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Policy & Regulation

Podcast: Novartis’s $9.7bn Gamble; Higher Drug Prices Post-Brexit? Jefferies Highlights

Join the London-based Eleanor Malone, Andrew McConaghie and Kevin Grogan as they review some of the most eyecatching stories in pharma and healthcare.

Europe Brexit BioPharmaceutical

Richard Torbett to Head Up UK ABPI

Richard Torbett, who negotiated the UK's new voluntary pricing scheme, is to be the new chief executive of the ABPI. 

Appointments Commercial BioPharmaceutical

Policy

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Latest From Policy

US Government Drug Pricing ‘Negotiation:’ Where We Go From Here

The House passage of a Democratic bill authorizing the federal government to negotiate drug prices in Medicare has sharpened the debate over how prices feed innovation, but the underlying policy stands little chance of being enacted without a Democratic wave in the next election. Pink Sheet's table highlights the key provisions of HR 3 and other pending pricing legislation.

Pricing Debate Legislation

For An Ultra-High-Priced Drug, Alnylam Brings A New Idea

The company will launch Givlaari with a novel prevalence-based adjustment feature for payers, which will trigger higher rebates if the number of diagnosed patients is higher than expected. 
Rare Diseases Pricing Strategies

HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead

Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.

Intellectual Property Infectious Diseases

Turkey’s Domestic Vaccine Production Drive Prompts New Partnerships

The Turkish government’s drive to establish domestic manufacturing for vaccines is showing tentative signs of getting off the ground. New partnerships are forming between Turkish and international partners. However, lack of local know-how is hampering progress.

 

Turkey Vaccines

Vertex Finally Inks Orkambi Deal In England

Vertex has finally managed to reach an agreement to bring its cystic fibrosis drugs Orkambi and Symkevi to patients in England, which constitutes an important slice of what is the second biggest market for the drugs.

Companies Reimbursement

Drugs With ‘Unsupported Price Increases’ Add $5bn To US Spending – ICER

Pharmaceutical Research and Manufacturers of America describes report as “flawed” and designed to advance the “false narrative that spending on medicines in increasing.”

Pricing Debate Policy
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Regulation

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Latest From Regulation

Surprise As FDA Approves Sarepta’s Duchenne Drug Vyondys 53

The FDA has overcome doubts about the drug's safety and reversed its decision in just four months.
Approvals BioPharmaceutical

Vascepa Gains European Filing Nod

On the cusp of US approval, Amarin must wait until late 2020 for EMA judgement

Cardiovascular BioPharmaceutical

AstraZeneca’s Calquence Catches Up With Imbruvica’s CLL Claim

AZ is counting on Calquence’s safety profile to gain ground against AbbVie/J&J’s blockbuster BTK inhibitor Imbruvica.
Approvals Cancer

EU Approvals: J&J's Darzalex Steps Ahead With New Indication

The European Commission has approved Johnson & Johnson’s/Genmab’s CD38-targeted MAb, daratumumab, and Merck & Co’s checkpoint inhibitor, pembrolizumab, in two first-line additional indications, in multiple myeloma and head and neck cancer, respectively.

 

 

ImmunoOncology Approvals

Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

Advisory Committees Drug Review

Merck’s Ervebo Becomes World’s First Approved Ebola Vaccine

Merck Sharp & Dohme will begin manufacturing licensed doses of Ervebo in Germany and will continue to send investigational vaccine doses to Democratic Republic of Congo.

Vaccines Approvals
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