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

Pfizer Completes Acquisition of Small Molecule Anti-Infective Business From AstraZeneca

[Business Wire] – Pfizer Inc. today announced that it has completed the acquisition of the development and commercialization rights to AstraZeneca’s late-stage small molecule anti-infective business, primarily outside the United States.

Filed under: Company

Novartis out-licenses three COPD products in the US

EAST HANOVER, N.J., Dec. 21, 2016 /PRNewswire/ — Novartis announced today that it has signed a licensing agreement with Sunovion Pharmaceuticals Inc. (Sunovion) for the US commercial rights to its three treatments for chronic obstructive pulmonary disease (COPD),  Utibron™ Neohaler® (inda…

Filed under: COPD

FDA extends review of Genentech’s application for multiple sclerosis drug OCREVUS

The US Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) date for review of Genentech’s Biologics License Application (BLA) for OCREVUS (ocrelizumab) to March 28, 2017.

Filed under: MS

GSK commences phase III study for triple combination asthma therapy

GlaxoSmithKline (GSK) and Innoviva have started started a triple combination therapy phase III study for the treatment of asthma.

Filed under: Respiratory

Eli Lilly, Boehringer Launch Long-Acting Basal Insulin in U.S.

NewsBASAGLAR will be available by prescription from retail and mail order pharmacies across the U.S. Topics: Drug Pipeline

Filed under: Diabetes, Insulin

Eisai and Arena Pharmaceuticals Announce Regulatory Approval of BELVIQ® (lorcaserin HCl) in Brazil

WOODCLIFF LAKE, N.J. and SAN DIEGO, Dec. 19, 2016 /PRNewswire/ — Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that Eisai Laboratórios Ltda., a subsidiary of Eisai Inc., has received regulatory approval from the Brazilian Health Surveillance Agency (ANVISA)…

Filed under: Metabolic

Novartis to acquire Ziarco to expand dermatology portfolio

Novartis has agreed to acquire Ziarco Group, a privately held firm engaged in the development of novel treatments in dermatology.

Filed under: Company

CMS Halts Medicare Part B Drug Payment Demo

(MedPage Today) — Rheumatology, oncology groups cheer

Filed under: Payer

Merck kicks off consumer campaign for Keytruda

On the heels of Keytruda’s approval in first-line lung cancer, the drugmaker kicked off an unbranded campaign raising awareness about on biomarkers.

Filed under: Cancer, Immunotherapy

Lilly and AstraZeneca to Develop Second Potentially Disease-Modifying Treatment for Alzheimer’s Disease

INDIANAPOLIS, Dec. 9, 2016 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and AstraZeneca announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase 1 trials as a potential disease-modifying treatment for…

Filed under: Alzheimer’s