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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
Biotechnology
There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22), first Japanese clearance for its ophthalmic drug Eylea (aflibercept) and, later in the day, a new indication in the USA for cancer drug Nexavar (sorafenib). 23 November 2013
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use has made a number of recommendations to help minimize the risk of blood clots obstructing arteries or veins in patients taking the leukemia medicine Iclusig (ponatinib). 23 November 2013
Pharmaceutical
The European Medicines Agency has now completed its review of combined hormonal contraceptives (CHCs), particularly of the risk of venous thromboembolism (VTE or blood clots in veins) associated with their use, with its Committee for Medicinal Products for Human Use (CHMP) concluding that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small. 23 November 2013
Pharmaceutical
At its late November meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a series of recommendation, including positive opinions for the approval of five new drugs. 22 November 2013
Biotechnology
The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labor and Welfare to adopt new procedures and rules that would accelerate the clinical development of regenerative medicine and cell therapies. 22 November 2013
Pharmaceutical
The US Food and Drug Administration yesterday (November 21) granted pharma behemoth Pfizer’s Xalkori (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 22 November 2013
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing of NovoRapid PumpCart in Europe, Danish insulin giant Novo Nordisk announced this morning. 22 November 2013
Pharmaceutical
The US Food and Drug Administration has issued a complete response letter regarding the New Drug Application for cariprazine, submitted by USA-based Forest Laboratories and Hungary’s largest drugmaker Gedeon Richter. 21 November 2013
Pharmaceutical
Australia’s medicines regulator the Therapeutic Goods Administration (TGA) has introduced a streamlined way for sponsors to submit adverse event reports for medicines and vaccines, to ease the administrative burden of the 7,000–8,000 annual reports. 21 November 2013
Biotechnology
ThromboGenics NV (Euronext Brussels: THR) and its partner Alcon, the ophthalmic unit of Novartis (NOVN: VX), have launched Jetrea (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA) in Canada. 21 November 2013
Pharmaceutical
Japan’s Otsuka Pharmaceutical (TYO: 4768) and partner Lundbeck (LUN: CO) have received approval from the European Commission for their Abilify Maintena (aripiprazole), an intramuscular once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. 21 November 2013
Pharmaceutical
A US Food and Drug Administration panel has voted in favor of approval of Vimizim for the treatment of Morquio A syndrome from BioMarin Pharmaceuticals (Nasdaq: BMRN). 20 November 2013
Pharmaceutical
Swiss drug major Roche says that Kadcyla (ado-trastuzumab emtansine or T-DM1), the latest targeted medicine from its HER2 franchise and its first antibody-drug conjugate, has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer. 20 November 2013
Pharmaceutical
The European Medicines Agency has finalized a thorough review of all medicines manufactured by Swiss pharma major Roche that was initiated following a routine pharmacovigilance inspection in early 2012, saying that no new safety concerns have been identified. 19 November 2013
Pharmaceutical
UK drug delivery specialist Skyepharma (LSE: SKP) has announced that Flutiform has been launched in Japan following a pricing reimbursement agreement. 19 November 2013
Pharmaceutical
The European Commission has granted marketing authorization for Relvar Ellipta (fluticasone furoate/vilanterol [FF/VI]), developed by UK pharma giant GlaxoSmithKline and US partner Theravance. 19 November 2013
Pharmaceutical
The US Food and Drug Administration has accepted the New Drug Application for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) from Anglo-Swedish drug major AstraZeneca, the company revealed this morning. 19 November 2013
Biosimilars
Israel-based Teva Pharmaceutical Industries announced two significant additions to its global oncology biologic portfolio with the recent launches of Lonquex (lipegfilgrastim) and Granix (tbo-filgrastim) Injection, and an update on the review status of balugrastim by the US Food and Drug Administration. 18 November 2013
Biotechnology
The European Commission has granted marketing authorization for US biotech firm Gilead Sciences’ Vitekta (elvitegravir) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir. 18 November 2013
Pharmaceutical
Danish insulin giant Novo Nordisk’s recombinant factor VIII product NovoEight (turoctocog alfa) has passed the review by the Committee on Drugs of Japan's Pharmaceutical Affairs and Sanitation Council. 18 November 2013
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