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Lilly/Pfizer’s Tanezumab Safety Takes A Hit With Latest Phase III Results

Larger of two doses of the NGF inhibitor hit two efficacy endpoints, but the rate of joint health outcomes on a composite measure was higher than control by a statistically significant margin.

Clinical Trials Drug Safety Research & Development

BI Bets On Expanding Jardiance As Diabetes Drug Sales Soar

The German major believes its drug will remain the biggest-selling SGLT-2 inhibitor boosted by expanded heart and renal disease approvals.

Commercial Companies Sales & Earnings

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 Business Strategies
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Commercial Explore this Topic

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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 Business Strategies

Kiadis Buying CytoSen Will Combine Natural Killer And T-Cell Immunotherapies

An all-stock transaction will see Europe’s Kiadis and US’s CytoSen bring together complementary approaches to improving stem cell transplants and cancer immunotherapy.

 

M & A ImmunoOncology Companies

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

Asia Begins To See Impact From Roche 'De-Siloing'

As part of a global strategy first unveiled last year, Roche is taking concrete steps to restructure its pharma operations in Asia, including the substantial downsizing of a Singapore office.

Business Strategies Asia Pacific

Finance Watch: Turning Point Launches IPO, Stock Rises 60% On First Day

Public Company Edition: Turning Point's offering priced at $18 and its stock closed at $28.90. Also, Achaogen's bankruptcy reflects difficult antibacterial market, Ophthotech's name change follows strategy shift, and Gilead lays off 150 sales reps. Plus, cell and gene therapy FOPOs flourish.

Financing Business Strategies

Deal Watch: Gilead To Use Insitro’s AI/Functional Genomics Tech For NASH Targets

Start-up Insitro will attempt to optimize up to five NASH targets for Gilead under three-year alliance. Catalent buys gene therapy CDMO Paragon for $1.2bn, Boehringer partners with PureTech in GI cancer, while Fibrocell inks gene therapy pact with Castle Creek.

Deals Business Strategies

Roche CEO: Novel But Costly Gene Therapies Justify New Payment Models

Roche CEO Severin Schwan says the process of paying for hugely expensive gene therapies that can cure diseases needs revamping.

Gene Therapy Pricing Strategies

Janssen India MD To Depart

Significant leadership change is underway at J&J India, with Janssen India chief Sanjiv Navangul on his way out. He will be succeeded by senior J&J hand, Sarthak Ranade, who will need to handle some delicate issues pertaining to Sirturo while also keeping the flow of innovative products from the parent company to India going.

Commercial Appointments

Policy & Regulation Explore this Topic

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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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Aptinyx Sees Path Forward In DPN With Long-Term Patients

After disappointing top-line Phase II data in diabetic peripheral neuropathy with NYX-2925, Aptinyx says the full dataset shows significance across endpoints in patients four years or more past diagnosis; a second Phase II study in this subgroup is planned.

Clinical Trials Business Strategies Research & Development

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

BIO-Europe Spring 2019: RedHill Preps NDA Submission For Antibiotic Talicia

Gilead Raday, chief operating officer of RedHill Biopharma, talks to Lucie Ellis, executive editor of In Vivo, about recently published late-stage data and next steps for its antibiotic asset, Talicia (RHB-105), for the treatment of Helicobacter pylori infection. 

Clinical Trials Infectious Diseases

Further Iclaprim Analyses Ahead Of Crucial Months For Motif Bio

A 3 May meeting with the FDA is likely to be crucial for the future commercialization strategy for the biotech’s precision-targeted antibacterial.

Infectious Diseases Clinical Trials
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