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Generics
According to estimates from Poland-based market research group PMR, Poland will be the most rapidly developing market in the area of generics in the next five years, given its traditionally unchangeable pro-generic policy and the generally attractive nature of the market, based on its affluence and size. 16 May 2016
Pharmaceutical
The UK’s medicines cost-effectiveness watchdog the National Institute for Health and Clinical Excellence (NICE) has come in for a lot of criticism for negative decisions, particularly with regards to new cancer drugs, and last week’s rejection of Bristol-Myers Squibb’s Opdivo was no exception. 15 May 2016
Pharmaceutical
Eisai has received approval from the US Food and Drug Administration for Lenvima (lenvatinib mesylate), the company's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy. 14 May 2016
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), at its May meeting, adopted a summary report following the review of a meta-analysis of data from three observational studies, aiming to assess the risk of developing inhibitors (antibodies) against individual recombinant factor VIII products in previously untreated patients with severe hemophilia A. 13 May 2016
Biotechnology
The European Commission has now approved Idelvion (coagulation Factor IX [recombinant], albumin fusion protein), from Australia’s CSL Limited, for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). 13 May 2016
Biotechnology
Nordic company Swedish Orphan Biovitrum and US biotech major Biogen have received European approval for their Alprolix (rFIXFc) extended half-life therapy for hemophilia B. 13 May 2016
Pharmaceutical
The US companies represented by trade group Pharmaceutical Research and Manufacturers of America (PhRMA) invested an estimated $58.8 billion into research and development (R&D), according to the latest survey of its members. 13 May 2016
Biotechnology
The first and only immuno-oncology combination therapy for the treatment of advanced melanoma has been approved by the European Commission. 12 May 2016
Biosimilars
The growing problem of high medicine prices and its impact on the sustainability of health care systems is getting more and more attention in many countries around the globe. 12 May 2016
Biotechnology
The European Commission has approved multiple myeloma drug Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone in adult patients who have received at least one prior therapy, it has been announced. 12 May 2016
Pharmaceutical
Around 88% of the bodies set up to deliver health care across England are not implementing national guidelines aimed at minimising the risk of antibiotic resistance. 12 May 2016
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has received orphan drug designation from the US Food and Drug Administration (FDA) for the MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). 12 May 2016
Pharmaceutical
The European Medicines Agency has published a report summarizing the experience with its small and medium-sized enterprise (SME) initiative over the last 10 years. 12 May 2016
Pharmaceutical
Bristol-Myers Squibb today confirmed a decision from the UK cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) that could deny National Health Service patients with the most common form of lung cancer access to Opdivo (nivolumab). 12 May 2016
Pharmaceutical
The US Food and Drug Administration is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body, the agency announced late Tuesday. 11 May 2016
Pharmaceutical
The Ukraine government plans to ease access to imported drugs to the domestic market, through the reduction of the time for registration of the newly-launched drugs from the current 30 to 10 days. 10 May 2016
Pharmaceutical
In our weekly expert view piece Dr Nick Meyers, programme director at Boyd Consultants examines the implications what the regulatory and legislative landscape in the biopharmaceutical industry could look like post-Brexit. 10 May 2016
Biosimilars
The US Generic Pharmaceutical Association (GPhA) and its Biosimilars Council have expressed fears over a proposed demonstration from the Centers for Medicare and Medicaid Services (CMS) to revamp how the Medicare Part B program pays for prescription drugs. 10 May 2016
Pharmaceutical
Ireland-incorporated Theravance Biopharma says that the US Food and Drug Administration has approved its supplemental New Drug Application (sNDA) for Vibativ (telavancin). 9 May 2016
Pharmaceutical
Spinning off attractive assets into new companies is a strategy that has worked well in the past for others in the healthcare sector, said Investopedia, commenting on Biogen’s decision last week to divest its hemophilia business into a new publicly-traded company. 8 May 2016
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
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
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