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Pharmafile 02/25/2020 04:21
Disruption to the US drug production pipeline from the coronavirus could hurt its domestic supply of 150 drugs. US senators wrote letters to the FDA to express their concern. Senator Chuck Grassley, Senate Finance Committee Chairman, said: “80 percent of Active Pharmaceutical Ingredients are produced abroad, the majority in China and India.”
Pharmafile 02/24/2020 12:01
Every year, Veeva asks clinical professionals to take part in the Veeva Unified Clinical Operations Survey to help the industry better understand the current challenges. had shown that sponsors and CROs are making progress in unifying clinical systems, streamlining end-to-end processes, and aligning stakeholders to improve trial performance.
Pharmafile 02/24/2020 10:02
The FDA has just authorised its first adjuvanted quadrivalent influenza vaccine, it has been announced. Seqirus’ Fluad Quadrivalent (influenza vaccine, adjuvanted) has been approved in the US to for the prevention of seasonal vaccine in patients over the age of 65. The new indication is crucial in seasonal flu; during the US influenza season of 2017/2018, 70% of flu-related hospitalisations occurred in over-65-year-olds, while 90% of flu-related deaths also occurred within this group.
Pharmafile 02/24/2020 08:04
Chinese biotech firm Clover Biopharmaceuticals has joined the race to develop interventions against the ongoing coronavirus outbreak with the announcement that it has partnered up with GlaxoSmithKline (GSK) to aid in development of its protein-based "COVID-19 S-Trimer" vaccine. As part of the newly announced partnership, Clover will leverage GSK’s pandemic adjuvant system to further improve the vaccine’s immunogenicity – its ability to provoke a response from the body’s immune system – in preclinical studies.
Pharmafile 02/24/2020 07:16
Eli Lilly’s Trulicity (duraglutide) has been awarded marketing authorisation from the FDA as a therapy to reduce major adverse cardiovascular events (MACE) in type 2 diabetes (T2D) patients with established cardiovascular (CV) disease or who exhibit multiple cardiovascular risk factors, it has been announced. According to the manufacturer, this makes Trulicity the first and only type 2 diabetes therapy approved for this indication in primary and secondary prevention populations.
Pharmafile 02/24/2020 05:17
Baudax Bio has revealed the FDA approval of its non-opioid painkiller Anjeso (meloxicam injection) as a therapy for the management of moderate to severe pain, either when administered as a monotherapy or when used in combination with analgesics which are not nonsteroidal anti-inflammatory drugs (NSAIDS). The decision was based on efficacy data from two Phase 3 studies and marks the first availability in the US of a 24-hour, intravenous (IV) COX-2 preferential NSAID.
Pharmafile 02/21/2020 06:32
Israeli firm Teva has shared disappointing results for its vesicular monoamine transporter 2 (VMAT2) Austedo (deutetrabenazine) after it failed to meet its primary endpoint two clinical trials at Phases 2/3 and 3 in the treatment of paediatric patients with moderate to severe Tourette’s Syndrome. In the studies, it was found that Austedo failed to reduce motor and phonic tics – the primary endpoint of the trials – compared to placebo, as measured on the Total Tic Score of the Yale Global Tic Severity Scale.
Pharmafile 02/21/2020 06:20
The coronavirus is again in the news, with the Indian government considering banning exports of medicine as the epidemic threatens vital pharmaceutical supplies from China. This is not just a regional issue, as Europe and the US are also having their drug production pipeline disrupted by the epidemic. In UK news, NICE gives initial ‘no’ to NHS England for kidney cancer drug, while experts have called on the organisation to ban the sale of over the counter codeine.
Pharmafile 02/20/2020 07:08
MSD’s blockbuster immunotherapy Keytruda has been stopped in its tracks by the FDA after the US regulator rejected its application for a new dosing regimen in six different cancers: melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma, and Merkel cell carcinoma. The therapy is already approved in those cancers when taken at 200mg dose every three weeks; the manufacturer was seeking to add the new dosing schedule of 400mg every six weeks on the grounds that it would provide patients with greater flexibility and mak.
Pharmafile 02/20/2020 05:23
The FDA covered a lot of ground in 2019 when it came to generic drugs, awarding at least tentative approval to over 1,000 such products over the course of the year. The achievement was confirmed with the release of the 2019 Annual Report of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) of the FDA. According to the report, the US regulator approved, either tentatively or otherwise, 1,014 Abbreviated New Drug Applications (ANDAs) for generic drugs over the course of 2019; 107 of these were the first generic therapies of their type.
Pharmafile 02/19/2020 07:17
The European Commission (EC) has awarded marketing approval to Pfizer’s Vyndaqel (tafamidis), it has emerged, for the treatment of wild-type or hereditary transthyretin amyloidosis in adult cardiomyopathy patients (ATTR-CM). The decision makes it the first and only treatment for ATTR-CM available to patients in the European Union; previously available treatments were limited to the management of symptoms or transplant of the heart and liver in rare cases.
Pharmafile 02/19/2020 07:06
Frank Reynolds, the CEO of Boston based PixarBio Corporation, was sentenced to seven years in prison for defrauding investors and obstructing a federal investigation. This follows a federal jury convicting Reynolds back in October, in which they said he had carried out manipulative trading of the company’s shares to defraud investors while making false statements about the company’s finances and the timeline for the FDA’s approval.
Pharmafile 02/19/2020 05:31
Five Prime Therapeutics and Bristol-Myers Squibb have confirmed that their randomised Phase 2 trial investigating the efficacy of the former’s cabiralizumab combined with the latter’s blockbuster immunotherapy Opdivo (nivolumab) in the treatment of advanced pancreatic cancer failed to meet its primary endpoint. The combo fell short both with and without chemotherapy in a study of around 160 enrolled participants with locally advanced or metastatic or locally advanced or metastatic pancreatic cancer that had progressed despite having received one line of chemotherapy.

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