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Embattled Biogen talks up Aduhelm

Biogen CEO admitted the company was experiencing “near-term challenges” after the controversial approval of Alzheimer’s drug, Aduhelm

- PMLiVE

Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm

Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its dealings with the company.

- PMLiVE

UK’s NICE recommends anti-cholesterol Leqvio for high-risk patients

The approval for the Novartis drug by the NHS gatekeeper could save 30,000 lives over 10 years

- PMLiVE

NICE recommends Novartis’ Rydapt for advanced SM treatment

The twice-daily, oral drug improves overall survival of people with the rare blood disorder

- PMLiVE

UK’s NICE to revamp its processes to make access to medicines “fairer”

The health technology assessment body is running a consultation to make its processes “clear, transparent and predictable”

- PMLiVE

UK’s NICE to revamp its processes to make access to medicines “fairer”

The health technology assessment body is running a consultation to make its processes “clear, transparent and predictable”

- PMLiVE

NICE approval for Lilly’s Verzenios is “fantastic news for thousands of women”

NICE declares Lilly’s breast cancer drug to be cost-effective, allowing routine use on the NHS

- PMLiVE

Biogen and Eisai present new data for controversial Alzheimer’s drug Aduhelm at AAIC

The data showed that high-dose Aduhelm treatment demonstrated consistent effects as measured by the Clinical Dementia Rating-Sum of Boxes

- PMLiVE

Novartis sees demand returning to pre-COVID-19 levels in Q2 results

Swiss pharma company also provided key updates on a number of drug candidates in its pipeline

- PMLiVE

NHS earmarks £340m for new medicines fund to fast-track ‘innovative’ treatments

The proposed Innovative Medicines Fund is an extension of the existing Cancer Drugs Fund

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Bayer’s BlueRock Therapeutics gains FDA fast track for Parkinson’s disease cell therapy

In 2019, Bayer bought out its private equity partner Versant Ventures and founders in BlueRock Therapeutics for $240m

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

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