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Astellas prostate cancer drug gets third approval from MHRA

May 12, 2021
Research and Development Astellas, MHRA, cancer research, cancer treatment, pharma, pharma news, prostate cancer

The MHRA has approved Astellas Pharma’s XTANDI (enzalutamide) drug for the treatment of a third form of prostate cancer, making …

News

NICE rejects Pfizer’s Vyndaqel for treating rare heart condition

May 12, 2021
Research and Development NICE, Pfizer, Vyandaqel

NICE has published final guidance today which rejects tafamidis, also known as Vyndaqel, for treating rare heart condition transthyretin amyloidosis …

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Endogena’s retinitis pigmentosa treatment granted Orphan Drug Designation by FDA

May 12, 2021
Research and Development DFA, Endogena, Orphan Drug Designation

Endogena Therapeutics Inc has been granted Orphan Drug Designation for its EA-2353 ophthalmic suspension targeting retinitis pigmentosa by the FDA. …

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Eli Lilly and MiNA Therapeutics to collaborate on saRNA research

May 12, 2021
Research and Development Eli Lilly

Eli Lilly and MiNA Therapeutics have announced a global research collaboration to develop novel drug candidates using MiNA’s proprietary small …

News

Bayer’s cardiovascular drug shows impressive Phase III results

May 11, 2021
Manufacturing and Production Bayer, chronic kidney disease, pharma, pharma news, type 2 diabetes

Bayer’s finerenone drug has been shown to significantly reduce cardiovascular death or other cardiovascular events in patients with chronic kidney …

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Abbvie psoriatic arthritis drug approved for use in Scotland

May 11, 2021
Manufacturing and Production AbbVie, NHS, arthritis, psoriatic arthritis

Abbvie’s RINVOQ (upadacitinib) drug, for the treatment of active psoriatic arthritis (PsA) in adults, has been approved for use in …

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FDA authorizes use of Pfizer vaccine for children aged 12-15

May 11, 2021
Manufacturing and Production COVID-19, FDA, Pfizer, Vaccine

The FDA announced it has expanded the emergency use of the Pfizer-BioNTech vaccine in children aged 12-15 yesterday.It was determined …

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Facio Therapies announces AI collaboration for FSHD drug design

May 11, 2021
Manufacturing and Production AI, drug discovery

Facio Therapies and Iktos have announced a collaboration to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of …

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Biogen and Capsigen to collaborate on novel gene therapies

May 11, 2021
Manufacturing and Production gene therapy

Biogen and Capsigen have announced a research collaboration to engineer novel adeno-associated virus (AAV) capsids that have the potential to …

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Self-administered Crysvita receives positive CHMP opinion

May 10, 2021
Sales and Marketing CHMP, EMA

Kyowa Kirin’s drug for a rare metabolic bone disease, Crysvita, has received a positive opinion from the EMA’s Committee for …

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NICE rejects Merck Serono’s Bavencio for urothelial cancer

May 10, 2021
Sales and Marketing MSD, Merck, NHS, NICE, cancer treatment, pharma, pharma news

The use of avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy is not recommended by …

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EMA begin review of GSK & Vir COVID-19 treatment

May 10, 2021
Sales and Marketing COVID-19, EMA, GSK, covid-19 treatment, pharma, pharma news, vir

The EMA has begun a rolling review of GSK and Vir’s sotrovimab treatment for COVID-19, which will continue until there …

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Pfizer commences process for full FDA approval of COVID-19 vaccine

May 10, 2021
Sales and Marketing BioNTech, COVID-19 vaccine, FDA, Pfizer, Pfizer vaccine, pharma, pharma news

Pfizer and BioNTech have begun a Biologics Licence Application (BLA) with the FDA for full approval of their mRNA COVID-19 …

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Eli Lilly to collaborate with diabetes tech companies on insulin pen

May 10, 2021
Sales and Marketing Eli Lilly, diabetes

Eli Lilly has signed strategic international agreements with four companies – Dexcom, Glooko, myDiabby Healthcare, and Roche – with the …

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Pharmafile's top 10 news roundup

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

May 7, 2021
Medical Communications covid 19 news, covid-19 news, news round up, pharma, pharma news, top 10

Among our ten most-read stories this week: NICE has announced that more patients are eligible for a £75,000-a-vial SMA drug, …

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Merck kidney and uterus cancer treatments granted priority review by FDA

May 7, 2021
Medical Communications FDA, MSD, Merck, cancer treatment, kidney cancer treatment, pharma, pharma news, uterus cancer treatment

The FDA has granted priority review for Merck (MSD) and Eisai’s application for two new approvals for the combination of …

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Deloitte acquires Iperion Life Sciences Consultancy

May 7, 2021
Medical Communications marketing, sales

Deloitte have announced the acquisition of Iperion Life Sciences Consultancy, a globally-operating firm working to support life sciences companies and …

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AstraZeneca secures MHRA licensing and NHS early access for lung cancer drug

May 7, 2021
Medical Communications Astrazenaca, oncology

AstraZeneca have announced that the MHRA has granted a license extension for Tagrisso (osimertinib) in the UK, for use as …

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Biomarker linked to male hair loss found to determine COVID-19 severity

May 7, 2021
Medical Communications COVID-19, hair loss

Findings presented at the European Academy of Dermatology and Venereology (EADV) Spring Symposium suggest that men with genetic characteristics (phenotypes) …

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GSK lupus treatment approved by European Commission

May 6, 2021
GSK, Lupus, lupus treatment, pharma, pharma news

GSK’s Benlysta treatment, for patients with active lupus nephritis (LN) in addition to systemic lupus erythematosus (SLE), has been approved …

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