The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and rare diseases. It is also aiming to bolster the competitiveness and the innovative capacity of the EU’s pharma industry. Enhancing crisis preparedness and response mechanisms, and addressing security of supply, drawing lessons from the COVID-19 crisis, are also namechecked as top policy priorities in the strategy, as well as a need to guarantee a strong EU voice on the global stage by promoting a high level of quality, efficacy and safety standards. “The COVID-19 pandemic has, and continues to have, a very serious impact on Europe. Though Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines or the availability ...
Last year the FDA inspected the AbbVie North Chicago manufacturing site during which time they discovered that the company failed to do a proper investigation on five death complaints received relating to Humira and Venclexta treatments. Though the drug maker reported the deaths, it didn’t collate the historical data of the lots in question. It was later discovered that the lots were tied to another 8 to 10 deaths.
It is broadly estimated that JAKs are likely to dominate around 24% of the market which is not a good news for products like Enbrel manufactured by Amgen. It is likely that the drug is to cascade into fast decline as physicians increasingly prefer JAK as a second drug after Humira of AbbVie.
This year AbbVie launched Imbruvica, a single tablet for blood cancer treatment. It has been designed as a convenient therapy measure for patients who used the old tablets as often as four times a day. Adapting the new single tablet in their treatment regimens will prove to be an expensive proposition for some patients as the new tablet comes with a price tag of $400 each, triple the cost of the older tablets.
As a new, erratic administration consolidated its position in the White House and firmed its foundations in the federal government, 2017 turned out to be uncertain for the biopharma industry. Then President-elect Donald Trump saying that the industry was getting away with murder on pricing did not bode well for the industry but more than a year later after the President assuming office, real reform has been spared for biopharma.
A particular proposal regarding displaying drug prices in TV ads flummoxed pharma marketers and ad agencies following the unveiling of the drug-pricing agenda by President Trump. Marketers have been hounded with the whys and hows of the proposal even as the administration remains firm on its implementation.
Prosecutors have already charged Insys founder John Kapoor and won guilty pleas from two characters in an ongoing kickbacks probe. Now, the Justice Department has escalated the case by joining in with whistleblowers who've detailed a stunning range of techniques the company allegedly used to push its powerful opioid painkiller.
The FDA granted approval to Pfizer for Retacrit (epoetin alfa-epbx), which is used for the treatment of anemia, biosimilar of Amgen, a drug which generated sales closely $ 1.8 billion in the U.S market last year for Amgen and Johnson & Johnson partners. Retacrit also received the go-ahead to be used in RBC transfusions by U.S health regulators.
In 2010, around 130 brands like Zoloft and Lipitor constituted for 34% of the universal pharma sector sales. Following the same year, many other drug companies hewed from the permit. The sector has changed in countless ways.
With a view to widening the scope of treatment for ovarian cancer patients, EU regulators have greenlighted MSD’s Lynparza and stamped approval for a new dosing regimen and tablet formulation for AstraZeneca.
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