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Otonomy’s OTIVIDEX ear medicine falls short in Phase III study

February 23, 2021
Manufacturing and Production meniere's disease, otividex, otonomy

Otonomy’s OTIVIDEX treatment for Meniere’s disease has failed to meet its primary endpoint in its Phase III trial, the company …

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Novo Holdings acquires pharma research company Altasciences

February 23, 2021
Manufacturing and Production Novo Holdings, altasciences, pharma research

Novo Holdings has agreed a deal to buy Canadian pharmaceutical research company Altasciences from Audax Private Equity, the two companies …

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dynavax

Dynavax’s hepatitis B vaccine gets EU approval

February 23, 2021
Manufacturing and Production EU, Vaccine, hepatitis B

The European Commission (EC) has granted marketing authorisation Dynavax Technologies Corporation’s HEPLISAV B vaccine for the active immunisation against hepatitis …

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libtayo

FDA approves Regeneron & Sanofi’s Libtayo for advanced non-small cell lung cancer

February 23, 2021
Manufacturing and Production Cancer, Sanofi

The FDA has approved Regeneron & Sanofi’s PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small …

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GSK and Sanofi to begin new Phase II trial of their COVID-19 vaccine

February 22, 2021
Sales and Marketing COVID, COVID Vaccine, COVID-19, GSK, Sanofi

GlaxoSmithKline (GSK) and Sanofi are set to begin a new Phase II study of their COVID-19 vaccine candidate, following setbacks …

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ONK and Anthony Nolan combine forces to work on blood cancer therapies

February 22, 2021
Sales and Marketing Anthony Nolan, Cancer, ONK, blood cancer, cancer treatment

ONK Therapeutics and blood cancer charity Anthony Nolan will work together on therapies for patients with haematological malignancies (blood cancers) …

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minaris-mg_7425-web

MaxiVAX and Minaris sign manufacturing deal for cell-based cancer immunotherapy

February 22, 2021
Sales and Marketing Cancer, MaxiVAX, Minaris

MaxiVAX and Minaris Regenerative Medicine have entered into a manufacturing agreement for MVX-ONCO-2, a cell-based immunotherapy for the treatment of …

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astrazeneca_plaque

AstraZeneca to withdraw Imfinzi US indication for bladder cancer

February 22, 2021
Sales and Marketing AstraZeneca, Imfinzi

AstraZeneca will voluntarily withdraw the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or …

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tukysa

Seagen’s breast cancer drug TUKYSA gets UK approval

February 22, 2021
Sales and Marketing Cancer, MHRA, Seagen

The MHRA has granted marketing authorisation in the UK for Seagen’s TUKYSA (tucatinib) in combination with trastuzumab and capecitabine, for …

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top 10

Pharmafile.com’s top 10 news stories of the week

February 19, 2021
Medical Communications COVID-19, COVID-19 vaccine, Vaccine, pharma news, top 10, top news stories

In the last week, a number of COVID-19 new vaccine developments have been made. Pfizer and BioNTech’s vaccine has proven …

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New Cell Guidance technology has potential to help treat cancer

February 19, 2021
Medical Communications Cancer, cancer treatment, cell guidance systems, macrophages, pharma news

Cell Guidance Systems’ new POlyhedrin Delivery System (PODS) technology has been shown to have therapeutic potential in the treatment of …

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cascade_chemistry_new_facility_rendering_highres

Cascade Chemistry begins $14m manufacturing facility expansion

February 19, 2021
Medical Communications Cascade Chemistry, manufacturing

Cascade Chemistry, a leading pharmaceutical contract development and manufacturing organisation, has initiated the $14 million construction of new facilities to …

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cream-4713579_1920

Dermavant announces positive Phase III findings for psoriasis treatment tapinarof

February 19, 2021
Medical Communications Dermavant Sciences, psoriasis

Dermavant Sciences has announced positive safety and efficacy results from a planned interim analysis of PSOARING 3, a long-term, open-label …

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RedHill enters manufacturing deal with Cosmo for two key products

February 19, 2021
Medical Communications RedHill Biopharma

RedHill Biopharma has announced agreements with Cosmo Pharmaceuticals to manufacture two of RedHill’s key products. Cosmo will manufacture Movantik, RedHill’s …

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Onward and Biomunex agree deal to collaborate on cancer treatment

February 18, 2021

Onward Therapeutics and Biomunex Pharmaceuticals have signed a co-development agreement of a bi-specific antibody for cancer patients.

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nektar-therapeutics

Nektar and SFJ collaborate to develop experimental head and neck cancer drug

February 18, 2021
Cancer, Nektar Therapeutics

Nektar Therapeutics has announced a financing and co-development collaboration with SFJ Pharmaceuticals to support the development of Bempegaldesleukin (BEMPEG), an investigational CD122-preferential …

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glaxosmithkline building

GSK and Vir agree deal worth $645m for influenza and respiratory treatments

February 18, 2021
GSK, Vaccine, flu, influenze, vir

GSK and Vir Biotechnology have extended their collaboration in a deal that could be worth up to $645 million, in …

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almirall-605x338

MC2 Therapeutics grants Almirall European commercial rights for psoriasis cream Wynzora

February 18, 2021
Almirall, MC2 Therapeutics, psoriasis

Biopharma company Almirall and MC2 Therapeutics, a pharmaceutical company focused on therapies for autoimmune and chronic inflammatory conditions, have announced …

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lilly_entrance_web

Eli Lilly’s diabetes drug tirzepatide reduces blood glucose and weight in Phase III trials

February 18, 2021
Eli Lilly, diabetes

Eli Lilly’s tirzepatide led to significant haemoglobin A1C (HbA1C) and body weight reductions from baseline in adults with type 2 …

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covid-19 virus

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

February 17, 2021
Research and Development COVID-19, COVID-19 vaccine, Vaccine, World Health Organisation, covid-19 roundup

The past week has continued to see positive COVID-19 vaccine news; a WHO panel approved the Oxford-AstraZeneca vaccine for all …

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