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GSK tells UK staff to turn off NHS COVID-19 tracking app while at work

October 7, 2020
Research and Development COVID, GSK, covid app

GlaxoSmithKline has told its employees to turn off the new NHS coronavirus tracking app at work as it could be …

News
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Johnson & Johnson to spend over $100m to settle 1,000 talc powder lawsuits

October 7, 2020
Research and Development

Johnson & Johnson have agreed to pay over $100 million to settle more than 1,000 lawsuits that blame the company’s …

News
glenmark

FDA greenlights Glenmark’s generic version of Biogen’s Tecfidera in relapsing multiple sclerosis

October 7, 2020
Research and Development, Sales and Marketing Biogen, Glenmark, generic, multiple sclerosis

Glenmark Pharma will be celebrating after it secured FDA approval in the US to market dimethyl fumarate, a generic version …

News
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EMA launches rolling regulatory review of Pfizer and BioNTech’s COVID-19 vaccine

October 7, 2020
Research and Development, Sales and Marketing BioNTech, COVID-19, EMA, Pfizer, Vaccine

European Medicines Agency has launched a “rolling review” of the promising COVID-19 vaccine candidate BNT162b2 currently in development from BioNTech …

News
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Pharmafile.com’s weekly COVID-19 news round-up

October 7, 2020
Research and Development COVID, COVID-19, corornavirus

The coronavirus news this week focuses on treatments, with Enlivex Therapeutics releasing positive data for its therapy Allocetra as a …

News
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Company veteran Belén Garijo named as Merck KGaA’s first-ever female CEO

October 6, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

German pharma firm Merck KGaA has taken the decision to appoint its first female Chief Executive Officer in its 352-year …

Appointment
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Aimovig reduces frequency of episodic migraines, five-year data reveals

October 6, 2020
Manufacturing and Production, Research and Development Aimovig

Amgen and Novartis have revealed new five-year Phase 2 data during the Migraine Trust Virtual Symposium for their calcitonin gene-related …

News
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NHS warns that UK could face drugs shortages after Brexit stockpile has been used to fight COVID-19

October 6, 2020
Manufacturing and Production

The NHS has warned that hospitals could face shortages of drugs during the second wave of coronavirus due to the …

News
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Opdivo/Yervoy combo secures FDA approval for malignant pleural mesothelioma

October 6, 2020
Manufacturing and Production, Research and Development Bristol-Myers Squibb, Yervoy, bristol myers squibb, opdivo

Bristol Myers Squibb’s therapy regimen of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) has secured FDA approval for the first-line …

News
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White House halts release of new FDA standards for the Emergency Use Authorization of COVID-19 vaccine

October 6, 2020
Manufacturing and Production FDA, Trump, Vaccine, coronavirus vaccines

The Trump White House is blocking new federal guidance for the emergency release of coronavirus vaccines that would essentially ensure …

News
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Bristol Myers Squibb agrees $13 billion deal to acquire MyoKardia

October 6, 2020
Manufacturing and Production BSM, FDA, MyoKardia

Bristol Myers Squibb (BMS) is to purchase MyoKardia for $13 billion to boost its heart disease treatments portfolio. The deal …

News
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Alivio Therapeutics receives $3.3m from US Department of Defense to support development of IBD drug candidate

October 5, 2020
Research and Development, Sales and Marketing Alivio, US, ibd, pharma

The US Department of Defense (DoD) has committed a Technology/Therapeutic Development Award to the value of $3.3 million to biotech …

News
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ViiV’s two-drug regimen proves non-inferior in treatment-naive HIV-1

October 5, 2020
Research and Development, Sales and Marketing HIV-1, ViiV Healthcare, pharma

ViiV Healthcare has taken the opportunity at the HIV Glasgow 2020 Virtual Congress to unveil three-year Phase 3 data from …

News

FDA defies advisory panel recommendation, rejecting Mesoblast’s Ryoncil in paediatric steroid-refractory acute graft versus host disease

October 5, 2020
Sales and Marketing FDA, Mesoblast, Ryoncil

The FDA has issued a surprising rejection of Mesoblast’s Ryoncil (remestemcel-L) as a treatment for paediatric steroid-refractory acute graft versus …

News
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Remdesivir has a “favourable” benefit/risk profile in COVID-19 but more data needed, DSRU review argues

October 5, 2020
Research and Development, Sales and Marketing COVID-19, Drug Safety Research Unit, pharma, remdesivir

Southampton’s Drug Safety Research Unit (DSRU) has released a systematic benefit/risk analysis of Gilead’s antiviral drug remdesivir in the treatment …

News
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Covis Group to acquire AMAG Pharmaceuticals in $647m deal

October 5, 2020
Sales and Marketing AMAG Pharmaceuticals, Covis group, acquisition, pharma

Luxembourg-based Covis Group is set to acquire Massachusetts-based AMAG Pharmaceuticals in a new deal worth approximately $647 million on an …

News
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Across Health to hold first iD.cast webcast ‘Digital Acceleration in Biopharma’ on 15 October

October 2, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Webinar, event

Across Health is hosting its first iD.cast webcast, titled Digital Acceleration in Biopharma on 15 October. This ninety-minute webinar online …

News
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IGT Biologika’s COVID-19 vaccine becomes third in Germany to be approved for human trials

October 2, 2020
Medical Communications, Research and Development COVID-19, IDT Biologika, Vaccine

German biotech IDT Biologika has become the third company in the country to secure approval from the nation’s vaccine regulator …

News
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AstraZeneca’s COVID-19 vaccine trials resume in Japan but still on hold in US

October 2, 2020
Medical Communications COVID, coronavirus

AstraZeneca’s experimental coronavirus vaccine has resumed clinical trials in Japan after a patient illness halted the global study, but the …

News
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Donald and Melania Trump test positive for COVID-19

October 2, 2020
Medical Communications COVID-19, Trump, coronavirus

President Donald Trump and First Lady Melania Trump have both tested positive for COVID-19.  Trump tweeted: “Tonight, @FLOTUS and I …

News
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