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Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting interested parties to provide feedback on Clinical Trial Regulation guidance documents. 2 August 2016
Pharmaceutical
The European Medicines Agency has launched a public consultation on revised guidance on the development of new medicines to treat tuberculosis (TB). 2 August 2016
Biotechnology
The European Medicines Agency has accepted for review the Marketing Authorization Application for sarilumab, an investigational human monoclonal antibody directed against the interleukin (IL)-6 receptor that is intended for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis (RA). 1 August 2016
Pharmaceutical
The US Food and Drug Administration has approved French drugmaker Ipsen’s Dysport (abobotulinumtoxinA) for injection for the treatment of pediatric lower limb (PLL) spasticity in children two years of age and older. 1 August 2016
Pharmaceutical
Drugs that currently exist to treat Alzheimer’s only relieve symptoms temporarily and they don’t work in all patients. Among the 244 Alzheimer’s drugs tested in clinical trials between 2002 and 2012, memantine from Eli Lilly, succeeded. However, last week a little known UK company – TauRx – came up with mixed results on its candidate that could nevertheless provide hope for some Alzheimer’s patients. 31 July 2016
Pharmaceutical
The European Commission has approved US pharma giant Merck & Co’s Zepatier (elbasvir/grazoprevir). 30 July 2016
Pharmaceutical
The US Food and Drug Administration approved Qbrelis (lisinopril) oral solution from Silvergate Pharmaceuticals, the first and only FDA-approved lisinopril oral solution. 30 July 2016
Pharmaceutical
Medicines regulator Health Canada is taking new action to improve the safe use of two prescription opioid drugs, codeine and hydrocodone, to help further address the rare but potentially life-threatening risk of breathing problems in children and adolescents. 29 July 2016
Pharmaceutical
The UK’s revamped Cancer Drugs Fund (CDF) which comes into force today (July 29) will not work for many modern cancer medicines and could leave patients without access to life saving treatment, according to the world’s largest pharmaceutical company. 28 July 2016
Pharmaceutical
The US Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. 28 July 2016
Pharmaceutical
Britain’s drug pricing watchdog has issued guidance recommending new treatments for acute lymphoblastic leukemia and advanced myeloma but has failed to approve Vertex Pharmaceutical’s Orkambi (lumacaftor/ivacaftor) for the treatment of cystic fibrosis (CF). 27 July 2016
Pharmaceutical
Italian CNS-focused drug developer Newron Pharmaceuticals (SIX: NWRN) and its partners Zambon and US WorldMeds announced today that the US Food and Drug Administration and the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the FDA no longer require Newron to perform any studies to clinically evaluate the potential abuse liability or dependence/withdrawal effects of Xadago (safinamide). 27 July 2016
Biotechnology
The US Food and Drug Administration has granted approval for US pharma major AbbVie’s New Drug Spplication (NDA) for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. 26 July 2016
Pharmaceutical
“With the advent of e-pharmacy, there is a need to amend the Drugs and Cosmetics Act, 1940, as it does not differentiate between offline and online pharmacies," said K B Aggarwal, the Additional Secretary (Food and Drugs), Union Ministry of Health and Family Welfare, India. 26 July 2016
Pharmaceutical
US ophthalmology specialist Ocular Therapeutix saw its share price plummet by 14.5% on Monday after announcing that the Food and Drug Administration (FDA) had not approved its new drug application (NDA) for Dextenza (dexamethasone insert), the company’s lead candidate. 26 July 2016
Biotechnology
NewLink Genetics says that partner US pharma giant Merck & Co has reached two key regulatory milestones for the Ebola Zaire vaccine candidate known as V920 (rVSV∆G-ZEBOV-GP). 26 July 2016
Biotechnology
The US Food and Drug Administration has granted Breakthrough therapy designation for Darzalex (daratumumab) as a treatment for previously treated multiple myeloma in combination with standard of care reigmens. 26 July 2016
Biotechnology
The US Food and Drug Administration has lifted its clinical hold on a Phase I/II trial of CGF166, a treatment for patients with severe to profound hearing loss which is being developed by Swiss pharma giant Novartis under a licensing agreement with US-based GenVec. 25 July 2016
Pharmaceutical
Sanofi Pasteur MSD UK says that the UK’S Medicines and Healthcare products Regulatory Agency (MHRA) has approved its quadrivalent influenza vaccine (split virion, inactivated), which contains two A strains (A/H1N1 and A/H3N2) and two B strains (B/Victoria and B/Yamagata) of the influenza virus. 25 July 2016
Pharmaceutical
The US Food and Drug Administration has told Canada-based Valeant Pharmaceuticals International that an inspection has identified deficiencies in the manufacturing of Vesneo (latanoprostene bunod), an ophthalmic solution for open angle glaucoma or ocular hypertension. 25 July 2016
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
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