FDA
J&J’s Imbruvica scores fifth FDA lymphoma approval
January 20, 2017Medical Communications, Research and Development, Sales and Marketing FDA, Marginal Zone Lymphoma, imbruvica
Johnson & Johnson’s Imbruvica (ibrutinib) has scored its fifth indication approval in the US for the treatment of Marginal Zone …
IBM and FDA collaborate to protect patient data with blockchain technology
January 12, 2017Medical Communications, Research and Development FDA, blockchain, blockchain technology, ibm
IBM Watson Health has agreed a research initiative with the FDA to develop and test the exchange of patients’ health …
Mylan and Biocon apply to FDA for biosimilar approval
January 12, 2017Sales and Marketing Biocon, FDA, Mylan, biosimilar, trastuzumab
Mylan, the US-based generics specialist, and Biocon, an Indian biopharmaceutical company, have applied for a biologics license application (BLA) for …
Egalet gains FDA approval for difficult to abuse painkiller
January 10, 2017Manufacturing and Production, Research and Development, Sales and Marketing Arymo ER, Egalet Corp, FDA
Egalet has gained FDA approval for Arymo ER, a long-acting opioid painkiller that is made to be difficult to breakdown. …
Wockhardt’s Gujarat plant hit with FDA warning letter
January 5, 2017Manufacturing and Production FDA, Wockhardt
Indian pharma and biotech firm Wockhardt has been accused of violating current good manufacturing practice (CGMP) regulations in a letter …
Morning sickness pill scientific backing called into question
January 5, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Diclectin, Diclegis, Duchesnay, FDA, kim kardashian, morning sickness
Many women suffer from morning sickness during the early stages of pregnancy and some suffer from hyperemesis gravidarum, acute morning …
FDA steps up fight against superbugs with livestock ruling
January 5, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Antibiotics, FDA, Guidelines, Livestock, agriculture, antibiotic resistance, farmers
The FDA began the year by announcing the implementation of ‘Guidance for Industry #213’. The new rule is a voluntary …
Texas launches lawsuit against FDA over lethal drug shipment
January 4, 2017Medical Communications, Research and Development FDA, texas
The state of Texas has filed a lawsuit against the FDA to try to force a decision to be made …
Biogen’s gains late-year drug approval first for controversially expensive drug
January 3, 2017Manufacturing and Production, Sales and Marketing Biogen, FDA
The FDA squeezed in one last approval before the year ended with the first approval for a drug to treat …
FDA new drug approvals sink to six year low
December 21, 2016Medical Communications, Research and Development FDA, NDA, new drug approvals
The FDA has released figures to show that drug approvals have fallen from last year’s high of 45 new drugs …
FDA orders new label warnings over anaesthetics risk in children
December 19, 2016Research and Development, Sales and Marketing FDA, anaesthetics
The FDA has announced a new Drug Safety Communication for label warnings on general anaesthetic and sedation products because of …
NICE and FDA to collaborate in medtech access scheme
December 15, 2016Medical Communications, Sales and Marketing FDA, NICE
The National Institute of Health and Care Excellence (NICE) and the US Food and Drugs Administration (FDA) have announced their …
Sun Pharma’s Halol plant’s leaky roof irks FDA
December 13, 2016Manufacturing and Production FDA, Sun Pharma, inspection
The FDA’s two week inspection of Sun Pharmaceutical’s Halol plant produced a 14-page report, with some criticisms reserved for poorly …
FDA approves another indication for Lilly/Boehringer diabetes treatment
December 5, 2016Sales and Marketing Boehringer Ingelheim, Eli Lilly, FDA, jardiance
Jardiance (empagliflozin), an oral SGLT02 inhibitor developed by Eli Lilly and distributed by Boehringer Ingelheim, has been approved by the …
Humira biosimilar proves efficacy in Phase 3 trial
November 30, 2016Research and Development AbbVie, Amgen, FDA, Humira, M923, Momenta
US-based biotechnology firm Momenta Pharmaceuticals has announced that its biosimilar version of Abbvie’s autoimmune drug Humira (adalimumab) – currently the …
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