Monthly Archives: August 2013

August 29, 2013 | By Márcio Barra

Trastuzumab, for the treatment of breast cancer, was the number one oncologic drug Portuguese hospitals spent the most money from January to May 2013

The Portuguese Government spends almost as much money on the NHS hospitals’ expenses with medicines as with the reimbursement of all drugs sold in pharmacies, according to data revealed by the Portuguese Ministry of Health.

The numbers disclosed show that, in 2012, the state spent about $ 2,200 million with drugs, 1.200 million of which with the reimbursement of medicines sold in pharmacies and 1.000 million with medicines provided in hospitals.

While the expenses on drugs sold in pharmacies are in control, thanks to successive price cuts by the Government over the years – just in 2013, about 1.400 brand drugs had mandatory a 7% price discount – the expenses with medicines in hospitals and debts to the Pharmaceutical Industry grew again this year, both in value and in average payments. This upward trend is ongoing for six consecutive months.

In July, the value of accumulated debt rose to 1.251 million and the average payment time increased to 526 days, according to data released yesterday by the Portuguese Association of Pharmaceutical Industries (APIFARMA). Questioned why is the debt increasing even though last year the state used 1,500 million in a debt settlement program, the president of APIFARMA, João Almeida Lopes stated that its due to “chronic underfunding of hospitals, which is not resolved with sudden debt payments but through a structural solution,”

“This is not an unusual or unexpected growth ‘, argues Margaret France, vice president of the Portuguese Association of Hospital Administrators, noting that it is” very difficult “to reverse the upward trend in drug expenditures in hospitals, where therapeutic innovation comes at a price.



August 28, 2013 | By Márcio Barra

Last Friday, INFARMED, the Portuguese National Competent Authority on Medicines, triggered an inspection in order to identify the causes of the reported difficulties some patients are having in accessing the Parkinson’s disease drug Azilect (Rasagiline).

According to a statement issued by INFARMED, in the course of this operation a total of 133 inspections were conducted – 129 pharmacies and four distributors – alongside telephone surveys with 111 pharmacies to collect additional information.

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August 27, 2013 | By Márcio Barra

Following the news yesterday on Amgen’s $10.4 billion Onyx buyout, Bayer AG announced today that the FDA has put its drug Nexavar, sold for liver and kidney cancer in the US in partnership with Onyx, on priority review for thyroid-cancer approval.

The priority review designation granted to Nexavar is for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer, with the submission being based on the results of the DECISION clinical trial. In this trial, a total of 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer – a type of cancer that doesn’t respond to treatment with radioactive iodine – that hadn’t receive prior therapy for thyroid cancer were randomized to receive 400 mg of oral Nexavar twice daily (207 patients) or matching placebo (210 patients). Nexavar doubled progression-free survival, to a median of 10.8 months in patients treated with it, compared with 5.8 months in control patients.

Under priority review status, the FDA aims to complete the evaluation within six months, rather than the standard review of about 10 months. The expected date for a decision is December 25, 2013.

Bayer stated that it will continue to study Nexavar in other types of cancer. Two phase III breast cancer trials are currently underway, as well as a trial of Nexavar as an adjuvant therapy in liver and kidney cancer patients.



August 26, 2013 | By Márcio Barra

Image source: Bloomberg

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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August 14, 2013 | By Márcio Barra

GSK announced yesterday that the FDA has given green light for ViiV Healthcare’s Tivicay(dolutegravir) 50-mg tablets, an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs). It can be used to treat infected adults who have been treated with other drugs or are new to treatment.

Integrase inhibitors are a new class of antiretroviral agents that block HIV replication in the body by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). In short, they stop the virus from entering cells.

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August 9, 2013 | By Márcio Barra

Pharmupdates will return to business as usual on Monday, August 12. The lack of updates this week was due to family matters and some developments concerning what’s next for me in my  (just starting) career.

To all of my viewers who check this website, I deeply thank you for your attention and interest! Traffic to this website has been growing steadily over the months, and I could not be more grateful for each of you that stop by. If you are here for the original articles, I hope that you have found what you were looking for! If not, leave a comment on what you would like to see me write next.

Keep checking Pharmupdates for more news and original articles, and don’t forget you can contact me anytime, just go to the About the Author section for more details on how to.

August 2, 2013 | By Márcio Barra

Teva Pharmaceutical Industries profits fell in the second quarter, due to a decline in U.S. and European Generic sales, accprding to the numbers released today by Teva. But the real issue is the company’s over reliance on the multiple sclerosis drug Copaxone, soon to go without patent, casts a bleak outlook over the company.

Teva earned $1.20 per share excluding one-time items in the second quarter, compared with $1.28 a year earlier and analysts’ forecasts of $1.20 a share. Revenue dropped by 1%to $4.92 billion versus a forecast $4.94 billion. The $452 million net loss for the second quarter was also helped by the $1.4 billion patent settlement for Teva’s and Sun Pharma patent infringement over Pfizer’s drug Protonix, an acid reflux medication. Under the settlement, Takeda, Pfizer’s partner in marketing the drug, will receive 36%, about $774 million from the settlement, with the remaining 64% going to Pfizer. Teva will pay $1.6 billion, half this year and the rest by October 2014. Indian generics maker Sun Pharma will pay $550 million in damages in 2013.

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