FDA
FDA weighs in to improve generic competition
June 27, 2017Medical Communications, Sales and Marketing FDA, generic drugs, pricing debate
Since Scott Gottlieb was appointed Commissioner, the FDA has been on a marked push to tackle two areas: drug pricing …
Pfizer’s biosimilar gets a second knock-back from FDA
June 23, 2017Medical Communications, Sales and Marketing Amgen, Epogen, FDA, Pfizer
Pfizer has been dealt a stinging blow by the FDA, after it received a second complete response letter from the …
FDA’s Gottlieb draws those ‘gaming’ system into pricing debate
June 22, 2017Medical Communications, Sales and Marketing Drug pricing, FDA, Trump
President Trump spoke often of how pharmaceutical companies were ‘getting away with murder’, in regards to drug pricing, and now …
FDA locks down import from 3 Indian IPCA facilities
June 21, 2017Manufacturing and Production, Research and Development FDA, India, Ipca
More drama in the Indian pharma sector as the FDA announces it has enforced a ban on the import of …
FDA-approved drugs in combination could provide new antibiotics
June 21, 2017Research and Development Antibiotics, FDA, antibiotic resistance
Research emerging from the University of Utah Health has built on knowledge that drugs used in combination can be more …
FDA fast-tracks Pfizer and Lilly’s chronic pain drug
June 15, 2017Research and Development, Sales and Marketing Eli Lilly, FDA, Pfizer
Pfizer and Eli Lilly are celebrating the FDA’s decision to grant fast-track designation to their joint venture tanezumab in the …
EMA lags behind FDA on continuous manufacturing regulation
June 15, 2017Manufacturing and Production EMA, FDA, continuous manufacturing
Continuous manufacturing is increasingly an area of fixation within the pharma industry for the benefits it can bring to the …
FDA to review effectiveness of abuse deterrent opioid drugs
June 14, 2017Research and Development, Sales and Marketing FDA, Scott Gottlieb, opioid, opioid crisis
FDA Commissioner Scott Gottlieb continues his fightback against the US opioid crisis after requesting an unprecedented recall of Endo Pharmaceuticals’ …
FDA calls for withdrawal of opioid product for first time in history
June 9, 2017Medical Communications Endo pharmaceuticals, FDA, Scott Gottlieb
The FDA, since the appointment of Scott Gottlieb as commissioner, has made strong noises about tackling the opioid crisis and …
FDA approves first generic versions of Lilly’s ADHD drug
May 31, 2017Research and Development, Sales and Marketing ADHD, Apotex, Aurobindo, FDA, Glenmark, Teva
The FDA has given its approval for the commercialisation of the first-ever generic versions of Eli Lilly’s Strattera (atomoxetine) for …
Glenmark greenlighted to market hypertension generic in US
May 30, 2017Manufacturing and Production, Sales and Marketing FDA, Glenmark, generic, hypertension
Glenmark Pharmaceuticals has revealed it has been awarded final approval by the FDA to market hypertension treatment nebivolol, a generic …
FDA approves Novartis’ Zykadia as first-line lung cancer treatment
May 30, 2017Manufacturing and Production, Sales and Marketing FDA, NSCLC, Novartis
The FDA has announced it has approved Novartis’ Zykadia (ceritinib) as a first line treatment in the expanded indication of …
New FDA Commissioner reveals strategy to drive down drug prices
May 26, 2017Manufacturing and Production, Sales and Marketing FDA, Scott Gottlieb, Trump, pricing
Deregulation, faster access and cheaper drug prices very quickly became the rallying cry for the Trump administration in the life …
26 die after attempting to replace Abbott’s blood pump controller themselves
May 24, 2017Medical Communications, Sales and Marketing Abbott, FDA, Medical device, deaths
At least 26 advanced heart failure patients have died and 19 have been injured by attempting to change the controller …
Opioid crisis “highest initial priority” for new FDA Commissioner
May 24, 2017Medical Communications, Research and Development FDA, Scott Gottlieb, opioid, opioid crisis
Scott Gottlieb, the newly appointment FDA Commissioner, has indicated that his first priority is to tackle the opioid crisis currently …
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