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Policy & Regulation

Big Pharma’s $1Bn Antibiotic Development Fund Offers ‘Breathing Room’ For Reimbursement Fix

Companies developing antibiotics to get financial and technical support from more than 20 firms contributing to new AMR Action Fund. Initiative is also pushing for reimbursement reform and other policies to support commercial marketing.

Infectious Diseases Reimbursement Clinical Trials

SillaJen Minority Shareholders Unite, Call For Trade Resumption

Faced with the risk of losing their investment from a possible stock delisting amid prosecutors’ probes into company’s management, SillaJen’s individual minority shareholders are demanding the Korea Exchange resume trading of the biotech’s stock, in a rare united move.

South Korea Legal Issues Cancer

Policy

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Latest From Policy

Pricing In ‘Exceptional’ Times: ICER Aims To Shape US Policy For Novel COVID Drugs, Vaccines

US Institute for Clinical and Economic Review lays out options ranging from the status quo (unrestricted pricing) to compulsory licensing and advanced market commitments in a new white paper.

Pricing Strategies Coronavirus COVID-19

Leading A Diverse Company: Biopharma Executives Offer Ways Forward

BIO hosted discussions during its annual meeting to reinforce the value of inclusion, offer advice to companies and reflect on recent US events. 

Leadership Business Strategies

Merck’s Frazier Urges Businesses To Use ‘Every Instrument At Their Disposal’ To Reduce Racial Inequity

‘What we have to guard against is that when the streets quiet down … a lot of people are going to go back to their normal lives,’ Merck CEO Ken Frazier says in an interview with CNBC.

Leadership United States

BIO’s New CEO, Michelle McMurry-Heath, Aims To ‘Change The Dialogue’ Around Science

Former senior leader in J&J’s medical devices business will take over the reins from Jim Greenwood in June; an immunologist by training, McMurry-Heath brings a resume that is long on scientific, regulatory and corporate experience, but she also has some political qualifications under her belt.

Policy Leadership

Coronavirus Update: Moderna Scales Up Manufacturing, Sosei Looks To Structure-Based Design, Taking Stock Of India’s Lockdown

Moderna details plans on how it will make enough of its coronavirus vaccine, and Sosei is using structure-based design technology to target a SARS-CoV-2 non-strucural protein. Meanwhile, the industry in India faces up to lockdown. 

Coronavirus COVID-19 Companies

Amarin's Vascepa May Face Generic Competition In US Next Year After Patents Ruled Invalid

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Legal Issues Intellectual Property
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Regulation

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Latest From Regulation

Biogen/Eisai Hit ‘Send’ On High Stakes BLA For Aducanumab In Alzheimer’s Disease

Some analysts see a 50-50 chance of US FDA approval despite the controversial dataset for the anti-amyloid antibody, but at least one expects an eventual CRL requesting a third Phase III trial.

FDA Neurology

US Approval For ViiV’s ‘Last Resort’ HIV Drug Rukobia

The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.

Approvals Infectious Diseases

First Vaccine Approval For Janssen With Two-Dose Ebola Prophylactic

The two-part vaccine becomes the second against Ebola to get approval. Janssen is now collaborating with the World Health Organization on vaccine pre-qualification to get it to people in need.

Approvals EU

AbbVie Expected To Ditch Abicipar After US FDA Setback

With a complete response letter for wet AMD drug abicipar, AbbVie is expected to move on from the drug acquired with Allergan. Molecular Partners now seems inclined to focus on IO, virology.

Drug Safety Regulation

Coronavirus Update: Amid Fears Of Trump Pressure, Fauci Warns Of Rushing Vaccine Authorization

Anthony Fauci says a hasty emergency use authorization for a vaccine would be a mistake - and the FDA commissioner will not be drawn on timelines.

Coronavirus COVID-19 Clinical Trials

The 2020 Worldwide Pharma & Biotech Industry R&D Scene

INFOGRAPHIC: A snapshot of the industry in key performance indicators, taken in early 2020.

Companies Research & Development
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