astrazeneca_plaque

AstraZeneca and Novoheart team up to develop human ‘heart-in-a-jar’

November 27, 2019
Research and Development Heart in a Jar, Novoheart, heart disease

AstraZeneca and Novoheart are collaborating on developing a functioning miniature human heart model of heart failure, a first of its …

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FDA approves GBT’s Oxbryta to treat sickle cell disease

November 26, 2019
Manufacturing and Production FDA, FDA Trump, Oxbryta, Sickle cell, sickle cell disease

The FDA announced yesterday that it has approved Global Blood Therapeutics’ marketing application for its haemoglobin polymerisation inhibitor Oxbryta, which …

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Singapore and South Korea agree to cooperate on Good Manufacturing Practice

November 26, 2019
Manufacturing and Production ASEAN, GMP, North Korea, ROK, Singapore, south korea

At a joint summit on Saturday, South Korea’s Ministry of Food and Drug Safety signed a memorandum of understanding (MOU) …

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US lawmakers call for FDA office in Israel

November 26, 2019
Manufacturing and Production FDA, Golan Heights, Israel FDA, Netanyahu, Trump, USA, congress, israel

A bipartisan group of 21 US members of Congress has called for the establishment of an FDA office in Israel, …

celltrion1

Europe approves first subcutaneous version of biosimilar infliximab

November 26, 2019
Manufacturing and Production, Sales and Marketing arthritis, biosimilars, celltrion, infliximab, pharma

The European Commission has chosen to authorise Celltrion Healthcare’s Remsima SC, a biosimilar of infliximab and the first subcutaneous formulation …

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Conservatives pledge to invest in preventing and curing disease in election manifesto

November 26, 2019
Manufacturing and Production Boris Johnson, Conservative Party, Election 2019, Tories NHS, Tory Manifesto

Prime Minister Boris Johnson launched the Conservative Party’s manifesto on Sunday, promising to invest more into research to prevent and …

The coming age of biosimilars

November 25, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing biosimilars, feature, pharma

With more and more biosimilars securing approval and the sheer potential value they have to offer for healthcare systems around …

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Sanofi’s head of strategy and business development to retire amid company review

November 25, 2019
Sales and Marketing Bristol Meyers, Gilead, Sanofi, Shell

One of Sanofi’s most senior strategy bosses is set to retire at the end of the month. Muzammil Mansuri, Executive …

FDA approves AstraZeneca’s Calquence in chronic lymphoma

November 25, 2019
Sales and Marketing Astrazenaca, Calquence, FDA, Health Canada, leukaemia, oncology

The FDA has approved AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) in the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic …

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FDA fast-tracks psilocybin treatment for major depressive disorder

November 25, 2019
Sales and Marketing Controlled Substance Act, FDA, breakthrough therapy, major depressive disorder, psilocybin

The FDA has granted a Breakthrough Therapy designation to the Usona Institute for its trial use of psilocybin in the …

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Novartis acquires The Medicines Company in a deal worth $9.7 billion

November 25, 2019
Sales and Marketing Novartis, The Medicines Company, pharma

Novartis agreed a $9.7 billion deal to acquire the US-based The Medicines Company, it announced Sunday. The transaction was unanimously …

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Roche’s Tecentriq combo outclasses Nexavar in unresectable hepatocellular carcinoma

November 25, 2019
Research and Development, Sales and Marketing Cancer, Roche, immunotherapy, pharma, tecentriq

Roche has revealed new Phase 3 data for its immunotherapy drug Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) in the …

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Scotland leading the UK in life science start-up growth, report reveals

November 20, 2019
Research and Development, Sales and Marketing BioCity, UK, biotech, pharma

A new report published by the life science incubator and business collective BioCity has painted a promising picture of UK …

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Lilly to boost Indianapolis manufacturing site with $400m injection, 100 jobs to be created

November 20, 2019
Manufacturing and Production, Research and Development Eli Lilly, US, pharma

Eli Lilly is poised to boost its manufacturing capacity with the investment of $400 million at its Lilly Technology Center …

merck-keytruda

Europe approves Keytruda for first-line head and neck squamous cell carcinoma, as a monotherapy or combo

November 20, 2019
Research and Development, Sales and Marketing Cancer, keytruda, pharma

MSD’s top-selling immunotherapy Keytruda (pembrolizumab) has secured another approval from the European Commission, this time in the first-line treatment of …

allergan

Allergan’s acute migraine therapy ubrogepant shows strength at Phase 3

November 20, 2019
Research and Development Allergan, pharma, ubrogepant

Allergan has revealed positive Phase 3 data on its oral calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant, illustrating the therapy’s …

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European Commission approves Genmab’s Darzalex combo in newly diagnosed multiple myeloma

November 20, 2019
Research and Development, Sales and Marketing Europe, Genmab, darzalex, pharma

Genmab’s Darzalex (daratumumab) has secured approval from the European Commission and is now authorised in Europe for the treatment of …

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Keytruda overtakes Opdivo to lead sales in global immune checkpoint inhibitor market, report reveals

November 19, 2019
Manufacturing and Production, Sales and Marketing Bristol-Myers Squibb, MSD, keytruda, opdivo, pharma

MSD’s Keytruda (pembrolizumab) overtook Bristol-Myers Squibb’s (BMS) blockbuster drug Opdivo (nivolumab) in total sales in the third quarter of 2019 …

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Amgen poised to cut 172 positions across US, including California HQ

November 19, 2019
Manufacturing and Production Amgen, US, pharma

As revealed in correspondence with the California Employment Development Department, Amgen plans to axe 172 staff positions across the US, …

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Bayer and MSD’s chronic heart failure drug meets main goal at Phase 3

November 19, 2019
Manufacturing and Production, Research and Development Bayer, MSD, pharma, vericiguat

MSD and Bayer have made it known that their jointly-developed soluble guanylate cyclase (sGC) stimulator vericiguat met its primary endpoint …

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