More Lost Than Gained In Shifting R&D Forecasts

Filed under: R&D

Janssen touts Xarelto’s broader uses, halts CV trial early

The blockbuster blood thinner has proven so effective at preventing heart attack and stroke in certain patients that a global phase 3 study is being stopped more than a year early.

Filed under: Cardiovascular

Propeller Health, Novartis to Develop Add-On Sensor for Breezhaler

Propeller Health, a Madison, WI-based startup that makes Internet-connected inhalers and sensors designed to help asthma and chronic obstructive pulmonary disease (COPD) patients, says it is teaming up with Novartis to build an add-on sensor for the Swiss pharma giant’s Breezhaler device. The agreement, announced on Wednesday, is focused on patients with COPD who live […]

Filed under: COPD

Immunotherapy Tops Cancer Advances Again

(MedPage Today) — Current, ongoing, future advances featured in ASCO report

Filed under: Cancer, Immunotherapy

EMA’s CHMP backs Pfizer’s Xeljanz for rheumatoid arthritis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Pfizer’s Xeljanz to treat rheumatoid arthritis (RA).

Filed under: Arthritis

AbbVie takes anti-tau drug into phase II for Alzheimer’s

Also testing
antibody in rare condition PSP, for which FDA has awarded
fast-track designation

Filed under: Alzheimer’s

Novartis reviewing options for Alcon, including possible spin-off

The Swiss pharma’s eye-care unit has struggled, spurring the review. At the same time, generic competition to Gleevec has put pressure on Novartis’ growth products.

Filed under: Company

J&J pondering future of diabetes device assets

Three diabetes
care subsidiaries under review as firm forecasts measured 2017 sales

Filed under: Diabetes

AstraZeneca expands 1st-line lung cancer Immuno-Oncology programme opportunities

AstraZeneca has provided an update on its Immuno-Oncology (IO) late-stage clinical development programme in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the Phase III MYSTIC trial. The MYSTIC trial was initially designed to assess the benefit of durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combination therapy versus

Filed under: Cancer, Immunotherapy

EMA validates Validates Gilead’s MAA for chronic hepatitis C therapy

The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.

Filed under: HCV

NICE supports use of asthma smartinhaler

NICE has published a Medtech Innovation Briefing recognising that Adherium’s Smartinhaler technology is more effective in improving adherence to asthma medication than current NHS practice.

Filed under: Respiratory

Kite inks China, Japan deals ahead of possible CAR-T drug approval

Through a joint venture with China’s Fosun Pharma, the CAR-T specialist gains a foothold for its lead drug candidate in the world’s second biggest pharmaceutical market.

Filed under: Cancer, Immunotherapy

AbbVie Unveils 4 Global R&D Collaborations Focused on Advancing Next-Gen Science

With more than 50 compounds in clinical development, AbbVie’s pipeline spans significant areas of medical need including oncology, immunology, neuroscience and virology.

Filed under: Company

Pieris Pharmaceuticals and Servier Forge Strategic Immuno-oncology Co-development Alliance

[Marketwired] – Pieris and Servier, an independent international pharmaceutical company headquartered in France with annual sales of more than EUR4 billion, to jointly pursue several bispecific therapeutic programs including …

Filed under: Cancer, Immunotherapy

US FDA issues final guidance on biosimilarity data use

The US FDA has published final guidance on the development and use of clinical pharmacology data for drugmakers to demonstrate biosimilarity.

Filed under: Biosimilar

Amgen Keeps Cholesterol Drug Patent vs. Regeneron

Filed under: Cardiovascular, PCSK9

Ionis Pharmaceuticals Reports Positive Data from Phase 2 Study of IONIS-GCGR Rx in Patients with Type 2 Diabetes

CARLSBAD, Calif., Jan. 4, 2017 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), today announced positive data from a Phase 2 study of IONIS-GCGRRx in 79 patients with type 2 diabetes. In this study, patients with type 2 diabetes uncontrolled on stable, maximal metformin…

Filed under: Diabetes

GSK targets COPD adherence with integrated inhaler sensors

Hopes real-time patient experience data will
improve clinical trial engagement

Filed under: COPD

Merck’s Zetia and Vytorin: More Generic Competition in 2017

Filed under: Cardiovascular

As R&D returns take a hit, some pharmas are ramping up spending

BioPharma Dive will be publishing several articles in the coming weeks focusing on R&D spending and comparing the dependence of some pharmas on revenue from best-selling drugs.

Filed under: R&D