US FDA committee recommends against fast-track approval of Clovis’ cancer drug, asks for more data
April 13, 2016Medical Communications, Research and Development
Shares in Clovis Oncology Inc (Nasdaq: CLVS) closed down 5.4% Tuesday after the US Food and Drug Administration advisory committee recommended …
Structure of Zika virus revealed in new study
April 13, 2016Research and Development NIH, Purdue, Zika, glycoprotein, structure
Researchers have examined the structure of the Zika virus in a new study and found that is broadly similar to …
FDA accepts biologics license application for MSD’s allergy immunotherapy drug
April 13, 2016Research and Development, Sales and Marketing MSD, Merck, allergy, dust mite, house, immunotherapy, mk-8237
MSD (NYSE: MRK) has announced that the US Food and Drug Administration has accepted for review the biologics license application …
Boehringer Ingelheim’s Giotrif significantly lowers lung cancer progression in Phase II trials
April 13, 2016Research and Development AstraZeneca, Boehringer Ingelheim, Iressa, giotrif, lung cancer
German drugmaker Boehringer Ingelheim on Wednesday said a mid-stage study has shown its cancer drug Giotrif (afatinib) reduced the risk …
Valeant bondholders issue notice to default
April 13, 2016Research and Development, Sales and Marketing Valeant, bondholders, default, fears, possibility
Valeant (NYSE: VRX) has issued a statement detailing plans from some of its bondholders to call a default because of …
Focus: Ovarian cancer and the case of elusive cure
April 12, 2016Research and Development J&J, JJ, Pfizer, drug trials, ovarian cancer
Each year, more than 21,000 women in the US are diagnosed with ovarian cancer, according to research and more than …
EUSA Pharma acquires global rights to oncology support drug
April 12, 2016Manufacturing and Production, Research and Development, Sales and Marketing Eusa Pharma, acroral, acroral tab, global rights, oncology
EUSA Pharma has announced the acquisition of global rights to oncology support care product, Arcoral Tab, from Arcoral Pharma.
Regeneron agrees six-year $75 million upfront licencing deal with Intellia for gene technology
April 12, 2016Manufacturing and Production, Research and Development, Sales and Marketing IPO, Intellia Therapeutics, Licencing, Regeneron Pharmaceuticals, crispr, deal, gene editing, genetics
Regeneron Pharmaceuticals Inc (Nasdaq: REGN) on Tuesday said it has signed a six-year licencing deal with biotech firm Intellia Therapeutics …
KaloBios announces new affordable pricing model, refuses to engage in “price gouging”
April 12, 2016Manufacturing and Production, Sales and Marketing CEO, Drug pricing, KaloBios, Martin Shkreli, Shkreli, affordable, price gouging, price model, responsible
Price gouging has become synonymous with drug costs in the US, with the infamous Martin Shkreli and troubled Valeant becoming …
Clinical studies point to consistent efficacy in AstraZeneca’s treatment for drug-resistance bacteria
April 12, 2016Manufacturing and Production, Research and Development AstraZeneca, avibactam, ceftazidime, gram resistant
AstraZeneca has presented results from a series of trials which show the consistent efficacy of investigational antibiotic, ceftazidime-avibactam (CAZ-AVI) in …
Roche’s Venclexta gets accelerated approval from US FDA for chronic lymphocytic leukemia
April 12, 2016Manufacturing and Production, Research and Development, Sales and Marketing AbbVie, Roche, US FDA, Venclexta, chronic lymphocytic leukemia
Swiss drug firm Roche (SIX: ROG) on Tuesday said the US Food and Drug Administration (FDA) has granted accelerated approval …
Insys Therapeutics sees revenue from Subsys at $61-$62 million; shares plunge 21%
April 11, 2016Business Services, Manufacturing and Production, Sales and Marketing Insys Therapeutics, Stock Price, Subsys, opioids, pain drug
Insys Therapeutics Inc (Nasdaq: INSY) stock plunged nearly 21% Monday after the company said sales for its pain drug will …
IQWiG says Gilead’s anti-HIV drug genvoya offers slightly lower benefits than competition
April 11, 2016Medical Communications, Research and Development Bristol-Myers Squibb, Gilead, HIV, anti-HIV
German Institute for Quality and Efficiency in Health Care (IQWiG) said USdrug maker Gilead’s (Nasdaq: GILD) anti-HIV drug Genvoya provides marginally …
GW Pharma starts Phase III trials for Tuberous Sclerosis Complex drug
April 11, 2016Research and Development Epidiolex, GW Pharmaceuticals, Tuberous Sclerosis Complex, genetics, rare disease
GW Pharmaceuticals Plc (Nasdaq: GWPH) said it has started late-stage trials for its Epidiolex (cannabidiol or CBD) to treat seizures …
Mylan launches new dosages of generic of Novartis hypertension drug in US
April 11, 2016Manufacturing and Production Mylan, Novartis, generic, high blood pressure, hypertension
Mylan (TASE: MYL) has announced the US launch of new dosages of its generic version of Novartis’s hypertension drug, Lopressor …
Former US CEO of Boehringer Ingelheim becomes chairman at Inotek Pharmaceuticals
April 11, 2016Medical Communications Boehringer Ingelheim, inotek, inotek pharma, j martin carroll
Inotek Pharmaceuticals has announced the appointment of J. Martin Carroll as the new chairman of the board. Carroll will succeed …
Weekly Movers: Array BioPharma, Amicus Therapeutics, Genocea Biosciences, Tesaro Inc, Incyte, Clovis Oncology
April 11, 2016Manufacturing and Production, Research and Development, Sales and Marketing Index, Movers, markets, stocks
Shares in Botox-maker Allergan (NYSE: AGN) plunged over 17% in intra-day trading as the $160 billion merger seal with US …
Depomed criticised by investors and urged to explore potential sale
April 11, 2016Sales and Marketing Depomed, board, horizon, sale, starboard, starboard value
Only a few short months after fighting off a $1 billion bid from Horizon Pharma, investors at Depomed have called …
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 …
Roche’s cancer immunotherapy for lung cancer gets US FDA priority review
April 11, 2016Business Services, Research and Development, Sales and Marketing Roche, US FDA, atezolizumab, lung cancer
Swiss drug firm Roche (SIX: ROG) on Monday said the US Food and Drug Administration (FDA) has accepted its Biologics …
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