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Generics
Perrigo has said it has filed an Abbreviated New Drug Application for desoximetasone topical spray 0.25%, currently marketed as Topicort by Taro. 30 July 2014
Pharmaceutical
The Russian government has significantly tightened responsibility for the sale and production of counterfeit drugs, through the introduction of amendments relating to activities in the national Criminal Code. 30 July 2014
Pharmaceutical
The US Food and Drug Administration has performed a general Good Manufacturing Practices (GMP) inspection and a Pre-Approval Inspection (PAI) at US generic drugmaker Impax Laboratories’ manufacturing facility in Taiwan. 30 July 2014
Pharmaceutical
Canada’s Minister of Health, Rona Ambrose, has issued a national Call for Proposals to improve the prescribing practices for prescription drugs that have a high risk of abuse or addiction. 29 July 2014
Pharmaceutical
Swiss drug major Roche has announced that its drug Gazyvaro (obinutuzumab) has been approved by the European Commission in combination with chlorambucil chemotherapy for the treatment of previously untreated lymphocytic leukemia with comorbidities making them unsuitable for an intensive therapy. 29 July 2014
Pharmaceutical
Eye disease specialist pSivida has been granted marketing authorization in Norway for its treatment Iluvien, which aids vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. It has also been approved for reimbursement in Portugal for the same indication. 29 July 2014
Pharmaceutical
The US Food and Drug Administration has granted USA-based Pharmacyclics approval for Imbruvica (ibrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17, including treatment naive and previously treated del 17p CLL patients. 29 July 2014
Pharmaceutical
On World Hepatitis Day today, the UK’s clinical standards body, the National Institute for Health and Care Excellence (NICE), has issued new quality standard guidance to improve treatment access and reduce the spread of hepatitis B. 28 July 2014
Biotechnology
Australian biotech firm Starpharma says it has achieved a major milestone with the receipt of Conformity Assessment Certification for the VivaGel (vaginal microbicide against sexually-transmitted infections) condom by the Australian Therapeutic Goods Administration. This TGA certification is similar to CE certification of devices in Europe. 28 July 2014
Pharmaceutical
Denmark-based Veloxis Pharmaceuticals and Italian company Chiesi Farmaceutici have said that the European Commission has granted marketing authorization for their drug Envarsus (formerly LCP-Tacro), which works to prevent organ rejection in adult kidney and liver transplant patients. 28 July 2014
Pharmaceutical
Eyecare specialist Alcon, a division of Swiss drug major Novartis, says its Simbrinza eye drops suspension (brinzolamide and brimonidine tartrate) has been approved by the European Commission to decrease elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient intraocular pressure reduction. 28 July 2014
Pharmaceutical
USA-based specialty pharma firm AcelRx Pharmaceuticals says that the US Food and Drug Administration has issued a Complete Response Letter for its New Drug Application for pain management product Zalviso (sufentanil sublingual tablet system). 28 July 2014
Biotechnology
The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting, backed the granting marketing authorizations for two new drugs with novel mechanisms of action for the treatment of different forms of rare cancers of the blood. 26 July 2014
Biosimilars
At its July 2014 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for the recommendation of a number of new drugs, including the following: 26 July 2014
Pharmaceutical
The European Society for Medical Oncology (ESMO) has expressed concern that the proposed European Union General Data Protection Regulation could make cancer research impossible and add a significant burden to cancer patients and doctors. 25 July 2014
Pharmaceutical
The US Food and Drug Administration has approved privately-held USA-based Purdue Pharma’s abuse-deterrent opioid analgesic Targiniq ER (oxycodone/naloxone) for the treatment of severe pain requiring long-term opioid treatment for which other therapies are inadequate. 25 July 2014
Biosimilars
The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA), by Sandoz, the generics business of Swiss pharma major Novartis. 25 July 2014
Pharmaceutical
UK pharma giant GlaxoSmithKline announced today that it has submitted a regulatory application to the European Medicines Agency for its malaria vaccine candidate, RTS,S. 24 July 2014
Pharmaceutical
The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. 24 July 2014
Pharmaceutical
US biotech firm Biogen Idec said that the European Commission has approved its subcutaneous injectable Plegridy (peginterferon beta-1a) for the treatment of adults with relapsing-remitting multiple sclerosis. 24 July 2014
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
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