Pharmacist Digest

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. ICER points to brain swelling and potential bleeding seen in approximately 30% of patients treated with aducanumab.

Labelling

Labelling Drug Pricing

STAT+: The FDA has approved a new Alzheimer’s drug, but wide access may depend on CMS easing restrictions

STAT

JANUARY 6, 2023

Food and Drug Administration has granted accelerated approval to the widely anticipated Alzheimer’s drug from Eisai and Biogen, a key question is the extent to which payers — private and public — will cover the treatment. Such decisions are based on myriad factors, starting with the average $26,500 price tag.

Drug Pricing

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

pharmaphorum

DECEMBER 24, 2021

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The post Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA appeared first on.

Biogen’s Aduhelm rollout goes from bad to worse

pharmaphorum

OCTOBER 21, 2021

Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. Biogen reported $1.6 That dragged down Biogen’s overall revenues, which fell 18% to $2.2

PharmaShots Weekly Snapshots (April 24 - 28, 2023)

PharmaShots

APRIL 28, 2023

Difficile Infection Date: Apr 27, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, C.

Diabetes

Diabetes Biosimilars

PharmaShots Weekly Snapshots (May 15 - 19, 2023)

PharmaShots

MAY 19, 2023

Alimera Acquires Rights from EyePoint Pharmaceuticals to Commercialise Yutiq in the US Date: May 19, 2023 | Tags: Alimera, EyePoint Pharmaceuticals, Yutiq, Iluvien, chronic non-infectious uveitis, US, Pharma Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A Date: May 19, 2023 | Tags: Sobi, Efanesoctocog Alfa, (..)

Medical Schools

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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

pharmaphorum

NOVEMBER 19, 2020

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.

Biosimilars

Biosimilars Labelling

Oligonucleotide synthesis market to reach $16.7 billion by 2027

European Pharmaceutical Review

DECEMBER 9, 2022

Biogen Inc. (US). Tag Copenhagen A/S (Denmark). Alnylam Pharmaceuticals, Inc. (US). ATDBio Ltd. ( Biolegio B.V. Netherlands). Biolytic Lab Performance Inc. (US). CSBIO (US). Danaher Corporation (US). Eton Bioscience, Inc. (US). Eurofins Scientific (Germany). Ionis Pharmaceuticals, Inc. (US). LGC Limited (UK).

Compounding

Biogen updates on its confirmatory Aduhelm trial

pharmaphorum

DECEMBER 17, 2021

Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one. Only a few patients have been getting treated with Aduhelm since launch, with Biogen reporting sales of $1.6

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

pharmaphorum

MAY 10, 2022

With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which is now fully filed with the FDA. Biogen and Eisai have another go appeared first on. Here we go again. The post Exit Aduhelm, enter lecanemab.

Free access to Zolgensma curbed, says Novartis

pharmaphorum

JANUARY 9, 2023

Along with Zolgensma – which made its debut in 2019 – Biogen has had approval to market its antisense-based therapy Spinraza (nusinersen) since 2016, while Roche got a green light for its orally-administered therapy Evrysdi (risdiplam) in 2020. .

NICE reaches a deal with Roche on access to oral SMA drug Evrysdi

pharmaphorum

NOVEMBER 19, 2021

The agreement has been hailed by patient associations, as it adds to current treatment options for the progressive muscle wasting disease – Biogen’s injectable Spinraza (nusinersen) and one-shot gene therapy with Novartis’ Zolgensma (onasemnogene abeparvovec) – which are also backed by NICE.

NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group

pharmaphorum

JUNE 2, 2021

The orally-administered drug is the third approved treatment for SMA after Biogen’s injectable Spinraza (nusinersen) and Novartis’ one-shot gene therapy Zolgensma (onasemnogene abeparvovec), which was administered to the first NHS patient this week. — Spinal Muscular Atrophy UK (@SMA_UK_) June 2, 2021.

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Documentation Communication

J&J builds case for antidepressant Spravato with head-to-head trial

pharmaphorum

NOVEMBER 24, 2022

One issue has been the cost of the drug, with health technology assessment agency NICE in the UK and the ICER organisation in the US both concluding its price tag means it is not a cost-effective option for health systems. The post J&J builds case for antidepressant Spravato with head-to-head trial appeared first on.

Labelling

Labelling Hospitals

Leading innovators in peptide nano-particle conjugates for the pharmaceutical industry

Pharmaceutical Technology

MAY 15, 2023

Innovation S-curve for the pharmaceutical industry Peptide nano-particle conjugates is a key innovation area in the pharmaceutical industry By tagging peptides with nanoparticles, peptide nano-particle conjugates allow enhanced control over their biological behaviour, overcoming intrinsic limitations of the individual materials.

Immunity

Immunity Immunization Pharmaceutical Companies Pharmaceutical Companies

PharmaShots Weekly Snapshots (March 06 - 10, 2023)

PharmaShots

MARCH 10, 2023

Vertex Receives the US FDA’s IND Clearance of VX-264 for the Treatment of Type 1 Diabetes Date: Mar 10, 2023 | Tags: Vertex, VX-264, Type 1 Diabetes, Regulatory, US, FDA, IND Alnylam Expands its Collaboration with Medison Pharma to Commercialize RNAi Therapies Date: Mar 10, 2023 | Tags: Alnylam, Medison Pharma, RNAi Therapies, Onpattro, patisiran, (..)

Diabetes

Diabetes Biosimilars Vaccines

Viagra ‘should be tested as Alzheimer’s therapy’

pharmaphorum

DECEMBER 7, 2021

That finding could provide some comfort to Biogen and Eisai, whose recently-approved amyloid-targeting drug Aduhelm (aducanumab) is struggling to gain traction in the market on the back of unconvincing efficacy data, safety concerns and a high price tag.

Compounding

Compounding Diabetes

Pharmacist Digest

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

STAT+: The FDA has approved a new Alzheimer’s drug, but wide access may depend on CMS easing restrictions

Trending Sources

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

Biogen’s Aduhelm rollout goes from bad to worse

PharmaShots Weekly Snapshots (April 24 - 28, 2023)

PharmaShots Weekly Snapshots (May 15 - 19, 2023)

FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

Oligonucleotide synthesis market to reach $16.7 billion by 2027

Biogen updates on its confirmatory Aduhelm trial

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

Free access to Zolgensma curbed, says Novartis

NICE reaches a deal with Roche on access to oral SMA drug Evrysdi

NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group

J&J builds case for antidepressant Spravato with head-to-head trial

Leading innovators in peptide nano-particle conjugates for the pharmaceutical industry

PharmaShots Weekly Snapshots (March 06 - 10, 2023)

Viagra ‘should be tested as Alzheimer’s therapy’

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