Press review

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Gilead guarantees supplies of remdesivir for Covid-19 in Spain - regulator

MADRID, 3 July (APM) - The director of Spain's regular AEMPS said in an interview with daily newspaper El País published on Friday that Gilead is guaranteeing supplies in the county of remdesivir for Covid-19 patients.
María Jesús Lamas told El País that AEMPS has been negotiating with Gilead for months and that this has made remdesivir available in the country via the two current procedures, namely compassionate use and clinical trials.
Asked about Europe's delay in approving the drug in Covid-19, Lamas said that following the recommendation by the European Medicines Agency (EMA), the approval is imminent.
She added that remdesivir will receive a conditional marketing approval, to be updated with data on future clinical data gathered as the medicine is used in clinical practice. She said that a decision on reimbursement in Spain will be made based on those data.
She added: "Some consider its price abusive in times of the pandemic, the law can make pharmaceutical companies share their knowledge." However, she cautioned that this kind of move has to be carefully considered, because different rules in terms of intellectual property could jeopardise Europe's competitiveness.
Daily newspapers El Periódico, 20 Minutos and a number of regional newspapers also carry the story, based on Lamas comments to two radio stations on Thursday.

U.S. secures Gilead's stock of remdesivir

The previous day, it was widely reported that the U.S. Department of Health and Human Services (HHS) has signed an agreement with Gilead to secure more than 500,000 treatment courses. (APMHE 68008)
Daily newspapers La Razón, La Vanguardia, El Mundo, El País, financial newspapers El Economista, Expansión, Cinco Días, a number of medical journals and regional newspapers also carried the story on Thursday.
On Friday, daily ABC carries a story with the headline: 'Is remdesivir safe and efficient?'

PharmaMar's claims Aplidin better than Gilead's remdesivir in Covid-19

Preliminary results show PharmaMar's Aplidin (plitidepsin) is more potent than Gilead's remdesivir in Covid-19, dailies El Mundo, La Razón, La Vanguardia, financial newspapers El Economista, Cinco Días and Expansión report on Friday.
El Mundo carries an interview with PharmaMar president José María Fernández Sousa-Faro, who said Aplidin is "the most potent antiviral drug ever described". The newspaper calls the results "more than good" and adds that the company expects to try the drug in Covid-19 patients by this year's third quarter.
The drug is approved in Australia to treat multiple myeloma, El Mundo notes.
According to La Razón, PharmaMar claims that Aplidin is 2,800 times more potent than remdesivir. Data disclosed by the firm's partner, South Korea's Boryung Pharmaceutical, the drug has shown antiviral properties in monkey kidney cells which are from 2,400 to 2,800 times more potent than remdesivir.
According to PharmaMar, Aplidin is also more targeted, attacking the virus without damaging healthy cells, La Razón reports. La Razón quoted Adolfo García Sastre, researcher at Mount Sinai Hospital in New York, as saying that these data support previous findings.
El Economista quotes Boryung Pharmaceutical CEO Sam Lee, as saying: "Going back to normal is the most important goal at this point of the current Covid-19 crisis; pharmaceutical companies will continue to seek diverse and innovative research to fight Covid-19."
Spain's regulator AEMPS approved a trial to assess the drug's safety and efficacy in patients in three Spanish hospitals, El Economista notes.

AstraZeneca's Lynparza linked to infertility - study

A new study conducted by researchers in Australia has found that AstraZeneca's cancer drug Lynparza (olaparib), can damage the store of immature eggs in the ovaries of lab mice, daily newspapers ABC and El Español reported on Wednesday.
The authors of the study, published in the journal Human Reproduction, warned that the drug is administered to young and elderly breast cancer patients with BRCA1 or BRCA2 mutation without knowing its potential effects on reproductive health, ABC reported.
According to ABC, researcher Amy Winship regretted that "fertility is very commonly overlooked in many safety tests in pre-clinical studies in animal models and also in human clinical trials for new cancer drugs, but we know this is an important concern of young cancer patients and survivors, particularly as survival rates for many cancers are improving".

Is a €2,000 price tag 'affordable'?

On Tuesday, daily newspaper ABC carried a lengthy story about the price of Gilead's remdesivir, with the headline: 'Is a Covid-19 drug affordable at €2,000?' (APMHE 67943)
The newspaper quoted a company press release as saying: "There is no playbook for how to price a new medicine in a pandemic. We are aware of the responsibility that comes with it." According to the statement, taking the example of the U.S., earlier hospital discharge [with remdesivir] would result in hospital savings of approximately $12,000 per patient, ABC reported.
On Wednesday, financial newspaper Cinco Días carried an editorial saying that Gilead's decision to avoid pushing for a higher price is a wise move.==Shortages of Bayer's Xarelto expected to last for four months
Spanish regulator AEMPS has said that shortages of Bayer's newer anticoagulant drug (NOAC) Xarelto (rivaroxaban) are expected to continue until October, medical journal Redacción Médica reported on Wednesday.
The drug, called Bayer's "blockbuster" in the story, is approved to treat various cardiovascular conditions, including the prevention of blood clots in at-risk patients with a history of acute coronary syndrome (ACS), patients with coronary artery disease (CAD) and peripheral artery disease (PAD), both in monotherapy or combination with other medicines, the journal said.

Branded pharma lobby presents annual report

Spanish branded pharma lobby Farmaindustria has presented its annual report, financial newspaper El Economista, Europa Press agency, medical journals Redacción Médica and Acta Sanitaria reported on Tuesday. (APMHE 67946)
El Economista focused on president Martín Sellés warning that Europe and Spain need to reactivate manufacturing to avoid dependence on supplies of medicines from China and other countries in Asia.

Novartis settles U.S. bribery charges with €600 million

Novartis will pay €600 million to settle charges that kickbacks were paid to doctors and patients to boost sales of its drugs, daily newspaper El Mundo, financial newspaper El Economista and medical journal Redacción Médica reported on Thursday. (APMHE 67993)
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