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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

China Winds Down 'COVID Zero' But Vaccine Fatigue, Other Worries Linger

Three years since the first cluster of SARS-CoV-2 infections were reported in Wuhan, China has finally put the first nail in the coffin of its strict "COVID Zero" policies. But as Beijing begins to relax its most restrictive rules, citizens remain concerned about ballooning infections, while a low vaccination rate among seniors and vaccine fatigue appear to be dimming hopes of a quick revitalization of the hard-hit economy and bruised consumer confidence.

China Coronavirus COVID-19

China Set To Green-Light First mRNA Vaccine

In what appears to be a step towards a gradual shift away from its strict "COVID Zero" policies, China is poised to approve its first mRNA vaccine - in this case developed domestically - and will accelerate the roll-out of COVID-19 vaccinations in general to seniors over 80.

China Coronavirus COVID-19

COVID Unrest, Health Sector Deep Freeze Hits Chinese Biotechs Hard

Much of the biopharma and other health-related industries in China were already feeling the chill from ongoing macro-economic and other headwinds this year, which now look set to be complicated further by the added strain of social unrest over strict COVID containment policies. The combination of factors is already prompting some to take steps towards restructuring and divestments to survive.

Coronavirus COVID-19 China

China Walks Back Some Relaxations Amid New COVID Outbreaks

With growing cases and deaths reported just as the country was preparing to ease some of its most restrictive COVID-19 measures, China takes new control steps amid low booster vaccine uptake and moves to halt the online sale of a repurposed domestic antiviral.

Coronavirus COVID-19 Policy

Departing Words: Merck’s Ken Frazier Cautions Against Profit Maximization

Pharma CEOs must balance optimizing access and profitability, former Merck CEO and soon-to-be ex executive chairman of the company said. Frazier says health care industry must come to table and admit the “system ain’t working,” talks about the need to protect democracy, in a sweeping interview at the STAT Summit.

Leadership Pricing Debate

China Eyes New COVID Vaccines As It Inches Towards Reopening

New planned changes around vaccine approvals and other COVID-19 measures signal China is preparing for a gradual reopening amid its strict policies, but the process could take months.

Coronavirus COVID-19 China
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Regulation

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Latest From Regulation

A Duchenne Breakthrough Awaits In 2023 - But Risks Remain For Sarepta And US FDA

The FDA and Sarepta have had a controversial history with the accelerated approvals of the firm’s earlier drugs for Duchenne muscular dystrophy – but the company’s investigational gene therapy, SRP-9001, now under a priority review, could be a genuine breakthrough.

Approvals Neurology

Rigel Ready To Hit The Ground Running After Early AML Drug Approval

Rezlidhia, which was only recently licensed by Rigal from Novo Nordisk-owned Forma Therapeutics, should challenge the market dominance of Servier's Tibsovo in the IDH-1 inhibitor subset of acute myeloid leukemia patients. 

Approvals Business Strategies

Roche Withdraws Tecentriq’s Frontline Bladder Cancer Indication, Ceding Market To Keytruda

The move marks the second time since last year that Roche has withdrawn a urothelial carcinoma indication after its confirmatory trial failed to show an overall survival benefit.

Cancer ImmunoOncology

UCB Makes Another Push To Get Bimzelx Over Finishing Line In US

The Belgian group was stunned by an FDA rejection in May for its dual IL-17A and IL-17F inhibitor and although the refiling is complete, UCB may still have to wait six months to get Bimzelx into the all-important US psoriasis market.

Dermatology Complete Response Letters

Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes

Blenrep’s withdrawal will add to GSK’s blockbuster drought, and hopes of separate trial success for the BCMA-targeting drug in earlier stage myeloma may now be harder to achieve.

Approvals Companies

Santhera Finalizes Vamorolone Filings And Now Seeks Funds

The Swiss biotech is hoping that its Duchenne muscular dystrophy prospect, vamorolone, will get on the FDA fast track to approval but acknowledges that getting more funds is an urgent priority to prepare for a potential US launch.

Business Strategies Rare Diseases
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