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Sanofi finally seals big deal with $11.6bn for Bioverativ

Sanofi interest in making a big acquisition has been clear for the last few years and its struggles to solidify such desire into concrete results have often been commented upon; twice it has been beaten to the punch by fellow big pharma companies, with Pfizer snagging Medivation in 2016 and Johnson & Johnson offering a more attractive deal to acquire Actelion in 2017.

This time round, the company hasn’t been thwarted by the competition and has announced the successful conclusion of a $11.6 billion deal to acquire Bioverativ.

Celgene confirms rumours, with $9bn deal for Juno

It seems like 2018 may well be the year for M&A that everyone had expected, as two major deals on the same day announced that acquisitions were back with a bang.

First, Sanofi managed to achieve a long-held goal of making a sizeable addition to its business and now Celgene has made the plunge to acquire Juno Therapeutics in a $9 billion deal.

Biogen’s Spinraza to go before NICE

Biogen received marketing approval from the European Commission for Spinraza (nusinersen), its treatment for spinal muscular atrophy (SMA), in May of last year but has struggled to generate access across Europe.

One step towards improving patients’ access to the treatment was announced with Biogen announcing that NICE had agreed to evaluate the treatment through its Single Technology Appraisal (STA) route.

Court fines Dr Reddy’s for improperly packaging products

On 18 December 2017, the District of New Jersey filed a complaint against Dr. Reddy’s Laboratories for failing to comply with the Poison Prevention Packaging Act (PPPA) and the Consumer Product Safety Act (CPSA).

Just over a month later, the district court handed down a $5 million penalty and entered a permanent injunction to prevent Dr. Reddy’s from distributing prescription drugs not in child-resistant packaging.

Novartis enters biosimilar agreement with Biocon

IMAGE: Sandoz facility

Novartis’ Sandoz unit had already staked a claim to being one of the leaders in the developing biosimilar market and has made another move to further expand its influence.

It announced that it has signed an exclusive global collaboration deal with Biocon that should see the generics manufacture expand its biosimilar portfolio in the future.

Gilead aims to claim edge with Pfizer CAR-T combo

Although those in pharma often dislike any references to drugs competing with each other for market as in a ‘race’, it’s inevitable that such allusions will be drawn between rivals.

Gilead’s recent acquisition, Kite Pharma, is one of two CAR-T therapies to receive approvals, alongside Novartis’ Kymriah, and comparing it to an arm’s race is the temptation. If that were the case, Kite’s recent team up with Pfizer looks set to test whether its treatment can go nuclear on refractory large B-cell lymphoma.

Riding the wave: The FDA and real world evidence

Published on 18/01/18 at 10:23am

Following on from this week's earlier piece on real world evidence, Jacqueline Corrigan-Curay, Director of CDER's Office of Medical Policy at the FDA, tells Pharmafocus how the US regulator has and continues to embrace the technology.

NICE meets Janssen halfway over Darzalex

NICE rejected Janssen’s Darzalex (Daratumumab) back in March last year, concluding that it wasn’t able to accurately determine the efficacy of the drug based on data submitted and therefore couldn’t reach a decision on cost-effectiveness.

Nearly one year later and a further appraisal on, NICE has reached the conclusion that it isn’t adequately able to determine the efficacy of the drug.

It will be some comfort to the company that NICE recommended that the drug be made available through the Cancer Drug Fund while it further evaluates the treatment.

Research calls for BRCA testing in all women

For women, possessing a mutated BRCA1 or BRCA2 gene significantly increases the chances of developing breast or ovarian cancer; at present, however, the standard method of screening for the genes is to invite women with a family history of either cancer for testing.

Ipsen ends P3 trial on liver cancer early due to strong data

Ipsen and Exelixis, partners in developing Cabometyx (cabozantinib), have revealed that they have cut short a Phase 3 trial into the benefit of the drug in liver cancer, after the treatment hit its primary endpoints.

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