Monthly Archives: April 2013

April 30, 2013 | By Márcio Barra

The US subsidiary of Novartis has been hit with two lawsuits filed by the federal government of the US, the first one early last week and the second last Friday for a series of alleged infractions, including paying kickbacks (incentives) to pharmacies and physicians  for prescribing the company’s medication in place of others.

The first lawsuit saw Novartis being accused by the US Government of fraud against the Medicare and Medicaid programs, where at least twenty pharmacies were paid for switching patients over to Novartis’ immunosuppressant drug Myfortic.

Read More

April 29, 2013 | By Márcio Barra

EMA’s CHMP 22-25 April 2013 meeting occurred last week, with 5 new drugs attaining marketing authorization (MA) and 2 new generics MAs approved. Here is the rundown of approvals and refusals:

Approved marketing authorizations for new drugs

Erivedge (vismodegib), Roche Registration Ltd –An oral, small-molecule antineoplastic agent that acts by blocking specific genes involved in proliferation, survival, and differentiation of cells.It is intended for the treatment of adult patients with symptomatic metastatic basal cell carcinoma. The recommendation is conditional, as further data is still needed. A pregnancy prevention plan will be implemented alongside the pharmacovigilance plan, as Erivedge can cause embryo-fetal death or severe birth defects.

Read More

April 27, 2013 | By Márcio Barra


The clinical development plan is a complex document that entails the entire clinical research strategy of a drug, describing the clinical studies that will be carried out for a pharmaceutical entity, created by a pharmaceutical company. The CDP is founded on the information of the Target product Profile (TPP), which states the goals for the drug product, estimates the net value and forms the basis for the go/ no go criteria.  The CDP presents how will the pharmaceutical company reach the criteria stated in the TPP  (1, 2).

The plan itself is absolutely crucial to the success and unbiased assessment of a potential pharmaceutical entity. Clinical trial projects are typically extensive, complex and expensive endeavors, and the CDP’s elements help by setting up beforehand what will the company plans to do in order to (3, 4):

Read More

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.

Read More

April 24, 2013 | By Márcio Barra

NICE, the UK price regulatory agency, gave today a final positive evaluation for two drugs, InterMune’s Esbriet for people who have chronic lung condition idiopathic pulmonary fibrosis, and Novartis’ asthma drug Xolair, in two guidances published today.

Esbriet (pirfenidone) is an oral antifibrotic drug that slows down the irreversible scarring damage that idiophatic pulmonary fibrosis causes in lung tissues. Pirfenidone is recommended for people with idiophatic pulmonary fibrosis who have a forced vital capacity – FVC, the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible – between 50% and 80%.

Read More

April 22, 2013 | By Márcio Barra

The FDA approved last friday Simbrinza, from Novartis eye care division Alcon, for glaucoma treatment.

Simbrinza’s indication is for the reduction of elevated intraocular pressure in patients with primary open – angle galucome or ocular hypertension, where the optic nerve is damaged slowly and gradually until patients lose vision. Elevated intraocular pressure is the only modifiable risk factor for glaucoma, which affects more than 67 million people worldwide and is the second-leading cause of preventable blindness.

This drug is a combination of brinzolamide – a carbonic anhydrase inhibitor which inhibits the carbonic anhydrase in the ciliary processes of the eye, decreasing aqueous humor secretion and thus lowering the intraocular pressure – and brimonidine, an α2 adrenergic agonist which decreases the synthesis of aqueous humor. It’s the only fixed-dose combination therapy for glaucoma in the US without a beta blocker. Patients have to administer one drop of Simbrinza into the affected eye(s) three times per day.

In Phase III clinical studies, Simbrinza showed that this combination is more effective that either of the two agents taken alone, decreasing elevated IOP by 21- 35%.  By combining these two agents in a single bottle, it helps to reduce the medication burden for glaucoma patients. The most frequently reported adverse reactions, which affected approximately 3-5% of patients in descending order of incidence were blurred vision, eye irritation, dysgeusia (bad taste), dry mouth and eye allergy


Seeking Alpha