Press review

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French drugs watchdog admits it did not anticipate Levothyrox crisis

PARIS, Dec 8 (APM) - Friday’s Le Monde (p15) reports that France's medicines agency ANSM has publicly acknowledged it did not sufficiently anticipate the possible consequences of the change in the formulation of Merck KGaA's thyroïd medicine Levothyrox.
"Retrospectively, ANSM believes 'information didn’t work' when the new formulation was launched, despite the 400,000 letters sent to healthcare professionals early 2017," the newspaper reports.
"This usual model of communication didn’t work and didn’t reach the patients," added its chairman, Dominique Martin.
Alain-Michel Ceretti, chairman of patients association France Assos Santé, also told the newspaper the lack of efficiency of the information system of the current healthcare professionals had already been underlined during a board meeting at ANSM in mid 2016.
According to the article, ANSM is thinking about launching a smartphone application, with a version for professionals and another for patients, to inform about important developments related to treatments.
"It had been discussed mid-2016, but had been set aside for budget reasons," added Ceretti.
The article highlighted the agency, despite the increase in its activity volume, has seen its financial resources reduced regularly in recnet years.
The newspaper also reminded these declarations come as the French minister of health has ordered an administrative investigation over the scandal.
Its conclusions should be made public before the end of May 2018, La Croix (brief p7) said on Tuesday.
In an interview broadcast by French radio FranceInfo on Sunday, the head of Merck France Thierry Hulot also regretted some groups were trying to "feed the buzz" over the crisis, regretting the debate was not enough centered on "facts".

Sanofi facing new troubles with dengue vaccine

Tuesday’s Les Echos (p10) and Libération (p15), as well as Monday’s Le Figaro (p25) and Le Monde (p5) reported Sanofi is facing new hurdles with its dengue vaccine Dengvaxia, after Brazil and the Philippines decided to take measures to limit its use.
Les Echos noted the Philippines have opened an investigation into the product after suspending the use of the vaccine, while Brazil recommended to limit its use following new recommendations issued by WHO and Sanofi itself.
According to an NGO from Philippines, the deaths of three children vaccinated in 2016 have been reported, while Sanofi declared it had not been made ware of those cases.
It is seen as a major blow for the company, which invested 1.5 billion euros in the development of the product, noted Les Echos, also pointing out Sanofi will incur a 100 million euros charge in its quarterly results to reflect the vaccines stock value.
These developments could also jeopardise the future of the plant where the vaccine is manufactured, located in Neuville-sur-Saône in France, it added.
The article also underlined Sanofi has encountered a separate failure, with the announcement it had to stop the development of its clostridium difficile vaccine, which it inherited with the acquisition of Acambis in 2007.
The product was expected to be launched in 2018, before competition from Pfizer and Valvena, and was credited with annual peak sales of more than $1 billion.
On Friday, Les Echos (brief p18) reports Sanofi faces being sued in the Philippines over the vaccine.

France's highest court to investigate role of aluminium-based adjuvants in vaccines

Monday’s Le Monde (brief p10 and website) reported that Conseil d’Etat, France's highest administrative court, has received a complaint requesting the ban of aluminium adjuvants in vaccines, filed by a lawyer on behalf of about 3,000 people.
The request has already been rejected by French healthcare minister Agnès Buzyn, which pushed for the group of people to go to court.
The newspaper said that scientific studies have given mixed conclusions about the safety of those adjuvants, while the authorities insist they are not dangerous.

Advicenne raises 27 million euros in flotation

Thursday’s Le Monde (Economy and Enterprises supplement, brief p4) and La Tribune (website) reported that French biotech Advicenne has raised 27 million euros in its public listing on Euronext Paris.
This sum is slightly lower than the target set by the company of 30 million euros, noted La Tribune (APMHE 55466).

Viagra to be sold without prescription in UK

On Monday, Le Parisien (brief p19) reported on the over-the-counter (OTC) switch of Pfizer’s Viagra in the UK as reported last week by APMHE (APMHE 55816).

Nestlé and Stada interested by Merck KGaA OTC business

Monday’s Le Figaro (brief p32) noted Nestlé and Stada are interested in buying the OTC business of Merck KGaA (APMHE 55878).

French HTA agency names new board chairman

Friday’s Les Echos (p35) notes that Dominique Le Gudulec has been appointed chairman of the board of French HTA agency HAS (Haute autorité de la santé), succeeding Agnès Buzyn, current health minister.
HAS is notably responsible for the negotiation of reimbursement prices of medicines and medical devices. Dominique Le Gudulec was until now manager of the Nuclear Medicine and Biophysic department in Bichat hospital in Paris.
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