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Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
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
Pharmaceutical
Pfizer yesterday revealed that Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) received US Food and Drug Administration approval for an expanded age indication to include adults 18 through 49 years of age. 13 July 2016
Biosimilars
Patient access to biosimilar medicines will hinge on critical policy decisions around extrapolation and biosimilar label content, asserts the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA) in comments to the Food and Drug Administration’s Arthritis Advisory Committee. 13 July 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending Belgian drugmaker UCB’s Cimzia (certolizumab pegol). 12 July 2016
Pharmaceutical
The Canadian subsidiary of Anglo-Swedish pharma major AstraZeneca has received approval for medicines regulator Health Canada for Tagrisso (osimertinib) once-daily tablets. 12 July 2016
Pharmaceutical
The Russian government is considering introducing a three-stage procedure for the public procurement of drugs, according to recent statements of an official spokesman of Denis Manturov, Russia’s Minister of Industry and Trade. 12 July 2016
Pharmaceutical
Ireland-incorporated Shire has received US Food and Drug Administration approval for Xiidra (lifitegrast ophthalmic solution) 5% as a treatment for dry eye disease. 12 July 2016
Pharmaceutical
The UK government has brought in pharma industry chiefs to co-chair a ministerial group aimed at ensuring Brexit does not damage the country’s life sciences sector. 11 July 2016
Pharmaceutical
At its July meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety referral on one medicine, and initiated three new safety referrals. 11 July 2016
Biosimilars
A biosimilar version of the world’s best-selling drug is ‘highly similar’ to the reference product, according to a US Food and Drug Administration staff briefing documents published ahead of tomorrow’s committee meeting. 11 July 2016
Pharmaceutical
Recent changes as a result of the introduction of medical price reforms in China are expected to eliminate public hospital mark-ups on drug prices and cut prices for medical examinations and supplies by the end of 2020, according to a guideline issued by the National Development and Reform Commission (NDRC) last week. 11 July 2016
Pharmaceutical
All Periodic Safety Update Reports (PSURS) for centrally and nationally authorized medicinal products in Europe must be submitted via the PSUR Repository as of June 13, 2016. 11 July 2016
Pharmaceutical
More than $1 billion was wiped from the market value of biotech groups racing to develop a revolutionary cancer treatment, after one of the companies, Juno Therapeutics, revealed that three young patients had died after receiving its experimental therapy on a clinical trial. 10 July 2016
Pharmaceutical
Bosses at Japanese pharma major Eisai are angry at the exclusion of its oncology drug Lenvima (lenvatinib) from the Cancer Drugs Fund (CDF) in England. 8 July 2016
Biotechnology
The European Commission has granted marketing authorization for US biotech giant Gilead Sciences’ Epclusa (sofosbuvir 400/velpatasvir), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 8 July 2016
Biosimilars
Knowing when to prescribe biosimilars is a massive issue internationally, and action is being taken on the issue in the UK to make sure they are used appropriately and in consultation with patients. 8 July 2016
Biotechnology
The deaths of two patients has led the US Food and Drug Administration to put a clinical hold on the Phase II trial of JCAR015, a leukemia drug being developed by USA-based biopharma company Juno Therapeutics. 8 July 2016
Biotechnology
The US Food and Drug Administration has approved Xolair (omalizumab), from Roche subsidiary Genentech, to treat moderate to severe persistent asthma in children six to 11 years of age. 8 July 2016
Biosimilars
The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration review. 8 July 2016
Generics
The US Food and Drug Administration has issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. 8 July 2016
Pharmaceutical
As European Union member states vie to get re-location of the European Medicines Agency to their country following the UK referendum vote to leave the EU, Spain being the latest to pitch its case, the EMA acknowledges the outcome and says it is now up to the UK government to decide how to act. 7 July 2016
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