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Gilead Lures Roche Pharma CEO O'Day As CEO; Genentech's CEO Will Replace Him

O'Day brings Gilead experience in oncology and M&A from a large, diversified organization.

Appointments Leadership Business Strategies

UK Receives £1bn Confidence Boost From Industry Investment In Life Sciences Sector

The international biopharma industry is backing the UK life sciences sector, with UCB spearheading the charge with a £1bn commitment to R&D in the nation still in a state of flux regarding its exit from the European Union in 2019.

United Kingdom Deals Innovation

Phase II Success Positions Ra For Potential Blockbuster Opportunity In Myasthenia Gravis

Ra hopes to launch a Phase III program for zilucoplan next year, with a goal of bringing an alternative therapy for MG patients into competition with Alexion’s Soliris.

Clinical Trials Rare Diseases Research & Development
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Cross-Country Collaborations, Business As Usual?

Pharmaceutical companies cannot afford to ignore the growing number of cross-country collaborations springing up in Europe aimed at securing more affordable medicines through actions such as jointly negotiated pricing deals. In Vivo looks at the factors that may influence the rise or fall of these collaborations and at how they may eventually make companies rethink the way they do business.

Market Access Outlook 2019 Pricing Strategies

Finance Watch: Moderna Launches Biggest Biopharma IPO Ever As US Market Resets Expectations

Public Company Edition: Moderna's $604m IPO launches as the US stock market is in decline and public biotechs are doing especially poorly. Also, as Shire acquisition closing moves near, Takeda firms up additional financing; and Global Blood, Theravance, Amarin capitalize on good news.

Financing Business Strategies Deals

Alnylam And Silence Settle Over RNAi Patents

Silence will receive a small royalty on future sales of Alnylam’s Onpattro in Europe, and Alnylam is free to use Silence IP in other products.

Intellectual Property Legal Issues

Data, Data, Everywhere, But How Much Of It Makes A Real Difference?

Having a single patient's complete health care information all in one place was a dream that US visionaries began to talk up around a decade ago. The idea was that fast, electronic support for doctors would aid clinical decision making and efficiency. Ten years on, there is still much work to do before the dream is realized, says Philips' Carla Kriwet. But a solution is within reach.

Digital Health Outlook 2019

Lessons From A Life Sciences Lifetime: An Interview With Sir John Bell

Professor Sir John Bell talks to In Vivo about how the life sciences sector has evolved during his career, lessons he has learned along the way, and the biggest challenges and changes ahead for the industry in 2019.

Leadership Brexit

Drug Price Waterloo: China's New Bidding Process Hits MNCs Hard

China's new so-called “4+7” drug bidding pilot scheme, already expected to be a killer for some companies, has cut prices by as much as 90%, leaving all but two multinationals to bid successfully and accept the revised levels. The big reductions could also lead to further price erosion for the winning products.

China Commercial

Menarini Owners Acquitted Of Fraud

Lucia and Giovanni Aleotti have been cleared of fraud against the Italian health system, and will continue to lead the Florentine company transformed into a major multinational by their father.

Italy Legal Issues

All Downhill: Ranbaxy Singh Brothers Trade Charges, Blows

The Singh brothers' feud has moved from a war of words allegedly to blows, with any efforts at reconciliation looking bleak. The siblings also find themselves in tight spot as Daiichi Sankyo presses ahead to enforce a INR35bn damages award.

Commercial Companies

Policy & Regulation Explore this Topic

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Brexit And Cooperation: Insights From Danish Medicines Agency Head Thomas Senderovitz

It was inevitable that Brexit would be the key theme of an interview with Danish Medicines Agency head Thomas Senderovitz earlier this year. The senior European regulator oversees one of the agencies that has taken on new staff to help deal with the impact, in drug regulatory terms, of the vote by the UK in June 2016 to leave the European Union. Senderovitz also chairs the management group of the EU Heads of Medicines Agencies network.

Leadership Outlook 2019 Policy & Regulation

Roche's Tecentriq Becomes Second In PD-1/L1 Family To Gain First-Line Lung Cancer Approval

The PD-L1 inhibitor's label excludes NSCLC patients with EGFR or ALK mutations, which could have been an advantage, but the indication largely reflects the registrational IMpower150 clinical trial's population.

Approvals ImmunoOncology

Pharma: Be Prepared For Tougher Price Negotiations For IO Combos And Expansions In Europe

Payers are increasingly likely to implement new strategies to manage price negotiations for immuno-oncology combinations, as competition  heats up among the drug class. Mechanisms allowing for the negotiation of different prices for combination therapies do not exist at present, but payers insist that new tools must emerge.

ImmunoOncology Health Technology Assessment

Lilly CEO Made New IFPMA President On Health Budget Mandate

David Ricks will lead IFPMA into 2020 with an eye on how to meet the healthcare needs of the world’s aging population, and stepping up the power of private-public partnerships.

International Leadership

Research & Development Explore this Topic

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Axovant Closes Chapter On Failed, Second-Rate Small Molecule Strategy

Termination of nelotanserin, a small molecule licensed from Arena, in Lewy body dementias comes after a dramatic shift toward gene therapy.

Research & Development Neurology BioPharmaceutical

Pipeline Watch: Phase III Starts With Elacestrant, Crizanlizumab And Vutrisiran

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

In NASH Race, Bad News For Conatus, Good News For Genfit In PBC

Conatus’ emricasan fails to meet the primary endpoint for portal hypertension in NASH patients with cirrhosis, but firm stresses promising subgroup data. Genfit hits Phase II primary endpoint in PBC with elafibranor, which is also in Phase III for NASH.

Liver & Hepatic Clinical Trials

EAGLE Crash Lands: AstraZeneca's Imfinzi/Tremelimumab Continues To Disappoint

The latest failure of the combination of AZ's PD-L1 inhibitor and its CLTA4 inhibitor is in advanced head and neck cancer. It follows recent failures of the MYSTIC and ARCTIC trials in lung cancer.

ImmunoOncology Clinical Trials
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