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BI/Lilly's Jardiance Is First Diabetes Drug With CV Benefit Claim

Companies are supporting new US-labeled indication for cardiovascular mortality risk reduction with a consumer education campaign, direct-to-consumer advertising and cardiologist detailing.

Approvals Advertising, Marketing & Sales Metabolic Disorders

AstraZeneca Puts Bicycles To Work In Multitarget Deal

AstraZeneca has entered a broad early stage collaboration with Bicycle Therapeutics to discover and develop bicyclic peptides (Bicycles). If all aspects of the multitarget deal reach fruition, the deal could be worth up to £1bn for the small biotech company.

BioPharmaceutical Commercial

Cinfa Outlines Biosimilar Development Areas, Deal Opportunities

Cinfa Biotech's managing director, Ruediger Jankowsky, chats to Mike Ward, global director of content for Informa Pharma Intelligence, about the company's founding and focus on biosimilar drug development.

Biosimilars Business Strategies Commercial

Industry’s Achievements Lauded At 12th Annual Scrip Awards

The world’s political tectonic plates may be shifting, but this has done little to undermine the achievements of the pharma, biotech and allied industries over the past year, and last night we celebrated the best of these at the 12th annual Scrip Awards in London.

Companies BioPharmaceutical Research & Development

 Recent Tweets from Scrip

Commercial Explore this Topic

Pfizer's Herceptin Biosimilar Moving Forward Amid Rising Competition

Pfizer hopes positive top-line Phase III trial data on its Herceptin (trastuzumab) biosimilar can help it tap the lucrative market in HER2-overexpressing cancers, but analysts say that therapeutic space looks increasingly crowded with no clear favorite yet in sight.

Biosimilars Cancer Clinical Trials

New CNS-Focused Biotech Cerevance Launches With Takeda Backing

Takeda invests in CNS startup, Cerevance, as part of its externalized R&D strategy.

Deals Neurology Financing

Latest From Commercial

Novartis, Kite Neck-And-Neck In CAR-T Race; Deaths Keep Juno In Third Place

Novartis and Kite both are set to submit their CD19-targeting CAR-T therapies for US FDA approval in early 2017, while neurotoxic deaths for two of Juno’s product candidates cast doubts on its programs.

Business Strategies Clinical Trials

First US Branded Ophthalmic Launch A ‘Milestone’ For Sun

India’s biggest drug firm Sun has just launched its first branded ophthalmic product in the US, marking what the company calls “a milestone” in its quest to build scale and seek steady revenue streams in the global specialty drug business.

Launches Ophthalmic

Deal Watch: Merck Digging Into Epigenetics With Proteros Partnership

Merck could pay up to $167m to try a new epigenetic target, which would build on its existing HDAC inhibitor. Meanwhile, Celgene buys epigenetics-focused Acetylon, which will spin out new company Regenacy to work with its lead HDAC6 inhibitor outside of oncology.

Deals M & A

Xencor's Coming Share Issue To Help Fund Immuno-Oncology Pipeline

Monrovia, California-based Xencor Inc.'s latest funding exercise is a public share offering to raise some $110m after expenses to advance its immuno-oncology pipeline.

Companies Commercial

Which Biopharmas Are Best Positioned For Five-Year Growth?

Morningstar expects 229% revenue growth during the 2015-2020 period for BioMarin, far stronger than larger competitors. Virology powerhouse Gilead is the only one of the 20 largest biopharmas expected to face a decline in revenue over the period.

Market Intelligence Business Strategies

Trump Win Is False Security For Drug Makers, Allergan CEO Warns

Industry should act on drug pricing now while there is a post-election reprieve, Allergan CEO Brent Saunders said during the Forbes Healthcare Summit. Trump is a populist who will jump on the next big pricing scandal, he said.

Pricing Debate Commercial

Policy & Regulation Explore this Topic

Merck's Keytruda Wins NSCLC Edge Over BMS' Opdivo

NICE has changed its mind and provisionally recommended Merck's Keytruda for non-small-cell lung cancer thanks to a discount. The news means Merck could gain an edge over rival drug Opdivo from BMS, which has so far had less success with NICE.

Market Access Companies Cancer

NICE Gives Nucala Initial OK In Severe Asthma After GSK Offers Price Cut

Adult patients with severe eosinophilic asthma in England and Wales look set to get a much needed treatment option following NICE's provisional backing of GlaxoSmithKline's new MAb therapy.

