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Thursday, December 12, 2019

FDA approves Elite Pharma and SunGen’s generic Adderall XR

Elite Pharmaceuticals (OTCQB:ELTP) has received FDA approval for a generic version of Shire’s Adderall XR, an extended-release mixed salt of a single entity Amphetamine product with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets.
The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder.
According to IQVIA, the branded product and its equivalents had total U.S. sales of $1.3B for year ended October 2019.
Generic Adderall XR is jointly owned and the second product of Elite and SunGen Pharma collaboration.

Grifols launches subcutaneously administered immunoglobulin

Grifols S.A. (OTCPK:GIKLYlaunches Xembify (immune globulin subcutaneous human-klhw), its first 20% subcutaneous immunoglobulin therapy for the treatment of patients at least two-year-olds with primary immunodeficiency.

Y-mAbs neuroblastoma vaccine nabs accelerated review status in U.S.

The FDA designates Y-mAbs Therapeutics’ (NASDAQ:YMAB) GD2-GD3 Vaccine for neuroblastoma a Rare Pediatric Disease product.
Rare Pediatric Disease status provides for the issuance of a rare pediatric disease priority review voucher following FDA approval. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.
The bivalent vaccine, in-licensed from MabVax Therapeutics Holdings (OTCPK:MBVXQ), is being evaluated in an escalating-dose Phase 1/2 clinical trial in high-risk patients. The estimated completion date is May 2020.

Gritstone down 15% on data on lead candidates

Thinly traded micro cap Gritstone Oncology (GRTS -14.6%) slumps on modestly higher volume in early trade on the heels of preliminary data from early-stage studies evaluating lead candidate GRANITE and candidate #2 SLATE. The results, apparently disappointing investors, were presented at ESMO IO in Geneva.
Interim data from the first stage of the Phase 1/2 GO-004 trial showed that GRANITE induced “large numbers” of CD8+ T cells against multiple neoantigens in four solid tumor patients. No dose-limiting toxicities related to either GRANITE or SLATE were noted.
Safety data from the first stage of the Phase 1/2 GO-005 study are still preliminary with one case of injection site reaction and one case of pruritis (itchy skin) reported in patients receiving SLATE.
GRANITE and SLATE are both personalized neoantigen-based immunotherapies. SLATE, an off-the-shelf alternative to GRANITE, utilizes the same antigen delivery system but contains a fixed set of neoantigens that are shared across a subset of cancer patients rather than neoantigens unique to a particular patient.

Kaleido Bio up 11% on advancement of KB174

Thinly traded micro cap Kaleido Biosciences (KLDO +10.5%) is up on below-average volume, a modest 39K shares, on the heels of its announced advancement of candidate KB174 for the potential treatment of hepatic encephalopathy, a decline in brain function due to severe liver disease.
The company made its decision based on results from a proof-of-concept study that showed a 26% reduction in a biomarker of microbiome ammonia production in patients with well-compensated cirrhosis while being well-tolerated.
KB174, one of the company’s Microbiome Metabolic Therapy (MMT) candidates, is designed to lower ammonia and multidrug-resistant pathogens in the body by modulating the metabolic output and profile of the microbiome.

Critics says government contract gifts NHS data to Amazon

A deal signed in the summer between the UK government and Amazon has been criticised after it emerged NHS data is being provided to the tech giant free of charge.
Back in July, the contract to deploy Amazon’s Alexa voice-assisted technology to provide healthcare information to the public was billed as a way to reduce the pressure on the NHS – particularly GPs and pharmacists – by providing information about common illnesses.
At the time Amazon was expected to gain access only to basic healthcare information on symptoms, causes and medical definitions etc, in order to allow Alexa to offer verified advice.
Since then, freedom of information requests by consumer advocacy group Privacy International has revealed that the terms also give Amazon access to all the content on the NHS website, including “all related copyrightable content, data, information and other materials”, as well as full access to the NHS Application Programming Interface (API).
The contract (now available online) has been heavily redacted so the full extent of what the NHS is granting Amazon may go further still, but is effectively “offering free advertisement to a company with a worrying track record on privacy – as well as on paying taxes,” says the group.
Amazon is also free to create new money-making products and services that could be rolled out in the UK and internationally – using data generated at the UK taxpayer’s expense – with no financial benefit coming back to the NHS.
“As Amazon is already making or planning to make moves into healthcare, we find this alarming,” says Privacy International, and it “also raises questions when it comes to competition regulation of dominant players in the digital era.”
“With their business model relying increasingly on the availability of consumers’ data, dominant online platforms can engage in various forms of data exploitation or even impose unfair terms for consumers,” it adds.
The NHS insists no patient data is being shared with the US tech giant, and Amazon has said that its access to data is restricted to what is on the NHS.uk website.
“Alexa does not have access to any personal or private information from the NHS. General health-related content from the NHS website has been freely available to the public and is now available to Alexa users via voice technology.
The Amazon contract was agreed just before an Ernst and Young report suggested data contained in NHS patient records could be worth several billion pounds to commercial organisations.

AstraZeneca Imfinzi Approved in China for Stage III Nonsmall-Cell Lung Cancer

AstraZeneca PLC (AZN.LN) said Thursday that it has received marketing authorization from China’s national medical products administration for Imfinzi for the treatment of patients with stage III nonsmall-cell lung cancer.
The U.K. pharmaceuticals company said approval of Imfinzi is based on results from the primary analysis of progression-free survival and supported by overall survival from the Phase III Pacific trial.