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Pharmafile 02/22/2019 05:54
Happy Friday! With the weekend within reach, check out our run-down of the top ten most popular articles on this week, including Keytruda's liver cancer failure, a "game-changing osteoasrthritis treatment, AstraZeneca's retirement of the MedImmune brand, and the promise of the first new asthma pill in two decades. 10. Poland and Slovenia included in US-EU mutual recognition agreement. read more.
Pharmafile 02/22/2019 05:19
The Justice Department and US Securities and Exchanges Commission are investigation healthcare giant Johnson & Johnson over allegations that Johnson’s Baby Powder is contaminated with asbestos. J&J made the disclosure in a regulatory filing noting that the two agencies have requested documents relating to the allegations. "The company is cooperating with these government inquiries and will be producing documents in response," the US healthcare conglomerate said in the filing. read more.
Pharmafile 02/22/2019 05:11
UK drug watchdog The Medicines and Healthcare products Regulatory Agency (MHRA) has warned of the potential side-effects of Neo-mercazole (carbimazole) in the treatment of hyperthyroidism, cautioning that its use can lead to an increased risk of congenital malformations during pregnancy, particularly in the first trimester. The malformations can manifest as absence of skin; facial dysmorphism; defects of the abdominal wall and gastrointestinal tract such as exomphalos, oesophageal atresia or omphalo-mesenteric duct anomaly; and ventricular septal defect. read more.
Pharmafile 02/21/2019 07:11
Cancer biopharma firm Xencor has revealed it is to place a hold on its ongoing Phase 1 trial of XmAb14045, its investigational CD123 x CD3 bispecific antibody, in patients with relapsed or refractory acute myeloid leukaemia and other CD123-expressing hematologic malignancies after the deaths of two patients which are considered to be "at least possibly related" to the use of the drug. The deaths were originally detailed in a safety report submitted by Xencor to the FDA. read more.
Pharmafile 02/21/2019 06:56
Indivior has announced the launch of an authorised generic version of Suboxone Film (buprenorphine/naloxone) a combination medicine used to treat opioid use disorder, following a US court’s decision to open the market to generic competitors. Novartis’ Sandoz unit will begin marketing the generic opioid use treatment in the US immediately. English firm, Indivior has been battling generic drugmakers in trying to prevent Suboxone generics from entering the market for years. read more.
Pharmafile 02/21/2019 05:41
Pfizer is set to overhaul the dosing groups in its ongoing study of Xeljanz (tofacitinib) after an evaluation from a Rheumatology Data Safety Monitoring Board (DSMB) highlighted safety concerns in the higher of the two doses. The Board identified a higher risk of pulmonary embolism in patients taking 10mg twice daily than in patients in the tumour necrosis factor inhibitor (TNFi) control group, prompting Pfizer to announce plans to transfer these patients to the lower 5mg twice daily dosing group. read more.
Pharmafile 02/21/2019 05:15
Teva Pharmaceuticals has settled a dispute with the Federal Trade Commission (FTC) over three separate federal court antitrust lawsuits involving the firm’s subsidiary Cephalon. The settlement comes after Teva was made to pay the FTC $1.2 billion over so-called ‘pay-to-delay’ policies in which the firm was accused of participating in blocking the entry of generic drugs into the market by receiving payments from companies producing branded drugs tin return for delaying generics market entry. read more.
Pharmafile 02/20/2019 06:12
Intercept Pharmaceuticals has publicised promising new data on the efficacy of Ocaliva (obeticholic acid) in the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH), sending the company’s shares up by 32%. The findings showed that the 25mg dose of Ocaliva met the study’s primary endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis. read more.
Pharmafile 02/20/2019 05:48
The US FDA has approved Guajarati firm Alembic Pharmaceuticals generic version of Teva’s Acetazolamide sold under the brand name Diamox, a medication used for the treatment of various conditions including glaucoma, epilepsy, altitude sickness, periodic paralysis, idiopathic intracranial hypertension, and heart failure. The FDA granted the drug approval under the Abbreviated New Drug Application (ANDA) application scheme for new generic drugs. read more.
Pharmafile 02/20/2019 05:11
US firms Pfizer and Eli Lilly have said that NGF inhibitor tanezumab met its primary endpoint in a phase 3 trial of patients with moderate to severe chronic low back pain (CLBP). Treatment with 10mg of tanezumab significantly improved pain at 16 weeks when compared to placebo. An estimated 33 million Americans suffer from CLBP, eight million of whom suffer from a moderate-to-severe form of the condition.
Pharmafile 02/20/2019 04:52
Poland and Slovenia have been deemed capable of carrying out Good Manufacturing Practice (GMP) inspections at an equivalent level to the United States. With the addition of Poland and Slovenia, 22 countries in the European Union (EU) are now approved to carry out GMP inspections. The agreement between the EU and the US allows partners to recognise the inspections carried out by other recognised countries. The partnership is aimed at reducing the regulatory burden associated with duplicating GMP inspections. read more.
Pharmafile 02/20/2019 04:51
MSD has revealed new Phase 3 data which indicates that its blockbuster immunotherapy Keytruda (pembrolizumab), in combination with best supportive care, failed to meet its primary endpoints of overall survival or progression-free survival in the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy. The company noted that both rates for the Keytruda arm of the study were superior to those in the placebo arm, but these did not reach statistical significance. read more.
Pharmafile 02/19/2019 07:22
The marketing authorisation for Sanofi’s dengue vaccine Dengvaxia has been revoked in the Philippines after the country’s Food and Drug Administration accused the French drugmaker of failing to comply with its stipulated post-marketing requirements. The decision means that all sales, distribution and marketing of Sanofi’s product in the country are currently on hold.
Pharmafile 02/19/2019 06:42
Scientists at UC San Francisco have used the gene editing tool CRISPR Cas9 to manufacture pluripotent stem cells (stem cells that can be generated directly from adult cells) that are functionally invisible to the immune system. As the ‘universal’ stem cells can be manufactured more efficiently they bring the promise of widespread regenerative medicine one step closer to being a reality. read more.
Pharmafile 02/19/2019 06:18
A novel and potentially "game-changing" oral therapy for the treatment of osteoarthritis (OA) has received a £675,000 cash injection from Innovate UK. The funding will help support the enactment of a clinical of study to evaluate the drug’s safety and efficacy, undertaken by a partnership of AKL Research and Development (AKLRD) and the University of Liverpool’s Clinical Trials Unit. read more.
Pharmafile 02/19/2019 05:26
China is set to establish a national collaborative network of hospitals for rare disease diagnosis and treatment to promote early detection and effective treatment of rare diseases. The initiative, announced by the National Health Commission, will see 324 hospitals, chosen for their capacity and experience in treating patients with rare disease, participate in the network. The network will facilitate the timely transfer of difficult and complicated cases between hospitals and the allocation of quality medical resources for patients. read more.
Pharmafile 02/18/2019 08:12
On 14 January, the European Commission issued marketing approval for Flucelvax Tetra, the first cell-based, quadrivalent influenza vaccine. Pharmafocus spoke to Seqirus’ Dr Rajaram on the challenges of tackling the H3N2 influenza virus, as well as threats to vaccination in general. What advantages does Flucelvax offer compared to similar products? read more.

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