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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

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

Doubts Over China's First Alzheimer's Drug Resurface Amid Research Miscount Allegation

Biogen/Eisai’s US filing of aducanumab for Alzheimer’s has a ripple effect in China, where a leading biomedical researcher has publicly questioned data for the country’s first approved drug for the disease, GV971.

China Policy & Regulation

Asia Deal Watch: Cipla’s Latest Diabetes Partner In India Is Boehringer Ingelheim

Also, deals involving Sumitomo Dainippon, Tolero, Boston Biomedical, Zai Lab, Turning Point, SciClone, EpicentRx, Yuhan, GI Innovation, Takeda, Carmine, HitGen, Morphic, CStone and Burning Rock.

Deals Business Strategies

Opdivo Secures India Patent, Fends Off Multi-Party Opposition

India clears Opdivo patent, turning down pre-grant representations from four opposing parties including Dr Reddy's. The patent office rejected the opponents' arguments including those around obviousness and "inherent anticipation."

Intellectual Property India

ITC Takes Medytox’s Hand In US Botulinum Case, Bans Daewoong’s Imports

USITC’s initial decision in the Medytox and Daewoong botulinum dispute is favorable to Medytox and poised to take a toll on the Korean firm and partner Evolus as they face a 10-year ban on imports of their product to the US.

Aesthetics Legal Issues

Boehringer Bets On External Innovation In Post-COVID China

From cell therapy to digital health, from fast follower to innovator, China continues to gain traction with global health companies, underscored by its early emergence from the global pandemic and focus on certain technologies, with Boehringer Ingelheim the latest to be attracted.

Commercial Digital Health
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Europe

Set Alert for Europe

Latest From Europe

Newly Launched Eir Ventures To Target ‘Early Nordic Opportunities’

The Nordic region’s vibrant life sciences ecosystem will be the chief focus for newly created Eir Ventures, a strategic partnership and investment company.  

Commercial Companies

EC Approves Extended Invokana Indication On Renal Outcomes In DKD

Mundipharma has announced the European Commission’s extension of the indications for Invokana to include renal outcomes data from the Phase III CREDENCE study.

Renal Approvals

Vertex Secures Rapid Deal In England For CF Triple Therapy

After a long-standing row with payer NHS England, the rapid market access deal will help Vertex move into growth phase.

Companies Commercial

Sanofi Confirms Up To 1,680 Job Losses In Europe

The layoffs are part of its bid to cut costs outlined in December.

Companies Commercial

UK Biotechs Maintain Fundraising During Pandemic

Buoyed by belief in its strengths, the UK biotech sector has defied the pandemic over the last three months – but smaller firms are still strapped for cash.

Brexit Commercial

$90m IPO Sets Up Sweden's Calliditas For Phase III Readout

The Stockholm-headquartered company has exceeded expectations with its IPO, and now faces the ‘big reveal’ for its lead asset Nefecon.

Companies Commercial
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United States

Set Alert for United States

Latest From United States

Keytruda/Lenvima CRL To Give Roche More Space In 1L HCC?

Merck/Eisai face US speed bump for combo in first-line liver cancer after FDA decision and although their Phase III trial is already enrolled, completion is not due until 2022, giving time for new competitor to make its mark.

Complete Response Letters United States

ITC Takes Medytox’s Hand In US Botulinum Case, Bans Daewoong’s Imports

USITC’s initial decision in the Medytox and Daewoong botulinum dispute is favorable to Medytox and poised to take a toll on the Korean firm and partner Evolus as they face a 10-year ban on imports of their product to the US.

Aesthetics Legal Issues

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

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

Novartis’s MS Franchise Setback For Ofatumumab In US

Novartis will not start to compete in the increasingly crowded US multiple sclerosis marketplace with ofatumumab this month, as regulators extend the review process for the B-cell depleting therapy until September.

Neurology Approvals

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
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