the study (1).

After coming up with a sound research question, the study design has to be elected. This choice is deeply connected with the desired information that the sponsor wishes to obtain regarding the drug product.

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Tests Find Cancer-Causing Chemical In 98 Personal Care Products

27 08 2013

Amgen buys Onyx for for $10.4 billion, acquires the drug Krypolis

27 08 2013

August 26, 2013 | By Márcio Barra

Amgen has announced today that it has agreed to buy Onyx Pharmaceuticals for $10.4 billion, giving Amgen, the largest biotechnology company by sales, access to a new blood cancer drug, Onyx’s Kyprolis. In an all-cash takeover, Amgen is to pay $125 a share for Onyx’s outstanding stock, with the acquisition expected to close at the beginning of the fourth quarter.

Krypolis (Carfilzomib), from Kypolis is an injectable tetrapeptide epoxyketone and a selective proteasome inhibitor, approved by the FDA on 20 July 2012 to treat patients with multiple myeloma, the second most commonly diagnosed blood cancer, who have received at least two prior therapies, including Velcade (bortezomib) and an immunomodulatory therapy.

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26 08 2013

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