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MSD’s Keytruda scores another EU okay, in head and neck cancer
First anti-PD-1 drug to improve overall survival in first-line setting
Vertex continues upward trajectory with French Orkambi deal
Comes on the heels of similar reimbursement deal in England
FDA clears Alnylam’s second RNAi drug for rare disease
Second drug in the class to be cleared by regulatory authority
UPDATED: BMS completes Celgene merger after FTC okay
Approval comes over ten months after acquisition announcement
J&J’s new Darzalex formulation OK’d for use in Europe
Extends use of multiple myeloma therapy even further
Myovant preps US filing for relugolix in prostate cancer
Takeda-partnered drug had 97% response rate in advanced prostate cancer
Novartis’ Mayzent and Roche’s Polivy lead CHMP recommendations
Sanofi Genzyme’s Lemtrada and Pfizer's Xeljanz receive label restrictions
BeiGene bags FDA approval for first product Brukinsa in lymphoma
Also the first approval for a Chinese-developed cancer drug in US
Amarin wins FDA advisory nod for Vascepa cardiovascular expansion
Approval likely for fish-oil derived drug following speedy review
‘Post-Brexit landscape for EU-wide IP Rights: The Story So Far’
Brexit means pharma must review its intellectual property rights across Europe
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Moving timesContinuity and stability are vital when it comes to the EMA's relocation when it leaves London
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SMC gives green light for Amgen’s KyprolisThe committee also gives verdict on three other products
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Shionogi scores FDA approval for new cUTI antibiotic Pivotal new treatment for adults with complicated urinary tract infection
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FDA advisors say no to empagliflozin in type 1 diabetesApproval of Boehringer, Lilly-partnered drug expansion looks unlikely
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Solid Bio falls as FDA halts DMD trial over safety concerns Shares in the biotech dropped dramatically following the announcement
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BMS scores FDA priority review for Opdivo/Yervoy combo in liver cancerPossible new treatment for difficult to treat cancer type
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Merck claims first-ever okay for Ebola vaccine, in EuropeComes shortly after J&J filed its Ebola candidate with EMA
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NICE backs first cannabis-based drugs, both from GW PharmaApproved to treat patients with epilepsy and multiple sclerosis
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J&J catches up to Merck, files Ebola vaccine in EuropeCompany is also in discussion with the FDA in the US to support regulatory filings
Latest regulatory appointments
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Professor Carole Longson moves from NICE to the ABPIShe joins the UK pharma body as its chief scientific officer
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MedTech Europe appoints new board of directors
Chair of the board Michelle Brennan is among those newly elected
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Greg Perry joins IFPMA as assistant director generalWill move to the global industry body from the Medicines Patent Pool
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AVEO appoints Nikhil Mehta as its senior VP, regulatory and quality assurance
He joins the biopharma from Tang Capital Management
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IFPMA names new communications director
Helen Gallagher joins the association from Ferring Pharmaceuticals
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- Genital herpes vaccine candidate heads for human studies
- Bayer, Merck’s high-risk heart failure drug comes good in phase 3
- Biogen under fire over $88,000 Vumerity annual price
- Novartis’ Mayzent and Roche’s Polivy lead CHMP recommendations
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- Bayer and Merck take high-risk heart failure drug into phase III
- Spotlight interview: 15 minutes on insights and market research in pharma
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- MSD’s Keytruda scores another EU okay, in head and neck cancer
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