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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
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 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
US drug firm Pozen has resubmitted the New Drug Application for PA8140/PA32540 (aspirin and omeprazole) delayed release tablets, to the US Food and Drug Administration. 2 July 2014
Pharmaceutical
Yesterday, the US Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. 2 July 2014
Pharmaceutical
Belgium-based biopharma firm ThromboGenics has said that Jetrea (ocriplasmin) has been approved in Uruguay for the treatment of adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. 2 July 2014
Pharmaceutical
Trade body Medicines Australia has applied for authorization of the 18th Edition of its Code of Conduct to the Australian Competition and Consumer Commission. 2 July 2014
Generics
After a three-year long struggle, humanitarian aid agency Medecins Sans Frontieres has received approval from the South African Medicines Control Council to import a dramatically more affordable version of an antibiotic, linezolid, in order to expand access to the drug and provide better treatment options to patients with drug-resistant tuberculosis in Khayelitsha, Western Cape. 1 July 2014
Biotechnology
USA-based Amgen, the world's largest independent biotech firm, says that the US Food and Drug Administration has granted Breakthrough Therapy designation to investigational bispecific T cell engager (BiTE) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia. 1 July 2014
Generics
In order for Ireland-headquartered generics major Actavis to complete its previously-announced $25 billion takeover of Forest Laboratories (The Pharma Letter February 18), the companies have agreed to sell or relinquish their rights to four generic pharmaceuticals, to settle US Federal Trade Commission charges that Actavis’ acquisition of Forest likely would be anticompetitive. 1 July 2014
Pharmaceutical
French drugmaker Ipsen has submitted a Supplemental New Drug Application to the US Food and Drug Administration for Somatuline Depot 120mg (lanreotide) injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 1 July 2014
Pharmaceutical
Drug delivery specialists pSivida says that the regulatory process for marketing authorizations of Iluvien (fluocinolone acetonide intravitreal implant) has entered the national phase in 10 European countries following the successful completion of the Mutual Recognition Procedure (MRP) for subsequent authorizations. 1 July 2014
Pharmaceutical
US pharma giant Merck & Co says that the European Medicines Agency has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company’s investigational anti-PD-1 antibody, for the treatment of advanced melanoma. 1 July 2014
Pharmaceutical
US drugmaker Allergan, the subject of a hostile $53 billion takeover pursuit by Canada’s Valeant Pharmaceuticals International, has provided updates on three of the company’s key R&D pipeline programs. 1 July 2014
Pharmaceutical
US pharma giant GlaxoSmithKline and US partner Theravance have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of Breo Ellipta. 30 June 2014
Pharmaceutical
Positive results have been announced by US pharma giant Merck & Co from a global, investigational Phase III study to evaluate the safety and efficacy of Emend (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged six months to 17 years. 30 June 2014
Pharmaceutical
In a much awaited decision, the US Food and Drug Administration on Friday approved MannKind Corp’s Afrezza (insulin human [rDNA origin]) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. The news on Friday sent the stock rocketing 80% to around $7.25. 30 June 2014
Pharmaceutical
At its end-June meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended six new medicines for approval. 27 June 2014
Pharmaceutical
Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), were several recommendations for additional indications for already approved medicines. These included: 27 June 2014
Generics
US biotech firm Acorda Therapeutics has been advised that Ireland-headquartered generics major Actavis has submitted an Abbreviated New Drug Application to the US Food and Drug Administration to market a generic version of Ampyra (dalfampridine) Extended Release Tablets, 10mg. 27 June 2014
Generics
Ohm Laboratories, a wholly owned subsidiary of India’s largest drugmaker Ranbaxy Laboratories, has received approval from the US Food and Drug Administration to manufacture and market valsartan, a generic of Swiss drug major Novartis’ Diovan, for the treatment of high blood pressure and heart failure. 27 June 2014
Biotechnology
US biotech firm Gilead Sciences revealed this morning it has submitted a New Drug Application to Japan's Pharmaceutical and Medical Devices Agency (PMDA) for approval of its controversially high-priced sofosbuvir, a once-daily nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. 27 June 2014
Pharmaceutical
UK health care watchdog the National Institute for Health and Care Excellence (NICE) has issued new draft guidance proposing to recommend Swiss drug major Novartis’ Glivec (imatinib) after surgery for some people with gastro-intestinal stromal tumors (GISTs). 27 June 2014
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