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Grünenthal to buy NebidoTM testosterone treatment from Bayer for €500m

European Pharmaceutical Review

Nebido is also patented until March 2024 in the European Union and until May 2027 in the United States. The deal is expected to close by the end of 2022, subject to approval by the relevant competition authorities. The long-acting injectable treatment for testosterone deficiency has been commercially approved in more than 80 countries.

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Novartis takes aim at MS blockbuster Tysabri in US and Europe

pharmaphorum

The looming competition piles further pressure on Biogen, whose MS franchise is already beset by generic competition to oral therapy Tecfidera (dimethyl glutamate), while its attempt to build a market for Alzheimer’s therapy Aduhelm (aducanumab) has ended in failure.

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Supreme court throws Novartis a lifeline for Gilenya defense

pharmaphorum

In a dramatic change in fortunes, Novartis has won a major victory in its bid to defend oral multiple sclerosis therapy Gilenya from early generic competition in the US. Gilenya made revenues of $2.8 Sales in the first half of this year fell 19% to $1.16

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Polpharma in pole position for biosimilar Tysabri in Europe

pharmaphorum

It had expected the drug would not face biosimilar competition in Europe until at least 2027. Last year, Polpharma and Sandoz won a patent challenge in Europe that resulted in revocation of a key patent on Tysabri in the EU, slashing Biogen’s protection for the brand by more than five years.

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Consequences of the First 10 Drugs Selected for Medicare’s Negotiation Program

PM360

They do not have biosimilar or generic competition available in the market. Additionally, highly competitive classes, such as rapid-acting insulin and immunologics are included on the selected drug list. They do not qualify for any exemption (e.g., for orphan products or plasma therapies).

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Horizon Europe deal signals UK research reinvigoration

European Pharmaceutical Review

Researchers can apply for grants and bid to take part in projects with certainty that the UK will be participating as a fully associated member until the deal reaches its end in 2027.

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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

EMA prepares for winter antibiotic shortages PFAS restriction in pharmaceutical manufacturing In its current form, the procedure currently underway could lead to a ban on all PFASs by 2027, with very limited derogations, EFPIA acknowledged.