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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 European Commission has granted marketing authorization for Danish CNS specialist Lundbeck’s Brintellix (vortioxetine) for the treatment of adults with major depressive episodes, commonly referred to as depression. 29 December 2013
Generics
The US Food and Drug Administration’s Center for Drug Evaluation and Research has approved plans to elevate the Office of Generic Drugs to an office that reports directly to the center director. This reorganization will strengthen OGD’s operations and enable the office to meet the evolving needs of generic drug review. 29 December 2013
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical has decided voluntarily to terminate the development activities for fasiglifam (TAK-875), an investigational treatment for type 2 diabetes, due to concerns about liver safety. 27 December 2013
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence has issued new draft guidance recommending National Health Service use of privately-held Swiss drugmaker Ferring Pharmaceutical’s Firmagon (degarelix) as an option for treating prostate cancer in people with spinal metastases who are at risk of impending spinal cord compression. 27 December 2013
Pharmaceutical
Doctors in China who take kickbacks from pharmaceutical companies or accept "red envelopes" from patients will face punishments ranging from reproach to dismissal, the National Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine announced in a joint circular on Thursday (December 26), reports the state news service Xinhua. 27 December 2013
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has opened a consultation on a negative draft guidance for Stelara (ustekinumab), a drug licensed to treat active psoriatic arthritis from US health care giant Johnson & Johnson subsidiary Janssen. 27 December 2013
Pharmaceutical
Chinese authorities on Friday issued a circular to ban the use of the recombinant hepatitis B vaccine produced by the Shenzhen-based BioKangtai company, reported the state news agency Xinhua. 26 December 2013
Pharmaceutical
The US Food and Drug Administration yesterday (December 23) approved Tretten, coagulation factor XIII A-subunit (recombinant), from Danish insulin giant Novo Nordisk. 24 December 2013
Pharmaceutical
Merck Serono, the biopharmaceutical division of Germany’s Merck KGaA, has gained European Commission approval for the Type II variation to amend the Erbitux (cetuximab) product information, updating the indication for the drug to the treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC). 24 December 2013
Pharmaceutical
The Russian government continues to create barriers for the business of foreign pharmaceutical producers operating in the country, according to local sources. 23 December 2013
Biotechnology
In what was seen by some observers as unexpected, the US Food and Drug Administration has approved United Therapeutic’s Orenitram (treprostinil) extended-release tablets for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity. 23 December 2013
Pharmaceutical
The US Food and Drug Administration has approved a revised US Prescribing Information and a Risk Evaluation and Mitigation Strategy (REMS) for Iclusig (ponatinib), from Ariad Pharmaceuticals (Nasdaq: ARIA), that allows immediate resumption of its marketing and commercial distribution in the USA. 22 December 2013
Biotechnology
Switzerland-based Actelion has received European Commission approval for Opsumit (macitentan), a novel dual endothelin receptor antagonist (ERA), for the long-term treatment of pulmonary arterial hypertension (PAH) in the European Union. 22 December 2013
Pharmaceutical
Following regular monthly meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP; December 16-19), there were positive opinions for four investigational drugs issued on Friday. 22 December 2013
Pharmaceutical
Danish insulin giant Novo Nordisk has filed separate regulatory submissions with the US Food and Drug Administration and the European Medicines Agency for a 3mg dose of liraglutide, a once-daily human GLP-1 analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or who are overweight with co-morbidities. 22 December 2013
Pharmaceutical
The US Food and Drug Administration has granted “Breakthrough Therapy” designation for tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria, from UK pharma giant GlaxoSmithKlin and Medicines for Malaria Venture. 22 December 2013
Pharmaceutical
After detailed negotiations, the Committee of Permanent Representatives (COREPER I) the Member States today (December 20) endorsed the agreement reached by the Lithuanian EU Council Presidency and the European Parliament on the Proposal for a Regulation on Clinical trials on medicinal products for human use (and repealing Directive 2001/20/EC). 20 December 2013
Pharmaceutical
US drugmaker Baxter International has received approval from the US Food and Drug Administration for its Feiba (anti-inhibitor coagulant complex], the first and only FDA-approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors. 20 December 2013
Pharmaceutical
Commenting in advance of the European Union Committee of Permanent Representatives (COREPER) agreement on Friday (December 20) on the final compromise text of the Clinical Trials Regulation, Steve Bates, BioIndustry Association (BIA) chief executive expressed reservations about what this might contain. 19 December 2013
Pharmaceutical
US ophthalmic pharma specialist Alimera Sciences has entered into labeling discussions with the US Food and Drug Administration for its fluocinolone acetonide intravitreal implant Iluvien and, as a result, reached an agreement with the FDA that Alimera's participation in the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting was no longer necessary. 19 December 2013
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