regulation
Sobi, Biogen’s haemophilia B therapy gets European approval
May 13, 2016Medical Communications, Research and Development, Sales and Marketing Biogen, haemophilia B, orphan designation, regulation, sobi
Sobi (STO: SOBI) and Biogen (Nasdaq: BIIB) on Friday said the European Commission has approved their drug to treat haemophilia B. The …
AstraZeneca says its trial drug for thyroid cancer granted US FDA orphan drug designation
May 12, 2016Research and Development, Sales and Marketing AstraZeneca, Orphan Drug Designation, US FDA, drug trial, regulation
AstraZeneca (LSE: AZN) on Thursday said the US Food and Drug Administration (FDA) has granted Orphan Drug Designation its trial …
Nice recommends two blood tests to rule out pre-eclampsia in pregnant women
May 11, 2016Medical Communications, Sales and Marketing NICE, Roche, regulation
The National Institute for Health and Care Excellence (Nice) has backed two blood tests to help rule-out a complication in …
Nice backs GSK’s lupus drug Benlysta
May 11, 2016Research and Development, Sales and Marketing GSK, NHS, NICE, regulation
The National Institute for Health and Care Excellence (Nice) has backed GlaxoSmithKline’s (LSE: GSK) Benlysta (belimumab) to treat lupus. The …
Scottish Medicines Consortium does not back Vertex’ cystic fibrosis drugs Orkambi, Kalydeco
May 10, 2016Manufacturing and Production, Research and Development Kalydeco, Orkambi, SMC, Vertex Pharma, cystic fibrosis, regulation
The Scottish Medicines Consortium did not back two cystic fibrosis therapies from Vertex Pharmaceutical (Nasdaq: VRTX). SMC did not recommend …
China evaluating investigations into pharma firms to take on drug pricing issue
May 9, 2016Business Services, Research and Development, Sales and Marketing China, France, G7, regulation
Lawmakers globally have acknowledged the concerns over unbridled drug costs as regulators stress the need for a more open debate …
Eisai says European Commission backs Halaven to treat of advanced Liposarcoma in Europe
May 5, 2016Research and Development, Sales and Marketing EC, Eisai, US FDA, oncology, regulation, soft tissue sarcoma
The European Commission has backed marketing for the Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) to treat advanced soft …
Eli Lilly’s cancer drug candidate scores FDA priority review
May 5, 2016Eli Lilly, US FDA, oncology, regulation
US drugmaker Eli Lilly (NYSE: LLY) said the US Food and Drug Administration (FDA) has granted priority review for its …
Nice extends price-negotiation talks for PTC’ muscle wasting drug
May 4, 2016Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, NICE, PTC Therapeutics, Translarna, market access, regulation
UK regulators have extended the cost negotiation talks with PTC Therapeutics (Nasdaq: PTCT) by a week for the drug to …
Novartis’ two cancer drugs get NICE backing as combination treatment for skin cancer
April 29, 2016Medical Communications NICE, Novartis, combination therapy, regulation, skin cancer
The National Institute for Health and Care Excellence (NICE) on Friday backed a combination therapy for skin cancer comprising two …
NICE backs BMS’ paclitaxel in ovarian cancer; drops Eli Lilly’s Gemzar, J&J’s Yondelis
April 27, 2016Research and Development, Sales and Marketing BMS, Eli Lilly, J&J, JJ, NICE, ovarian cancer, regulation
The National Institute for Health and Care Excellence (NICE) has backed Bristol-Myers Squibb’s paclitaxel as a treatment for ovarian cancer. …
Eli Lilly gets European marketing authorisation for psoriasis drug
April 26, 2016EC, EU, Eli Lilly, drug trial, psoriasis, regulation
US pharma firm Eli Lilly and Co (NYSE: LLY) on Tuesday said the European Commission backed marketing authorisation for its …
NICE recommends PTC Therapeutics’ Translarna to treat Duchenne muscular dystrophy
April 18, 2016Sales and Marketing DMD, Duchenne Muscular Dystrophy, NICE, PTC Therapeutics, Translarna, regulation
Shares in drug maker PTC Therapeutics (Nasdaq: PTCT) jumped after the National Institute for Health and Care Excellence (NICE) backed …
FDA staff raises doubts on efficacy, safety of Clovis’ trial drug for lung cancer, shares plunge
April 11, 2016AstraZeneca, Clovis Oncology, US FDA, drug trial, lung cancer, regulation, rociletinib
Shares in Clovis Oncology Inc (Nasdaq: CLVS) plunged to close down nearly 18% after the US regulators expressed doubts if …
FTC launches tool to help mobile health app developers determine applicable regulations
April 8, 2016Medical Communications, Sales and Marketing FDA, FTC, apps, health, health apps, regulation
The US Federal Trade Commission has created a new web-based tool for developers of health-related mobile apps to help them …
