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Policy & Regulation

Novo Executive Calls For ‘Real AMR Action’ In Davos

The Novo Nordisk Foundation is sponsoring a panel at Davos this week on finding solutions to the global crisis on antimicrobial resistance – and hopes world leaders will listen.

Companies Research & Development Infectious Diseases

AZ's Lynparza Gets Prostate Cancer Priority Review

The race is firmly on to be the first PARP inhibitor approved for metastatic castration-resistant prostate cancer, with the FDA giving a speedy review to AstraZeneca and Merck & Co's Lynparza just days after granting the same to Clovis Oncology's Rubraca.

Drug Review Cancer Companies

Policy

Set Alert for Policy

Latest From Policy

Biopharma Leaders Join Trump And Thunberg In Davos

Often dismissed as a meeting of the global elite, Davos is nevertheless a chance for biopharma leaders to take part in ‘big picture’ debates

Business Strategies Commercial

Bayer's Efforts To Pioneer Tumor-Agnostic Market In Europe Held Back

Bayer’s drive to lead a new market opportunity in Europe for histology-independent cancer agents like Vitrakvi has been set back by interim decisions from the UK’s NICE and Germany’s IQWiG, but there is a now a clear pathway to follow.

 

Cancer Health Technology Assessment

The Big Five To Catalyze Primary Care In Africa

Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Novartis and Pfizer are helping to fund a public-private partnership aimed at improving the primary care health infrastructure in Africa; the collaboration will also exploit the companies’ experience providing therapies and using digital and web-enabled technologies.

 

Deals Middle East and Africa

Lilly Adds Two More Humalog Authorized Generics As Insurance Deductibles Reset

With rebate reform efforts stalled, insulin manufacturer broadens efforts to lower prices through authorized generics, but PBMs may still like the big rebates they can get on the original brands.

Pricing Debate Generic Drugs

Scrip Asks…What Does 2020 Hold For Biopharma? Part 3: Policy And Regulation

The US election will intensify  the spotlight on drug costs, regulators will have their hands full with advanced therapy filings, and the need to address rising infectious disease threats will mount. Biosimilars, cannabis and Brexit are among other hot topics for 2020.

Policy Regulation

AMR Crisis Experts See Hopeful Signs For 2020

2020 could be a watershed year in tackling AMR, but success needs market reforms that ensure new antibiotics get to market and prevent innovators going bust, experts tell Scrip. 

Policy Research & Development
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Regulation

Set Alert for Regulation

Latest From Regulation

Novartis Inks World-First Pact With NHS England For Inclisiran

The innovative collaboration should accelerate access to the first-in-class cholesterol lowering drug acquired with The Medicines Company buy.

United Kingdom Deals

Scrip Asks…What Does 2020 Hold For Biopharma? Part 3: Policy And Regulation

The US election will intensify  the spotlight on drug costs, regulators will have their hands full with advanced therapy filings, and the need to address rising infectious disease threats will mount. Biosimilars, cannabis and Brexit are among other hot topics for 2020.

Policy Regulation

Lynparza Gets US OK For Pancreatic Cancer

The leading PARP inhibitor gets a new tumor type added to its label after a narrow ODAC vote in favor less than a fortnight ago.

Approvals United States

J&J’s Spravato Gets EU Okay For Drug-Resistant Depression

Concerns that written interventions might delay the expected EU approval of the novel ketamine-based antidepressant have come to naught.

Approvals Companies

FDA Panel Tentative Yes To AZ’s Lynparza In Pancreatic Cancer

Lynparza doubled PFS in metastatic patients with germline mutations in BRCA but the FDA usually wants to see OS data before approving drugs for pancreatic cancer. Its advisory committee narrowly voted in favor of approval of the PARP inhibitor but will the agency follow suit?

Approvals Cancer

GSK Files Its BCMA Drug In Multiple Myeloma

GSK has filed its anti-BCMA agent with the FDA after full Phase II DREAMM-2 data showed an overall response rate of 31% in patients with heavily pre-treated multiple myeloma.

Companies Regulation
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