Press review

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Time to rethink medicines evaluation in France - consultants

Country : France, U.S.

Keywords :
PARIS, Nov 3 (APM) - Friday’s Les Echos (website) publishes an op-ed from healthcare consulting firms Aromates and Ultrace Development Partners calling for a complete reworking of medicines evaluation procedures in France.
In their article, Jacques Marceau, chairman of Aromates, and Yannick Pletan, a consultant at Ultrace, say that the evidence-based medicine concept, which is the basis of the country's current drugs evaluation system, has done its time and must be replaced.
They argue this method has reached its limit at a time where new therapeutic strategies and technologies are emerging, personalised medicine is on the increase, and where patients are ageing and receiving a larger number of medicines.
These factors make the evaluation of pharmaceuticals through clinical trials obsolete, say Marceau and Pletan.
They also say that current medicines evaluation procedures, notably in cancer, suffer due to the premature halting of clinical trials and to too early approvals, which deprive regulators of precious data on the new compounds.
“Most studies are stopped prematurely, since it is considered that sufficient evidence has been gathered and that it is not necessary, or financially interesting, to let them go further,” they note.
The authors also say that it has become inevitable that data sciences should be integrated into the procedures, since they could offer precious help in understanding the individualisation of therapeutic evaluation.
They consider these evolutions and new paradigms require a deep reform of the regulatory framework, which they consider to be “from another time” and whose renovation has become urgent.

Big pharma also facing scientific fraud

Monday’s Le Monde (Eco & Enterprises supplement, p1) published an article saying that big pharma like Pfizer, AstraZeneca and Novartis have to deal with scientific fraud.
The article notably cites the example of how AstraZeneca faced this problem with Acerta’s acalabrutinib, in which the large company had a 55% stake.
The compound was lauded by the U.S. Food and Drug Administration as a breakthrough therapy, but “the story nearly became a nightmare” after a scientist from the biotech was accused of manipulating data on the drug.

Opiates crisis shakes America

Tuesday’s Le Monde (Economy and Enterprises supplement, p8) published an article about the scandal around U.S. pharma company Insys, which is accused of corrupting doctors in order to push sales of its opiate-based painkillers.
The newspaper reported that company head John Kapoor has been arrested by the police and will be prosecuted in this case.
Le Monde added that this scandal is shaking the U.S., where an epidemic of opiate-related overdoses has been raging for several years and is on the increase, causing the death of more than 40,000 people last year.

Amazon prepares entry to U.S. prescription medicines wholesale market

On Thursday, Le Monde (Economy and Enterprises supplement, p5) reported that giant U.S. online retailer Amazon may be about to enter the prescription medicines retail business.
The newspaper wrote that Amazon has gained wholesale licenses for these kinds of products in at least 13 states, spurring concern in the pharmacies business.
But for now the company refuse to give any detail about its strategy in this market, it added, citing information published by Bloomberg.

Sanofi signs deal to use A.I. in R&D on vaccines

Tuesday’s Le Figaro (brief p21) reported briefly on the deal inked by Sanofi and U.S. biotech Berg that will allow the big pharma to rely on the biotech’s artificial intelligence platform to increase the performance of its R&D efforts in vaccines.

French government to launch HPV self-test campaign

Free newspaper 20 Minutes reported on Monday (p14) that French public cancer institute INCa will launch a large-scale HPV diagnosis campaign which will for the first time include the use of self-testing.
This is also the first time the French government is launching an organised screening campaign for HPV, the newspaper noted.

Eurocept acquires biotech Lucane Pharma

Parisian biotech Lucane Pharma has been bought by Dutch pharma Eurocept from investment firm Seventure Partners, Capital Finance (website) reported on Tuesday.
The biotech generates sales of 6.4 million euros and specialises in rare metabolic diseases, with two products approved in Europe.

Advicenne prepares IPO

French biotech Advicenne has submitted an official request to French market authorities in view of an IPO on Euronext.
The operation aims to allow the company to advance the clinical development of ADV7103 in ATRd, an orphan renal disease, with commercialisation expected in 2020.

Chines firm buys wholesaler Tridem

Tuesday’s Les Echos (website) reported that French pharmaceutical wholesaler Tridem has been bought by Chinese conglomerate Fosun for up to 63 million euros.
Tridem specialises in the distribution of medicines in French-speaking African countries.

National Assembly votes extension of mandatory vaccines

Monday’s Le Monde (brief p9) and La Croix (p9) noted that the French National Assembly (lower house of parliament) has approved a measure extending the number of mandatory vaccines to 11, for children born as of early 2018.

Op2Lysis seeks capital increase

Young French company Op2Lysis is seeking to raise 250,000 euros to advance the development of its stroke treatment, reported Le Parisien (Economy supplement, brief p6) on Monday.
The company has discovered a compound, O2L-001, which aims to treat stroke with a single administration.
The molecule is an antithrombotic agent and is in very early stages of development.

New target for malaria

Monday’s Le Figaro (p9) reported on the discovery by Swiss researchers of a potential new target in the treatment of malaria.
This target concerns two key proteins responsible for the parasite’s development and dissemination. The researchers say they have discovered a molecule to block them.
Their work is published in the latest edition of Science journal.
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