Cost Effectiveness Respiratory Reimbursement

Latest From Policy & Regulation

Pfizer’s Avelumab Poised For Speedy Review By FDA

Avelumab could be the fourth PD-1/L1 inhibitor to reach the market now that the US FDA has accepted Pfizer’s and Merck KGaA’s BLA for priority review in the treatment of metastatic Merkel cell carcinoma.

Cancer BioPharmaceutical

GOLD Pushes LABA/LAMA Class In New COPD Treatment Update

New guidelines for the treatment of COPD could change the way this serious condition is managed, with knock-on effects for pharma companies with respiratory franchises.

Respiratory Companies

AbbVie's Humira Tops NHS Drug Spend List

A National Health Service spending report reveals the top 20 most expensive NICE approved drugs in England for 2016.

Pricing Strategies Reimbursement

Amid Brexit Chaos, UK PM Promises More R&D Funding, Lower Taxes, And Other Pro-Innovation Measures

The UK prime minister has promised more government R&D funding and other incentives in an attempt to reassure businesses worried by the uncertainty created by the Brexit vote. The move comes shortly before the Chancellor’s autumn statement and the next meeting of the UK EU Life Sciences Steering Group.

Brexit Innovation

Teva Under Pressure As NICE Calls For More Reslizumab Analyses

UK HTA body NICE has called for clarifications and updated analyses in draft guidance on Teva’s MAb biologic Cinqaero, a decision that may give heart to potential competitors in the race to dominate the eosinophilic asthma market.

Market Intelligence Health Technology Assessment

Australia Needs Stronger Leadership For Biotech To Prosper

As Australia ends a resources boom, a decline in manufacturing has left the country vulnerable, and a concerted investment in biotechnology could transform the country, according to a new report.

Australia Policy

Research & Development Explore this Topic

Pipeline Watch: Phase III Progress With Biosimilar Adalimumab And Trastuzumab

Pipeline Watch has been updated to bring greater depth and detail to a potential therapeutic product’s progress through the R&D pipeline. The table brings you a snapshot of selected late-stage clinical trial events in the pharma and biotech industries.

Pipeline Watch Clinical Trials Approvals

GSK Kicks Off Two Large Outcomes Trials In A Competitive CKD Category

The company initiated a Phase III development program for the oral HIF-PH inhibitor daprodustat as a treatment for anemia associated with chronic kidney disease. Two trials will enroll 7,500 patients.

Blood & Coagulation Disorders Clinical Trials Commercial

Latest From Research & Development

Novartis, Kite Neck-And-Neck In CAR-T Race; Deaths Keep Juno In Third Place

Novartis and Kite both are set to submit their CD19-targeting CAR-T therapies for US FDA approval in early 2017, while neurotoxic deaths for two of Juno’s product candidates cast doubts on its programs.

Business Strategies Clinical Trials

New Drugs Aim To Move Needle In Tough-to-Treat Acute Myeloid Leukemia

Response rates for candidates from Stemline, Seattle Genetics and Karyopharm look highly encouraging, but the real test in AML will be survival, as the field is still in the shadow of Pfizer's failed Mylotarg.

Cancer Clinical Trials

Watson Health And Pfizer Partner To Harness Big Data For Drug Discovery

The advanced data analytics provider IBM Watson Health has signed its first big pharma partner – Pfizer – for a new drug discovery tool, with a focus on immuno-oncology.

ImmunoOncology Research and Development Strategies

Arrowhead Misfires: Abandons Clinical Programs, But Keeps Amgen Deal

Arrowhead Pharmaceuticals shifts focus to subcutaneous platform after abandoning lead hepatitis B program and related products due to toxicity concerns, resolving to lay off 30% of staff.

Commercial Liver & Hepatic

MiNA Pursuing The Other Side Of RNA Interference With Small Activating RNA Approach

London biotech seeks to up-regulate CEBP alpha gene in the liver to provide a therapeutic option for patients with both cirrhosis and hepatocellular carcinoma. MiNA’s first candidate is in Phase I and should move into a pair of Phase II trials in 2017.

StartUps and SMEs Platform Technologies

The P5 Partnership Starts First Phase III HIV Vaccine Study

The P5 public-private-partnership that includes Sanofi and GlaxoSmithKline has started a pivotal Phase II/III study of a two-vaccine approach to HIV infection prevention, that could be the final nail in the coffin for HIV-AIDS if it works or yet another unwelcome victory for the virus if it doesn’t.

Clinical Trials Research & Development