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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
The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of the use of Xarelto (rivaroxaban) in an additional indication filed for by US health care giant Johnson & Johnson’s Janssen Research & Development unit under its partnership with Germany’s Bayer. 17 January 2014
Pharmaceutical
Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect in July of 2012, pharma and biotech companies have certainly taken note, according to a new report rom EP Vantage. 17 January 2014
Biosimilars
South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar monoclonal antibody Herzuma (trastuzumab), Swiss drug major Roche’s blockbuster cancer drug Herceptin, from Korea’s Ministry of Food and Drug Safety. 16 January 2014
Pharmaceutical
The US Food and Drug Administration is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325mg of acetaminophen per tablet, capsule, or other dosage unit. 16 January 2014
Pharmaceutical
There was a positive outcome for US pharma giant Merck & Co yesterday, when a US Food and Drug Administration advisory panel voted in favor of approving the firm’s antithrombotic vorapaxar, which will carry the trade name Zontivity if approved. 16 January 2014
Pharmaceutical
Privately-owned Israeli pharmaceutical company MegaPharm, partner of Dutch biotech company Pharming Group (NYSE Euronext: PHARM), has received marketing approval for Ruconest (recombinant human C1 inhibitor) in Israel. 15 January 2014
Biotechnology
A new UK report condemns the European Union’s “anti-biotech legislation” which is damaging Europe’s bioscience economy. 15 January 2014
Biotechnology
A US Food and Drug Administration advisory panel has voted 16-one to recommend approval of US biotech firm Chelsea Therapeutics’ Northera (droxidopa), causing the company’s shares to leap 10.9% to $2.55 in after-hours trading yesterday. 15 January 2014
Pharmaceutical
US drug giant Merck & Co says it has started a rolling submission to the US Food and Drug Administration of a Biologics License Application for MK-3475, the company’s investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab. 14 January 2014
Pharmaceutical
There was a hint of positive news for German drug major Bayer, when the German Institute for Quality and Efficiency in Health Care (IQWiG) announced that, following an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), it has concluded that the company’s cancer drug Stivarga (regorafenib) offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). 13 January 2014
Pharmaceutical
Japanese drug major Daiichi Sankyo has filed a New Drug Application for its investigational, oral, once-daily direct factor Xa-inhibitor Savaysa (edoxaban) tablets with the US Food and Drug Administration. 10 January 2014
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos/Osseor (strontium ranelate), from independent French drugmaker Laboratoires Servier, should no longer be used to treat osteoporosis. 10 January 2014
Biotechnology
The overall success rate for drugs moving through clinical trials to US Food and Drug Administration approval from late 2003 to the end of 2011 is near one in 10, according to a new study. 10 January 2014
Biosimilars
Health care giant Johnson & Johnson’s Janssen Pharmaceutical companies have submitted a Citizen Petition to the US Food and Drug Administration, calling on the agency to require biosimilars to bear non-proprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars. 9 January 2014
Pharmaceutical
This week US drugmaker Allergan (NYSE: AGN) announced that it has closed a $65 million license agreement with South Korea’s Medytox and has gained marketing authorization for botulinum toxin (botox) in the UK. 9 January 2014
Pharmaceutical
Due to its large population and substantial unmet medical needs, India represents a market with strong commercial opportunities for pharmaceutical firms, notes a new report on India’s pharmaceuticals and health care sector from Business Monitor. 9 January 2014
Pharmaceutical
Reversing a previous 2012 negative decision, the US Food and Drug Administration yesterday approved Anglo-Swedish drug major’s AstraZeneca’s dapagliflozin, (proposed US trade name Farxiga), to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. 9 January 2014
Pharmaceutical
In yet another negative opinion from the German Institute for Quality and Efficiency in Health Care (IQWiG) this week, the agency has issued a negative view of French drug major Sanofi’s multiple sclerosis drug Aubagio (teriflunomide). 8 January 2014
Pharmaceutical
Japanese drug major Daiichi Sankyo (TYO: 4568) has submitted a Marketing Authorization Application to the European Medicines Agency for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban. 8 January 2014
Generics
The Canadian subsidiary of Ranbaxy Laboratories has received approval to manufacture and market RAN-Donepezil Hydrochloride 5mg and 10mg tablets, a generic version of Japanese drug major Eisai’s Aricept, from Health Canada. 8 January 2014
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