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Shire's lanadelumab successful in late-stage HAE study; shares ahead 6% premarket

Shire plc (NASDAQ:SHPG) is up 6% premarket on increased volume in response to its announcement of positive results from a Phase 3 clinical trial, …

FDA Approves Keytruda Approved for Urothelial Carcinoma

Keytruda (pembrolizumab) was granted an approval by the Food and Drug Administration (FDA) to treat patients with locally advanced or metastatic …

Shire’s multibillion-dollar gamble on lanadelumab pays off with stellar PhIII data, quick marketing application

Flemming Ornskov<p>When Shire bought out Dyax for up to $6.5 billion in 2015, the big prize was a new drug for hereditary angioedema dubbed DX-2930 …

Nextgen

Tread carefully with altmetrics, European Commission told

Alternative metrics should be used by the European Commission alongside expert judgement and other measures of research quality, according to a new …

Assessing the importance of scientific work

ONE role academic journals have come to play that was not, as it were, part of their original job-description of disseminating scientific results …

Should Merck, BMS Fear Roche's Drug Becoming The I-O King?

<b>Background</b><p>Roche Holdings (OTCQX:RHHBY), the major subsidiary of which is the biotech giant Genentech, provided an informative review of operations …

Why Biosimilar Drug Names Contain Unhelpful Gibberish

Have you ever wondered how drugs are named? Is there ever a discernible meaning behind drug names? Who manages this mess anyway–drug companies, the FDA or perhaps some toddler with magnetic letters on a refrigerator?<p>Earlier this year, the FDA released its final rule (PDF here) on how companies …

Therapy Focus - Against The Odds, Cancer Vaccines Plough On

In spite of a near-100% track record of failure, and in the face of overwhelming scientific rationale to the contrary, late-stage development of …

Genentech doubles down on its PhIII Alzheimer’s campaign for crenezumab

Andrea Pfeifer<p>Roche’s big biotech group Genentech is doubling down on one of the most prominent drugs in late-stage development for Alzheimer’s. The …

Alzheimer's Disease

Exelixis, Bristol-Myers mount pivotal study of Cabo/Opdivo combo for frontline kidney cancer

Fouad Namouni, Bristol-Myers Squibb<p>Just days after reviewing a promising start combining Bristol-Myers Squibb’s checkpoint inhibitor Opdivo …

Bristol-Myers Squibb

Merck, Pfizer’s avelumab under review for Merkel cell carcinoma

Patients with Merkel cell carcinoma (MCC) are a step closer to having access to the first drug indicated for the disease after regulators in Europe …

Cancer

Pharmaceutical R&D Pipeline - Bristol-Myers Squibb

<b>Phase I</b> – clinical trials investigating safety of an investigational medicine in a small number of human subjects.<p><b>Phase II</b> – clinical trials …

Clinical Trials

BMS won't seek quick okay for Opdivo combo in lung cancer

<b>Bristol-Myers Squibb's hopes of carving out a slice of the first-line non-small cell lung cancer (NSCLC) market for its cancer immunotherapies have</b> …

Immunotherapy

Early-stage study shows encouraging results for Shire's candidate for hereditary angioedema; shares ahead 1% premarket

Results from a Phase 1b study assessing Shire plc's (NASDAQ:SHPG) lanadelumab for the treatment of a rare genetic disorder called hereditary …

FDA Grants Avelumab Priority Review for Metastatic Urothelial Carcinoma

Luciano Rossetti, MD<p>The FDA has granted a priority review to a biologics license application (BLA) for avelumab for the treatment of patients with …

Cancer

UK rejects Merck's Keytruda as initial treatment for lung cancer

LONDON (Reuters) - Britain’s healthcare watchdog NICE, which assesses the cost-effectiveness of medical treatments, has stopped short of recommending the use by the National Health Service (NHS) of Merck & Co Inc’s immunotherapy drug Keytruda in newly diagnosed lung cancer patients, after giving …

Roche's Renal Success Spells Danger For All-Comer Studies

Patient selection by PD-L1 status could be necessary for developing checkpoint inhibitors in first-line renal cell carcinoma, if data from Roche’s …

Bristol-Myers staggered by a stunning checkpoint setback, hands Merck a free pass on frontline lung cancer combo

Bristol-Myers Squibb $BMY fans can scratch any hopes of an accelerated filing for a combination of Opdivo and Yervoy as a frontline therapy for lung …

line lung cancer Immuno-Oncology programme opportunities

17 January 2017<p><b>Refined endpoints and statistical analysis plan in the Phase III MYSTIC trial</b><p><b>China regulatory submission opportunity strengthened with</b> …

Immune System

The Threats And Opportunities In NASH: What Next For Allergan?

Allergan stepped in the NASH space with the acquisitions of Tobira and Akarna announced in November 2016 for around $650M of upfront payment plus …

European Ad Comm backs Roche's Alecensa for certain type of lung cancer

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Roche's …

Cautious Optimism for Biosimilars in Rheumatology

(MedPage Today) -- Price discounts likely to be modest for Inflectra and others

Keep Your Patients Engaged And Help Improve Their Lives

A new year is almost upon us and with brings new opportunities to help your patients become more involved when it comes to their health. Why is it so …

More Progress for Novel PCSK9 Drug

(MedPage Today) -- RNAi-based synthesis inhibitor appears headed to phase III trials

Mobile Apps in Oncology: A Survey on Health Care Professionals’ Attitude Toward Telemedicine, mHealth, and Oncological Apps

Background: Mobile apps are an evolving trend in the medical field. To date, few apps in an oncological context exist. Objective: The aim was to …

Digital Health

Smartphones Bring Digital Transformation to the Physician’s Examining Room

Advances in medical technology have given clinicians ways find the genetic cause of disease and, in some cases, precisely match a drug to the precise …

GlaxoSmithKline initiates late-stage programme for experimental anaemia drug daprodustat

GlaxoSmithKline on Thursday announced the start of Phase III testing for daprodustat as a potential treatment for anaemia associated with chronic …

After a painful stumble, AstraZeneca gets top checkpoint cancer program back on track

The FDA has lifted the partial hold it dropped on AstraZeneca’s top pipeline drug durvalumab a month ago, allowing investigators to resume recruiting …

Novartis swoops in to bag Selexys and its sickle cell drug in $665M deal

Bruno Strigini, CEO Novartis Oncology<p>Whatever Oklahoma City-based Selexys Pharmaceuticals just saw in its newly-wrapped Phase II study for sickle …