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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 Commercial

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 Research & Development

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 Commercial
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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 India

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 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

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

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

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

CymaBay Following The Leaders, Pursues NASH, PBC Simultaneously

Biotech thinks its PPAR delta agonist will prove much more potent than Genfit’s elafibranor from the same class and will offer a better tolerability profile than Intercept’s OCA.

Liver & Hepatic Business Strategies

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

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Cassiopea Hails Breezula's 'Good Hair Day' And Plans FDA Talks On Phase III

Italy-based Cassiopea says “very positive results” from Breezula's 12-month Phase II alopecia trial support progressing  it to Phase III, particularly given the clean safety profile.

Clinical Trials Companies Dermatology

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

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

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
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