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Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD
Published:

GvHD is a potentially life-threatening medical complication, which can affect patients receiving such transplants to treat certain genetic diseases and haematologic cancers. Orencia is an immunomodulator that disturbs

The post Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD appeared first on Pharmaceutical Business review.

Gatehouse Bio collaborates with AstraZeneca to accelerate new drug discovery
Published:

Gatehouse Bio’s ‘sRNAlytics platform’ identifies novel small RNA (sRNA) signatures and illuminates molecular pathways correlated to and potentially driving disease. “Our annotation library of over 1.4M small RNA

The post Gatehouse Bio collaborates with AstraZeneca to accelerate new drug discovery appeared first on Pharmaceutical Business review.

AWS announces strategic collaboration with Novartis to accelerate digital transformation of its business operations
Published:

This enterprise-wide data and analytics platform is expected to form the foundation for custom solutions powered by AWS AI and ML services to help drive agility, innovation, and

The post AWS announces strategic collaboration with Novartis to accelerate digital transformation of its business operations appeared first on Pharmaceutical Business review.

Biogen divulges more data on Alzheimer’s trials
Published: 5 Dec 2019 | 19:14 UTC

Biotech’s shares fluctuate as it tries to win over sceptics of aducanumab

Biogen divulges more data on Alzheimer’s trials
Published: 5 Dec 2019 | 19:14 UTC

Biotech’s shares fluctuate as it tries to win over sceptics of aducanumab

Novartis highlights emerging assets and late-stage pipeline at R&D day
Published: 5 Dec 2019 | 12:18 UTC

Also plans to expand established brands into new indications

New typhoid vaccine could transform fight against the infection
Published: 5 Dec 2019 | 11:19 UTC

Could help to prevent millions of cases worldwide

Lynparza cleared for first-line ovarian cancer use in China
Published: 5 Dec 2019 | 10:57 UTC

Continues to cement lead in PARP inhibitor category

INTCR 2020 Executive Steering Group Chair shares insight into this ever-growing competition
Published: 5 Dec 2019 | 9:27 UTC

Flying the flag for clinical research for over 20 years, this competition continues to grow and develop year after year.

Late-stage Ibsrela success for Ardelyx
Published: 5 Dec 2019 | 9:18 UTC

If approved, the drug will be the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis.

EMA to review Amarin’s Vascepa filing
Published: 5 Dec 2019 | 9:14 UTC

The fish oil-derived therapy is already approved in the US for patients with severe hypertriglyceridaemia.

Pivot Pharmaceuticals re-brands as BetterLife Pharma Inc
Published: 5 Dec 2019 | 0:00 UTC

Pivot Pharmaceuticals Inc.announced its corporate name change to BetterLife Pharma Inc.

BioSpace Global Roundup, Dec. 5
Published: 5 Dec 2019 | 0:00 UTC

Companies from across the globe provide updates on their business and pipelines.

Meitheal Pharmaceuticals Announces FDA Approval of Enoxaparin Sodium Injection, USP in the United States
Published: 5 Dec 2019 | 0:00 UTC

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox®.

ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
Published: 5 Dec 2019 | 0:00 UTC

Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.

FDA approves first generics of Gilenya
Published: 5 Dec 2019 | 0:00 UTC

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

Arecor Announces Positive Headline Results for the First Phase I Clinical Trial of AT247, a Novel Ultra Rapid Acting Formulation of Insulin Favourable pharmacokinetic/pharmacodynamic profile compared to current best in class insulin treatment
Published: 5 Dec 2019 | 0:00 UTC

Arecor Limited announces positive headline results for the Phase I clinical trial of its ultra-rapid acting insulin product candidate, AT247.

Trump administration willing to drop USMCA pharma provisions
Published: 4 Dec 2019 | 7:09 UTC

Bid to win support from Democrats in deal seen as template for future negotiations

Trump administration willing to drop USMCA pharma provisions
Published: 4 Dec 2019 | 7:09 UTC

Bid to win support from Democrats in deal seen as template for future negotiations

How pot stocks lost their highs
Published: 4 Dec 2019 | 4:00 UTC

Momentum has stalled in key markets such as New York, New Jersey and Connecticut

How pot stocks lost their highs
Published: 4 Dec 2019 | 4:00 UTC

Momentum has stalled in key markets such as New York, New Jersey and Connecticut

FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Published: 3 Dec 2019 | 20:12 UTC

South San Francisco, CA -- December 3, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy...

FDA Approves RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
Published: 2 Dec 2019 | 20:12 UTC

NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for RediTrex, its new...

Tories can’t be trusted to look after the NHS | Letters
Published: 1 Dec 2019 | 18:25 UTC

Only Labour’s policies can help solve the healthcare crisis, write 12 nurses. Plus, Dr Robert Oulton says NHS England’s latest reorganisation needs scrutiny, Fiona Henderson worries about price rises in a drug crucial for her husband, and Dr Andrew Hill offers ideas on how to protect the NHS in UK-US trade deals

We are frontline nurses who have faced the reality of government mismanagement over the disastrous years of coalition and Conservatism.

The outlandish and widely ridiculed promise from the Conservatives to recruit 50,000 more nurses (If voters think all politicians lie, then the Tories win, Journal, 30 November) would be unnecessary had they not spent the last nine years driving services and staff to breaking point. Tens of thousands of nursing posts remain vacant, impacting severely on the quality of care our patients deserve. Our colleagues face unprecedented levels of stress and distress in their work, with little support or insight from government.

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There’s a simple way to protect the NHS from US trade negotiators | Emily Jones
Published: 1 Dec 2019 | 14:45 UTC

Pass a law stating the health service is not on the table – this would allow UK negotiators to declare the whole area off limits

No wonder there is alarm when we hear the NHS is on the negotiating table in UK-US talks. In the US, citizens struggle to afford their prescriptions, and medical bills are so high that they are a leading cause of bankruptcy. The US spends more per person on medicines than anywhere else in the world.

The US pharmaceutical industry is large and politically powerful, and the US uses trade deals to pressure other countries to follow its approach to regulation. Throughout this election the Conservative party has made repeated claims that “the NHS is off the negotiating table”, but has not followed up with any efforts to turn this promise into reality.

Related: A US trade deal could cost the NHS tens of millions. My investigation shows how | Antony Barnett

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The Guardian view on Boris Johnson and the NHS: a problem of trust | Editorial
Published: 27 Nov 2019 | 18:56 UTC

The prime minister’s promise to protect the health service in trade talks is made worthless by his record of lies and broken pledges

Whether Conservatives can be trusted with the NHS is an old question at election time. Whether Boris Johnson can be trusted on anything is an issue for the current campaign. The two questions make a dangerous combination for the Tory leader, who is expecting the country to believe that he would protect the health service in a post-Brexit trade deal with Donald Trump.

There is not much reason to believe that he would. On Wednesday Labour sought to probe that concern, revealing documents containing a full account of preliminary discussions between US and UK officials.

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Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy
Published: 26 Nov 2019 | 3:11 UTC

SAN DIEGO, Nov. 26, 2019 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug...

FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease
Published: 25 Nov 2019 | 21:11 UTC

SOUTH SAN FRANCISCO, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) --  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval...

Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for Fintepla for the Treatment of Dravet Syndrome
Published: 25 Nov 2019 | 2:11 UTC

EMERYVILLE, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the...

Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film
Published: 22 Nov 2019 | 2:11 UTC

MARLBOROUGH, Mass.--(BUSINESS WIRE) November 22, 2019 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apomorphine sublingual film...



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