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fdaoutsideweb

FDA issues emergency use authorisation for Pfizer-BioNTech vaccine

December 14, 2020
Sales and Marketing COVID-19, FDA, US, Vaccine

The US Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine for emergency use in those aged 16 and …

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US pharma lobby launches legal action against the Trump administration over drug pricing proposals

December 8, 2020
Manufacturing and Production, Sales and Marketing Drug pricing, PhRMA, Trump, US

US industry organisations including the Pharmaceutical Research and Manufacturers of America (PhRMA) have launched legal action against the Trump administration …

tt

How the US election could affect the pharmaceutical industry

November 4, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Donald Trump, Joe Biden, Trump, US, US election 2020, pharma

The US is one of the most lucrative markets for the pharmaceutical industry. This is a country where a lack of …

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

November 4, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, GSK, Sanofi, UK, US, remdesivir

As European nations fall one by one back into lockdown, hopes weigh heavily on a vaccine to pave a path …

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US reserves 300,000 doses of Lilly’s COVID-19 treatment in $375 million deal

October 28, 2020
Manufacturing and Production, Research and Development, Sales and Marketing COVID-19, Eli Lilly, US, pharma

The US Government has signed a $375 million deal with Eli Lilly to buy 300,000 700mg doses of bamlanivimab, its …

Pfizer won’t apply for COVID-19 vaccine emergency authorisation until after US election, CEO says

October 19, 2020
Sales and Marketing COVID-19, Pfizer, US, Vaccine

The Chief Executive Officer of Pfizer has said that the company will now submit their vaccine for FDA Emergency Use …

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34 reported coronavirus infections in White House-linked staff

October 8, 2020
Medical Communications COVID, Trump, US, white house

The coronavirus outbreak that has infected notable figures of the Trump administration has spread to 34 White House Staffers and …

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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 …

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HHS Secretary Alex Azar accused of overruling FDA on COVID-19 test quality reviews

September 16, 2020
Research and Development COVID-19, FDA, US, USA

Allegations have emerged accusing US Health and Human Services Secretary Alex Azar of overruling the FDA over the review of …

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US won’t join COVAX coronavirus vaccine initiative because it is linked to the WHO

September 2, 2020
Research and Development Trump, Trump Administration, US, USA

The US has said it will not participate in an international effort to develop and distribute a coronavirus vaccine.COVAX is …

moderna

Moderna commits 100 million COVID-19 vaccine doses to the US

August 12, 2020
Manufacturing and Production, Research and Development, Sales and Marketing COVID-19, Moderna, US, Vaccine, pharma

Moderna continues to rise to meet the demands of the pandemic, signing a new deal with the US Government to …

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US Government commits $2.1bn to GSK and Sanofi’s COVID-19 vaccine candidate

July 31, 2020
Medical Communications, Research and Development COVID-19, GSK, Sanofi, US, Vaccine

The US Government has announced additional funding into Sanofi and GlaxSmithKline’s efforts to develop a recombinant protein-based vaccine to the …

regeneron

Regeneron seals $450m BARDA contract to scale up production of its COVID-19 vaccine

July 9, 2020
Manufacturing and Production, Sales and Marketing BARDA, Operation Warp Speed, Regeneron, US, vaccine COVID-19

Regeneron has revealed that REGN-COV2, its two-antibody vaccine for the treatment and prevention of COVID-19, has been awarded a manufacturing …

roche

Roche’s Phesgo combo secures US approval for metastatic HER2-positive breast cancer

June 30, 2020
Manufacturing and Production, Sales and Marketing FDA, Phesgo, Roche, US, breast cancer

The FDA has awarded marketing authorisation in the US to Roche’s Phesgo, a combination of subcutaneously injected Herceptin (trastuzumab) with …

malaria_usa

FDA grants marketing approval for US Army’s malaria treatment

May 28, 2020
Business Services Malaria drug, US, US army, US., malaria

The FDA has granted marketing approval for the US Army Medical Research and Development Command’s (USAMRDC) Artesunate for injection, which …

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