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Winner Takes All: New China Bidding Scheme Marks Price Watershed?

With tens of millions of dollars in sales at stake, a number of mostly commonly used drugs are subject to the first-ever nationwide drug price bidding process in China, with foreign firms seeing the move as opening the floodgate to a potential downward price spiral in the world’s second-largest pharma market.

China Pricing Strategies Policy & Regulation

Leo Lines Up PellePharm Buy In Rare Skin Cancer Deal

The Danish dermatology specialist could be hitting the acquisition trail again soon having taken an option to buy BridgeBio's PellePharm and its skin cancer drug patidegib in a deal that could be worth $760m.

Dermatology M & A Deals

Pharma Products Face Uncertain Future In Boston Scientific's 'Logical' £3.3bn Bid For UK's BTG

Boston Scientific CEO says US group has been tracking UK-based BTG "for more than two years" and that interventional medicine is a key attraction.

M & A Blood & Coagulation Disorders Cancer
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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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Few Signs Of An IPO Slowdown Despite US Biotech Stock Slump

Biotech stock valuations wavered in October with the average IPO return in the US nearing negative territory, but observers say there is still a healthy market for new biopharma offerings in 2018 and into next year.

Business Strategies Financing Outlook 2019

Sobi Advances Growth Strategy With Gamifant Launch In Early 2019 For Primary HLH

The interferon gamma blocker is the first new therapy for HLH in 24 years. FDA approval came about four months after Sobi acquired global rights from NovImmune in a deal meant to improve the company's growth prospects.

Approvals Rare Diseases Commercial

US Suboxone Win Lifts Dr Reddy’s As Embattled Indivior Fights On

Dr Reddy’s can re-launch its generic version of Indivior’s Suboxone (buprenorphine/naloxone) sublingual film in the US following a crucial court ruling that has gone its way. Indivior faces significant turbulence ahead if a generic entry materializes soon.

Generic Drugs Intellectual Property

Fresh Funding Pushes Inflazome Into Clinic With Inflammation Inhibitors

With $46m funding fresh in its pocket, Dublin biotech Inflazome tells Scrip how it will advance its clinical candidates in multiple indications.

Inflammation Financing

Roivant Buoys Anti-Infective Portfolio With Novel iNtRON Asset

Roivant Sciences has added iNtRON Biotechnology’s novel biologic candidate to its existing anti-infective portfolio in a sizable licensing deal amid recent increased global health attention on antimicrobial resistance issues but generally decreasing pharma industry interest.

South Korea Deals

Takeda/Shire Clears Last Antimonopoly Hurdle – Shareholders Up Next

European Commission gives an expected conditional regulatory approval for the acquisition of Shire by Takeda, removing the last potential antitrust hurdle to the deal, meaning that attention is now turning to the upcoming shareholders' meetings that would open the final path to the early January completion of the record-setting transaction.

Japan Commercial

Kolon Bounces Back From Failed Japan Invossa Deal With Bigger Mundipharma Alliance

Kolon Life Science has reached a sizable license deal with Mundipharma for the development in Japan of the South Korean company’s first-in-class cell and gene therapy for osteoarthritis of the knee, easing uncertainties after an agreement with Mitsubishi Tanabe for the product collapsed last year.

South Korea Japan

Redx Ready To Get Back To The Clinic After Tough Year

CEO Lisa Anson has brought "a sense of urgency, focus and realism" to Redx since she took over five months ago, says its chairman, and the firm has high hopes for its investigational porcupine inhibitors.

Business Strategies Cancer

Policy & Regulation Explore this Topic

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Sage Gets More Time For Zulresso Launch Preparations With Delay Of US FDA Approval

After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.

Drug Safety Neurology Business Strategies

The Inevitable Is Coming: Price Increases, Starting With Pfizer

Drug makers are planning for annual price increases, but with the industry in President Trump's crosshairs it remains to be seen if 2019 price hikes will be more modest than in the past. Pfizer confirmed plans to raise prices, but only on 10% of its portfolio.

Pricing Debate Pricing Strategies

AZ's Lynparza PARP Lead Likely To Lengthen With FDA Priority Review

Despite suffering a setback at the hands of NICE, AstraZeneca's ambitious plans for Lynparza have been boosted by the FDA agreeing to speed up a review of the recent SOLO-1 data which took ESMO by storm last month.

Cancer FDA

‘Drastic’ Japan Price Reforms Hitting R&D Incentives, Plans - EFPIA

European research-based pharma group proposes reconsideration of Japan’s revised pricing system, warning it is already affecting corporate R&D decisions and will stifle industry investment, innovation and patient access to new therapies if incentives are not improved.

Japan Business Strategies

Research & Development Explore this Topic

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What The New US Cholesterol Treatment Guidelines Mean For Esperion

Guidelines place high emphasis on low cost, but also outcomes data. Esperion plans to file bempedioc acid next year, but outcomes data won’t be available until 2022.

Cardiovascular Cost Effectiveness Pricing Strategies

'Cashing In' On Biobank Networking: BC Platforms Aims To Globalize Its Finnish Model

Privately-held BC Platforms is one of the networked groups leading the way in clinical genomics data management. Its CEO tells Scrip how the company's foundational start in Finland 21 years ago allowed it to create a critical mass from which it is now expanding globally in the quest to better understand the pathogenic mechanism of diseases.

Digital Health Innovation

Pipeline Watch: Phase III Starts With Rimegepant And Modufolin

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.

 

Pipeline Watch Approvals

Merck KGAA/Pfizer's Anti-PD-L1 Bavencio Loses An Opportunity In Ovarian Cancer

PD-1/L1 inhibitors are eagerly awaited in ovarian cancer, but the combination of Bavencio with chemotherapy doesn't work well in platinum-resistant disease.

Clinical Trials Cancer
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