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Pfizer overhauls Xeljanz study over concerns of increased risk of pulmonary embolism and death

February 21, 2019
Research and Development Pfizer, Xeljanz, pharma, rheumatoid arthritis

Pfizer is set to overhaul the dosing groups in its ongoing study of Xeljanz (tofacitinib) after an evaluation from a …

News

Teva settles ‘pay-to-delay’ case with FTC

February 21, 2019
Business Services, Sales and Marketing FTC, Teva, antitrust, drugs, generics, monopoly

Teva Pharmaceuticals has settled a dispute with the Federal Trade Commission (FTC) over three separate federal court antitrust lawsuits involving …

News
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Avara Avlon falls into administration putting 270 Bristol jobs at risk

February 21, 2019
Manufacturing and Production AstraZeneca, Avara Avlon, Bristol, CDMO, Jobs, UK, manufacturing

Bristol-based pharma firm Avara Avlon Pharmaceuticals has fallen into administration putting the jobs of all 270 of its staff at …

News
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Intercept’s NASH liver fibrosis drug shows promise at Phase 3

February 20, 2019
Research and Development Intercept Pharmaceuticals, nash, non-alcoholic steatohepatitis, ocaliva, pharma

Intercept Pharmaceuticals has publicised promising new data on the efficacy of Ocaliva (obeticholic acid) in the treatment of liver fibrosis …

News
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FDA approves Indian firm Alembic’s generic of Teva’s Diamox

February 20, 2019
Research and Development ANDA, Alembic, Gujurat, US FDA, diamox, generics

The US FDA has approved Guajarati firm Alembic Pharmaceuticals generic version of Teva’s Acetazolamide sold under the brand name Diamox, …

News

Pfizer and Eli Lilly’s chronic low back pain (CLBP) treatment meets primary endpoint in Phase 3 trial

February 20, 2019
Research and Development

US firms Pfizer and Eli Lilly have said that NGF inhibitor tanezumab met its primary endpoint in a phase 3 …

News
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Poland and Slovenia included in US-EU mutual recognition agreement

February 20, 2019
Research and Development EU, GMP, Poland, Slovenia, USA, mutual recognition

Poland and Slovenia have been deemed capable of carrying out Good Manufacturing Practice (GMP) inspections at an equivalent level to …

News
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Keytruda falls short at Phase 3 in advanced liver cancer

February 20, 2019
Research and Development Cancer, MSD, keytruda, liver cancer, pharma

MSD has revealed new Phase 3 data which indicates that its blockbuster immunotherapy Keytruda (pembrolizumab), in combination with best supportive …

News

Philippines’ FDA halts sales of Sanofi’s dengue vaccine

February 19, 2019
Manufacturing and Production, Sales and Marketing Philippines, Sanofi, dengue, dengvaxia, pharma

The marketing authorisation for Sanofi’s dengue vaccine Dengvaxia has been revoked in the Philippines after the country’s Food and Drug …

News
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San Francisco scientists use CRISPR to develop stem cells invisible to the immune system

February 19, 2019
Manufacturing and Production Nature Biotechnology, Stem cells, UC San Francisco, iPSCs, regenerative medicine

Scientists at UC San Francisco have used the gene editing tool CRISPR Cas9 to manufacture pluripotent stem cells (stem cells …

News
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“Game-changing” osteoarthritis drug receives £675k funding from Innovate UK

February 19, 2019
Manufacturing and Production, Research and Development AKL Research and Development, Innovate UK, osteoarthritis, pharma

A novel and potentially “game-changing” oral therapy for the treatment of osteoarthritis (OA) has received a £675,000 cash injection from …

News
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China to establish national rare disease network

February 19, 2019
Manufacturing and Production China, NHC, healthcare, rare diseases

China is set to establish a national collaborative network of hospitals for rare disease diagnosis and treatment to promote early …

News

Japanese researchers to trial stem cell therapy in four patients with serious spinal injuries

February 19, 2019
Manufacturing and Production Japan, Keio University, Parkinson's, cell therapy, iPS

The Japanese health ministry has approved a study testing the use of induced pluripotent stem (iPS) cells to treat four …

News
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Beating the flu

February 18, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing flu, influenza, pharma, seqirus

On 14 January, the European Commission issued marketing approval for Flucelvax Tetra, the first cell-based, quadrivalent influenza vaccine. Pharmafocus spoke …

Feature

Astellas’ Xtandi “significantly improves” progression-free survival in advanced hormone-sensitive prostate cancer

February 18, 2019
Research and Development, Sales and Marketing Astellas, Cancer, Xtandi, pharma, prostate cancer

Japanese pharma firm Astellas has lifted the curtain on new data for its androgen receptor signalling inhibitor Xtandi (enzalutamide), when …

News

Smoking may limit immune system’s ability to fight cancer, study shows

February 18, 2019
Sales and Marketing Cancer, cancer research, immune system, immunology, melanoma, oncology, smoking

Smoking may limit the body’s ability to fight melanoma, according to a study published in the journal Cancer Research. The …

News
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Bavencio+Inlyta combo boosts progression-free survival in advanced kidney cancer

February 18, 2019
Research and Development, Sales and Marketing Bavencio, Cancer, Kidney cancer, Merck KGaA, Pfizer, inlyta, pharma

New interim data for the combination of Pfizer’s Bavencio (avelumab) and Merck KGaA’s Inlyta (axitinib) have been released, showing that …

News

Researchers activate gene to reverse depression in mice

February 18, 2019
Sales and Marketing SIRT1, depression, genetics, mental health

Scientists at the Medical College of Georgia at Augusta University were able to directly activate a gene associated with depression …

News
merckwindow_web

MSD’s Keytruda combo therapy significantly improves survival in advanced renal cell carcinoma

February 18, 2019
Sales and Marketing Cancer, MSD, Merck Sutent, Pfizer, inlyta, keytruda, oncology, rcc, renal cell carcinoma

Merck & Co’s Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib) significantly extended the lives of those with advanced renal …

News
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Lilly and Boehringer’s Trajenta matches glimepiride in delaying cardiovascular events in type 2 diabetes patients

February 15, 2019
Medical Communications, Research and Development Boehringer, Eli Lilly, cardiovascular disease, pharma, type 2 diabetes

Boehringer Ingelheim and Eli Lilly’s Trajenta (linagliptin) met its primary endpoint in a recent trial, it has emerged, proving itself …

News
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