Pharminent

Teva secures European approval for severe asthma drug Cinqaero

Teva Pharmaceutical Industries has secured marketing authorization from the European Commission for Cinqaero (reslizumab) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. http://regulatoryaffairs.pharmaceutical-business-review.com/news/teva-secures-european-approval-for-severe-asthma-drug-cinqaero-190816-4983521

Filed under: Respiratory

FDA Delays Approval of Portola’s NOAC Reversal Drug

(MedPage Today) — Agency wants more information http://www.medpagetoday.com/Cardiology/CardioBrief/59741

Filed under: Cardiovascular

Amgen and Advaxis enter global cancer immunotherapies collaboration

Amgen (NASDAQ:AMGN) and Advaxis, Inc. (NASDAQ:ADXS) announced a global agreement for the development and commercialization of Advaxis’ ADXS-NEO, a novel, preclinical investigational cancer immunotherapy treatment that is designed to activate a patient’s immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient’s tumor. http://www.worldpharmanews.com/amgen/3588-amgen-and-advaxis-enter-global-cancer-immunotherapies-collaboration

Filed under: Cancer, Immunotherapy

Novartis plans major expansion of French antibody facility

Project aims to boost capacity by 70% and create new jobs http://www.pmlive.com/pharma_news/novartis_plans_major_expansion_of_french_antibody_facility_1099432

Filed under: Company

AstraZeneca wins UK cost approval for longer use of heart drug

LONDON (Reuters) – Long term use of AstraZeneca’s blood thinner Brilinta has been recommended as a cost-effective option for treating patients after a heart attack, Britain’s healthcare cost watchdog NICE said on Friday.
http://www.reuters.com/article/us-astrazeneca-britain-idUSKCN10M2LY

Filed under: Cardiovascular

Analysts: Payers moving to address MS market as prices rise

The impending payer crackdown of the cost of MS drugs could portend the fate of other specialty drug markets, according to analysts. http://www.mmm-online.com/analysts-payers-moving-to-address-ms-market-as-prices-rise/article/515426/

Filed under: MS

In China, IBM Watson To Aid 12,000 Daily Cancer Diagnoses

IBM is bringing its Watson artificial intelligence system to China through a cancer treatment partnership with Hangzhou CognitiveCare, which will work with hospitals across China to improve oncology services and speed diagnosis. http://www.forbes.com/sites/brucejapsen/2016/08/11/in-china-ibm-watson-to-aid-12000-daily-cancer-diagnoses/

Filed under: Emerging Markets

MannKind maps out Afrezza strategy

After Sanofi broke off its partnership, Mannkind has scaled up to meet the demands of marketing Afrezza by itself. But a turnaround is going to take more than just resources.  http://www.biopharmadive.com/news/mannkind-maps-out-afrezza-strategy/424216/

Filed under: Diabetes, Insulin

Highly curative hep C treatment safe, effective for drug users

Hep C patients being treated for opioid addiction achieved high rates of sustained virologic response after 12 weeks of therapy with elbasvir-grazoprevir compared to those taking placebo for 12 weeks before beginning the drug treatment. The patients in the elbasvir-grazoprevir group saw a reduced viral load, regardless of ongoing drug use. https://www.sciencedaily.com/releases/2016/08/160809095006.htm

Filed under: HCV

Merck locks up another cancer approval for Keytruda

Merck’s latest success comes on the heels of Bristol-Myers Squibb’s CheckMate-026 failure in non-small cell lung cancer.  http://www.biopharmadive.com/news/merck-locks-up-another-cancer-approval-for-keytruda/424012/

Filed under: Cancer, Immunotherapy

Eisai: FDA confirms enough data to move Alzheimer’s drug to Phase III studies

TOKYO (Reuters) – Japan’s Eisai Co said on Tuesday the U.S. Food and Drug Administration had confirmed that there was sufficient data to start Phase III studies of a drug it is co-developing to treat early Alzheimer’s disease.
http://www.reuters.com/article/us-eisai-biogen-alzheimers-idUSKCN10K0LX

Filed under: Alzheimer’s

AstraZeneca Provides Update On Phase III Trial Of Selumetinib In Non-Small Cell Lung Cancer

BOULDER, Colo., Aug. 9, 2016 /PRNewswire/ — AstraZeneca (LON/STO/NYSE: AZN) today announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive… http://www.prnewswire.com/news-releases/astrazeneca-provides-update-on-phase-iii-trial-of-selumetinib-in-non-small-cell-lung-cancer-300310826.html

Filed under: Cancer, Immunotherapy

Mesoblast cell treatment shows promise in rheumatoid arthritis : study

(Reuters) – Mesoblast Ltd on Monday said its experimental stem-cell treatment led to significant improvements of symptoms and disease activity in patients whose rheumatoid arthritis had stopped being helped by widely used biotech medicines, according to data from a mid-stage trial.
http://www.reuters.com/article/us-mesoblast-arthritis-idUSKCN10J2I5

Filed under: Arthritis

CVS Health Formularies to Favor Biosimilars, Follow-ons

(MedPage Today) — Competition begins to weigh on pioneer biologics http://www.medpagetoday.com/PublicHealthPolicy/GeneralProfessionalIssues/59582

Filed under: Biosimilar

How to Label Biosimilars: Groups Disagree

The drug industry, the AARP and pharmacists disagree on what information should be included in biosimilar… http://www.bna.com/label-biosimilars-groups-b73014446026/

Filed under: Biosimilar

Bristol-Myers’ High Risk Opdivo Lung Cancer Study Shows Challenges Of Clinical Trials

Merck clearly took the safer route with its NSCLC clinical trial design with Keytruda by selecting a subset of patients most likely to benefit from its drug. But, from a scientific standpoint, the BMS study has importantly contributed to the body of knowledge being generated by these exciting immune-oncology drugs and will help guide oncologists in how best to treat NSCLC patients. http://www.forbes.com/sites/johnlamattina/2016/08/08/bristol-myers-high-risk-opdivo-lung-cancer-study-shows-challenges-of-clinical-trials/

Filed under: Cancer, Immunotherapy

Novartis’ fevipiprant hailed a “game-changer” in asthma treatment

Researchers are hailing Novartis’ fevipiprant (QAW039) as a game-changer in asthma treatment after a Lancet-published trial showed its potential to significantly reduce the severity of the condition. http://www.pharmatimes.com/news/novartis_fevipiprant_hailed_a_game-changer_in_asthma_treatment_1092300

Filed under: Respiratory

MSD files Lantus biosimilar with FDA

MSD, known as Merck in the US and Canada, has filed a new drug application with the US Food and Drug Administration (FDA) for MK-1293, a biosimilar candidate for Sanofi’s Lantus (insulin glargine) in the treatment of type-1 and type-2 diabetes.
http://www.pharmafile.com/news/506218/msd-files-lantus-biosimilar-fda

Filed under: Biosimilar

PBMs push forward toward outcomes-based pricing, despite challenges

The implementation of a broad outcomes-based pricing scheme is a wildly, almost gratuitously complicated project. http://www.mmm-online.com/pbms-push-forward-toward-outcomes-based-pricing-despite-challenges/article/513442/

Filed under: Payer

When to Avoid Apixaban Dose Reductions in AF: ARISTOTLE Insights

“These data send a strong message to clinicians that apixaban and the other direct oral anticoagulants have to be given at the right dose for the individual patient,” an expert says. Heartwire from Medscape http://www.medscape.com/viewarticle/867075

Filed under: Cardiovascular

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