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Genentech announces positive Phase III results for faricimab

December 22, 2020
Manufacturing and Production

Genentech, a member of the Roche group, today announced positive top-line results from two identically designed global Phase III studies …

News
8

Kobayashi Kako under inspection over contaminated medicines

December 22, 2020
Manufacturing and Production Kobayashi Kako, rilmazafone

Japanese pharmaceutical firm Kobayashi Kako is under inspection by authorities after it emerged that the company adopted illegal manufacturing procedures …

News
credit_-_daniel_leal-olivas-afp

EU gives green light to Pfizer-BioNTech COVID-19 vaccine

December 22, 2020
Manufacturing and Production COVID-19, EMA, Pfizer, Vaccine

The EMA has recommended the Pfizer-BioNTech COVID-19 vaccine for use across the EU’s 27 countries, with the first doses set …

News

The importance of ethics and patient centricity in managed and early access programmes

December 21, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Matt Fellows explores how early and managed access schemes are mutually beneficial to sponsors and patients alike, as well as how …

Feature
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4BIO Capital appoints Akiko Iwasaki to its Scientific Advisory Board

December 21, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

4BIO Capital, an international venture capital firm focused on advanced therapies addressing high unmet medical and social needs, has appointed …

Appointment

Shionogi’s novel antibiotic selected for UK pilot subscription reimbursement model

December 21, 2020
Sales and Marketing NICE, Shionogi, antibiotic

Japanese pharmaceutical company Shionogi today announced that NICE and NHS England and Improvement (NHSE&I) have selected its novel antibiotic Fetcroja …

News
european_commission_web

European Commission approves EU’s first peanut allergy treatment

December 21, 2020
Sales and Marketing Aimmune, European Commission, allergy

Aimmune Therapeutics today announced that the European Commission (EC) has approved PALFORZIA as the EU’s first-ever treatment of peanut allergy. …

News
astrazeneca_plaque

AstraZeneca’s cancer drug Tagrisso gets FDA approval

December 21, 2020
Sales and Marketing AstraZeneca, Cancer, FDA

The FDA has approved AstraZeneca’s Tagrisso (osimertinib) for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated …

News
fda2outsideweb

Moderna’s COVID-19 vaccine receives emergency approval from FDA

December 21, 2020
Sales and Marketing COVID-19, FDA, Moderna, US, Vaccine

Moderna has announced that the FDA yesterday authorised the emergency use of mRNA-1273, the biotechnology company’s vaccine against COVID-19 in …

News
1070297_viiv-healthcare-office-16

ViiV Healthcare announces authorisation of Europe’s first long-acting HIV injection

December 21, 2020
Sales and Marketing GlaxoSmithKline, HIV, ViiV

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline, has announced the authorisation of Europe’s first complete long-acting …

News
stanley_crooke

Ionis founder Stanley T Crooke to retire

December 18, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Ionis Pharmaceuticals has announced that its founder, Dr Stanley T Crooke, will retire from the company and its board of …

Appointment
barry-green-headshot

Sage Therapeutics appoints Barry Greene as CEO

December 18, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Sage Therapeutics, a biopharmaceutical company focused on developing treatments for central nervous system disorders, has appointed Barry Greene as Chief …

Appointment

NICE recommends GSK’s Nucala for more asthma patients

December 18, 2020
Medical Communications GlaxoSmithKline, NICE, asthma, mepolizumab

NICE has today published final draft guidance recommending GlaxoSmithKline’s Nucala (mepolizumab) as an add-on treatment option for severe refractory eosinophilic …

News
top10

Top Ten most popular articles on Pharmafile.com this week

December 18, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Vaccine, antibody

The top news stories of the past week continue to centre around the COVID-19 pandemic; a new variant of the …

News
ipos0_l

Regeneron announces initial clinical data for COVID-19 antibody cocktail

December 18, 2020
Medical Communications COVID-19, Regeneron, antibody

Regeneron Pharmaceuticals has announced that initial clinical data published in the New England Journal of Medicine shows that its antibody …

News
nasal_spray

Ena Respiratory’s nasal spray reduces COVID-19 replication by 96%

December 18, 2020
Medical Communications COVID-19, Nasal Spray

Australian biotech Ena Respiratory has revealed that its self-administered nasal spray INNA-051, when taken once or twice weekly, reduced viral …

News
biogen

Biogen agrees to pay $22m to settle kickback allegations

December 18, 2020
Medical Communications Biogen, multiple sclerosis

Biogen has agreed to pay $22 million to put an end to an investigation into claims that it illegally used …

News
1_1

Samsung Biologics names John Rim as CEO and President

December 17, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Samsung BioLogics

Samsung Biologics has appointed John Rim as the company’s President and CEO. The appointment was made effective immediately and formalised via the …

Appointment
covid_cell_1

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

December 17, 2020

Developments in the race to vaccinate against COVID-19 have dominated the news this week; a vaccine roll-out is underway in …

News

European approval for Kite’s CAR-T therapy Tecartus in elapsed or refractory mantle cell lymphoma

December 17, 2020
Sales and Marketing CAR-T, Europe, Gilead, Kite, Tecartus

Gilead-owned Kite Therapeutics has secured marketing authorisation from the European Commission for its chimeric antigen receptor (CAR) T cell therapy …

News
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