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BACE Hopes Finally Fizzle As Biogen/Eisai End Elenbecestat Alzheimer's Studies

Biogen investors cheered the end of the company’s investment in the Phase III studies due to an unfavorable risk-benefit ratio – a widely expected result for the last clinical BACE inhibitor program.

Clinical Trials Neurology Research and Development Strategies

AZ, Novartis, Roche Take Part In UK’s Big Data Push

Seven hubs will bring together data sets and help accelerate clinical trials.

 

 

Digital Health United Kingdom Clinical Trials

Merck KGaA Says New Meds Will Add €2bn Sales

The German group believes its €2bn target of pipeline sales by 2022 is achievable. It is hoping for a healthy contribution from rare lung cancer drug tepotinib.

Strategy Clinical Trials Cancer
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Ardelyx Gets IBS-C Approval, But Focus Remains On Hyperphosphatemia

Tenapanor approved for IBS-C as Ibsrela, but Ardelyx is still seeking a commercial partner for that indication – and is maintaining focus on same molecule in hyperphosphatemia.

Approvals Business Strategies

Sanofi India Aligns Manufacturing, Sheds Site To Zentiva

Sanofi sells Indian facility to Zentiva, a key customer for products made at the site, and hopes to make up for the earnings gap through a renewed push for its “core activities and brands.”

India Commercial

Finance Watch: SpringWorks, Satsuma Launch IPOs; BioNTech Filing Shows US-China Trade War Impact

BioNTech has plenty of cash and is gearing up for an IPO, but money from a Hong Kong investor is in limbo. Plus, Satsuma and SpringWorks bring US IPO total to 34 this year, Fate's FOPO raises $150.5m and Pharvaris brings in $66m.

Financing Business Strategies

PE Interest In Hisun's Biosimilars Arm As Hong Kong Firm Acquires $540m Majority Stake

Asia-focused PE firm PAG has purchased a majority stake in Hisun BioRay, the biotech division of Chinese state-owned generic company Zhejiang Hisun Pharmaceutical, for $540m, boosting its presence in a nascent, fast-growing segment of the country’s drug industry.

China Business Strategies

GSK Buys One Of Eight Firms Formed In VC Partnership With Avalon

Celiac disease specialist Sitari was the first company formed under the six-year collaboration. Three were shut down and Avalon controls the other four, which aren't compatible with GSK's new R&D focus.

Deals Financing

Purdue Nears Settlement Of Opioid Multidistrict Litigation, But State AGs Vow To Press On

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

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BioMarin's Brineura Pricing Deal Allows UK Market Access

More than two years after EU approval, BioMarin and the National Health Service have agreed pricing for the ultra-rare disease therapy, Brineura, allowing it to be publicly funded while further clinical data are collected as part of a managed access agreement.

 

Neurology Market Access

Purdue Nears Settlement Of Opioid Multidistrict Litigation, But State AGs Vow To Press On

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Legal Issues Policy

Novartis Prepares for UK Luxturna Rollout After Rapid NICE OK

Novartis/Spark’s gene therapy Luxturna has been OKd for NHS use by NICE in record time thanks to early engagement and close collaboration between the two parties. 

United Kingdom Health Technology Assessment
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Kyprolis-Plus-Darzalex Boosts Amgen's Myeloma Pipeline, After MCL-1 Drugs' Clinical Holds

The company's proteasome inhibitor reduced the risk of death in combination with J&J's CD38 inhibitor in a Phase III trial. A day earlier, Amgen reported clinical holds on its Phase I MCL-1 inhibitors due to cardiac safety.

Clinical Trials Drug Safety

Pipeline Watch: Phase III Starts With Evobrutinib, Gaboxadol

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 

Approvals Pipeline Watch

First Filing, In Japan, For Daiichi’s Lead ADC As Others Progress

In a further positive step for its oncology ambitions, Japanese company files first submission for promising lead antibody-drug conjugate, partnered globally with AstraZeneca, while other pipeline ADCs mark development progress.

Cancer Clinical Trials
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