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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
Taiwan-based drug developer TaiGen Biotechnology says that the Taiwan Food and Drug Administration has approved the New Drug Application of Taigexyn (nemonoxacin) oral formulation for the treatment of community-acquired bacterial pneumonia (CAP). 13 March 2014
Biotechnology
USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received verbal notice from the US Food and Drug Administration that its Investigational New Drug application for imetelstat has been placed on full clinical hold, affecting all ongoing company-sponsored clinical trials. 12 March 2014
Pharmaceutical
The US Food and Drug Administration has approved Ireland-headquartered specially drugmaker Mallinckrodt’s Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablets (previously known as MNK-795). 12 March 2014
Pharmaceutical
Anglo-Swedish drug major AstraZeneca’s type 2 diabetes drug Xigduo is now available in the UK. 11 March 2014
Pharmaceutical
US health care giant Johnson & Johnson’s European subsidiary Janssen-Cilag has been granted conditional approval by the European Commission for Sirturo (bedaquiline), for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. 10 March 2014
Pharmaceutical
The US subsidiary of Danish CNS specialist Lundbeck says that the Food and Drug Administration has accepted for review a New Drug for its investigational therapy intravenous carbamazepine an IV formulation of the anti-epileptic drug (AED) carbamazepine. 10 March 2014
Pharmaceutical
US drugmaker Keryx Biopharmaceuticals has submitted a Marketing Authorization Application to the European Medicines Agency seeking the approval of Zerenex (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease, including dialysis- and non-dialysis dependent CKD. 10 March 2014
Pharmaceutical
India’s largest drugmaker Ranbaxy Laboratories (BSE: 500359) has recalled more than 64,000 bottles of the generic version of Pfizer’s cholesterol drug Lipitor (atorvastatin) in the USA. 10 March 2014
Pharmaceutical
French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration has directed the company, and US partner Regeneron, to determine whether any neurocognitive adverse events occurred in any trials of the global development program for their experimental PCSK9 inhibitor alirocumab, particularly in longer-term studies. 10 March 2014
Pharmaceutical
The US Food and Drug Administration has approved label changes for the antibacterial Doribax (doripenem) to warn of increased risk of death in certain patients. 10 March 2014
Pharmaceutical
Takeda Pharmaceutical, Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese Ministry of Health, Labor and Welfare for trelagliptin succinate (SYR-472), a once weekly dosage treatment for type 2 diabetes. 9 March 2014
Pharmaceutical
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations on three safety referrals at its March 2014 meeting. 9 March 2014
Pharmaceutical
Swiss pharma major Novartis today announced positive results from a pivotal Phase III trial of Jakavi (ruxolitinib) compared to best available therapy in the treatment of a rare blood cancer. 7 March 2014
Pharmaceutical
From April 1, the Australian government will implement a new streamlined process to reduce the time taken to list medicines on the Pharmaceutical Benefits Scheme (PBS) and improve access to medicines. 7 March 2014
Pharmaceutical
Endo International says its operating company Endo Pharmaceuticals has received US Food and Drug Administration approval of Aveed (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. 6 March 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim announced positive results from STARTVerso 4 in patients with HCV/HIV co-infection with its investigational drug faldaprevir. 6 March 2014
Pharmaceutical
There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer Ingelheim when the US Food and Drug Administration issued a complete response letter for the New Drug Application of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin. 5 March 2014
Pharmaceutical
California, USA-based Titan Pharma and its partner, Braeburn Pharmaceuticals, have agreed in principle with the US Food and Drug Administration on the design of a clinical study in support of the New Drug Application for Probuphine (buprenorphine), the company’s investigational subdermal implant for the maintenance treatment of opioid dependence. 4 March 2014
Biotechnology
Emerging Israeli biotech firm RedHill Biopharma, together with Canadian drug delivery specialist IntelGenx, has submitted a response to the Complete Response Letter of the US Food and Drug Administration for the New Drug Application for RHB-103, an oral thin-film rizatriptan for the treatment of acute migraines. 4 March 2014
Generics
Israel-based Teva Pharmaceutical Industries says it has received approval from the US Food and Drug Administration to market its generic equivalent to Evista (raloxifene) Tablets, 60mg, in the USA. 4 March 2014
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