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Policy & Regulation

New National Security Checks Could Hinder Investment, Warns UK Biotech Sector

Life science SMEs and their investors need to comply with new UK government checks on their dealmaking.

Companies Commercial Regulation

Novo Nordisk On The Pluses And Minuses Of The UK Post-Brexit R&D Environment

Post-Brexit Britain offers a fertile R&D ecosystem, but it needs to improve uptake in novel medicines there and strike a lasting deal with the EU over batch testing, Novo Nordisk’s UK general manager Pinder Sahota tells Scrip.

Brexit Clinical Trials Companies

Policy

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Latest From Policy

Drug Pricing Measures Clear US Senate Judiciary Committee

They may have a good shot at passage given recent actions by President Biden and the Federal Trade Commission, and bipartisan interest in drug pricing. 

Pricing Debate Legislation

Price Negotiation In Part D: Big Savings On Revlimid, Ibrance, Xtandi Projected in CAP Analysis

As Democrats in the US Congress work to move legislation empowering the Health and Human Services Department to negotiate drug prices directly with manufacturers, the Center For American Progress releases an analysis on which drugs would be targeted by House bill HR 3 and how much prices could be reduced.

Pricing Debate Legislation

With Access Restricted, Aduhelm Appears Poised For A Slow Start

Reimbursement, health policy and medical experts predicted a slow rollout ahead for Biogen's new Alzheimer's treatment at a public meeting sponsored by ICER.

Neurology Market Access

Importation, Pay-For-Delay Reform Backed By Biden Order; March-In Rights For Pricing Suggested

The policies have long been Democratic priorities, but of the three, the order’s implicit support for march-in rights might lead to the biggest change.

Pricing Debate Intellectual Property

Korea Kick-Starts Major Consortium For Next-Gen mRNA Vaccines

South Korea is stepping on the gas to develop its own mRNA COVID-19 vaccine and eventually next generation mRNA platform technology for use in other diseases, to meet its goal of becoming a global vaccine hub.

South Korea Coronavirus COVID-19

Start Designing Vaccines For The Next Pandemic, Urges NIH Chief

NIH director Francis Collins and former FDA commissioner Margaret Hamburg outline learnings from the COVID-19 pandemic and what needs to be done next amid concerns around the dangerous Delta and also Lambda variants. They also discuss the role of the WHO, which has “many masters to try and satisfy.”

Research & Development Coronavirus COVID-19
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Regulation

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Latest From Regulation

The Wait For Inspections: Biocon Seeks FDA Stance On Mutual Recognition Agreement Route

Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Biosimilars Regulation

Coronavirus Update: EMA To Update Comirnaty And Spikevax Labels On Cardiac Safety

Comirnaty and Spikevax to get EU label update on cardiac safety, Japanese filing for REGEN-COV, plus vaccine progress for ReiThera and Genexine.

Coronavirus COVID-19 Vaccines

To Boost Or Not To Boost? Pfizer At Odds With US FDA

US regulators indicate that authorizing booster shots is not a priority - but Pfizer still plans to seek an EUA in the fall.

Companies Coronavirus COVID-19

Keytruda May Stay Competitive In Gastric Cancer Despite Losing Third-Line Claim

While Opdivo’s first-line approval has altered the treatment landscape, Keytruda may expand its presence there in the next few years with new indications.

Cancer Regulation

10 US Approval Decisions To Look Out For In Q3

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

Approvals Companies

Lilly’s Donanemab Could Be A Near-Term Aduhelm Competitor

Lilly said it will seek accelerated approval in the US based on Phase II data for its amyloid-clearing antibody, potentially narrowing Biogen/Eisai’s newly approved therapy Aduhelm’s time on the market as the only disease-modifying Alzheimer’s drug. 

Neurology Research and Development Strategies
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