Press review

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Experts say France should reorganise clinical trials and market access regulations

Country : France, Germany

Keywords :
PARIS, 6 July (APM) - Two healthcare market experts, economist Nicolas Bouzou and healthcare entrepreneur Jean-David Zeitoun, wrote in Thursday's Les Echos that France should reorganise its regulations on clinical trials and market access procedures.
As the French government is to meet pharma industry representatives under the CSIS (Conseil stratégique des industries de santé, Healthcare industry strategic committee), the authors wrote that France "should modify two or three regulatory levers" if it wants to maintain its capacity to access pharmaceutical innovations.
France is suffering from an overly heavy administrative burden concerning clinical trials, which lead big pharma to exclude France from clinical development of new molecules, they pointed out, particularly in fields other than cancer.
Bouzou and Zeitoun also underlined that the main problem in France for the pharmaceutical companies are the lengthy delays required to get reimbursement and prices, three times longer than they are for example in Germany, up to 400 days.
They also noted the current debate over the rocketing pricing of innovations should not be fuelled, but instead the authorities should focus on those two matters, since the cost of their reorganisation should be minimal.

Novartis separates from Alcon

Monday’s Les Echos (p22) reported on Novartis's decision to sell its ophthalmology business Alcon after an 18 month review. The unit will be spun out through a separate stock market listing.
The newspaper reminded that Alcon was bought by the Swiss giant in 2008 under Daniel Vasella to broaden the group's business from just prescription drugs.
But after the end of the integration process, which was finalised in 2011, Alcon faced a decline in its margins, which led Vasella’s successor, Joe Jimenez, to reconsider keeping the business.
Vas Narasimhan, who took over as CEO from Jimenez, decided to float the company.

Senate committee investigates drug shortages

Friday’s Le Figaro (p11) reports that a Senate committee is working on an investigation into drug shortages that have increased in recent years in France.
The newspaper notes the committee should give its conclusions by the end of the year.

Gynaecologist who triggered the Distilben scandal dies

Wednesday’s Libération (p13), as well as Tuesday’s 20 Minutes (‘brief p3) and Les Echos (brief p12) reported that the gynaecologist who sounded the alarm over the dangers of UCB Pharma's Distilben for pregnant women has died at the age of 81.
Anne Cabau started studying the matter in 1981 and her scientific studies were published in the media in 1983, leading to the uncovering of the large scale side effects of the product.

Dynacure raises €47 million

Friday’s Les Echos (p24) reports that French biotech Dynacure raised €47 million from Andera Partners, Pontifax and BPI France speed up the development of its orphan diseases treatments.
Les Echos notes the sum raised was "a record" for a company focused on this field, and will allow the company to launch a Phase I/II trial of its lead candidate Dyn101 in muscular dystrophy in the first quarter of 2019 in Europe.

Netbiotix raises €7 million

Biotech Nextbiotix has raised €7 million euros with its first financing round, Les Echos said on Thursday (p24).
The company is focused on the development of chronic inflammatory bowel diseases using Faecalibacterium prausnitzii bacteria and will launch clinical trials in 2020.

Osivax developing universal flu vaccine

French biotech Osivax, which is developing a universal flu vaccine, has raised €4.5 million, announced Les Echos on Tuesday (p22).
The company’s lead product is a flu vaccine that targets the NP antigen of the virus, and if successful would end the need for the pharma industry to develop a new flu vaccine every year, noted Les Echos.
Its vaccine has proved to be 100% efficient in preclinical trials and has just started Phase I studies.
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