MSD’s Keytruda meets primary endpoint in triple-negative breast cancer
September 30, 2019Sales and Marketing
MSD have announced results from its Phase 3, KEYNOTE-522 trial that pathological complete response (pCR) in patients with early triple-negative …
Roche secures US paediatric approval for Rituxan in two rare forms of vasculitis
September 30, 2019Sales and Marketing MabThera, Rituxan, Roche, pharma, vasculitis
Roche has revealed that Rituxan (rituximab), also known as MabThera, has been awarded US approval from the FDA in combination …
Novartis reports positive Phase 3 PALLADIUM results in uncontrolled asthma
September 30, 2019Sales and Marketing
Novartis has announced that its investigational, once-daily, fixed-dose inhaled QMF149 (indacaterol acetate and mometasone furoate) was superior to mometasone furoate …
AZ and Merck’s ovarian cancer combo improves progression-free survival
September 30, 2019Sales and Marketing
AstraZeneca and Merck have announced that their combination treatment for newly diagnosed ovarian cancer significantly improved progression free survival. The …
Top Ten most popular articles on Pharmafile.com this week
September 27, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharma, top ten
Another week comes to a close, and it’s time to review the biggest stories of the week. Check out the …
Takeda’s Entyvio outperforms AbbVie’s Humira in moderate-to-severe ulcerative colitis
September 27, 2019Medical Communications, Research and Development AbbVie, Entyvio, Humira, Takeda, pharma, ulcerative colitis
Takeda has released strong new data for Entyvio (vedolizumab), showing that the gut-selective biologic outperformed AbbVie’s blockbuster anti-tumour necrosis factor-alpha …
AbbVie’s Mavyret scores FDA label expansion to shorten treatment duration for hepatitis C patients
September 27, 2019Medical Communications, Sales and Marketing AbbVie, FDA, hepatitis, hepatitis C, mavyret, pharma
The FDA has chosen to expand the existing label for AbbVie’s Mavyret (glecaprevir/pibrentasvir), it has been revealed, to include the …
FDA approves Genmab’s Darzalex combo in newly diagnosed multiple myeloma
September 27, 2019Medical Communications, Sales and Marketing FDA, Genmab, darzalex, pharma
Genmab’s CD38 inhibitor Darzalex (daratumumab) has been awarded marketing authorisation from the FDA in combination with bortezomib, thalidomide and dexamethasone …
Cell and Gene Therapy Catapult doubles capacity at UK site
September 26, 2019Manufacturing and Production, Medical Communications
The United Kingdom’s Cell and Gene Therapy Catapult (CGT Catapult) has added six additional modules of cleanroom space at its …
Male infertility linked to prostate cancer risk
September 26, 2019Research and Development
Research published in the British Medical Journal has found a link that men who have fertility treatment have a higher …
Iran reveals plans to domestically produce 135 strategic drugs
September 26, 2019Manufacturing and Production Iran, pharma, production
Iran has announced plans to promote self-sufficiency within the country with regard to its medicines production, with an aim of …
UK announces research plan on evolving global health threats
September 26, 2019Research and Development
The UK’s Chief Medical Officer, Professor Dame Sally Davies has announced funding for projects to help combat antimicrobial resistance (AMR) …
NICE shoots down Novartis’ migraine drug Aimovig outside of Scotland
September 26, 2019Sales and Marketing Aimovig, NICE, Novartis, UK, migraine, pharma
NICE has announced its decision to reject Novartis’ drug Aimovig (erenumab) for use on the NHS in England and Wales …
Springworks’ nirogacestat receives EC orphan status
September 26, 2019Research and Development
Springworks, a clinical-stage biopharmaceutical company focusing on severe rare disease and cancer has been granted orphan status by the European …
Corbyn announces plan to ‘put public health before private profit’
September 25, 2019Research and Development
Jeremy Corbyn has announced a new plan to set up a state-run drugs manufacturer to sell cheap medications to the …
Takeda’s investigational therapy shows promise as cytomegalovirus treatment
September 25, 2019Research and Development, Sales and Marketing Takeda, cytomegalovirus, maribavir, pharma
New Phase 2 data has been released on Takeda’s investigational antiviral therapy TAK-620 (maribavir) in patients with cytomegalovirus (CMV) infection …
Novartis blames former AveXis execs for Zolgensma data manipulation
September 25, 2019Research and Development
Novartis has placed blame on former executives Brian and Allan Kaspar for the manipulation of data behind its $2.1 million …
EMA’s CHMP recommends new dosing schedule for Opdivo in melanoma
September 25, 2019Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, CHMP, EMA, melanoma, opdivo, pharma
Bristol-Myers Squibb has revealed that its blockbuster immunotherapy drug Opdivo (nivolumab) has secured recommendation from the EMA’s Committee for Medicinal …
Ipsen announces positive phase 3 results in limb spastic hemiparesis
September 24, 2019Manufacturing and Production, Research and Development
Ipsen has announced results from its ENGAGE study for the combination of Dysport (abobotulinumtoxinA) alongside Guided Self-rehabilitation contracts (GSC) which …
Celltrion’s subcutaneous infliximab biosimilar secures CHMP recommendation
September 24, 2019Manufacturing and Production, Sales and Marketing EMA, EU, Europe, biosimilar, celltrion, infliximab, pharma
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous …
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