Press review

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Biopharma a strategic asset for Italy which must be supported with effective R&D model - Farmindustria chief

MILAN, 18 Apr (APM) - The head of the industry body Farmindustria has urged Italy to support its biopharmaceutical sector with an effective R&D model and public/private partnerships, Il Sole 24 Ore reported on Saturday.
Massimo Scaccabarozzi, the organisation’s president, was speaking at Pharmaintech Exhibition 2019 in Bologna. He described biopharma as a strategic asset and highlighted the sector's enormous potential.
A study by Farmindustria and EY consultants was presented at the event, and showed there are 200 biopharma companies in Italy employing 4,000 people in R&D and investing more than €700 million in 2017. Annual sales of biotech companies are around €10 billion, accounting for around 5% of the global sector’s revenues and 32% of the pharma industry in Italy.
Scaccabarozzi noted that the Italian industry has played a leading role in development of advanced therapies, with three of those approved in Europe coming from Italian companies.
But the Farmindustria chief warned that the industry must continue to improve if it wants to keep up with global competition. “This is why it is necessary to strengthen the open source R&D model and synergies with public and private research centres, start-ups and universities,” he said
Scaccabarozzi is confident Italy can become a hub for research, as it already has in pharma manufacturing. But to achieve this it will have to provide clear and stable rules which support innovation, he advised.

Italy's AIFA approves reimbursement of low dose chemotherapy

Medicines agency AIFA has approved Italian reimbursement of metronomic chemotherapy with oral vinorelbine for breast cancer patients when the chemotherapy is given in a low-dose, according to Tuesday’s La Repubblica.
It has been authorised under Law 648/96 which allows the national health service to pay for therapies used off-label or when they have not been approved in Italy for the relevant indication.
Marina Cazzaniga, director of the Phase I Research Centre, ASST in Monza, described it as a long-awaited development, both for clinicians and cancer patients.
“Metronomic is a widely used chemotherapy in clinical practice but now, backed by numerous published data, it can enter into full use in dozens of cancer centres. The guidelines for its use in breast cancer were reported at ESMO two years ago. This decision by AIFA represents a huge step forward,” she said.
The paper described metronomic chemotherapy as an innovative strategy which involves a low dose oral therapy taken daily or two or three times a week.
Cazzaniga said the metronomic plus oral vinorelbine regimen not only acts directly on tumour cells but also inhibits neoplastic angiogenesis, the mechanism which generates new blood vessels responsible for tumour growth and metastasis. She also emphasised the reduced side effects including just 1% cases of hair loss.

Boehringer Ingelheim Italy had €437 million sales in 2018

Boehringer Ingelheim’s Italian subsidiary had sales of €437 million in 2018 as global revenues increased to €17.5 billion, About Pharma reported on Wednesday.
Its best performance in Italy came from human pharma, especially in the cardiovascular, diabetes and respiratory areas, the specialist publication said.
The company invested €14 million in its Bidachem site last year, aimed at expanding its quality control facilities, and plans to put a further €13 million into plant innovation in 2019.

New health pact to be agreed with Italian regions

Drafting of a new health pact with the various administrative regions across Italy is expected to get underway after Easter, Il Sole 24 Ore reported on Wednesday.
A delegation of regional officials on Tuesday met for preliminary talks with health undersecretary, Luca Coletto, a former health assessor in Veneto, as well as the head of the cabinet office Guido Carpani.
Governance of pharma spending is one of six subjects which will be discussed after the Easter break.
The others are management of chronic diseases, regional health spending deficits, personnel, public and private health contracts and health service investment in building and technology.

AIFA withdraws fluoroquinolone, quinolone antibiotics

Medicines agency AIFA has withdrawn some antibiotics and imposed restrictions on the use of others on recommendations from the European Medicines Agency (EMA), according to Tuesday’s Corriere della Sera.
The regulator has told doctors to avoid prescribing all quinolone antibiotics for a series of indications, including urinary tract infection, acute bronchitis and ear and throat infections and to limit their use when there is no alternative (APMHE 60635).
The alert about this antibiotics is in place across Europe, the paper said. It follows evidence of serious side effects in some patients.

Diana Bracco reappointed to head life sciences cluster ALISEI

Diana Bracco has been reappointed as president of ALISEI, the national life sciences technology cluster, for another three years, Affari Italiani reported on Tuesday.
Ugo Di Francesco, CEO of Chiesi, has also been appointed to the management board as the industry representative.
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