Press review

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French biotechs complain about increasing difficulty of carrying out clinical trials in France

Country : France, Israel

Keywords :
PARIS, Dec 15 (APM) - Wednesday’s Le Parisien (p8) reported that French biotech association France Biotech has sent a public letter to the French health minister Agnès Buzyn, expressing concern over the increasing difficulty to carry out clinical trials in the country.
According to its chairman Maryvonne Hiance, 68% of clinical trials are now carried out outside the country due to increasingly cumbersome administrative hurdles.
The executive added it takes up to 18 months to get approval for a trial in France, compared to a month elsewhere, which could push the companies to move outside the country.
According to the newspaper, French biotech companies are already increasingly deserting France for their studies. It cited Carmat, Cellectis and Ose as examples.
The complexity of the system could jeopardise France's efforts to attract jobs in the biotech sector, and it also constitutes a threat to access to innovation, France Biotech warned.

Sanofi gets 3 million-euro fine in Depakine case

Tuesday’s Libération (p17) and Les Echos (p17) reported that a French court has fined Sanofi 3 million euros to compensate a victim of its epilepsy treatment Depakine (sodium valproate).
This is the first time the company’s responsibility has been established by the legal system, the two newspapers noted.

Launch of new haemophilia treatment blocked by reimbursement issues

Wednesday’s Libération reported that an unnamed new treatment for type B haemophilia, approved in March 2016, has still not been approved for reimbursement by the French authorities, despite lobbying by France's biggest patients' association.
The newspaper said the reimbursement process is "totally blocked", for unknown reasons, as CEPS, the committee in charge of reimbursement procedures, has taken no decision on the matter and refuses to comment.
Libération noted that the drug would only benefit 400 patients in France, and would not have a big impact on the healthcare budget.

British pharma, chemicals industries brace for Brexit impact

Les Echos (p16) on Thursday published an article on how the British chemical and pharmaceutical industries are bracing for the impact of Brexit, noting they were the first sectors to voice their concerns about the move.
The newspaper quoted a letter written by the two sectors to environment minister Michael Grove, and published by the Financial Times.
The politician was urged to "maintain the cooperation between the U.K. and Europe, as 82 million boxes [of drugs] cross the Channel every month", asking for measures to ensure unwanted delays do not hinder these flows. (APMHE 56036).

Sanofi wants to 'bet on innovation' again

Thursday’s Les Echos (p19) and Le Figaro (p26) reported that Sanofi pledged to "return to an innovation-based strategy" after the company's recent focus on large-scale acquisitions.
The reports were published as the company presented its R&D portfolio to the financial community (APMHE 56041, APMHE 56057, APMHE 56047).

Merck KGaA warns it will stop supplying old version of Levothyrox in March 2018

Friday’s Le Parisien (p10) and Les Echos (brief p16) report that Merck KGaA has announced it will stop supplying the previous formulation of its thyroid disorder treatment Levothyrox (levothyroxine) after March 2018.
The company was forced by the legal system to supply this older formulation after the scandal that erupted over the new version of the product.
Thierry Hulot, leader of the company’s French subsidiary, added that Merck would "respect and help" patients to transition to the new formulation, or to existing alternatives.
The newspaper said those alternatives are Sanofi’s L-Thyroxin and Serb’s L-Thyroxine, as well as a recent product, UniPharma’s Thyrofix, which was launched in early December.

Teva reduces workforce by a quarter

On Friday, Les Echos (p21) reports on Teva's decision to reduce its workforce by 25%, or 14,000 jobs (APMHE 56052).
The newspaper says around 1,750 jobs would be cut in Israel, and three manufacturing sites closed or sold.
This is "a measure that says a lot about the amplitude of the crisis the company is facing," Libération says.
The article adds that a strike affecting not only the company but also other sectors (banks, administration) has been announced in Israel.
The most important workers union in Israel, Hisdraout, has vigorously criticised the measure, noting that the company's success was based on Copaxone, an invention from public research organisation Institut Weizman.

GPs increase antibiotics prescriptions

Friday’s Libération (brief p19) writes that French drugs agency ANSM has said prescriptions of antibiotics by GPs rose by 1.3% between 2015 and 2016.
The newspaper noted this figure was declining at the beginning of the 2000s, thanks to communication campaigns intended to raise awareness about over-consumption, but increased again in the 2010s.
A new campaign has also been launched, with the slogan "Let’s be responsible, let’s be concerned".

Biotech seeks funds to develop cannabis addiction treatment

Tuesday’s Les Echos (p23) reported that French biotech Aelis Farma is aiming to raise 30 million euros in order to finance the development of a treatment for cannabis addiction.
The potential commercialisation of the compound is not expected before 2020, as the company needs to carry out Phase I trials in the U.S., as well as Phase II studies in France, which should start early 2018.
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