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Featured Stories


Bristol’s Focus Returns To IO Following Celgene Vote

Q1 Earnings Preview: With the positive vote on its merger with Celgene behind it, Bristol now needs to focus on growing its immuno-oncology business, where several upcoming catalysts could bolster Opdivo.

Sales & Earnings Business Strategies Commercial

Q1 Drug Sales, Pipeline, 2019 Catalysts Top Themes For AstraZeneca Update

Q1 Earnings Preview: When AstraZeneca reports first-quarter results on April 26 investor focus will be on new product sales growth, pipeline catalysts and clues on possible fresh divestment and licensing deals.

Sales & Earnings Companies Commercial

Novartis’s Zolgensma In Spotlight As Second Death Is Probed

Reports of patient deaths could raise questions around safety for Novartis's gene therapy Zolgensma which is expected to get the green light imminently from the FDA.

Gene Therapy Neurology Safety
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Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

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Commercial Explore this Topic

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Asia Deal Watch: Shionogi Finds Commercial Partners For Symproic In US, Europe

Shionogi licenses US commercial rights for OIC drug to BioDelivery and rights in three EU markets to Sandoz. Tessa will test its T-cell therapy with Merck’s Keytruda in cervical cancer.

Deals Business Strategies Commercial

Taltz Results In Spondyloarthritis Add To Lilly Franchise Hopes

Taltz has sailed through the latest trial in Lilly’s COAST program, in non-radiographic axial spondyloarthritis, but choppy waters may be ahead; meanwhile, Lilly signs an immunology deal with Avidity Biosciences.

Clinical Trials Inflammation Deals

Piramal’s Sensipar Generic Blocked In US, For Now

Piramal halted sales of its generic version of Amgen’s Sensipar following a US court order that also required Amgen to furnish a $39m bond. The Sensipar generic launch landscape continues to be complex with multiple legal challenges, including those from Cipla and Sun at various stages.

Generic Drugs Legal Issues

Novartis CEO Issues Staunch Defense of Zolgensma As Sales Soar

The Swiss major has got off to a strong start in 2019 with Cosentyx and Entresto sales soaring and Mayzent – and possibly very soon Zolgensma – getting US approvals.

Sales & Earnings Companies

Hepalink-Backed HighTide Bets On NASH For Global Markets

Emerging Company Profile: Fatty liver disease has been a hot development area that keeps getting more attention, and one Chinese startup backed by the world’s largest heparin manufacturer is looking to launch a new therapy globally.


China Liver & Hepatic

Poseida's CAR-T, Gene Therapy Programs Get $142m Boost, Including Novartis Cash

Despite its sidetracked IPO, a registrational trial for the company's BCMA-targeting CAR-T is underway to support a late 2020 BLA filing and this new VC funding could accelerate additional programs. CAR-T pioneer Novartis is strictly an investor in the Series C round, but takes a board seat.
Financing Cancer

Arrakis Pivots From Platform To Pipeline With $75m For RNA-Targeting Small Molecules

CEO Michael Gilman, who now helms the company full time, said Arrakis will use its Series B venture capital funding to build a pipeline of drug candidates, primarily in cancer, with the goal of taking its first medicines into the clinic in the next two to three years.
Financing StartUps and SMEs

Finance Watch: Hatteras Nearly Halfway To $200m Goal For New Early-Stage VC Fund

Private Company Edition: General Partner Clay Thorp says the venture capital firm's longtime focus on seed and early-stage investments is unchanged and bolstered by market fundamentals. Also, Talaris and insitro each raised $100m Series A rounds, plus other financings.

Financing StartUps and SMEs

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

India New Trial Rules - Sponsors Interested But 'FAQ' Could Help

India’s new clinical trial regulations could revive sponsor interest in the country, but some norms around local Phase III trial waivers appear open to interpretation and could potentially weigh down momentum.

Clinical Trials India Policy & Regulation

Gelesis's Obesity Product FDA Acceptance Gives Boost To PureTech's Portfolio


PureTech's affiliate Gelesis has received FDA clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half. 
Approvals Metabolic Disorders

Insulin Assistance Programs: Big Help Or Just A Band-Aid?

Drug makers and other stakeholders have been rolling out insulin savings programs as the high cost of insulins come under scrutiny on Capitol Hill. Sanofi announced an expanded cost-savings program during a House hearing, but one Congresswoman called them a band-aid. 

Pricing Debate Policy & Regulation

PBMs Were On Capitol Hill, But Pharma Still Took Some Heat

Drug makers remained front and center during the Senate Finance Committee's third hearing on drug pricing, even though leaders from five pharmacy benefit managers were testifying.

Pricing Debate Politics

Research & Development Explore this Topic

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Japan's Healios Progresses Novel Cell Therapy For ARDS

Activity in Japan's cell and regenerative therapy space continues apace as venture starts trial with lead development asset for acute respiratory distress syndrome.

Japan Regenerative Medicine Clinical Trials

Teva’s Ajovy Failure In Cluster Headaches Good For Lilly’s CGRP Inhibitor Emgality

Lilly's Emgality looks set to benefit from Teva ending clinical development of its CGRP antibody competitor in cluster headaches due to lack of efficacy in Phase III.

Clinical Trials Companies

The 2019 Worldwide Pharma & Biotech Industry R&D Scene

INFOGRAPHIC: A snapshot of the industry in key performance indicators, taken in early 2019.

 

Market Intelligence Research & Development

Pipeline Watch: Phase III Starts For Lumasiran, CS1001 And Sepofarsen

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
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