FDA authorizes first direct-to-consumer genetic test panel for predisposition to Alzheimer’s disease and other serious disorders

The FDA has announced its decision to grant a de novo application submitted by 23andMe for the company’s direct-to-consumer (DTC) Personal Genome Service Genetic Health Risk (“GHR") tests. The GHR test panel currently includes genetic variants…By: DLA Piper

Filed under: Alzheimer’s

Boehringer looks to cancer immunotherapy combinations

BI developing combinations with its own checkpoint inhibitors
The post Boehringer looks to cancer immunotherapy combinations appeared first on Pharmaphorum.

Filed under: Cancer, Immunotherapy

Novartis Aims to Turn Around Its Surgical Business in 2017

Filed under: Company

Endo 2017: Sanofi Presents New Observational Study Data for Toujeo in Type 2 Diabetes

NewsComplementing these observational studies in routine clinical practice and the EDITION program of Phase 3 clinical trials.Topics: Drug Discovery

Filed under: Diabetes

New guidelines to make China a more drug-friendly market

CFDA announces draft guidelines that would allow Phase I trials in China to encourage simultaneous development alongside global trials.

Filed under: Emerging Markets

CMS Will Give Labs More Time to Report PAMA-Required Payor Data

Filed under: Payer

FDA Grants Priority Review to Novartis’s CAR-T Cell Therapy

NewsThe priority review designation is expected to shorten the anticipated review time by the FDA.Topics: Drug Pipeline

Filed under: Cancer, Immunotherapy

Merck advances R&D strategy through unique development model with Avillion for Anti IL-17 A/F Nanobody

Merck, a leading science and technology company, today announced a development agreement with Avillion, a UK-based company focused on increasing R&D output through innovative models, for anti IL-17 A/F Nanobody®. Merck’s Anti IL-17 A/F Nanobody® is an investigational therapy which has completed Phase I development, and is expected to begin Phase II in plaque psoriasis in 2017.

Filed under: R&D

AZ gets rapid approval in China for Tagrisso

Lung cancer treatment becomes first medicine to pass through the country’s Priority Review pathway

Filed under: Emerging Markets

Japan Grants Priority Review to AbbVie’s Investigational Regimen for all Major HCV Genotypes

NewsThe Japanese MHLW designates priority review to certain medicines based on the clinical usefulness of the treatment and severity of the disease. Topics: Drug Pipeline

Filed under: HCV

Amgen wins European approval for Humira biosimilar Amgevita

European Commission approves the first version of AbbVie’s blockbuster

Filed under: Biosimilar

Drug prices set to increase on ‘essential medicines’ list in India

The annual review of drug prices will see the price of drugs, on the National List of Essential Medicines, increase by just under 2%. The Indian Government has strict measures to control the pricing of drug prices, something that the Indian pharmaceutical industry has found increasingly difficult, with the latest price increases set to bring medicines in-line with inflation.
read more

Filed under: Emerging Markets

iMedicalApps: Diabetes App Cleared for OTC Use

(MedPage Today) — Helps with self-care in type 2 patients, delivers reports to providers

Filed under: Diabetes

PD-1 and IDO Inhibitor Combo Slated to Change Practice in Melanoma

Thomas F. Gajewski, MD, PhD, discusses how the combination of PD-1 and IDO inhibitors could change the standard of care for patients with melanoma, and highlights other emerging targets on the horizon.

Filed under: Cancer, Immunotherapy

Gene Therapy for Rare Diseases: Challenges and opportunities encountered

LONDON, March 21, 2017 /PRNewswire/ — Throughout the past decade, the orphan drug landscape has undergone a considerable amount of maturing. As a result, an increasing amount of orphan drugs are being approved, while pharma and biotech’s get closer to revealing new and innovative…

Filed under: General

Lilly offers up drug pricing details amid ongoing scrutiny of industry

Following criticism over the cost of its insulin drugs, the company gave a glimpse into its pricing decisions in an annual report.

Filed under: Pricing

Siemens Healthineers Gets FDA Premarket Approval for HCV Genotyping Test

Filed under: HCV

AstraZeneca study shows cardiovascular benefit to SGLT-2 drugs

The British pharma hopes the results, assessed from real-world data, will help boost use of the newer class of diabetes drugs.

Filed under: Diabetes, SGLT-2

Genentech plans second Phase 3 Alzheimer’s trial following endpoint failures

Genentech, Roche’s biotech group, has announced its plans to conduct a second Phase 3 study for crenezumab, its anti-Abeta antibody for the treatment of early Alzheimer’s disease.
The trial is designed to further elucidate earlier traces data on the drug’s efficacy in treating Alzheimer’s; crenezumab failed to meet its primary endpoint of slowing cognitive degeneration in mild-to-moderate forms of the disease in two 2014 Phase 2 studies, but did show promise as a treatment in the earliest stages.
read more

Filed under: Alzheimer’s

Circassia signs deal for US rights to two AstraZeneca COPD drugs

UK-based Circassia Pharmaceuticals has agreed to pay up to $230m for certain US commercial rights for Tudorza and Duaklir, two drugs developed by AstraZeneca to treat chronic obstructive pulmonary disease (COPD).

Filed under: COPD